Abacavir | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
| C13920 | | Human immunodeficiency virus (HIV) infection
Patient must be less than 13.00 years of age.
Patient must be unable to take a solid dose form of this drug; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures |
Abacavir with Lamivudine | C4527 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4527 |
| C4528 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4528 |
Abatacept | C14488 | | Severe active rheumatoid arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C14507 | | Severe active rheumatoid arthritis
First continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment. | Compliance with Authority Required procedures |
| C14519 | | Severe active rheumatoid arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14523 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS‑subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
Patients who have received PBS‑subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.
Up to a maximum of 4 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
| C14524 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14555 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14555 |
| C14604 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14604 |
| C14617 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA‑approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
If methotrexate is contraindicated according to the TGA‑approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of authority application, medical practitioners should request the appropriate number of vials to provide sufficient drug, based on the weight of the patient, for a single infusion.
Up to a maximum of 4 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
Adalimumab | C12120 | | Severe active juvenile idiopathic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) ‑ balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C14061 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
| C14063 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic; and
(b) the date of the last continuing prescription.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14064 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti‑rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
At the time of authority application, medical practitioners must request the appropriate number of injections of appropriate strength, based on the weight of the patient, to provide a sufficient amount for two doses. Up to a maximum of 3 repeats will be authorised.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14107 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14107 |
| C14136 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction. An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14136 |
Adefovir | C4490 | | Chronic hepatitis B infection
Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4490 |
| C4510 | | Chronic hepatitis B infection
Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA.
Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4510 |
Alemtuzumab | C6847 | P6847 | Multiple sclerosis
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must not receive more than one PBS‑subsidised treatment per year; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6847 |
| C7714 | P7714 | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7714 |
| C9589 | P9589 | Multiple sclerosis
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
Patient must not receive more than one PBS‑subsidised treatment per year; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9589 |
| C9636 | P9636 | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9636 |
Ambrisentan | C11229 | | Pulmonary arterial hypertension (PAH)
Triple therapy ‑ Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) PBS‑subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS‑subsidised selexipag with one endothelin receptor antagonist, (ii) PBS‑subsidised selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The authority application for selexipag must be approved prior to the authority application for this agent.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13496 | | Pulmonary arterial hypertension (PAH)
Initial 1 ‑ combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application. | Compliance with Written Authority Required procedures |
| C13497 | | Pulmonary arterial hypertension (PAH)
Initial 3 ‑ changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing. | Compliance with Authority Required procedures |
| C13499 | | Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application. | Compliance with Authority Required procedures |
| C13500 | | Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Written Authority Required procedures |
| C13575 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13576 | | Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13582 | | Pulmonary arterial hypertension (PAH)
Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
Anakinra | C5450 | | Moderate to severe cryopyrin associated periodic syndromes (CAPS)
Must be treated by a rheumatologist or in consultation with a rheumatologist; OR
Must be treated by a clinical immunologist or in consultation with a clinical immunologist.
A diagnosis of CAPS must be documented in the patient’s medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5450 |
Anifrolumab | C15387 | | Systemic lupus erythematosus Continuing or recommencement of treatment (within 12 months of a treatment break) Patient must have previously been issued with an authority prescription for this drug for this condition; AND Patient must be responding to treatment if they have received less than 12 months of treatment with this drug for this condition; OR Patient must have attained a Lupus Low Disease Activity State (LLDAS) and maintained this state while on treatment. Must be treated by a specialist physician experienced in the management of this condition. Lupus Low Disease Activity State (LLDAS) is defined as: (a) Total SLEDAI-2K of not greater than 4, with no major activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever); and (b) No new features of lupus disease activity compared with the previous assessment, and (c) Physician Global Assessment (PGA) of not greater than 1, and (d) Current prednisolone (or equivalent) dose of not greater than 7.5 mg daily, and (e) Well tolerated standard maintenance doses of anti-malarial and immunosuppressive drugs are allowed. Where retreatment with anifrolumab after a break in PBS-subsidised treatment with anifrolumab is being sought, the date of cessation of the previous treatment course with anifrolumab must be included in the application. Recommencement of treatment with anifrolumab for severe SLE is within 12 months from the date that treatment was ceased. | Compliance with Authority Required procedures |
| C15388 | | Systemic lupus erythematosus Initial treatment Patient must have a confirmed and documented diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE Classification Criteria 2019; AND Patient must have persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points; AND Patient must be currently receiving hydroxychloroquine, with treatment received for at least 12 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND Patient must be currently receiving immunosuppressant medication, with treatment received for at least 12 weeks, with either: (i) minimum dose of methotrexate 20 mg per week, (ii) azathioprine 100 mg per day, (iii) mycophenolate 1,000 mg per day unless contraindicated/intolerant necessitating treatment withdrawal; AND Patient must be currently receiving prednisolone or equivalent of at least 7.5 mg per day, with treatment received for at least 4 weeks, unless contraindicated/intolerant necessitating treatment withdrawal; AND Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus. Must be treated by a specialist physician experienced in the management of this condition. If prednisolone or equivalent is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated of at least 7.5 mg per day, the patient must have received at least 12 weeks of continuous treatment with each of at least 2 of the following: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day. Where two of: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; or (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to prednisolone or equivalent: at least one of the remaining tolerated therapies must be trialled at a minimum dose as mentioned above. If the patient has a contraindication/severe intolerance to each of: (i) prednisolone or equivalent of at least 7.5 mg per day; (ii) hydroxychloroquine; (iii) methotrexate at a dose of at least 20 mg per week; (iv) azathioprine at a dose of at least 100 mg per day; (v) mycophenolate at a dose of at least 1,000 mg per day; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application. The authority application must be made in writing via HPOS form upload or mail and must include: (a) details of the ACR/EULAR SLE Classification Criteria 2019 confirming diagnosis of SLE; (b) details (date and score) of the completed SLEDAI-2K score sheet; (c) details of current systemic therapy used (dosage, date of commencement and duration of therapy including prior anifrolumab use); (d) details of contraindication/intolerances to prior therapies (drug name, the degree of toxicity and dose). All the reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C15426 | | Systemic lupus erythematosus Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 July 2024; AND Patient must have had a confirmed and documented diagnosis of systemic lupus erythematosus (SLE) according to the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) SLE Classification Criteria 2019 prior to commencing therapy with this drug for this condition; AND Patient must have had persistent disease activity as supported by a SLE Disease Activity Index 2000 (SLEDAI-2K) score of at least 10 points prior to commencing therapy with this drug for this condition; AND Patient must have been receiving hydroxychloroquine for at least 12 weeks prior to commencing therapy with this drug for this condition; AND Patient must have been receiving immunosuppressant medication for at least 12 weeks with either (i) minimum dose of methotrexate 20 mg per week (ii) azathioprine 100 mg per day (iii)mycophenolate 1,000 mg per day, prior to commencing therapy with this drug for this condition unless contraindicated/intolerant necessitating treatment withdrawal; AND Patient must have been receiving prednisolone or equivalent of at least 7.5 mg per day for at least 4 weeks prior to commencing therapy with this drug for this condition unless contraindicated/intolerant necessitating treatment withdrawal; AND Patient must not have either: (i) severe active lupus nephritis, (ii) severe active central nervous system systemic lupus erythematosus. Must be treated by a specialist physician experienced in the management of this condition. If prednisolone or equivalent is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated of at least 7.5 mg per day, the patient must have received at least 12 weeks of continuous treatment with each of at least 2 of the following: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day. Where two of: (i) hydroxychloroquine; (ii) methotrexate at a dose of at least 20 mg per week; or (iii) azathioprine at a dose of at least 100 mg per day; (iv) mycophenolate at a dose of at least 1,000 mg per day, are either contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to prednisolone or equivalent: at least one of the remaining tolerated therapies must be trialled at a minimum dose as mentioned above. If the patient has a contraindication/severe intolerance to each of: (i) prednisolone or equivalent of at least 7.5 mg per day; (ii) hydroxychloroquine; (iii) methotrexate at a dose of at least 20 mg per week; (iv) azathioprine at a dose of at least 100 mg per day; (v) mycophenolate at a dose of at least 1,000 mg per day; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application. The authority application must be made in writing via HPOS form upload or mail and must include: (a) details of the ACR/EULAR SLE Classification Criteria 2019 confirming diagnosis of SLE; (b) details (date and score) of the completed SLEDAI-2K score sheet; (c) details of current systemic therapy used (dosage, date of commencement and duration of therapy including prior anifrolumab use); (d) details of contraindication/intolerances to prior therapies (drug name, the degree of toxicity and dose). All the reports must be documented in the patient's medical records. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. | Compliance with Written Authority Required procedures |
Apomorphine | C10830 | | Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
The treatment must be commenced in a specialist unit in a hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10830 |
| C10863 | | Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
The treatment must be commenced in a specialist unit in a hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10863 |
| C11385 | | Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
The treatment must be commenced in a specialist unit in a hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 11385 |
| C11445 | | Parkinson disease
Patient must have experienced severely disabling motor fluctuations which have not responded to other therapy; AND
The treatment must be commenced in a specialist unit in a hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 11445 |
Atazanavir | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Atazanavir with cobicistat | C4454 | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial
Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Avatrombopag | C14054 | | Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under first continuing or re‑initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS‑subsidised treatment with this drug; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C14130 | | Severe thrombocytopenia
Initial treatment ‑ New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
A maximum of 24 weeks of treatment with this drug will be authorised under this criterion. | Compliance with Written Authority Required procedures |
| C15340 | | Severe thrombocytopenia Balance of supply or change of therapy The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition; AND Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; OR Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR Patient must be changing therapy from romiplostim or eltrombopag to this drug for this condition; AND The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction. Patients receiving treatment with romiplostim or eltrombopag may change to avatrombopag under this restriction. | Compliance with Authority Required procedures |
| C15375 | | Severe thrombocytopenia First Continuing treatment or Re-initiation of interrupted continuing treatment The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR Patient must have changed treatment from either romiplostim or eltrombopag to this drug under the Balance of Supply/Change of Therapy restriction and demonstrated a sustained response; OR Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition. For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment. The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records. | Compliance with Authority Required procedures |
Azacitidine | C12439 | | Acute Myeloid Leukaemia The treatment must be used in combination with venetoclax (refer to Product Information for timing of azacitidine and venetoclax doses). | Compliance with Authority Required procedures |
| C12983 | | Myelodysplastic syndrome
Initial treatment
The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND
The condition must be classified as Intermediate‑2 according to the International Prognostic Scoring System (IPSS); OR
The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS).
Classification of the condition as Intermediate‑2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations:
a. 11% to 30% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 0 to 1 cytopenias; OR
b. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR
c. 11% to 20% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
d. 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
e. 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR
f. Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.
Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations:
a. 21% to 30% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
b. 21% to 30% marrow blasts with intermediate (other abnormalities) or poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
c. 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
d. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.
The following information must be provided by the prescriber at the time of application:
(a) The patient's International Prognostic Scoring System (IPSS) score
The following reports must be documented in the patient's medical records:
(a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and
(b) full blood examination report; and
(c) pathology report detailing the cytogenetics demonstrating intermediate‑2 or high‑risk disease according to the International Prognostic Scoring System (IPSS).
No more than 3 cycles will be authorised under this restriction in a patient's lifetime. | Compliance with Authority Required procedures |
| C12986 | | Acute Myeloid Leukaemia
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12986 |
| C13010 | | Acute Myeloid Leukaemia
Initial treatment
The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND
The condition must have 20% to 30% marrow blasts and multi‑lineage dysplasia, according to World Health Organisation (WHO) Classification.
The following reports must be documented in the patient's medical records:
(a) bone marrow biopsy report demonstrating that the patient has acute myeloid leukaemia; and
(b) full blood examination report. | Compliance with Authority Required procedures |
| C13011 | | Myelodysplastic syndrome
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease.
Up to 6 cycles will be authorised. | Compliance with Authority Required procedures |
| C13012 | | Acute Myeloid Leukaemia
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13012 |
| C13015 | | Chronic Myelomonocytic Leukaemia
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease.
Up to 6 cycles will be authorised. | Compliance with Authority Required procedures |
| C13029 | | Chronic Myelomonocytic Leukaemia
Initial treatment
The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND
The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.
The first authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and
(b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following reports must be documented in the patient's medical records:
(a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and
(b) full blood examination report
No more than 3 cycles will be authorised under this restriction in a patient's lifetime. | Compliance with Written Authority Required procedures |
Azithromycin | C6356 | | Mycobacterium avium complex infection The treatment must be for prophylaxis; AND Patient must be human immunodeficiency virus (HIV) positive; AND Patient must have CD4 cell counts of less than 75 per cubic millimetre. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6356 |
| C9604 | | Mycobacterium avium complex infection
The treatment must be for prophylaxis; AND
Patient must be human immunodeficiency virus (HIV) positive; AND
Patient must have CD4 cell counts of less than 75 per cubic millimetre. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9604 |
Baclofen | C6911 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6911 |
| C6925 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6925 |
| C6939 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6939 |
| C6940 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6940 |
| C7134 | | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to multiple sclerosis. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7134 |
| C7148 | | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7148 |
| C7152 | | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity of cerebral origin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7152 |
| C7153 | | Severe chronic spasticity Patient must have failed to respond to treatment with oral antispastic agents; OR Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND Patient must have chronic spasticity due to spinal cord injury. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7153 |
| C9488 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9488 |
| C9489 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9489 |
| C9524 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9524 |
| C9525 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9525 |
| C9562 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity of cerebral origin. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9562 |
| C9606 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9606 |
| C9637 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to multiple sclerosis. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9637 |
| C9638 | | Severe chronic spasticity
Patient must have failed to respond to treatment with oral antispastic agents; OR
Patient must have had unacceptable side effects to treatment with oral antispastic agents; AND
Patient must have chronic spasticity due to spinal cord injury. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9638 |
Benralizumab | C15353 | | Uncontrolled severe asthma Continuing treatment Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. An adequate response to this biological medicine is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5. All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following information must be provided at the time of application and must be documented in the patient's medical records: (a) if applicable, details of maintenance oral corticosteroid dose; and (b) a completed Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
| C15376 | | Uncontrolled severe asthma Balance of supply Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must have received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction. | Compliance with Authority Required procedures |
| C15383 | | Uncontrolled severe asthma Initial treatment - Initial 2 (Change of treatment) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course sufficient for up to 32 weeks of therapy, based on a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter (refer to the TGA-approved Product Information). A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (b) details (date and duration of treatment) of prior biological medicine treatment; and (c) eosinophil count and date; and (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). | Compliance with Written Authority Required procedures |
| C15444 | | Uncontrolled severe asthma Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. At the time of the authority application, medical practitioners should request up to 4 repeats to provide for an initial course of benralizumab sufficient for up to 32 weeks of therapy, at a dose of 30 mg every 4 weeks for the first three doses (weeks 0, 4, and 8) then 30 mg every eight weeks thereafter. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and (b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (d) the eosinophil count and date; and (e) Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
Bictegravir with emtricitabine with tenofovir alafenamide | C4470 | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470 |
C4522 | | HIV infection
Initial
Patient must be antiretroviral treatment naive. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522 |
Bosentan | C11229 | | Pulmonary arterial hypertension (PAH)
Triple therapy ‑ Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) PBS‑subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS‑subsidised selexipag with one endothelin receptor antagonist, (ii) PBS‑subsidised selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The authority application for selexipag must be approved prior to the authority application for this agent.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C12425 | | Pulmonary arterial hypertension (PAH)
Cessation of treatment (all patients)
Patient must be receiving PBS‑subsidised treatment with this PAH agent; AND
The treatment must be for the purpose of gradual dose reduction prior to ceasing therapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment. Treatment beyond 1 month will not be approved. | Compliance with Authority Required procedures |
| C13495 | | Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA‑approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA‑approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA‑approved Product Information. | Compliance with Authority Required procedures |
| C13496 | | Pulmonary arterial hypertension (PAH)
Initial 1 ‑ combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application. | Compliance with Written Authority Required procedures |
| C13497 | | Pulmonary arterial hypertension (PAH)
Initial 3 ‑ changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing. | Compliance with Authority Required procedures |
| C13499 | | Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application. | Compliance with Authority Required procedures |
| C13571 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13582 | | Pulmonary arterial hypertension (PAH)
Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13632 | | Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA‑approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA‑approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA‑approved Product Information. | Compliance with Written Authority Required procedures |
Buprenorphine | C15355 | | Opioid dependence The treatment must be within a framework of medical, social and psychological treatment. A medical practitioner must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15355 |
| C15356 | | Opioid dependence Must be treated by a health care professional. The treatment must be within a framework of medical, social and psychological treatment; AND Patient must be stabilised on one of the following prior to commencing treatment with this drug for this condition: (i) weekly prolonged release buprenorphine (Buvidal Weekly) (ii) sublingual buprenorphine (iii) buprenorphine/naloxone. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15356 |
| C15385 | | Opioid dependence Must be treated by a health care professional. The treatment must be within a framework of medical, social and psychological treatment. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15385 |
| C15439 | | Opioid dependence Must be treated by a health care professional. The treatment must be within a framework of medical, social and psychological treatment; AND Patient must be stabilised on sublingual buprenorphine or buprenorphine/naloxone prior to commencing treatment with this drug for this condition. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15439 |
Buprenorphine with naloxone | C15355 | | Opioid dependence The treatment must be within a framework of medical, social and psychological treatment. A medical practitioner must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15355 |
Burosumab | C13330 | | X‑linked hypophosphataemia
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have achieved normalisation in serum phosphate levels; AND
Patient must have radiographical evidence of stabilisation/improvement in rickets in patients without growth plate fusion.
Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
Where adequate response to treatment with this drug cannot be demonstrated, the treating physician must confirm that continuing therapy has been determined to be clinically required by a second specialist physician with expertise in the treatment of X‑linked hypophosphataemia.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C13377 | | X‑linked hypophosphataemia
Initial treatment ‑ New patient
Patient must have a documented confirmation of PHEX pathogenic variant; OR
Patient must have a confirmed diagnosis of X‑linked hypophosphataemia demonstrated by the presence of all of the following: (i) a serum phosphate concentration below the age adjusted lower limit of normal; (ii) current or historical (for those with growth plate fusion) radiographic X‑ray evidence of rickets; (iii) elevated (or inappropriately normal) serum or plasma FGF‑23 levels of above the mean of the assay‑specific reference range; (iv) renal phosphate wasting demonstrated by a ratio of tubular maximum reabsorption rate of phosphate to glomerular filtration rate (TmP/GFR) according to age specific normal ranges using the second morning urine void and paired serum sample measuring phosphate and creatinine.
Must be treated by a medical practitioner identifying as at least one of the following specialists: (i) paediatric endocrinologist, (ii) paediatric nephrologist, (iii) endocrinologist, (iv) nephrologist.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength(s) to provide sufficient drug, based on the weight of the patient, adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. | Compliance with Authority Required procedures |
Cabotegravir | C12619 | | HIV infection
Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND
The treatment must be in combination with rilpivirine tablets; AND
Patient must intend to proceed to treatment with intramuscular administration of cabotegravir and rilpivirine. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12619 |
Cabotegravir and rilpivirine | C12636 | | HIV infection
Patient must have previously received PBS‑subsidised therapy for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12636 |
Ciclosporin | C6628 | | Management of transplant rejection The treatment must be used by organ or tissue transplant recipients. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6628 |
| C6631 | | Nephrotic syndrome Management (initiation, stabilisation and review of therapy) Patient must have failed prior treatment with steroids and cytostatic drugs; OR
Patient must be intolerant to treatment with steroids and cytostatic drugs; OR
The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND
Patient must not have renal impairment.
Must be treated by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6631 |
| C6638 | | Severe active rheumatoid arthritis Management (initiation, stabilisation and review of therapy) The condition must have been ineffective to prior treatment with classical slow‑acting anti‑rheumatic agents (including methotrexate); OR
The condition must be considered inappropriate for treatment with slow‑acting anti‑rheumatic agents (including methotrexate).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6638 |
| C6643 | | Management of transplant rejection Management (initiation, stabilisation and review of therapy) Patient must have had an organ or tissue transplantation; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6643 |
| C6660 | | Severe atopic dermatitis Management (initiation, stabilisation and review of therapy) Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist.
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6660 |
| C9694 | | Nephrotic syndrome
Management (initiation, stabilisation and review of therapy)
Patient must have failed prior treatment with steroids and cytostatic drugs; OR
Patient must be intolerant to treatment with steroids and cytostatic drugs; OR
The condition must be considered inappropriate for treatment with steroids and cytostatic drugs; AND
Patient must not have renal impairment.
Must be treated by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9694 |
| C9695 | | Severe atopic dermatitis
Management (initiation, stabilisation and review of therapy)
Must be treated by a dermatologist; OR
Must be treated by a clinical immunologist.
The condition must be ineffective to other systemic therapies; OR
The condition must be inappropriate for other systemic therapies. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9695 |
| C9742 | | Severe active rheumatoid arthritis
Management (initiation, stabilisation and review of therapy)
The condition must have been ineffective to prior treatment with classical slow‑acting anti‑rheumatic agents (including methotrexate); OR
The condition must be considered inappropriate for treatment with slow‑acting anti‑rheumatic agents (including methotrexate).
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9742 |
| C9764 | | Management of transplant rejection
Management (initiation, stabilisation and review of therapy)
Patient must have had an organ or tissue transplantation; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9764 |
| C9831 | | Management of transplant rejection
The treatment must be used by organ or tissue transplant recipients. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9831 |
| C15360 | | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; OR Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar. For patients who do not demonstrate an adequate response to ciclosporin, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to 'biological medicines' for the treatment of 'severe chronic plaque psoriasis'. This assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 15360 |
| C15361 | | Severe psoriasis Management (initiation, stabilisation and review of therapy) The condition must be ineffective to other systemic therapies; OR The condition must be inappropriate for other systemic therapies; AND The condition must have caused significant interference with quality of life. Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; OR Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar. For patients who do not demonstrate an adequate response to ciclosporin, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to 'biological medicines' for the treatment of 'severe chronic plaque psoriasis'. This assessment must be documented in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 15361 |
Cinacalcet | C10063 | | Secondary hyperparathyroidism
Continuing treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient’s response and tolerability. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10063 |
| C10067 | | Secondary hyperparathyroidism
Continuing treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition.
During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient’s response and tolerability. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10067 |
| C10073 | | Secondary hyperparathyroidism
Initial treatment
Must be treated by a nephrologist.
Patient must have chronic kidney disease; AND
Patient must be on dialysis; AND
Patient must have failed to respond to conventional therapy; AND
Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L; OR
Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.
During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.
During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient’s response and tolerability. | Compliance with Authority Required procedures |
Clozapine | C4998 | | Schizophrenia
Continuing treatment
Must be treated by a psychiatrist; OR
Must be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist.
Patient must have previously received PBS‑subsidised therapy with this drug for this condition; AND
Patient must have completed at least 18 weeks therapy; AND
Patient must be on a clozapine dosage considered stable by a treating psychiatrist; AND
The treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.
A medical practitioner should request a quantity sufficient for up to one month’s supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4998 |
| C5015 | | Schizophrenia
Initial treatment
Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient.
Patient must be non‑responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents.
Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.
The name of the consulting psychiatrist should be included in the patient’s medical records.
A medical practitioner should request a quantity sufficient for up to one month’s supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5015 |
| C9490 | | Schizophrenia
Initial treatment
Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient.
Patient must be non‑responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents.
Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.
The name of the consulting psychiatrist should be included in the patient’s medical records.
A medical practitioner should request a quantity sufficient for up to one month’s supply. Up to 5 repeats will be authorised. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9490 |
Darbepoetin Alfa | C6294 | | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294 |
| C9688 | | Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9688 |
Darunavir | C4313 | | Human immunodeficiency virus (HIV) infection The treatment must be in addition to optimised background therapy, AND The treatment must be in combination with other antiretroviral agents, AND The treatment must be co‑administered with 100 mg ritonavir, AND Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen, AND Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4313 |
| C5094 | | Human immunodeficiency virus (HIV) infection The treatment must be in addition to optimised background therapy, AND The treatment must be in combination with other antiretroviral agents, AND The treatment must be co‑administered with 100 mg ritonavir twice daily, AND Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5094 |
Darunavir with cobicistat | C6377 | | Human immunodeficiency virus (HIV) infection The treatment must be in addition to optimised background therapy; AND The treatment must be in combination with other antiretroviral agents; AND The treatment must not be in combination with ritonavir; AND Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen. Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6377 |
| C6413 | | Human immunodeficiency virus (HIV) infection Initial treatment Patient must be antiretroviral treatment naive; AND The treatment must be in combination with other antiretroviral agents; AND The treatment must not be in combination with ritonavir. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6413 |
| C6428 | | Human immunodeficiency virus (HIV) infection Continuing treatment Patient must have previously received PBS‑subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents; AND The treatment must not be in combination with ritonavir. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6428 |
Darunavir with cobicistat, emtricitabine and tenofovir alafenamide | C10317 | | HIV infection
Continuing treatment
Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner.
Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must not be in combination with ritonavir. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10317 |
| C10324 | | HIV infection
Initial treatment
Must be treated by a medical practitioner or an authorised nurse practitioner in consultation with a medical practitioner.
Patient must be antiretroviral treatment naive; OR
Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen; AND
The treatment must not be in combination with ritonavir.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10324 |
Daunorubicin with cytarabine | C15390 | | Acute Myeloid Leukaemia Consolidation therapy The treatment must be for consolidation treatment following induction treatment with this product; AND The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND The treatment must not exceed two cycles of consolidation therapy under this restriction. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The TGA-approved Product Information recommended dosing schedule for consolidation is daunorubicin 29 mg/m2and cytarabine 65 mg/m2on days 1 and 3. With each authority application, state the body surface area (m2) of the patient. Based on this prescribe up to: 1 vial where the body surface area is between 1 m2to 1.53 m2 2 vials where the body surface area is above 1.53 m2or up to and including 3.07 m2 | Compliance with Authority Required procedures |
| C15413 | | Acute Myeloid Leukaemia Induction therapy Patient must not have received prior chemotherapy as induction therapy for this condition; AND The condition must be either: (i) newly diagnosed therapy-related acute myeloid leukaemia (AML), (ii) newly diagnosed AML with myelodysplasia-related changes (MRC) (prior myelodysplastic syndromes (MDS) or MDS-related cytogenetic or molecular abnormality); AND The condition must not be either: (i) internal tandem duplication (ITD); (ii) tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3), mutation positive; AND Patient must not have favourable cytogenetic risk acute myeloid leukaemia (AML); AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND The treatment must not exceed two cycles of induction therapy under this restriction. This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. The prescriber must confirm whether the patient has newly diagnosed therapy-related AML or AML-MRC. The test result and date of testing must be provided at the time of application and documented in the patient's file. The TGA-approved Product Information recommended dosing schedule is as follows: (i) First Induction: daunorubicin 44 mg/m2and cytarabine 100 mg/m2on days 1, 3 and 5 (ii) Second Induction: daunorubicin 44 mg/m2and cytarabine 100 mg/m2on days 1 and 3 With each authority application, state the body surface area (m2) of the patient. Based on (i) to (ii), prescribe up to: 1 vial where the body surface area is up to and including 1 m2; 2 vials where the body surface area is above 1 m2or up to and including 2 m2; 3 vials where the body surface area is above 2 m2or up to and including 3 m2. | Compliance with Authority Required procedures |
Deferasirox | C7374 | P7374 | Chronic iron overload Initial treatment Patient must not be transfusion dependent; AND The condition must be thalassaemia. | Compliance with Authority Required procedures |
| C7375 | P7375 | Chronic iron overload Initial treatment Patient must be transfusion dependent; AND Patient must not have a malignant disorder of erythropoiesis. | Compliance with Authority Required procedures |
| C7385 | P7385 | Chronic iron overload Initial treatment Patient must be red blood cell transfusion dependent; AND Patient must have a serum ferritin level of greater than 1000 microgram/L; AND Patient must have a malignant disorder of haemopoiesis; AND Patient must have a median life expectancy exceeding five years. | Compliance with Authority Required procedures |
| C8326 | P8326 | Chronic iron overload
Continuing treatment
Patient must be red blood cell transfusion dependent; AND
Patient must have a malignant disorder of haemopoieisis; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8326 |
| C8328 | P8328 | Chronic iron overload
Continuing treatment
Patient must be transfusion dependent; AND
Patient must not have a malignant disorder of erythropoiesis; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8328 |
| C8329 | P8329 | Chronic iron overload
Continuing treatment
Patient must not be transfusion dependent; AND
The condition must be thalassaemia; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8329 |
| C9222 | P9222 | Chronic iron overload
Continuing treatment
Patient must not be transfusion dependent; AND
The condition must be thalassaemia; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9222 |
| C9258 | P9258 | Chronic iron overload
Continuing treatment
Patient must be red blood cell transfusion dependent; AND
Patient must have a malignant disorder of haemopoieisis; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9258 |
| C9302 | P9302 | Chronic iron overload
Continuing treatment
Patient must be transfusion dependent; AND
Patient must not have a malignant disorder of erythropoiesis; AND
Patient must have previously received PBS‑subsidised therapy with deferasirox for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9302 |
Deferiprone | C6403 | | Iron overload Patient must have thalassaemia major; AND Patient must be one in whom desferrioxamine therapy has proven ineffective. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6403 |
| C6448 | | Iron overload Patient must have thalassaemia major; AND Patient must be unable to take desferrioxamine therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6448 |
| C9228 | | Iron overload
Patient must have thalassaemia major; AND
Patient must be one in whom desferrioxamine therapy has proven ineffective. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9228 |
| C9286 | | Iron overload
Patient must have thalassaemia major; AND
Patient must be unable to take desferrioxamine therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9286 |
| C9590 | | Iron overload
Patient must have thalassaemia major; AND
Patient must be one in whom desferrioxamine therapy has proven ineffective. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9590 |
| C9623 | | Iron overload
Patient must have thalassaemia major; AND
Patient must be unable to take desferrioxamine therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9623 |
Desferrioxamine | C6394 | | Disorders of erythropoiesis The condition must be associated with treatment‑related chronic iron overload. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6394 |
| C9696 | | Disorders of erythropoiesis
The condition must be associated with treatment‑related chronic iron overload. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9696 |
Difelikefalin | C15171 | | Moderate to severe pruritus (itching) associated with chronic kidney disease Initial treatment Patient must be on optimised haemodialysis; AND Patient must be on haemodialysis for at least 3 months; AND The condition must be confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; AND Patient must have experienced itch that persists for at least 6 weeks despite best supportive care; AND Patient must have a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) baseline score of more than 4; AND Patient must not receive more than 12 weeks of treatment under this restriction. Must be treated by a nephrologist. Patient must be at least 18 years of age. Prescriber must exclude any other causes of pruritus which include any of the following: (i) drug/dialysis related (e.g., opioid-related pruritus); (ii) drug hypersensitivity or adverse effect; contact dermatitis; allergy; (iii) differential diagnoses (e.g., xerosis; infestations; iron deficiency; liver disease; polycythaemia vera/leukemia/lymphoma; hypothyroidism; uncontrolled diabetes). Best supportive care for patients with chronic kidney disease-associated pruritus is not limited to but includes: (i) optimisation of dialysis; (ii) skin hydration and nutrition (with the use of moisturiser, emollients, barrier creams or oils); (iii) patient education on the importance of avoiding or minimising scratching. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 2 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4. | Compliance with Authority Required procedures |
| C15211 | | Moderate to severe pruritus (itching) associated with chronic kidney disease Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have demonstrated an adequate response to treatment with this drug including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score. Must be treated by a nephrologist; OR Must be treated by a medical practitioner in consultation with a nephrologist. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 5 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4. | Compliance with Authority Required procedures |
| C15227 | | Moderate to severe pruritus (itching) associated with chronic kidney disease Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS-subsidised supply was commenced, the patient: (i) was on optimised haemodialysis; (ii) was on haemodialysis for at least 3 months; (iii) had a condition confirmed based on both physical examination and patient history to exclude any factors that may be triggering the pruritus; (iv) had experienced itch that persists for at least 6 weeks despite best supportive care; (v) had a 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) of more than 4 at baseline; AND Patient must have demonstrated an adequate response to the most recent non-PBS-subsidised treatment with this drug for this condition, including at least a 3-point improvement from baseline in 24-hour Worst Itching Intensity Numerical Rating Scale (WI-NRS) score. Must be treated by a nephrologist. Patient must be at least 18 years of age. Confirmation of eligibility for treatment with diagnostic reports must be documented in the patient's medical records. At the time of authority application, medical practitioners must request the appropriate number of vials to provide sufficient drug, based on the dry body weight of the patient (in kg), adequate for 4 weeks, according to the specified dosage in the approved Product Information (PI). Up to a maximum of 5 repeats will be authorised. No more than 4 doses per week will be authorised even if the number of haemodialysis treatments in a week exceeds 4. | Compliance with Authority Required procedures |
Dolutegravir | C4454 | | HIV infection Continuing Patient must have previously received PBS subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Dolutegravir with abacavir and lamivudine | C9981 | | HIV infection
Initial treatment
Patient must be antiretroviral treatment naive. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9981 |
| C10116 | | HIV infection
Continuing treatment
Patient must have previously received PBS‑subsidised therapy for HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10116 |
Dolutegravir with lamivudine | C9987 | | HIV infection
Initial treatment
Patient must be antiretroviral treatment naive; AND
Patient must not have suspected resistance to either antiretroviral component. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9987 |
| C11066 | | HIV infection
Continuing or change of treatment
Patient must have previously received PBS‑subsidised therapy for HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 11066 |
Dolutegravir with rilpivirine | C8214 | | HIV infection
Initial treatment
Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND
The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8214 |
| C8226 | | HIV infection
Continuing treatment
Patient must have previously received PBS‑subsidised therapy with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8226 |
Dornase alfa | C5634 | | Cystic fibrosis
Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non‑responsive to conventional medicines; OR
Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy.
Patient must be less than 5 years of age.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six‑monthly intervals. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5634 |
| C5635 | | Cystic fibrosis
Continuing treatment
Patient must have initiated treatment with dornase alfa at an age of less than 5 years,AND
Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit.
Patient must be 5 years of age or older.
Further reassessments must be undertaken and documented at six‑monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5635 |
| C5740 | | Cystic fibrosis
Patient must be 5 years of age or older.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.
To be eligible for continued PBS‑subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six‑monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5740 |
| C9591 | | Cystic fibrosis
Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough, wheeze or tachypnoea) requiring hospital admissions more frequently than 3 times per year; OR
Patient must have significant bronchiectasis on chest high resolution computed tomography scan; OR
Patient must have severe cystic fibrosis bronchiolitis with persistent wheeze non‑responsive to conventional medicines; OR
Patient must have severe physiological deficit measure by forced oscillation technique or multiple breath nitrogen washout and failure to respond to conventional therapy.
Patient must be less than 5 years of age.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Following an initial 6 months therapy, a comprehensive assessment must be undertaken and documented. Treatment with this drug should cease if there is not agreement of benefit, as there is always the possibility of harm from unnecessary use. Further reassessments must be undertaken and documented at six‑monthly intervals. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9591 |
| C9592 | | Cystic fibrosis
Continuing treatment
Patient must have initiated treatment with dornase alfa at an age of less than 5 years; AND
Patient must have undergone a comprehensive assessment which documents agreement that dornase alfa treatment is continuing to produce worthwhile benefit.
Patient must be 5 years of age or older.
Further reassessments must be undertaken and documented at six‑monthly intervals. Treatment with this drug should cease if there is not agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9592 |
| C9624 | | Cystic fibrosis
Patient must be 5 years of age or older.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with dornase alfa at a dose of 2.5 mg daily.
To be eligible for continued PBS‑subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six‑monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9624 |
Doxorubicin ‑
Pegylated Liposomal | C6234 | | Kaposi sarcoma
The condition must be AIDS‑related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6234 |
| C6274 | | Kaposi sarcoma
The condition must be AIDS‑related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6274 |
| C9223 | | Kaposi sarcoma
The condition must be AIDS‑related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive visceral involvement. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9223 |
| C9287 | | Kaposi sarcoma
The condition must be AIDS‑related; AND
Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
The condition must include extensive mucocutaneous involvement. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9287 |
Dupilumab | C15341 | | Uncontrolled severe asthma Initial treatment - Initial 2 (Change of treatment) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have had a total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and (c) if applicable, the eosinophil count and date; and (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (e) if applicable, the IgE result and date; and (f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). | Compliance with Written Authority Required procedures |
| C15348 | | Uncontrolled severe asthma Continuing treatment Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. An adequate response to this biological medicine is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5. All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and, for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following information must be provided at the time of application and must be documented in the patient's medical records: (a) if applicable, details of maintenance oral corticosteroid dose; and (b) a completed Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
| C15424 | | Uncontrolled severe asthma Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have been receiving regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; OR Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids as outlined in the clinical criteria. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and (b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (d) Asthma Control Questionnaire (ACQ-5) score; and (e) if applicable, the eosinophil count and date; and (f) if applicable, the IgE result and date. | Compliance with Written Authority Required procedures |
| C15425 | | Uncontrolled severe asthma Initial treatment - Initial 2 (Change of treatment) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have each of: (i) total serum human immunoglobulin E of at least 30 IU/mL measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma, (ii) past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND Patient must have received regular maintenance oral corticosteroids (OCS) in the last 6 months with a stable daily OCS dose of 5 to 35 mg/day of prednisolone or equivalent over the 4 weeks prior to treatment initiation; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment at around 28 weeks, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy at a dose of 600 mg as an initial dose, followed by 300 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (b) details (treatment, date of commencement, duration of therapy) of prior biological medicine treatment; and (c) if applicable, the eosinophil count and date; and (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (e) if applicable, the IgE result and date; and (f) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). | Compliance with Written Authority Required procedures |
| C15433 | | Uncontrolled severe asthma Initial treatment 1 - (New patient; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; OR Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured in the last 12 months that has past or current evidence of atopy, documented by either: (i) skin prick testing; (ii) an in vitro measure of specific IgE; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. At the time of the authority application, medical practitioners should request up to 8 repeats to provide for an initial course of dupilumab sufficient for up to 32 weeks of therapy, at a dose of 400 mg as an initial dose, followed by 200 mg every 2 weeks thereafter. A swapping between 200 mg and 300 mg strengths is not permitted as the respective strengths are PBS approved for different patient cohorts. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and (b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (d) Asthma Control Questionnaire (ACQ-5) score; and (e) if applicable, the eosinophil count and date; and (f) if applicable, the IgE result and date. | Compliance with Written Authority Required procedures |
Eculizumab | C13458 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment ‑ (initial 3) switching from PBS‑subsidised pegcetacoplan for pregnancy (induction doses)
Patient must be planning pregnancy; OR
Patient must be pregnant; AND
Patient must have received PBS‑subsidised treatment with pegcetacoplan for this condition; AND
The treatment must not be in combination with any of (i) ravulizumab, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS‑subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria. | Compliance with Written Authority Required procedures |
| C13459 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Return from PBS‑subsidised pegcetacoplan ‑ induction doses
Patient must have received PBS‑subsidised treatment with at least one Complement 5 (C5) inhibitor for this condition; AND
Patient must have received PBS‑subsidised treatment with pegcetacoplan for this condition; AND
Patient must have developed resistance or intolerance to pegcetacoplan; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
For continuing PBS‑subsidised treatment with this drug, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria. | Compliance with Written Authority Required procedures |
| C13464 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Grandfather 1 (transition from non‑PBS‑subsidised treatment) ‑ maintenance phase
Patient must have received non‑PBS‑subsidised eculizumab for this condition prior to 1 March 2022; AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Written Authority Required procedures |
| C13560 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment ‑ initial 1 (new patient) induction doses
Patient must not have received prior treatment with this drug for this condition; AND
Patient must have a diagnosis of PNH established by flow cytometry; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Written Authority Required procedures |
| C13660 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Grandfather 2 (transition from LSDP‑funded eculizumab)
Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Written Authority Required procedures |
| C13661 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Subsequent Continuing Treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Switch' criteria; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13684 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment ‑ Initial 2 (switching from PBS‑subsidised ravulizumab for pregnancy)
Patient must be planning pregnancy; OR
Patient must be pregnant; AND
Patient must have received PBS‑subsidised treatment with ravulizumab for this condition; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Patient may qualify under this treatment phase more than once. In the event of miscarriage, patient may continue on eculizumab if patient is stable, and/or is planning a subsequent pregnancy. For continuing PBS‑subsidised treatment, a 'Switching' patient must proceed under the 'Subsequent Continuing Treatment' criteria. | Compliance with Written Authority Required procedures |
| C13845 | | Paroxysmal nocturnal haemoglobinuria (PNH)
First Continuing Treatment
Patient must have received PBS‑subsidised treatment with this drug for this condition under an 'Initial', 'Balance of Supply', or 'Grandfather' treatment criteria; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) | Compliance with Written Authority Required procedures |
| C13857 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Balance of Supply (transition from non‑PBS‑subsidised treatment during induction phase)
Patient must have received non‑PBS‑subsidised eculizumab for this condition prior to 1 March 2022; AND
Patient must have received insufficient quantity to complete the induction treatment phase; AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with eculizumab; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with eculizumab; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners should request the appropriate number of vials to complete the induction treatment phase, as per the Product Information.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) | Compliance with Written Authority Required procedures |
| C14750 | | Atypical haemolytic uraemic syndrome (aHUS)
Recommencement - Balance of Supply
Patient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; AND
Patient must not receive more than 20 weeks supply under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. | Compliance with Written Authority Required procedures |
| C14753 | | Atypical haemolytic uraemic syndrome (aHUS)
Switch from PBS-subsidised ravulizumab (all phases) - loading dose
Patient must have previously received PBS-subsidised ravulizumab under the 'Initial treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised ravulizumab under the 'Continuing treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised ravulizumab under the 'Extended continuing treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised ravulizumab under the 'Recommencement of treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised ravulizumab under the 'Continuing recommencement of treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised ravulizumab under the 'Grandfather (transitioning from non-PBS to PBS-subsidised treatment)' restriction for this condition; AND
Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
Patient must not receive more than 24 weeks of C5 inhibitor supply for this current treatment phase under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
The application must indicate the most recent treatment phase that the patient is switching from.
For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted. | Compliance with Written Authority Required procedures |
| C14754 | | Atypical haemolytic uraemic syndrome (aHUS)
Continuing treatment
Patient must have received PBS-subsidised eculizumab under the initial treatment phase for this condition; OR
Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the initial treatment phase for this condition; OR
Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; AND
Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND
Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND
Patient must not receive more than 80 weeks of eculizumab treatment in total under this restriction; OR
Patient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
(2) One of the following:
a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
A treatment failure is defined as a patient who is:
(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted;
(5) A family history of aHUS, if applicable;
(6) A history of kidney transplant if applicable (especially if required due to aHUS);
(7) An inclusion of the individual consequences of recurrent disease, if applicable;
(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;
(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;
(10) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. | Compliance with Written Authority Required procedures |
| C14781 | | Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment
Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND
Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND
Patient must have clinical features of active organ damage or impairment; AND
Patient must not receive more than 4 weeks of treatment under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
Evidence of active and progressing TMA is defined by the following:
(1) a platelet count of less than 150x10^9/L; and evidence of two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range;
OR
(2) in recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA;
AND
(3) evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment; and/or
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment; or
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients; or
(iv) a renal biopsy consistent with aHUS;
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment.
Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised eculizumab (where possible), and should be supported by objective clinical measures. The prescriber's cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A detailed cover letter from the prescriber;
(4) A measurement of body weight at the time of application;
(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay;
(6) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 27 days of commencement of eculizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised eculizumab treatment, under Initial treatment - Balance of Supply;
(7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;
(8) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of application;
(9) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application. | Compliance with Written Authority Required procedures |
| C14792 | | Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment - Balance of Supply
Patient must have received PBS-subsidised initial supply of eculizumab for this condition; AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
Patient must not receive more than 20 weeks supply under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion, and must have been submitted to Services Australia within 27 days of commencement of eculizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. | Compliance with Written Authority Required procedures |
| C14793 | | Atypical haemolytic uraemic syndrome (aHUS)
Continuing recommencement of treatment
Patient must have received PBS-subsidised eculizumab under the recommencement of treatment phase for this condition; OR
Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; OR
Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing recommencement of treatment phase for this condition; AND
Patient must have demonstrated ongoing treatment response to 'Recommencement of treatment' with a C5 inhibitor for this condition; AND
Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND
Patient must not receive more than 24 weeks of treatment with eculizumab per continuing treatment course authorised under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
(2) One of the following:
a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
A treatment failure is defined as a patient who is:
(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted;
(5) A family history of aHUS, if applicable;
(6) A history of multiple episodes of aHUS before recommencing eculizumab treatment, if applicable;
(7) A history of kidney transplant if applicable (especially if required due to aHUS);
(8) An inclusion of the individual consequences of recurrent disease, if applicable;
(9) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;
(10) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;
(11) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. | Compliance with Written Authority Required procedures |
| C14799 | | Atypical haemolytic uraemic syndrome (aHUS)
Recommencement of treatment
Patient must have demonstrated treatment response to previous treatment with PBS-subsidised eculizumab for this condition; OR
Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the recommencement treatment phase for this condition; AND
Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND
Patient must have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
(2) One of the following:
a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
A treatment failure is defined as a patient who is:
(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted;
(5) A family history of aHUS if applicable;
(6) A history of multiple episodes of aHUS following the treatment break, if applicable;
(7) A history of kidney transplant if applicable (especially if required due to aHUS);
(8) An inclusion of the individual consequences of recurrent disease;
(9) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;
(10) Evidence that the patient has had a treatment response to their previous treatment with eculizumab;
(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;
(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required. | Compliance with Written Authority Required procedures |
| C14805 | | Atypical haemolytic uraemic syndrome (aHUS)
Extended Continuing treatment
Patient must have received PBS-subsidised eculizumab under the continuing treatment phase for this condition; OR
Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the continuing treatment phase for this condition; OR
Patient must have received PBS-subsidised eculizumab under the switch from ravulizumab in the extended continuing treatment phase for this condition; AND
Patient must have demonstrated on-going treatment response with PBS-subsidised eculizumab for this condition; AND
Patient must not have experienced treatment failure with eculizumab for this condition in the most recent treatment phase; AND
Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; OR
Patient must have severe TMA-related neurological impairment; OR
Patient must have severe TMA-related gastrointestinal impairment; OR
Patient must have severe TMA-related pulmonary impairment on current objective measurement; OR
Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); OR
Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with eculizumab; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
(2) One of the following:
a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with eculizumab will not be permitted if a patient has experienced treatment failure with eculizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
A treatment failure is defined as a patient who is:
(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted;
(5) A family history of aHUS, if applicable;
(6) A history of multiple episodes of aHUS before commencing eculizumab treatment, if applicable;
(7) A history of kidney transplant, if applicable (especially if required due to aHUS);
(8) An inclusion of the individual consequences of recurrent disease;
(9) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment;
(10) Evidence that the patient has had a treatment response including haematological results of no more than 4 weeks old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 4 weeks old at the time of application;
(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing eculizumab is severe extra-renal complications that have significantly improved;
(12) If the indication for continuing eculizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with eculizumab. | Compliance with Written Authority Required procedures |
Elexacaftor with tezacaftor and with ivacaftor, and ivacaftor | C13932 | | Cystic fibrosis Initial treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must have at least one F508del mutation in the cystic fibrosis transmembrane conductance (CFTR) gene; AND The treatment must be given concomitantly with standard therapy for this condition; AND Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug. Patient must be aged between 6 and 11 years inclusive. This pharmaceutical benefit is not PBS‑subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information. The authority application must be in writing and must include: (1) a completed authority prescription; and (2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and (3) details of the pathology report substantiating the patient having at least one F508del mutation ‑ quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and (4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C13962 | | Cystic fibrosis Initial treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must have at least one F508del mutation in the cystic fibrosis transmembrane conductance (CFTR) gene; AND The treatment must be given concomitantly with standard therapy for this condition; AND Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug. Patient must be at least 6 years of age. This pharmaceutical benefit is not PBS‑subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information. The authority application must be in writing and must include: (1) a completed authority prescription; and (2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and (3) details of the pathology report substantiating the patient having at least one F508del mutation ‑ quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and (4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C13980 | | Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be at least 6 years of age.
This pharmaceutical benefit is not PBS‑subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C13991 | | Cystic fibrosis Continuing treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged between 6 and 11 years inclusive. This pharmaceutical benefit is not PBS‑subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information. The authority application must be in writing and must include: (1) a completed authority prescription; and (2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and (3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
Eltrombopag | C13327 | | Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under first continuing or re‑initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS‑subsidised treatment with this drug; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C14126 | | Severe thrombocytopenia
Initial treatment ‑ New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C14127 | | Severe thrombocytopenia
Balance of supply or change of therapy
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re‑initiation of interrupted continuing treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
Patient must be changing therapy from romiplostim or avatrombopag to this drug for this condition; AND
The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
Patients receiving treatment with romiplostim or avatrombopag may change to eltrombopag under this restriction. | Compliance with Authority Required procedures |
| C14129 | | Severe thrombocytopenia
First Continuing treatment or Re‑initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS‑subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
Patient must have changed treatment from either romiplostim or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS‑subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS‑subsidised course of treatment with this drug and must be documented in the patient's medical records. | Compliance with Authority Required procedures |
| C15173 | | Severe aplastic anaemia Continuing treatment - Second line treatment The condition must be severe aplastic anaemia; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition under the initial treatment restriction; AND Patient must have demonstrated a response to PBS-subsidised treatment with this drug. Platelet, haemoglobin and neutrophil counts must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. Once platelet count is greater than 50 x 109/L, haemoglobin is greater than 100 g/L in the absence of red blood cell (RBC) transfusion, and absolute neutrophil (ANC) is greater than 1 x 109/L for more than 8 weeks, the dose of eltrombopag should be reduced as per the Product Information. For the purposes of this restriction, a response is defined as no longer meeting the criteria for severe aplastic anaemia. | Compliance with Authority Required procedures |
| C15174 | | Severe aplastic anaemia Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements - First line treatment Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND The condition must be severe aplastic anaemia; AND Patient must not have received treatment with immunosuppressive therapy for this condition prior to initiating non-PBS-subsidised treatment; AND The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND Patient must be considered ineligible for haemopoietic stem cell transplant; AND Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). A patient may qualify for PBS-subsidised treatment under this restriction once only. | Compliance with Authority Required procedures |
| C15191 | | Severe aplastic anaemia First line treatment The condition must be severe aplastic anaemia; AND Patient must not have received treatment with immunosuppressive therapy for this condition; AND The treatment must be administered in combination with standard immunosuppressive therapy, including anti-thymocyte antibody and ciclosporin; AND Patient must be considered ineligible for haemopoietic stem cell transplant; AND Patient must not receive more than 24 weeks of treatment under this restriction in a lifetime. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Authority Required procedures |
| C15192 | | Severe aplastic anaemia Initial treatment - Second line treatment The condition must be severe aplastic anaemia; AND Patient must not have achieved an adequate response to prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; OR Patient must have relapsed following prior immunosuppressive therapy including anti-thymocyte antibody and ciclosporin; AND Patient must not receive more than 16 weeks of treatment under this restriction. The authority application must be made via the online PBS Authorities (real time assessment), or in writing via HPOS form upload or mail and must include: (a) prior immunosuppressive therapy, including dates of treatment. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C15482 | | Cystic fibrosis Initial treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must have at least one F508del mutation in the cystic fibrosis transmembrane conductance (CFTR) gene; AND The treatment must be given concomitantly with standard therapy for this condition; AND Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities, prior to initiating treatment with this drug. Patient must be 2 to 5 years of age. This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information. The authority application must be in writing and must include: (1) details of the proposed prescription; and (2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and (3) details of the pathology report substantiating the patient having at least one F508del mutation - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and (4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C15511 | | Cystic fibrosis Continuing treatment Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation. Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be 2 to 5 years of age. This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information. The authority application must be in writing and must include: (1) details of the proposed prescription; and (2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and (3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
Emtricitabine with rilpivirine with tenofovir alafenamide | C4470 | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470 |
| C4522 | | HIV infection
Initial
Patient must be antiretroviral treatment naive. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522 |
Emtricitabine with tenofovir alafenamide | C4454 | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial
Patient must be antiretroviral treatment naive; AND
The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Entecavir | C4993 | | Chronic hepatitis B infection
Patient must not have cirrhosis, AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND
Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4993 |
| C5036 | | Chronic hepatitis B infection
Patient must have cirrhosis, AND
Patient must have detectable HBV DNA.
Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5036 |
| C5037 | | Chronic hepatitis B infection
Patient must have cirrhosis, AND
Patient must have failed lamivudine, AND
Patient must have detectable HBV DNA.
Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5037 |
| C5044 | | Chronic hepatitis B infection
Patient must not have cirrhosis, AND
Patient must have failed lamivudine, AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5044 |
Epoetin Alfa | C6294 | | Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294 |
| C9688 | | Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9688 |
Epoetin Beta | C6294 | | Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294 |
| C9688 | | Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9688 |
Epoetin lambda | C6294 | | Anaemia associated with intrinsic renal disease Patient must require transfusion; AND Patient must have a haemoglobin level of less than 100 g per L; AND Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294 |
| C9688 | | Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9688 |
Epoprostenol | C13491 | | Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13505 | | Pulmonary arterial hypertension (PAH)
Initial 3 ‑ changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13506 | | Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13510 | | Pulmonary arterial hypertension (PAH)
Initial 1 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application. | Compliance with Written Authority Required procedures |
| C13512 | | Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class IV PAH; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Written Authority Required procedures |
| C13577 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13634 | | Pulmonary arterial hypertension (PAH)
Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
Etanercept | C9417 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) ‑ balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C14068 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
| C14070 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti‑rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14071 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 3 repeats will be authorised.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) the date of the last continuing prescription.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14154 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14154 |
| C14155 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of injections to provide sufficient for four weeks of treatment. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14155 |
Etravirine | C5014 | | HIV infection
The treatment must be in addition to optimised background therapy, AND
The treatment must be in combination with other antiretroviral agents, AND
Patient must be antiretroviral experienced, AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5014 |
Everolimus | C5554 | | Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5554 |
| C5795 | | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5795 |
| C9691 | | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9691 |
| C9693 | | Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9693 |
Filgrastim | C6621 | | Severe chronic neutropenia
Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; OR
Patient must have neutrophil dysfunction; AND
Patient must have experienced a life‑threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; OR
Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6621 |
| C6640 | | Chronic cyclical neutropenia
Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND
Patient must have experienced a life‑threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; OR
Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6640 |
| C6653 | | Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non‑myeloid malignancy who has had myeloablative or myelosuppressive therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6653 |
| C6654 | | Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6654 |
| C6655 | | Assisting autologous peripheral blood progenitor cell transplantation
The treatment must be following marrow‑ablative chemotherapy for non‑myeloid malignancy prior to the transplantation. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6655 |
| C6679 | | Assisting bone marrow transplantation
Patient must be receiving marrow‑ablative chemotherapy prior to the transplantation. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6679 |
| C6680 | | Severe congenital neutropenia
Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND
Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6680 |
| C7822 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7822 |
| C7843 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7843 |
| C8667 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8667 |
| C8668 | | Mobilisation of peripheral blood progenitor cells
The treatment must be in a normal volunteer for use in allogeneic transplantation. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8668 |
| C8669 | | Severe congenital neutropenia
Patient must have an absolute neutrophil count of less than 100 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; AND
Patient must have had a bone marrow examination that has shown evidence of maturational arrest of the neutrophil lineage. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8669 |
| C8670 | | Severe chronic neutropenia
Patient must have an absolute neutrophil count of less than 1,000 million cells per litre measured on 3 occasions, with readings at least 2 weeks apart; OR
Patient must have neutrophil dysfunction; AND
Patient must have experienced a life‑threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics in the previous 12 months; OR
Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8670 |
| C8671 | | Assisting bone marrow transplantation
Patient must be receiving marrow‑ablative chemotherapy prior to the transplantation. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8671 |
| C8672 | | Mobilisation of peripheral blood progenitor cells
The treatment must be to facilitate harvest of peripheral blood progenitor cells for autologous transplantation into a patient with a non‑myeloid malignancy who has had myeloablative or myelosuppressive therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8672 |
| C8673 | | Chronic cyclical neutropenia
Patient must have an absolute neutrophil count of less than 500 million cells per litre lasting for 3 days per cycle, measured over 3 separate cycles; AND
Patient must have experienced a life‑threatening infectious episode requiring hospitalisation and treatment with intravenous antibiotics; OR
Patient must have had at least 3 recurrent clinically significant infections in the previous 12 months. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8673 |
| C8674 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8674 |
| C8696 | | Assisting autologous peripheral blood progenitor cell transplantation
The treatment must be following marrow‑ablative chemotherapy for non‑myeloid malignancy prior to the transplantation. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8696 |
Ganciclovir | C5000 | | Cytomegalovirus retinitis
Patient must be severely immunocompromised, including due to HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5000 |
| C15782 | | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15782 |
| C15784 | | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15784 |
| C15800 | | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15800 |
| C15814 | | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15814 |
Glecaprevir with pibrentasvir | C7593 | P7593 | Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 8 weeks. | Compliance with Authority Required procedures |
| C7615 | P7615 | Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks. | Compliance with Authority Required procedures |
| C10268 | P10268 | Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 16 weeks.
The application must include details of the prior treatment regimen containing an NS5A inhibitor. | Compliance with Authority Required procedures |
Iloprost | C13491 | | Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13505 | | Pulmonary arterial hypertension (PAH)
Initial 3 ‑ changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13506 | | Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13510 | | Pulmonary arterial hypertension (PAH)
Initial 1 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application. | Compliance with Written Authority Required procedures |
| C13577 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13631 | | Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class III drug and toxins induced PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the Therapeutic Goods Administration (TGA) approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Written Authority Required procedures |
| C13634 | | Pulmonary arterial hypertension (PAH)
Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
Infliximab | C4524 | | Acute severe ulcerative colitis
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology].
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital.
Patient must be 6 years of age or older.
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C‑reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient’s medical records.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient’s medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4524 |
| C7777 | | Complex refractory Fistulising Crohn disease Balance of supply Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Change or Re‑commencement of treatment after a break in therapy of less than 5 years (Initial 2) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses (Initial 1 or Initial 2 treatment) or 2 repeats (first Continuing or Subsequent Continuing treatment). | Compliance with Authority Required procedures |
| C8296 | | Severe chronic plaque psoriasis
Continuing treatment, Whole body or Continuing treatment, Face, hand, foot ‑ balance of supply
Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the first continuing treatment, Face, hand, foot restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
The treatment must be as systemic monotherapy (other than methotrexate).
Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C8844 | | Severe chronic plaque psoriasis
Subsequent continuing treatment, Whole body
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The measurement of response to the prior course of therapy must be documented in the patient’s medical notes.
Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8844 |
| C8881 | | Severe chronic plaque psoriasis
Subsequent continuing treatment, Face, hand, foot
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient’s condition.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C8883 | | Severe chronic plaque psoriasis
First continuing treatment, Face, hand, foot
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient’s condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C8940 | | Severe chronic plaque psoriasis
Subsequent continuing treatment, Face, hand, foot
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The measurement of response to the prior course of therapy must be documented in the patient’s medical notes.
Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8940 |
| C8941 | | Severe chronic plaque psoriasis
Subsequent continuing treatment, Whole body
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient’s condition.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C8962 | | Severe chronic plaque psoriasis
First continuing treatment, Whole body
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient’s condition.
The most recent PASI assessment must be no more than 1 month old at the time of application.
Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS‑subsidised treatment with this drug for this condition.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9065 | | Severe psoriatic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under the first continuing treatment restriction, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9067 | | Severe psoriatic arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9068 | | Severe psoriatic arthritis
Continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9111 | | Severe psoriatic arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND
The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9188 | | Severe psoriatic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient’s medical records.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9188 |
| C9472 | | Severe psoriatic arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
The measurement of response to the prior course of therapy must have been conducted following a minimum of 12 weeks of therapy with this drug and must be documented in the patient’s medical records.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9472 |
| C9559 | | Ankylosing spondylitis
Initial treatment ‑ Initial 1 (new patient), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug under the Initial 1 (new patient) restriction to complete 18 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 18 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 18 weeks treatment; AND
The treatment must provide no more than the balance of up to 18 weeks treatment available under the above restrictions.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C9584 | | Severe chronic plaque psoriasis
Subsequent continuing treatment, Face, hand, foot
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
The measurement of response to the prior course of therapy must be documented in the patient’s medical notes.
Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.
The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9584 |
| C9602 | | Severe chronic plaque psoriasis
Subsequent continuing treatment, Whole body
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
The measurement of response to the prior course of therapy must be documented in the patient’s medical notes.
Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9602 |
| C9632 | | Acute severe ulcerative colitis
Must be treated by a gastroenterologist; OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology].
Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i) Temperature greater than 37.8 degrees Celsius; (ii) Pulse rate greater than 90 beats per minute; (iii) Haemoglobin less than 105 g/L; (iv) Erythrocyte sedimentation rate greater than 30 mm/h; OR
Patient must be a child aged 6 to 17 years inclusive, and prior to initiation of infliximab treatment in hospital must have had a Paediatric Ulcerative Colitis Activity Index (PUCAI) greater than or equal to 65, with the diagnosis confirmed by a gastroenterologist, or a consultant physician as specified below; AND
Patient must have failed to achieve an adequate response to at least 72 hours treatment with intravenous corticosteroids prior to initiation of infliximab treatment in hospital.
Patient must be 6 years of age or older.
For adults aged 18 years or older, failure to achieve an adequate response to intravenous corticosteroid treatment is defined by the Oxford criteria where:
(i) If assessed on day 3, patients pass 8 or more stools per day or 3 or more stools per day with a C‑reactive protein (CRP) greater than 45 mg/L
(ii) If assessed on day 7, patients pass 3 or more stools per day with visible blood.
For children aged 6 to 17 years, failure to achieve an adequate response to intravenous corticosteroids means a PUCAI score greater than 45 at 72 hours.
At the time of authority application, prescribers should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single infusion at a dose of 5 mg per kg.
Before administering infliximab to a child aged 6 to 17 years, the treating clinician must have consulted with a paediatric gastroenterologist or with an institution experienced in performance of paediatric colectomy. The name of the specialist or institution must be included in the patient’s medical records.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient’s medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9632 |
| C9668 | | Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
The PCDAI assessment must be no more than 1 month old at the time of prescribing.
The PCDAI score must be documented in the patient’s medical notes as the measurement of response to the prior course of therapy.
Patients are only eligible to receive subsequent continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9668 |
| C9669 | | Moderate to severe Crohn disease
Balance of supply for paediatric patient
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment or subsequent continuing treatment restrictions to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment. | Compliance with Authority Required procedures |
| C9677 | | Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C9719 | | Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient’s condition.
The PCDAI assessment must be no more than 1 month old at the time of application.
Each application for subsequent continuing treatment with this drug must include an assessment of the patient’s response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment, unless the patient has experienced serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Patients are only eligible to receive subsequent continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C9721 | | Moderate to severe Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the completed Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet along with the date of the assessment of the patient’s condition.
The PCDAI assessment must be no more than 1 month old at the time of application.
The application for first continuing treatment with this drug must include a PCDAI assessment of the patient’s response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C9732 | | Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological agent treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
The measurement of response to the prior course of therapy must be documented in the patient’s medical notes.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9732 |
| C9751 | | Moderate to severe Crohn disease
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition more than once in the current treatment cycle; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. | Compliance with Written Authority Required procedures |
| C9754 | | Moderate to severe ulcerative colitis
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment. | Compliance with Authority Required procedures |
| C9775 | | Moderate to severe Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
Patient must have a reduction in PCDAI Score by at least 15 points from baseline value; AND
Patient must have a total PCDAI score of 30 points or less; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
The PCDAI assessment must be no more than 1 month old at the time of prescribing.
The PCDAI score must be documented in the patient’s medical notes as the measurement of response to the prior course of therapy.
Patients are only eligible to receive subsequent continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9775 |
| C9779 | | Severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment. | Compliance with Authority Required procedures |
| C9783 | | Complex refractory Fistulising Crohn disease
First continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes a completed Fistula Assessment form including the date of the assessment of the patient’s condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
The application for first continuing treatment with this drug must include an assessment of the patient’s response to the initial course of treatment. The assessment must be made up to 12 weeks after the first dose so that there is adequate time for a response to be demonstrated. This assessment must be submitted no later than 4 weeks from the cessation of that treatment course.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
A maximum of 24 weeks of treatment with this drug will be authorised under this restriction.
At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly.
Up to a maximum of 2 repeats will be authorised. | Compliance with Written Authority Required procedures |
| C9787 | | Complex refractory Fistulising Crohn disease
Subsequent continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological agent treatment for this condition in this treatment cycle; AND
Patient must have demonstrated an adequate response to treatment with this drug.
An adequate response is defined as:
(a) a decrease from baseline in the number of open draining fistulae of greater than or equal to 50%; and/or
(b) a marked reduction in drainage of all fistula(e) from baseline, together with less pain and induration as reported by the patient.
The measurement of response to the prior course of therapy must be documented in the patient’s medical notes.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Patients are eligible to receive subsequent continuing treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9787 |
| C9803 | | Complex refractory Fistulising Crohn disease
Change or Recommencement of treatment after a break in therapy of less than 5 years (Initial 2)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS‑subsidised therapy with this drug for this condition more than once in the current treatment cycle.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient’s condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
The most recent fistula assessment must be no more than 1 month old at the time of application.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and this assessment must be submitted to the Department of Human Services no later than 4 weeks from the date that course was ceased.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient’s response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not provided within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. | Compliance with Written Authority Required procedures |
| C11158 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or re‑commencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years) ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years ) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (re‑commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Face, hand, foot (new patient) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 22 weeks treatment; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions.
Must be treated by a dermatologist. | Compliance with Authority Required procedures |
| C12003 | | Moderate to severe ulcerative colitis Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; OR Patient must have previously received PBS‑subsidised treatment with a biological medicine (adalimumab or infliximab) for this condition in this treatment cycle if aged 6 to 17 years; AND Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; OR Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle more than once if aged 6 to 17 years. Patient must be 6 years of age or older. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition if relevant; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted no later than 4 weeks from the date of completion of treatment. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If patients aged 6 to 17 years fail to respond to PBS‑subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C12025 | | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of the most recent clinical assessment. All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application. Each application for subsequent continuing treatment with this drug must include an assessment of the patient's response to the prior course of therapy. If the response assessment is not provided at the time of application the patient will be deemed to have failed this course of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C12042 | | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years. Patient must be 6 years of age or older. Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug. Patients are only eligible to receive continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If patients aged 6 to 17 years fail to respond to PBS‑subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12042 |
| C12043 | | Severe Crohn disease First continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or (ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment. All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C12049 | | Moderate to severe ulcerative colitis Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years; OR Patient must have previously received induction therapy with this drug for an acute severe episode of ulcerative colitis in the last 4 months and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a PUCAI score less than 10 (if aged 6 to 17 years). Patient must be 6 years of age or older. Application for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following: (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8‑weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application. Where treatment for an acute severe episode has occurred, an adequate response to induction therapy needs to be demonstrated by achieving and maintaining a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1, or a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 (if aged 6 to 17 years), within the first 12 weeks of receiving this drug for acute severe ulcerative colitis. A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated. An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. Details of the accepted toxicities including severity can be found on the Services Australia website. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C12051 | | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12051 |
| C12059 | | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years. Patient must be 6 years of age or older. Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug. Patients are only eligible to receive continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg eight weekly. Up to a maximum of 2 repeats will be authorised. An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If patients aged 6 to 17 years fail to respond to PBS‑subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
| C12063 | | Severe Crohn disease Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction. Patient must be aged 18 years or older. Applications for authorisation must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following: (i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or (ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and (iii) the date of clinical assessment; and (iv) the details of prior biological medicine treatment including the details of date and duration of treatment. An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below. Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted no later than 4 weeks from the date that course was ceased. If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine. A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised. If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C12069 | | Severe Crohn disease Subsequent continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 18 years or older. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12069 |
| C12074 | | Moderate to severe ulcerative colitis Continuing treatment Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR Must be treated by a paediatrician; OR Must be treated by a specialist paediatric gastroenterologist. Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; OR Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 while receiving treatment with this drug, if aged 6 to 17 years. Patient must be 6 years of age or older. Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug. Patients are only eligible to receive continuing PBS‑subsidised treatment with this drug in courses of up to 24 weeks at a dose of 5 mg per kg per dose providing they continue to sustain the response. The measurement of response to the prior course of therapy must be documented in the patient's medical notes. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. If patients aged 6 to 17 years fail to respond to PBS‑subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12074 |
| C12313 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg (for a child, 1 to 2 mg/kg up to 40 mg) prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6 if an adult patient; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); OR
Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years.
Patient must be 6 years of age or older.
Application for authorisation must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8‑weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.
An adult patient who has previously received induction therapy with PBS‑subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic scoreless than or equal to 2, with no subscore greater than 1, will not be required to demonstrate failure to prior treatment with a 5‑aminosalicylate oral preparation and one of azathioprine, 6‑mercaptopurine or oral steroids.
A patient, aged 6 to 17 years, who has previously received induction therapy with PBS‑subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a PUCAI score of less than 10 will not be required to demonstrate failure to prior treatment with a 5‑aminosalicylate oral preparation and one of azathioprine, 6‑mercaptopurine or oral steroids.
A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Written Authority Required procedures |
| C13518 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly for a minimum period of 3 months; AND
Patient must have failed to achieve an adequate response to sulfasalazine at a dose of at least 2 g per day for a minimum period of 3 months; OR
Patient must have failed to achieve an adequate response to leflunomide at a dose of up to 20 mg daily for a minimum period of 3 months; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Where treatment with methotrexate, sulfasalazine or leflunomide is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
Where intolerance to treatment with methotrexate, sulfasalazine or leflunomide developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
The following initiation criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; and
either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C13526 | | Severe Crohn disease
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be at least 18 years of age.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C13584 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C13586 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Whole body (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C13587 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 3, Face, hand, foot (re‑commencement of treatment after a break in biological medicine of more than 5 years)
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C13639 | | Severe Crohn disease
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be at least 18 years of age.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C13640 | | Severe psoriatic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an erythrocyte sedimentation rate (ESR) no greater than 25 mm per hour or a C‑reactive protein (CRP) level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Severe Psoriatic Arthritis PBS Authority Application ‑ Supporting Information Form.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C13641 | | Complex refractory Fistulising Crohn disease
Initial treatment (new patient or Recommencement of treatment after more than 5 years break in therapy ‑ Initial 1)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Fistulising Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition.
The most recent fistula assessment must be no more than 1 month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
An assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (up to 6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. | Compliance with Written Authority Required procedures |
| C13691 | | Moderate to severe Crohn disease
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. | Compliance with Authority Required procedures |
| C13692 | | Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (change or re-commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
An adequate response to treatment is defined as:
A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C13702 | | Moderate to severe Crohn disease
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; OR
Must be treated by a paediatrician; OR
Must be treated by a specialist paediatric gastroenterologist.
Patient must have confirmed diagnosis of Crohn disease, defined by standard clinical, endoscopic and/or imaging features including histological evidence; AND
Patient must have failed to achieve an adequate response to 2 of the following 3 conventional prior therapies including: (i) a tapered course of steroids, starting at a dose of at least 1 mg per kg or 40 mg (whichever is the lesser) prednisolone (or equivalent), over a 6 week period; (ii) an 8 week course of enteral nutrition; or (iii) immunosuppressive therapy including azathioprine at a dose of at least 2 mg per kg daily for 3 or more months, or, 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more months, or, methotrexate at a dose of at least 10 mg per square metre weekly for 3 or more months; OR
Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contra‑indication to each of prednisolone (or equivalent), azathioprine, 6‑mercaptopurine and methotrexate; AND
Patient must have a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 30 preferably whilst still on treatment; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
Patient must be aged 6 to 17 years inclusive.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Paediatric Crohn Disease PBS Authority Application ‑Supporting Information Form which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) calculation sheet including the date of assessment of the patient's condition which must be no more than one month old at the time of application; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition.
The PCDAI score should preferably be obtained whilst on conventional treatment but must be obtained within one month of the last conventional treatment dose.
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
A PCDAI assessment of the patient's response to this initial course of treatment must be made up to 12 weeks after the first dose (6 weeks following the third dose) so that there is adequate time for a response to be demonstrated.
This assessment, which will be used to determine eligibility for the first continuing treatment, must be submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. | Compliance with Written Authority Required procedures |
| C13719 | | Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (change or re-commencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing:
(i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
(ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following:
(i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of prior biological treatment, including dosage, date and duration of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C14359 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Face, hand, foot (new patient)
Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) Chronic plaque psoriasis classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
(i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment; or
(ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment;
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area as assessed at baseline.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C14360 | | Severe chronic plaque psoriasis
Initial treatment ‑ Initial 1, Whole body (new patient)
Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg once daily for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 22 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a dermatologist.
Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA‑approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be provided at the time of application.
Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application:
(a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
(b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
(ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. | Compliance with Written Authority Required procedures |
| C14502 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA‑approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details of the contraindications/severe intolerances; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
If methotrexate is contraindicated according to the TGA‑approved product information or cannot be tolerated at a 20 mg weekly dose, details of the contraindication or intolerance including severity to methotrexate must be provided at the time of application and documented in the patient's medical records. The maximum tolerated dose of methotrexate must be provided at the time of the application, if applicable, and documented in the patient's medical records.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided at the time of application and documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the active joint count, ESR and/or CRP result and date of results;
(b) details of prior treatment, including dose and date/duration of treatment.
(c) If applicable, details of any contraindications/intolerances.
(d) If applicable, the maximum tolerated dose of methotrexate.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
| C14504 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient's medical records. These values will be used for patients who transition to subcutaneous form of infliximab.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14504 |
| C14505 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient's medical records. These values will be used for patients who transition to subcutaneous form of infliximab.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14505 |
| C14507 | | Severe active rheumatoid arthritis
First continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment. | Compliance with Authority Required procedures |
| C14544 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the active joint count, ESR and/or CRP result and date of result;
(b) the most recent biological agent and the date of the last continuing prescription.
(c) If applicable, the new baseline scores.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures |
| C14546 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA‑approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
If methotrexate is contraindicated according to the TGA‑approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14547 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14548 | | Severe active rheumatoid arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 22 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 22 weeks treatment; AND
The treatment must provide no more than the balance of up to 22 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C14585 | | Severe active rheumatoid arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient's medical records. These values will be used for patients who transition to subcutaneous form of infliximab.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14585 |
| C14597 | | Severe active rheumatoid arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 2 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14615 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS‑subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
Patients who have received PBS‑subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
| C14623 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS‑subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 22 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
Patients who have received PBS‑subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
Up to a maximum of 3 repeats will be authorised.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Authority Required procedures |
| C14638 | | Severe active rheumatoid arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient's medical records. These values will be used for patients who transition to subcutaneous form of infliximab.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14638 |
| C14667 | | Ankylosing spondylitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of at least 5 years from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale that is no more than 4 weeks old at the time of application; AND
Patient must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour that is no more than 4 weeks old at the time of application; OR
Patient must have a C‑reactive protein (CRP) level greater than 10 mg per L that is no more than 4 weeks old at the time of application; OR
Patient must have a clinical reason as to why demonstration of an elevated ESR or CRP cannot be met and the application must state the reason; AND
Patient must not receive more than 18 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a baseline ESR and/or CRP level.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
Up to a maximum of 3 repeats will be authorised.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C14683 | | Ankylosing spondylitis
First continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14683 |
| C14689 | | Ankylosing spondylitis
First continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14689 |
| C14701 | | Ankylosing spondylitis
Subsequent continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14701 |
| C14705 | | Ankylosing spondylitis
Continuing treatment ‑ balance of supply
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the subsequent continuing Authority Required (in writing) treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis. | Compliance with Authority Required procedures |
| C14707 | | Ankylosing spondylitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 18 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a patient is changing from PBS‑subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C14716 | | Ankylosing spondylitis
First continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C14718 | | Ankylosing spondylitis
Initial treatment ‑ Initial 1 (new patient)
The condition must be either radiologically (plain X‑ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
Patient must have failed to achieve an adequate response following treatment with at least 2 non‑steroidal anti‑inflammatory drugs (NSAIDs), whilst completing an appropriate exercise program, for a total period of 3 months; AND
Patient must not receive more than 18 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The application must include details of the NSAIDs trialled, their doses and duration of treatment.
If the NSAID dose is less than the maximum recommended dose in the relevant TGA‑approved Product Information, the application must include the reason a higher dose cannot be used.
If treatment with NSAIDs is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of the contraindication.
If intolerance to NSAID treatment develops during the relevant period of use which is of a severity to necessitate permanent treatment withdrawal, the application must provide details of the nature and severity of this intolerance.
The following criteria indicate failure to achieve an adequate response and must be demonstrated at the time of the initial application:
(a) a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0‑10 scale; and
(b) an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 10 mg per L.
The baseline BASDAI score and ESR or CRP level must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. All measurements must be no more than 4 weeks old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reason this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be provided at the time of application and documented in the patient's medical records:
(i) details (name of the radiology report provider, date of the radiology report and unique identifying number/code that links report to the individual patient) of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a baseline BASDAI score; and
(iii) a completed Exercise Program Self Certification Form included in the supporting information form; and
(iv) baseline ESR and/or CRP level.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, will be authorised.
Up to a maximum of 3 repeats will be authorised.
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C14723 | | Ankylosing spondylitis
Subsequent continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14723 |
| C14724 | | Ankylosing spondylitis
Subsequent continuing treatment
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C14737 | | Ankylosing spondylitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 18 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners should request the appropriate quantity of vials, based on the weight of the patient, to provide for infusions at a dose of 5 mg per kg.
Up to a maximum of 3 repeats will be authorised.
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 5 years, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a patient is changing from PBS‑subsidised treatment with a biosimilar medicine for this condition, the prescriber must submit baseline disease severity indicators with this application, in addition to the response assessment outlined below.
An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0‑10) in the BASDAI score combined with at least 1 of the following:
(a) an ESR measurement no greater than 25 mm per hour; or
(b) a CRP measurement no greater than 10 mg per L; or
(c) an ESR or CRP measurement reduced by at least 20% from baseline.
Where only 1 acute phase reactant measurement is supplied in the first application for PBS‑subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
The assessment of response to treatment must be documented in the patient's medical records.
Where a response assessment is not conducted within these timeframes, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Interferon Gamma‑1b | C6222 | | Chronic granulomatous disease
Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6222 |
| C9639 | | Chronic granulomatous disease
Patient must have frequent and severe infections despite adequate prophylaxis with antimicrobial agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9639 |
Ivacaftor | C15251 | | Cystic fibrosis Initial treatment - New patient (gating mutations) Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged 4 months or older. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks. Ivacaftor is not PBS-subsidised for this condition as a sole therapy. Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers: Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide. The authority application must be in writing and must include: (1) a completed authority prescription; and (2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and (3) details of the pathology report substantiating G551D mutation or other gating (Class III) mutation on the CFTR gene - quote each of the: (i) the specific CFTR mutation listed in the TGA approved Product Information, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient, and (4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C15252 | | Cystic fibrosis Continuing treatment (gating mutations) Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged 4 months or older. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks. Ivacaftor is not PBS-subsidised for this condition as a sole therapy. Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers: Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide. The authority application must be in writing and must include: (1) a completed authority prescription; and (2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and (3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C15253 | | Cystic fibrosis Initial treatment - New patient (non-gating mutations) Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND Patient must have at least one mutation in the CFTR gene that is responsive to ivacaftor potentiation based on clinical and/or in vitro assay data; AND Patient must not have either: (i) G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; (ii) other gating (class III) mutation in the CFTR gene; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged 4 months or older. For the purposes of this restriction, the list of mutations considered to be responsive to ivacaftor is defined in the TGA approved Product Information. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks. Ivacaftor is not PBS-subsidised for this condition as a sole therapy. Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers: Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide. The authority application must be in writing and must include: (1) a completed authority prescription; and (2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and (3) details of the pathology report substantiating the specific mutation considered to be responsive to ivacaftor as listed in the TGA approved Product Information. Quote each of the: (i) the specific mutation listed in the TGA approved Product Information, (ii) name of the pathology report provider, (iii) date of pathology report, (iv) unique identifying number/code that links the pathology result to the individual patient, and (4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C15255 | | Cystic fibrosis Continuing treatment (non-gating mutations) Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction per authority application; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged 4 months or older. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks. Ivacaftor is not PBS-subsidised for this condition as a sole therapy. Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers: Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide. The authority application must be in writing and must include: (1) a completed authority prescription; and (2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and (3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
Lamivudine | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
| C4993 | | Chronic hepatitis B infection
Patient must not have cirrhosis, AND
Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR
Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND
Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4993 |
| C5036 | | Chronic hepatitis B infection
Patient must have cirrhosis, AND
Patient must have detectable HBV DNA.
Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5036 |
Lamivudine with zidovudine | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Lanreotide | C4575 | | Functional carcinoid tumour The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 120 mg every 28 days Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4575 |
| C7025 | | Acromegaly The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS‑subsidised pegvisomant. In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7025 |
| C7509 | | Functional carcinoid tumour Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 120 mg every 28 days. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7509 |
| C7532 | | Acromegaly Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The condition must be active; AND Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND The treatment must be after failure of other therapy including dopamine agonists; OR The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND The treatment must cease if IGF1 is not lower after 3 months of treatment; AND The treatment must not be given concomitantly with PBS‑subsidised pegvisomant. In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7532 |
| C9260 | | Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 120 mg every 28 days.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9260 |
| C9261 | | Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS‑subsidised pegvisomant.
In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9261 |
| C10061 | | Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10061 |
| C10075 | | Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10075 |
| C10077 | | Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10077 |
Lanthanum | C5530 | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5530 |
| C9762 | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762 |
Lenalidomide | C13782 | | Relapsed and/or refractory multiple myeloma
Triple combination therapy consisting of elotuzumab, lenalidomide and dexamethasone
Patient must be undergoing concurrent treatment with elotuzumab obtained through the PBS; AND
Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing. | Compliance with Authority Required procedures |
| C13785 | | Multiple myeloma
Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 21‑day treatment cycle
The condition must be newly diagnosed; AND
The condition must be confirmed by a histological diagnosis; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
Patient must not have been treated with lenalidomide or bortezomib for this condition; AND
The treatment must not exceed a total of 4 cycles under this restriction.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
(2) nomination of which disease activity parameters will be used to assess response.
To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine ‑ the percentage of plasma cells; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13786 | | Multiple myeloma
Initial treatment with triple therapy (this drug, bortezomib and dexamethasone) for the first 4 treatment cycles (cycles 1 to 4) administered in a 28‑day treatment cycle
The condition must be newly diagnosed; AND
The condition must be confirmed by a histological diagnosis; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
Patient must not have been treated with lenalidomide or bortezomib for this condition; AND
The treatment must not exceed a total of 4 cycles under this restriction.
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
(2) nomination of which disease activity parameters will be used to assess response.
To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine ‑ the percentage of plasma cells; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13787 | | Multiple myeloma
Continuing treatment until progression in patients initiated on dual combination therapy (this drug and dexamethasone), or, in patients initiated on triple therapy (this drug, bortezomib and dexamethasone during treatment cycles 1 up to 8) and are now being treated with treatment cycle 9 or beyond
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C13791 | | Multiple myeloma
Initial treatment with lenalidomide monotherapy in newly diagnosed disease
The treatment must be as monotherapy; AND
The condition must be confirmed by a histological diagnosis; AND
Patient must have undergone an autologous stem cell transplant (ASCT) as part of frontline therapy for newly diagnosed multiple myeloma; AND
Patient must not have progressive disease following autologous stem cell transplant (ASCT).
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
(2) the date the autologous stem cell transplant was performed; and
(3) nomination of which disease activity parameters will be used to assess progression.
To enable confirmation of eligibility for treatment, the details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f) of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine ‑ the percentage of plasma cells; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine progression, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13801 | | Myelodysplastic syndrome
Continuing treatment
Patient must have received PBS‑subsidised initial therapy with lenalidomide for myelodysplastic syndrome; AND
Patient must have achieved and maintained transfusion independence; or at least a 50% reduction in red blood cell unit transfusion requirements compared with the four month period prior to commencing initial PBS‑subsidised therapy with lenalidomide; AND
Patient must not have progressive disease; AND
The condition must not have progressed to acute myeloid leukaemia.
The first authority application for continuing supply must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. Subsequent authority applications for continuing supply may be made via the Online PBS Authorities System or by telephone.
The following evidence of response must be provided at each application:
(i) a haemoglobin level taken within the last 4 weeks; and
(ii) the date of the last transfusion; and
(iii) a statement of the number of units of red cells transfused in the 4 months immediately preceding this application;
All reports must be documented in the patient's medical records.
For first continuing applications, if the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13803 | | Multiple myeloma
Initial treatment as monotherapy or dual combination therapy with dexamethasone for progressive disease
The condition must be confirmed by a histological diagnosis; AND
The treatment must be as monotherapy; OR
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must have undergone or be ineligible for a primary stem cell transplant.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma; and
(2) prior treatments including name(s) of drug(s) and date of most recent treatment cycle; and
(3) date of prior stem cell transplant or confirmation of ineligibility for prior stem cell transplant; and
(4) details of the basis of the diagnosis of progressive disease or failure to respond; and
(5) nomination of which disease activity parameters will be used to assess response.
To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine ‑ the percentage of plasma cells; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/declared. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held in the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13804 | | Multiple myeloma
Continuing treatment with lenalidomide monotherapy following initial treatment with lenalidomide therapy in newly diagnosed disease
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be as monotherapy.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C13805 | | Multiple myeloma
Continuing treatment as monotherapy or dual combination therapy with dexamethasone following initial treatment for progressive disease
Patient must have previously received PBS‑subsidised treatment with this drug for relapsed or refractory multiple myeloma; AND
The treatment must be as monotherapy; OR
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone. | Compliance with Authority Required procedures |
| C13810 | | Myelodysplastic syndrome
Initial treatment
The treatment must be limited to a maximum duration of 16 weeks; AND
Patient must be classified as Low risk or Intermediate‑1 according to the International Prognostic Scoring System (IPSS); AND
Patient must have a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities; AND
Patient must be red blood cell transfusion dependent.
Classification of a patient as Low risk requires a score of 0 on the IPSS, achieved with the following combination: less than 5% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 0/1 cytopenias.
Classification of a patient as Intermediate‑1 requires a score of 0.5 to 1 on the IPSS, achieved with the following possible combinations:
1. 5%‑10% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 0/1 cytopenias; OR
2. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
3. less than 5% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 2/3 cytopenias; OR
4. less than 5% marrow blasts with intermediate karyotypic status (other abnormalities), and 2/3 cytopenias; OR
5. 5%‑10% marrow blasts with intermediate karyotypic status (other abnormalities), and 0/1 cytopenias; OR
6. 5%‑10% marrow blasts with good karyotypic status (normal, ‑Y alone, ‑5q alone, ‑20q alone), and 2/3 cytopenias; OR
7. less than 5% marrow blasts with poor karyotypic status (complex, greater than 3 abnormalities), and 0/1 cytopenias.
Classification of a patient as red blood cell transfusion dependent requires that:
(i) the patient has been transfused within the last 8 weeks; and
(ii) the patient has received at least 8 units of red blood cell in the last 6 months prior to commencing PBS‑subsidised therapy with lenalidomide; and would be expected to continue this requirement without lenalidomide treatment.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has myelodysplastic syndrome; and
(b) details (date, unique identifying number/code or provider number) of the full blood examination report; and
(c) details (date, unique identifying number/code or provider number) of the pathology report and details of the cytogenetics demonstrating Low risk or Intermediate‑1 disease according to the IPSS (note: using Fluorescence in Situ Hybridization (FISH) to demonstrate MDS ‑5q is acceptable); and
(d) details of transfusion requirements including: (i) the date of most recent transfusion and the number of red blood cell units transfused; and (ii) the total number of red blood cell units transfused in the 4 and 6 months preceding the date of this application.
All the reports must be documented in the patient's medical records.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13811 | | Multiple myeloma
Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 to 8 inclusive (administered using 21‑day treatment cycles)
Patient must have received PBS‑subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
The treatment must not exceed a total of 4 cycles under this restriction. | Compliance with Authority Required procedures |
| C13812 | | Multiple myeloma
Initial treatment in combination with dexamethasone, of newly diagnosed disease in a patient ineligible for stem cell transplantation
The condition must be newly diagnosed; AND
The condition must be confirmed by a histological diagnosis; AND
Patient must be ineligible for a primary stem cell transplantation; AND
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the histological report confirming the diagnosis of multiple myeloma, and
(2) confirmation of ineligibility for prior stem cell transplant; and
(3) nomination of which disease activity parameters will be used to assess response.
To enable confirmation of eligibility for treatment, details (date, unique identifying number/code or provider number) of the current diagnostic reports (for items a, b, c, d, f (if applicable), g), or, confirmation that diagnosis was based on (for items e, f), of at least one of the following must be provided:
(a) the level of serum monoclonal protein; or
(b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine ‑ the percentage of plasma cells; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters will be used to determine response, results for either (a) or (b) or (c) should be provided for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) should be stated/provided. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be held on the patient's medical records.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13813 | | Multiple myeloma
Continuing treatment of triple therapy (this drug, bortezomib and dexamethasone) for treatment cycles 5 and 6 (administered using 28‑day treatment cycles)
Patient must have received PBS‑subsidised treatment with this drug under the treatment phase covering cycles 1 to 4; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
The treatment must not exceed a total of 2 cycles under this restriction. | Compliance with Authority Required procedures |
| C14362 | | Relapsed and/or refractory multiple myeloma
Triple combination therapy consisting of carfilzomib, lenalidomide and dexamethasone
Patient must be undergoing concurrent treatment with carfilzomib obtained through the PBS; AND
Patient must not be undergoing simultaneous treatment with this drug obtained under another PBS listing. | Compliance with Authority Required procedures |
Levodopa with carbidopa | C10138 | P10138 | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital‑based movement disorder clinic. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10138 |
| C10161 | P10161 | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital‑based movement disorder clinic. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10161 |
| C10363 | P10363 | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital‑based movement disorder clinic; AND
Patient must require continuous administration of levodopa without an overnight break; OR
Patient must require a total daily dose of more than 2000 mg of levodopa. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10363 |
| C10375 | P10375 | Advanced Parkinson disease
Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND
The treatment must be commenced in a hospital‑based movement disorder clinic; AND
Patient must require continuous administration of levodopa without an overnight break; OR
Patient must require a total daily dose of more than 2000 mg of levodopa. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10375 |
Lipegfilgrastim | C7822 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7822 |
| C7843 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7843 |
| C9224 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9224 |
| C9322 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9322 |
Lopinavir with ritonavir | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Lumacaftor with ivacaftor | C14757 | | Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 1 year of age or older.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C14765 | | Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 1 year of age or older.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C14783 | | Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be aged between 6 and 11 years inclusive.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C14784 | | Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be aged between 6 and 11 years inclusive.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C14785 | | Cystic fibrosis
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 12 years of age or older.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C14796 | | Cystic fibrosis
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition.
Patient must be 12 years of age or older.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
Macitentan | C11229 | | Pulmonary arterial hypertension (PAH)
Triple therapy ‑ Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) PBS‑subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS‑subsidised selexipag with one endothelin receptor antagonist, (ii) PBS‑subsidised selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The authority application for selexipag must be approved prior to the authority application for this agent.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13496 | | Pulmonary arterial hypertension (PAH)
Initial 1 ‑ combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application. | Compliance with Written Authority Required procedures |
| C13497 | | Pulmonary arterial hypertension (PAH)
Initial 3 ‑ changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing. | Compliance with Authority Required procedures |
| C13499 | | Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH; AND
Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application. | Compliance with Authority Required procedures |
| C13500 | | Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Written Authority Required procedures |
| C13575 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13576 | | Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13582 | | Pulmonary arterial hypertension (PAH)
Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one prostanoid; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
Mannitol | C7362 | | Cystic fibrosis The treatment must be as monotherapy; AND Patient must be intolerant or inadequately responsive to dornase alfa. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS‑subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six‑monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7362 |
| C7367 | | Cystic fibrosis The treatment must be in combination with dornase alfa; AND Patient must be inadequately responsive to dornase alfa; AND Patient must have trialled hypertonic saline for this condition. Patient must be 6 years of age or older. Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result. Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit. Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease. Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily. To be eligible for continued PBS‑subsidised treatment with this drug following 3 months of initial treatment: (1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND (2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient. Further reassessments must be undertaken and documented at six‑monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7367 |
| C9527 | | Cystic fibrosis
The treatment must be as monotherapy; AND
Patient must be intolerant or inadequately responsive to dornase alfa.
Patient must be 6 years of age or older.
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.
To be eligible for continued PBS‑subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six‑monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9527 |
| C9593 | | Cystic fibrosis
The treatment must be in combination with dornase alfa; AND
Patient must be inadequately responsive to dornase alfa; AND
Patient must have trialled hypertonic saline for this condition.
Patient must be 6 years of age or older.
Patient must have been assessed for bronchial hyperresponsiveness as per the TGA approved Product Information initiation dose assessment for this drug, prior to therapy with this drug, with a negative result.
Patient must be assessed at a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis or by a specialist physician or paediatrician in consultation with such a unit.
Prior to therapy with this drug, a baseline measurement of forced expiratory volume in 1 second (FEV1) must be undertaken during a stable period of the disease.
Initial therapy is limited to 3 months treatment with mannitol at a dose of 400 mg twice daily.
To be eligible for continued PBS‑subsidised treatment with this drug following 3 months of initial treatment:
(1) the patient must demonstrate no deterioration in FEV1 compared to baseline; AND
(2) the patient or the patient’s family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
Further reassessments must be undertaken and documented at six‑monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9593 |
Maraviroc | C5008 | | HIV infection
Patient must be infected with CCR5‑tropic HIV‑1, AND
The treatment must be in addition to optimised background therapy, AND
The treatment must be in combination with other antiretroviral agents, AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity.
A tropism assay to determine CCR5 only strain status must be performed prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5008 |
Mepolizumab | C13865 | | Chronic rhinosinusitis with nasal polyps (CRSwNP)
Continuing treatment
Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have both demonstrated and sustained an adequate response to this drug, defined as having at least one of: (i) an improvement in bilateral endoscopic nasal polyp score of at least 1.0 compared to the baseline level provided with the initial authority application, (ii) an improvement in nasal obstruction visual analogue scale (VAS) score of at least 3.0 compared to the baseline level provided with the initial authority application, (iii) an improvement in overall symptom VAS score of at least 2.5 compared to the baseline level provided with the initial authority application.
Patient must be at least 18 years of age. | Compliance with Authority Required procedures |
| C13890 | | Chronic rhinosinusitis with nasal polyps (CRSwNP)
Initial treatment
Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) ear nose and throat specialist (ENT), (v) general physician experienced in the management of patients with CRSwNP.
Patient must have a diagnosis of CRSwNP confirmed by at least one of: (i) nasal endoscopy, (ii) computed tomography (CT) scan, with the results documented in the patient's medical records; OR
Patient must have a diagnosis of CRSwNP from at least two physicians of the above mentioned prescriber types; AND
Patient must have undergone surgery for the removal of nasal polyps; OR
Patient must have the written advice from at least two physicians of the above mentioned prescriber types demonstrating inappropriateness for surgery; AND
Patient must have, despite optimised nasal polyp therapy, at least two of: (i) bilateral endoscopic nasal polyp score of at least 5 (out of a maximum score of 8, with a minimum score of 2 in each nasal cavity), (ii) nasal obstruction visual analogue scale (VAS) score greater than 5 (out of a maximum score of 10), (iii) overall symptom VAS score greater than 7 (out of a maximum score of 10); AND
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; OR
Patient must have had a 12 month break in PBS‑subsidised treatment with a biological medicine for this condition; AND
The treatment must not be used in combination with and within 4 weeks of another PBS‑subsidised biological medicine prescribed for any of: (i) nasal polyps, (ii) uncontrolled severe allergic asthma, (iii) uncontrolled severe asthma; AND
Patient must have failed to achieve adequate control with optimised nasal polyp therapy which has been documented; AND
Patient must have blood eosinophil count greater than or equal to 300 cells per microlitre in the last 12 months.
Patient must be at least 18 years of age.
Optimised nasal polyp therapy includes:
(a) adherence to intranasal corticosteroid therapy for at least 2 months, unless contraindicated or not tolerated
(b) if required, nasal irrigation with saline
Where the patient has a contraindication or intolerance to intranasal corticosteroid therapy, document the reasons for the contraindication or intolerance in the patient's medical file.
The authority application must be made in writing and must include:
(a) a completed authority prescription form,
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice),
(c) details (date of commencement and duration of therapy) of prior optimised nasal polyp medicine treatment,
(d) details (date and treatment) of nasal polyp surgery; or
(e) if applicable, details of surgical exception including serious comorbid disease (e.g. cardiovascular, stroke) making the risk of surgery unacceptable,
(f) the eosinophil count and date,
(g) two of the following, measured within the past 12 months: (i) baseline bilateral endoscopic nasal polyp score, (ii) baseline nasal obstruction VAS score, (iii) baseline overall VAS score. | Compliance with Written Authority Required procedures |
| C15344 | | Uncontrolled severe asthma Initial treatment - Initial 2 (Change of treatment) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have had a blood eosinophil count of at least 300 cells per microlitre and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; OR Patient must have had a blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids and that is no older than 12 months immediately prior to commencing PBS-subsidised biological medicine treatment for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. An application for a patient who has received PBS-subsidised biological medicine treatment for severe asthma who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (b) details (date and duration of treatment) of prior biological medicine treatment; and (c) eosinophil count and date; and (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). | Compliance with Written Authority Required procedures |
| C15353 | | Uncontrolled severe asthma Continuing treatment Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. An adequate response to this biological medicine is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5. All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment or the assessment of oral corticosteroid dose, should be made from 20 weeks after the first dose of PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate number of repeats to provide for a continuing course of this drug sufficient for up to 24 weeks of therapy. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following information must be provided at the time of application and must be documented in the patient's medical records: (a) if applicable, details of maintenance oral corticosteroid dose; and (b) a completed Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
| C15376 | | Uncontrolled severe asthma Balance of supply Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must have received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction. | Compliance with Authority Required procedures |
| C15400 | | Uncontrolled severe asthma Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have a blood eosinophil count of at least 300 cells per microlitre in the last 12 months; OR Patient must have blood eosinophil count of at least 150 cells per microlitre while receiving treatment with oral corticosteroids in the last 12 months; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. To avoid an interruption of supply for the first continuing treatment, the assessment should be provided no later than 2 weeks prior to the patient completing their current treatment course, unless the patient is currently on a treatment break. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within the same treatment cycle. A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines within the same treatment cycle. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. At the time of the authority application, medical practitioners should request up to 7 repeats to provide for an initial course of mepolizumab sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) details (treatment, date of commencement, duration of therapy) of prior optimised asthma drug therapy; and (b) if applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (d) the eosinophil count and date; and (e) Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
Methadone | C15358 | | Opioid dependence The treatment must be within a framework of medical, social and psychological treatment. A medical practitioner must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. A medical practitioner must not request the maximum listed quantity or number of repeats if lesser quantity or repeats are sufficient for the patient's needs. | Compliance with Authority Required procedures - Streamlined Authority Code 15358 |
Methoxsalen | C10971 | P10971 | Erythrodermic stage III‑IVa T4 M0 Cutaneous T‑cell lymphoma
Initial treatment
Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa‑2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND
Patient must not have previously received PBS‑subsidised treatment with this drug for this PBS indication.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Patient must be aged 18 years or over. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10971 |
| C10985 | P10985 | Erythrodermic stage III‑IVa T4 M0 Cutaneous T‑cell lymphoma
Initial treatment
Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa‑2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND
Patient must not have previously received PBS‑subsidised treatment with this drug for this PBS indication.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Patient must be aged 18 years or over. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10985 |
| C10988 | P10988 | Erythrodermic stage III‑IVa T4 M0 Cutaneous T‑cell lymphoma
Continuing treatment
Patient must have received PBS‑subsidised treatment with this drug for this PBS indication; AND
Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa‑2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS‑subsidy. Response only needs to be demonstrated after the first six months of treatment | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10988 |
| C10989 | P10989 | Erythrodermic stage III‑IVa T4 M0 Cutaneous T‑cell lymphoma
Continuing treatment
Patient must have received PBS‑subsidised treatment with this drug for this PBS indication; AND
Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa‑2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS‑subsidy. Response only needs to be demonstrated after the first six months of treatment | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10989 |
| C12531 | P12531 | Chronic graft versus host disease
Continuing treatment
Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis‑MBS benefit for initial treatment; AND
Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS‑subsidised extracorporeal photopheresis treatment) obtained through this drug's 'Initial treatment' PBS‑listing for the same treatment episode.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND
Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND
Patient must not be undergoing re‑treatment through this treatment phase immediately following a relapse ‑ see 'Initial treatment' for resuming treatment following relapse. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12531 |
| C12546 | P12546 | Chronic graft versus host disease
Initial treatment in a treatment episode
The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; OR
The condition must have relapsed within 8 weeks of prior PBS‑subsidised treatment with this drug administered via extracorporeal photopheresis; OR
The condition must have relapsed with each of the following conditions being met: (i) prior PBS‑subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed.
Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25thdose) of a treatment episode; AND
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND
Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND
Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12546 |
| C12567 | P12567 | Chronic graft versus host disease
Continuing treatment
Patient must have received, at anytime prior to this pharmaceutical benefit within the same treatment episode, both: (i) this drug subsidised through the Initial treatment listing, (ii) the extracorporeal photopheresis‑MBS benefit for initial treatment; AND
Patient must have demonstrated a response to initial treatment with this drug (administered as part of MBS‑subsidised extracorporeal photopheresis treatment) obtained through this drug's 'Initial treatment' PBS‑listing for the same treatment episode.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND
Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition; AND
Patient must not be undergoing re‑treatment through this treatment phase immediately following a relapse ‑ see 'Initial treatment' for resuming treatment following relapse. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12567 |
| C12579 | P12579 | Chronic graft versus host disease
Initial treatment in a treatment episode
The condition must be inadequately responsive to systemic corticosteroid treatment at a therapeutic dose, but has never been treated with this drug; OR
The condition must have relapsed within 8 weeks of prior PBS‑subsidised treatment with this drug administered via extracorporeal photopheresis; OR
The condition must have relapsed with each of the following conditions being met: (i) prior PBS‑subsidised treatment with this drug administered via extracorporeal photopheresis last occurred at least 8 weeks ago, (ii) a subsequent trial of systemic corticosteroids at therapeutic doses has been completed.
Patient must be undergoing treatment with this drug that is being administered within at least one of: (i) the first 12 weeks of a treatment episode, (ii) the first 25 doses (inclusive of the 25thdose) of a treatment episode; AND
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types; AND
Patient must be undergoing treatment with this drug following allogeneic haematopoietic stem cell transplantation; AND
Patient must be undergoing concurrent treatment with extracorporeal photopheresis as described in the Medicare Benefits Schedule for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12579 |
Methoxy polyethylene glycol‑epoetin beta | C6294 | | Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6294 |
| C9688 | | Anaemia associated with intrinsic renal disease
Patient must require transfusion; AND
Patient must have a haemoglobin level of less than 100 g per L; AND
Patient must have intrinsic renal disease, as assessed by a nephrologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9688 |
Midostaurin | C11699 | | Acute Myeloid Leukaemia
Maintenance therapy ‑ Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the initial maintenance treatment restriction; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
Patient must not be undergoing or have undergone a stem cell transplant.
A maximum of 9 cycles will be authorised under this restriction in a lifetime.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
Progressive disease is defined as the presence of any of the following:
Leukaemic cells in the CSF;
Re‑appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
Extramedullary leukaemia.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures |
| C13001 | | Acute Myeloid Leukaemia
Induction / Consolidation therapy
Patient must not have received prior chemotherapy as induction therapy for this condition; OR
The treatment must be for consolidation treatment following induction treatment with midostaurin in combination with chemotherapy and the patient must not have progressive disease; AND
The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority; AND
The condition must not be acute promyelocytic leukaemia; AND
The treatment must be in combination with standard intensive remission induction or consolidation chemotherapy for this condition.
A maximum of 6 cycles will be authorised under this restriction in a lifetime.
Standard intensive remission induction combination chemotherapy must include cytarabine and an anthracycline.
The prescriber must confirm whether the patient has FLT3 ITD or TKD mutation. The test result and date of testing must be provided at the time of application and documented in the patient's file.
This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
Progressive disease is defined as the presence of any of the following:
Leukaemic cells in the CSF;
Re‑appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
Extramedullary leukaemia.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug. | Compliance with Authority Required procedures |
| C13013 | | Acute Myeloid Leukaemia
Maintenance therapy ‑ Initial treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated complete remission after induction and consolidation chemotherapy in combination with midostaurin confirmed through a bone marrow biopsy pathology report; AND
Patient must not be undergoing or have undergone a stem cell transplant; AND
The condition must be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive before initiating this drug for this condition confirmed through a pathology report from an Approved Pathology Authority.
A maximum of 3 cycles will be authorised under this restriction in a lifetime.
Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
If abnormal blood counts suggest the potential for relapsed AML, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
Progressive disease is defined as the presence of any of the following:
Leukaemic cells in the CSF;
Re‑appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy;
Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause;
Extramedullary leukaemia.
A patient who has progressive disease when treated with this drug is no longer eligible for PBS‑subsidised treatment with this drug.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) confirmation that the patient is not undergoing or has not undergone a stem cell transplant; and
(b) confirmation that the patient does not have progressive disease; and
(c) details (date, unique identifying number/code or provider number) of a recent bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient is in complete remission; and
(d) details (date, unique identifying number/code or provider number) of the pathology test demonstrating that the condition was FMS tyrosine kinase 3 (FLT3) (ITD or TKD) mutation positive prior to commencing midostaurin.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
Mycophenolic Acid | C4084 | | Prophylaxis of renal allograft rejection Management The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required Procedures – Streamlined Authority Code 4084 |
| C4095 | | WHO Class III, IV or V lupus nephritis Management The condition must be proven by biopsy, Must be treated by a nephrologist or in consultation with a nephrologist. The name of the consulting nephrologist must be included in the patient medical records. | Compliance with Authority Required Procedures – Streamlined Authority Code 4095 |
| C5554 | | Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5554 |
| C5600 | | Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5600 |
| C5653 | | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5653 |
| C5795 | | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5795 |
| C9689 | | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9689 |
| C9690 | | Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy )
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9690 |
| C9691 | | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9691 |
| C9692 | | Prophylaxis of renal allograft rejection
Management
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9692 |
| C9693 | | Management of cardiac allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of cardiac allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9693 |
| C9809 | | WHO Class III, IV or V lupus nephritis
Management
The condition must be proven by biopsy.
Must be treated by a nephrologist or in consultation with a nephrologist.
The name of the consulting nephrologist must be included in the patient medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9809 |
Natalizumab | C13625 | | Clinically definite relapsing‑remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13625 |
| C13718 | | Clinically definite relapsing‑remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support); AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR
Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient.
The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient.
Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug.
For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13718 |
Nevirapine | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
| C4526 | | HIV infection
Initial Patient must have been stabilised on nevirapine immediate release; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4526 |
Nivolumab with relatlimab | C14812 | P14812 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be uveal melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must weigh 40 kg or more; AND
Patient must be at least 12 years of age.
Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 14812 |
| C14815 | P14815 | Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 14815 |
| C14819 | P14819 | Unresectable Stage III or Stage IV malignant melanoma
Initial treatment
Patient must not have received prior treatment with ipilimumab or a PD-1 (programmed cell death-1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
Patient must not have experienced disease progression whilst on adjuvant PD-1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD-1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
The condition must not be uveal melanoma; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Patient must weigh 40 kg or more; AND
Patient must be at least 12 years of age.
Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 14819 |
| C14829 | P14829 | Unresectable Stage III or Stage IV malignant melanoma
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen. | Compliance with Authority Required procedures - Streamlined Authority Code 14829 |
Nusinersen | C12672 | | Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)
Initial treatment ‑ Loading doses
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND
The treatment must not be in combination with PBS‑subsidised treatment with risdiplam for this condition; AND
The treatment must be given concomitantly with best supportive care for this condition; AND
The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND
Patient must be untreated with gene therapy.
Patient must be 18 years of age or under.
Defined signs and symptoms of type I SMA are:
i) Onset before 6 months of age; and
ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age‑matched child.
Defined signs and symptoms of type II SMA are:
i) Onset between 6 and 18 months; and
ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or
iii) Proximal weakness; or
iv) Weakness in trunk righting/derotation; or
v) Hypotonia; or
vi) Absence of deep tendon reflexes; or
vii) Failure to gain weight appropriate for age; or
viii) Any active chronic neurogenic changes; or
ix) A compound muscle action potential below normative values for an age‑matched child.
Defined signs and symptoms of type IIIa SMA are:
i) Onset between 18 months and 3 years of age; and
ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age‑matched child.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:
i) specification of SMA type (I, II or IIIa); and
(ii) sign(s) and symptom(s) that the patient has experienced; and
(iii) patient's age at the onset of sign(s) and symptom(s). | Compliance with Written Authority Required procedures |
| C12676 | | Spinal muscular atrophy (SMA)
Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with one of: (i) Type 1 SMA, or, (ii) pre‑symptomatic SMA
Patient must have experienced a regression in a developmental state listed below (see 'Definition') despite treatment with gene therapy ‑ confirm that this: (i) not due to an acute concomitant illness; (ii) not due to non‑compliance to best‑supportive care, (iii) apparent for at least 3 months, (iv) verified by another clinician in the treatment team ‑ state the full name of this clinician plus their profession (e.g. medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); AND
The treatment must not be a PBS‑subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND
The treatment must be given concomitantly with best supportive care for this condition; AND
The treatment must not be in combination with PBS‑subsidised treatment with risdiplam for this condition.
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND
Patient must be undergoing treatment under this Treatment phase listing once only ‑ for continuing treatment beyond this authority application, refer to the drug's relevant 'Continuing treatment' listing for the patient's SMA type.
Patient must have a prior authority approval for any drug PBS‑listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy; OR
Patient must have a prior authority approval for any drug PBS‑listed for pre‑symptomatic SMA, with at least one approval having been for gene therapy.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.
Confirm that a previous PBS authority application has been approved for one of the following:
(i) Symptomatic Type 1 SMA; or
(ii) Pre‑symptomatic SMA treated with nusinersen.
Definition:
Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.
0. Absence of developmental states (1 to 9) listed below:
1. Rolls from side to side on back;
2. Child holds head erect for at least 3 seconds unsupported;
3. Sitting, but with assistance;
4. Sitting without assistance:
(a) Child sits up straight with the head erect for at least 10 seconds;
(b) Child does not use arms or hands to balance body or support position.
5. Hands and knees crawling:
(a) Child alternately moves forward or backwards on hands and knees;
(b) The stomach does not touch the supporting surface;
(c) There are continuous and consecutive movements at least 3 in a row.
6. Standing with assistance:
(a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;
(b)The body does not touch the stable object, and the legs support most of the body weight;
(c) Child thus stands with assistance for at least 10 seconds.
7. Standing alone:
(a) Child stands in upright position on both feet (not on the toes) with the back straight;
(b) The leg supports 100% of the child's weight;
(c) There is no contact with a person or object;
(d) Child stands alone for at least 10 seconds.
8. Walking with assistance:
(a) Child is in an upright position with the back straight;
(b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;
(c) One leg moves forward while the other supports part of the body weight;
(d) Child takes at least 5 steps in this manner.
9. Walking alone:
(a) Child takes at least 5 steps independently in upright position with the back straight;
(b) One leg moves forward while the other supports most of the body weight;
(c) There is no contact with a person or object.
Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 ‑ 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient's current overall developmental state (i.e. a number that is lower than stated in (i).
Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS‑subsidy of this benefit is not available. | Compliance with Written Authority Required procedures |
| C13222 | | Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)
Initial PBS‑subsidised treatment in a child
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.
Patient must be of an age that is prior to their 19thbirthday at the time of this authority application; AND
Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rdbirthday, but before their 19thbirthday (SMA type IIIB/IIIC).
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND
Patient must be undergoing initial PBS‑subsidised treatment for untreated disease ‑ prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); OR
Patient must be undergoing initial PBS‑subsidised treatment, but the patient has initiated treatment via non‑PBS supply (e.g. clinical trial, sponsor compassionate access) ‑ prescribe zero repeat prescriptions where loading doses are complete; AND
Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:
(i) Failure to meet or regression in ability to perform age‑appropriate motor milestones,
(ii) Proximal weakness,
(iii) Hypotonia,
(iv) Absence of deep tendon reflexes,
(v) Any active denervation or chronic neurogenic changes found on electromyography,
(vi) A compound muscle action potential below normative values for an age‑matched child.
In this authority application, confirm:
(1) the patient's medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,
(2) which of the above (i to vi) (at least 1) were present after their 3rdbirthday, but before their 19thbirthday,
(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed. | Compliance with Written Authority Required procedures |
| C13270 | | Spinal muscular atrophy (SMA)
Initial PBS‑subsidised treatment in an adult who did not initiate PBS subsidy during childhood
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.
Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND
Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19thbirthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS‑subsidised).
Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR
Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND
Patient must be undergoing initial PBS‑subsidised treatment for untreated disease ‑ prescribe up to 3 repeat prescriptions to enable dosing occurring at days: 0 (original prescription), 14 (repeat 1), 28 (repeat 2), 63 (repeat 3) (i.e. the loading doses); OR
Patient must be undergoing initial PBS‑subsidised treatment, but the patient has initiated treatment via non‑PBS supply (e.g. clinical trial, sponsor compassionate access) ‑ prescribe zero repeat prescriptions where loading doses are complete; AND
Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:
(i) Failure to meet or regression in ability to perform age‑appropriate motor milestones,
(ii) Proximal weakness,
(iii) Hypotonia,
(iv) Absence of deep tendon reflexes,
(v) Failure to gain weight appropriate for age,
(vi) Any active denervation or chronic neurogenic changes found on electromyography,
(vii) A compound muscle action potential below normative values for an age‑matched child.
In this authority application, confirm:
(1) the patient's medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,
(2) which of the above (i to vii) (at least 1) were present during childhood,
(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed. | Compliance with Written Authority Required procedures |
| C14370 | | Spinal muscular atrophy (SMA) Changing the prescribed therapy Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated after the patient's 19thbirthday; AND Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment. Patient must be untreated with gene therapy; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. The prescriber has given consideration to whether a 'wash out' period is recommended or not prior to changing the prescribed therapy. | Compliance with Authority Required procedures |
| C14421 | | Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA) Changing the prescribed therapy Patient must be undergoing a change in prescribed SMA drug to this drug - the drug treatment being replaced was a PBS benefit initiated prior to the patient's 19thbirthday for SMA type IIIB/IIIC; AND Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS-subsidised disease modifying treatment. Patient must be untreated with gene therapy; AND Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. The prescriber has given consideration to whether a 'wash out' period is recommended or not prior to changing the prescribed therapy. | Compliance with Authority Required procedures |
| C14433 | | Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)
Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood
The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND
Patient must be undergoing continuation of existing PBS‑subsidised treatment with this drug; AND
Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. | Compliance with Authority Required procedures |
| C14459 | | Spinal muscular atrophy (SMA)
Continuing/maintenance treatment in an adult where treatment was initiated in adulthood
The treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; OR
The treatment must be occurring within the first 104 weeks from the first administered dose; AND
Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.
Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR
Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND
Patient must be undergoing continuation of existing PBS‑subsidised treatment with this drug; AND
Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response.
A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline.
PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present.
Undertake re‑assessments for a clinically meaningful response at least every six months. Document these re‑assessments in the patient's medical records.
In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient's motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale ‑ Expanded (HFMSE) or 6‑minute walk test (6MWT), and the patient's quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA‑HI) or SMA Functional Rating Scale (SMAFRS). | Compliance with Authority Required procedures |
| C15066 | | Pre-symptomatic spinal muscular atrophy (SMA)
Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 1 or 2 copies of the SMN2 gene - Loading doses
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
The condition must be pre-symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND
The treatment must be given concomitantly with best supportive care for this condition; AND
The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND
Patient must be untreated with gene therapy.
Patient must be aged under 36 months prior to commencing treatment.
Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:
(a) a completed authority prescription form; and
(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:
(i) confirmation of genetic diagnosis of SMA; and
(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA) | Compliance with Written Authority Required procedures |
| C15069 | | Spinal muscular atrophy (SMA) Continuing/maintenance treatment of either symptomatic Type I, II or IIIa SMA, or of a patient commenced on this drug under the pre-symptomatic SMA (1 or 2 copies of the SMN2 gene) listing Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND Patient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy. Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND The treatment must be given concomitantly with best supportive care for this condition; AND The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug. Patient must have been 18 years of age or younger at the time of initial treatment with this drug. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required. | Compliance with Authority Required procedures |
| C15112 | | Spinal muscular atrophy (SMA) Continuing/maintenance treatment of a patient commenced on this drug under the pre-symptomatic SMA (3 copies of the SMN2 gene) listing Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or initiated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND Patient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy. Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR Patient must be eligible for continuing PBS-subsidised treatment with risdiplam for this condition; AND The treatment must not be in combination with PBS-subsidised treatment with risdiplam for this condition; AND The treatment must be given concomitantly with best supportive care for this condition; AND The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug. Patient must have been 18 years of age or younger at the time of initial treatment with this drug. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. In a patient who wishes to switch from PBS-subsidised risdiplam to PBS-subsidised nusinersen for this condition a wash out period may be required. | Compliance with Authority Required procedures |
| C15116 | | Pre-symptomatic spinal muscular atrophy (SMA)
Initial treatment of pre-symptomatic spinal muscular atrophy (SMA) with 3 copies of the SMN2 gene - Loading doses
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
The condition must be pre-symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND
The treatment must be given concomitantly with best supportive care for this condition; AND
The treatment must not exceed four loading doses (at days 0, 14, 28 and 63) under this restriction; AND
Patient must be untreated with gene therapy.
Patient must be aged under 36 months prior to commencing treatment.
Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:
(a) a completed authority prescription form; and
(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:
(i) confirmation of genetic diagnosis of SMA; and
(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA) | Compliance with Written Authority Required procedures |
Ocrelizumab | C7386 | | Multiple sclerosis
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7386 |
| C7699 | | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7699 |
| C9523 | | Multiple sclerosis
Initial treatment
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
The condition must be diagnosed as clinically definite relapsing‑remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS‑subsidised disease modifying therapy for this condition; AND
Patient must be ambulatory (without assistance or support).
Must be treated by a neurologist.
Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9523 |
| C9635 | | Multiple sclerosis
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not show continuing progression of disability while on treatment with this drug; AND
The treatment must be the sole PBS‑subsidised disease modifying therapy for this condition; AND
Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
Must be treated by a neurologist. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9635 |
Octreotide | C5901 | | Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5901 |
| C5906 | | Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections, AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months’ therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5906 |
| C6369 | | Vasoactive intestinal peptide secreting tumour (VIPoma) The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6369 |
| C6390 | | Functional carcinoid tumour The condition must be causing intractable symptoms; AND Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy. Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6390 |
| C8161 | | Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS‑subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8161 |
| C8165 | | Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
The treatment must not be given concomitantly with PBS‑subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8165 |
| C8197 | | Acromegaly
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS‑subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8197 |
| C8198 | | Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8198 |
| C8208 | | Functional carcinoid tumour
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 8208 |
| C9232 | | Vasoactive intestinal peptide secreting tumour (VIPoma)
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9232 |
| C9233 | | Acromegaly
The condition must be active; AND
Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
The treatment must be after failure of other therapy including dopamine agonists; OR
The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; OR
The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 times daily; AND
The treatment must not be given concomitantly with PBS‑subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9233 |
| C9262 | | Acromegaly
The condition must be controlled with octreotide immediate release injections; AND
The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
The treatment must not be given concomitantly with PBS‑subsidised lanreotide or pegvisomant for this condition.
In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9262 |
| C9288 | | Vasoactive intestinal peptide secreting tumour (VIPoma)
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9288 |
| C9289 | | Functional carcinoid tumour
The condition must be causing intractable symptoms; AND
Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti‑histamines, anti‑serotonin agents and anti‑diarrhoea agents; AND
Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months’ therapy.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9289 |
| C9313 | | Functional carcinoid tumour
Patient must have achieved symptom control on octreotide immediate release injections; AND
The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9313 |
| C10061 | | Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10061 |
| C10075 | | Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10075 |
| C10077 | | Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)
The condition must be unresectable locally advanced disease or metastatic disease; AND
The condition must be World Health Organisation (WHO) grade 1 or 2; AND
The treatment must be the sole PBS‑subsidised therapy for this condition.
Patient must be aged 18 years or older.
WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10077 |
Omalizumab | C7046 | | Severe chronic spontaneous urticaria Continuing treatment Must be treated by a clinical immunologist; OR Must be treated by an allergist; OR Must be treated by a dermatologist; OR Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU). Patient must have demonstrated a response to the most recent PBS‑subsidised treatment with this drug for this condition; AND Patient must not receive more than 24 weeks per authorised course of treatment under this restriction. | Compliance with Authority Required procedures |
| C7055 | | Severe chronic spontaneous urticaria Initial treatment Must be treated by a clinical immunologist; OR Must be treated by an allergist; OR Must be treated by a dermatologist; OR Must be treated by a general physician with expertise in the management of chronic spontaneous urticaria (CSU). The condition must be based on both physical examination and patient history (to exclude any factors that may be triggering the urticaria); AND Patient must have experienced itch and hives that persist on a daily basis for at least 6 weeks despite treatment with H1 antihistamines; AND Patient must have failed to achieve an adequate response after a minimum of 2 weeks treatment with a standard therapy; AND Patient must not receive more than 12 weeks of treatment under this restriction. A standard therapy is defined as a combination of therapies that includes H1 antihistamines at maximally tolerated doses in accordance with clinical guidelines, and one of the following: 1) a H2 receptor antagonist (150 mg twice per day); or 2) a leukotriene receptor antagonist (LTRA) (10 mg per day); or 3) doxepin (up to 25 mg three times a day) If the requirement for treatment with H1 antihistamines and a H2 receptor antagonist, or a leukotriene receptor antagonist or doxepin cannot be met because of contraindications according to the relevant TGA‑approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the authority application. A failure to achieve an adequate response to standard therapy is defined as a current Urticaria Activity Score 7 (UAS7) score of equal to or greater than 28 with an itch score of greater than 8, as assessed while still on standard therapy. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Chronic Spontaneous Urticaria Omalizumab Initial PBS Authority Application ‑ Supporting Information Form which must include: (i) demonstration of failure to achieve an adequate response to standard therapy; and (ii) drug names and doses of standard therapies that the patient has failed; and (iii) a signed patient acknowledgment that cessation of therapy should be considered after the patient has demonstrated clinical benefit with omalizumab to re‑evaluate the need for continued therapy. Any patient who ceases therapy and whose CSU relapses will need to re‑initiate PBS‑subsidised omalizumab as a new patient. | Compliance with Written Authority Required procedures |
| C15346 | | Uncontrolled severe asthma Initial treatment - Initial 2 (Change of treatment) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND Patient must have past or current evidence of atopy, documented by skin prick testing or an in vitro measure of specific IgE in the past 12 months or in the 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to initiating PBS-subsidised treatment with a biological medicine for severe asthma; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change therapy to this biological medicine, must be accompanied by the results of an ACQ-5 assessment of the patient's most recent course of PBS-subsidised biological medicine treatment. The assessment must have been made not more than 4 weeks after the last dose of biological medicine. Where a response assessment was not undertaken, the patient will be deemed to have failed to respond to treatment with that previous biological medicine. An ACQ-5 assessment of the patient may be made at the time of application for treatment (to establish a new baseline score), but should be made again around 28 weeks after the first PBS-subsidised dose of this biological medicine under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this biological medicine. At the time of the authority application, medical practitioners should request an appropriate maximum quantity based on IgE level and body weight (refer to the TGA-approved Product Information) to be administered every 2 to 4 weeks and up to 7 repeats to provide for an initial course sufficient for up to 32 weeks of therapy. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5 item version) score (where a new baseline is being submitted or where the patient has responded to prior treatment); and (b) details (date and duration of treatment) of prior biological medicine treatment; and (c) the IgE results and date; and (d) if applicable, the dose of the maintenance oral corticosteroid (where the response criteria or baseline is based on corticosteroid dose); and (e) the reason for switching therapy (e.g. failure of prior therapy, partial response to prior therapy, adverse event to prior therapy). | Compliance with Written Authority Required procedures |
| C15347 | | Uncontrolled severe asthma Continuing treatment Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must have received this drug as their most recent course of PBS-subsidised biological agent treatment for this condition in this treatment cycle; AND Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma; AND Patient must not receive more than 24 weeks of treatment under this restriction. Patient must be aged 12 years or older. An adequate response to omalizumab treatment is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ-5) score of at least 0.5 from baseline, OR (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 score from baseline or an increase in ACQ-5 score from baseline less than or equal to 0.5, OR (c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline (this criterion is only applicable for patients transitioned from the paediatric to the adolescent/adult restriction). All applications for second and subsequent continuing treatments with this drug must include a measurement of response to the prior course of therapy. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to the prior course of treatment, the assessment of oral corticosteroid dose or the assessment of time adjusted exacerbation rate should be made from 20 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated. The assessment should, where possible, be completed by the same physician who initiated treatment with this drug. Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with this drug. Where treatment was ceased for clinical reasons despite the patient experiencing improvement, an assessment of the patient's response to treatment made at the time of treatment cessation or retrospectively will be considered to determine whether the patient demonstrated or sustained an adequate response to treatment. A patient who fails to respond to treatment with this biological medicine for uncontrolled severe asthma will not be eligible to receive further PBS-subsidised treatment with this biological medicine for severe asthma within the current treatment cycle. At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of this biological medicine consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for up to 24 weeks of therapy. The following information must be provided at the time of application and must be documented in the patient's medical records: (a) Asthma Control Questionnaire (ACQ-5) score; and (b) If applicable, maintenance oral corticosteroid dose; and (c) For patients transitioned from the paediatric to the adolescent/adult restrictions, confirmation that the time-adjusted exacerbation rate has reduced. The most recent Asthma Control Questionnaire (ACQ-5) score must be no more than 4 weeks old at the time of application. | Compliance with Authority Required procedures |
| C15350 | | Uncontrolled severe allergic asthma Initial treatment Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either: a (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma in consultation with a respiratory physician, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility, (b) airway hyperresponsiveness, (c) peak expiratory flow (PEF) variability; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have past or current evidence of atopy, documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND Patient must not receive more than 28 weeks of treatment under this restriction. Patient must be aged 6 to less than 12 years. Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. Patient must be under the care of the same physician for at least 6 months. Optimised asthma therapy includes: (i) Adherence to optimal inhaled therapy, including high dose inhaled corticosteroid (ICS) and long-acting beta-2 agonist (LABA) therapy for at least six months. If LABA therapy is contraindicated, not tolerated or not effective, montelukast, cromoglycate or nedocromil may be used as an alternative; AND (ii) treatment with at least 2 courses of oral or IV corticosteroids (daily or alternate day maintenance treatment courses, or 3-5 day exacerbation treatment courses), in the previous 12 months, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications (including those specified in the relevant TGA-approved Product Information) and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) An Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month (for children aged 6 to 10 years it is recommended that the Interviewer Administered version - the ACQ-IA be used), AND (b) while receiving optimised asthma therapy in the previous 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) or ACQ-IA assessment of the patient's response to this initial course of treatment, the assessment of oral corticosteroid dose, and the assessment of exacerbation rate should be made at around 24 weeks after the first dose so that there is adequate time for a response to be demonstrated and for the application for continuing therapy to be processed. This assessment, which will be used to determine eligibility for continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with omalizumab. A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased. At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab of up to 28 weeks, consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) details of prior optimised asthma drug therapy (dosage, date of commencement and duration of therapy); and (b) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (c) the IgE result and date; and (d) Asthma Control Questionnaire (ACQ-5) score; or (e) Asthma Control Questionnaire interviewer administered version (ACQ-IA) score. | Compliance with Written Authority Required procedures |
| C15352 | | Uncontrolled severe allergic asthma Continuing treatment Patient must have a documented history of severe allergic asthma; AND Patient must have demonstrated or sustained an adequate response to PBS-subsidised treatment with this drug for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction. Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. An adequate response to omalizumab treatment is defined as: (a) a reduction in the Asthma Control Questionnaire (ACQ-5) or ACQ-IA score of at least 0.5 from baseline, OR (b) maintenance oral corticosteroid dose reduced by at least 25% from baseline, and no deterioration in ACQ-5 or ACQ-IA score from baseline, OR (c) a reduction in the time-adjusted exacerbation rates compared to the 12 months prior to baseline. A measurement of response to the prior course of therapy must be provided at the time of application and should be used to determine eligibility for continuing treatment. The Asthma Control Questionnaire (5 item version) or Asthma Control Questionnaire interviewer administered version (ACQ-IA) assessment of the patient's response to the prior course of treatment, the assessment of systemic corticosteroid dose, and the assessment of time-adjusted exacerbation rate should be made from 20 weeks after the first dose of PBS-subsidised omalizumab so that there is adequate time for a response to be demonstrated. The first assessment should, where possible, be completed by the same physician who initiated treatment with omalizumab. Where a response assessment is not undertaken and provided at the time of application, the patient will be deemed to have failed to respond to treatment with omalizumab. A patient who fails to respond to a course of PBS-subsidised omalizumab for the treatment of uncontrolled severe allergic asthma will not be eligible to receive further PBS-subsidised treatment with omalizumab for this condition within 6 months of the date on which treatment was ceased. At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide for a continuing course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information), sufficient for 24 weeks of therapy. The following information must be provided at the time of application and must be documented in the patient's medical records: (a) If applicable, the baseline and maintenance oral corticosteroid dose; and (b) baseline and current Asthma Control Questionnaire (ACQ-5) date and score; or (c) baseline and current Asthma Control Questionnaire interviewer administered version (ACQ-IA) date and score; and (d) if applicable, confirmation that the time-adjusted exacerbation rate has reduced. The most recent Asthma Control Questionnaire (ACQ-5) score or Asthma Control Questionnaire interviewer administered version (ACQ-IA) score must be no more than 4 weeks old at the time of application. | Compliance with Authority Required procedures |
| C15376 | | Uncontrolled severe asthma Balance of supply Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must have received insufficient therapy with this drug under the Initial 1 (new patients or recommencement of treatment in a new treatment cycle) restriction to complete 32 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Initial 2 (change of treatment) restriction to complete 32 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must not provide more than the balance of up to 32 weeks of treatment if the most recent authority approval was made under an Initial treatment restriction; OR The treatment must not provide more than the balance of up to 24 weeks of treatment if the most recent authority approval was made under the Continuing treatment restriction. | Compliance with Authority Required procedures |
| C15401 | | Uncontrolled severe asthma Initial treatment - Initial 1 (New patients; or Recommencement of treatment in a new treatment cycle following a break in PBS subsidised biological medicine therapy) Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma. Patient must be under the care of the same physician for at least 6 months; OR Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND Patient must not have received PBS-subsidised treatment with a biological medicine for severe asthma; OR Patient must have had a break in treatment of at least 12 months from the most recently approved PBS-subsidised biological medicine for severe asthma; AND Patient must have a diagnosis of asthma confirmed and documented in the patient's medical records by either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma, defined by at least one of the following standard clinical features: (a) forced expiratory volume (FEV1) reversibility greater than or equal to 12% and greater than or equal to 200 mL at baseline within 30 minutes after administration of salbutamol (200 to 400 micrograms), (b) airway hyperresponsiveness defined as a greater than 20% decline in FEV1 during a direct bronchial provocation test or greater than 15% decline during an indirect bronchial provocation test, (c) peak expiratory flow (PEF) variability of greater than 15% between the two highest and two lowest peak expiratory flow rates during 14 days; OR Patient must have a diagnosis of asthma from at least two physicians experienced in the management of patients with severe asthma with the details documented in the patient's medical records; AND Patient must have a duration of asthma of at least 1 year; AND Patient must have past or current evidence of atopy that is no more than 1 year old at the time of application that is documented by either: (i) skin prick testing, (ii) an in vitro measure of specific IgE; AND Patient must have total serum human immunoglobulin E of at least 30 IU/mL, measured no more than 12 months prior to the time of application; AND Patient must have failed to achieve adequate control with optimised asthma therapy, despite formal assessment of and adherence to correct inhaler technique, which has been documented in the patient's medical records; AND Patient must not receive more than 32 weeks of treatment under this restriction; AND The treatment must not be used in combination with and within 4 weeks of another PBS-subsidised biological medicine prescribed for severe asthma. Patient must be aged 12 years or older. Optimised asthma therapy includes: (i) Adherence to maximal inhaled therapy, including high dose inhaled corticosteroid (ICS) plus long-acting beta-2 agonist (LABA) therapy for at least 12 months, unless contraindicated or not tolerated; AND (ii) treatment with oral corticosteroids, either daily oral corticosteroids for at least 6 weeks, OR a cumulative dose of oral corticosteroids of at least 500 mg prednisolone equivalent in the previous 12 months, unless contraindicated or not tolerated. If the requirement for treatment with optimised asthma therapy cannot be met because of contraindications according to the relevant TGA-approved Product Information and/or intolerances of a severity necessitating permanent treatment withdrawal, details of the contraindication and/or intolerance must be provided in the Authority application. The following initiation criteria indicate failure to achieve adequate control and must be demonstrated in all patients at the time of the application: (a) an Asthma Control Questionnaire (ACQ-5) score of at least 2.0, as assessed in the previous month, AND (b) while receiving optimised asthma therapy in the past 12 months, experienced at least 1 admission to hospital for a severe asthma exacerbation, OR 1 severe asthma exacerbation, requiring documented use of systemic corticosteroids (oral corticosteroids initiated or increased for at least 3 days, or parenteral corticosteroids) prescribed/supervised by a physician. The Asthma Control Questionnaire (5 item version) assessment of the patient's response to this initial course of treatment, and the assessment of oral corticosteroid dose, should be made at around 28 weeks after the first PBS-subsidised dose of this drug under this restriction so that there is adequate time for a response to be demonstrated and for the application for the first continuing therapy to be processed. This assessment, which will be used to determine eligibility for the first continuing treatment, should be conducted within 4 weeks of the last dose of biological medicine. Where a response assessment is not undertaken and provided, the patient will be deemed to have failed to respond to treatment with this drug. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for severe asthma within the same treatment cycle. A treatment break in PBS-subsidised biological medicine therapy of at least 12 months must be observed in a patient who has either failed to achieve or sustain a response to treatment with 4 biological medicines for severe asthma within the same treatment cycle. The length of the break in therapy is measured from the date the most recent treatment with a PBS-subsidised biological medicine was administered until the date of the first application for recommencement of treatment with a biological medicine under the new treatment cycle. There is no limit to the number of treatment cycles that a patient may undertake in their lifetime. At the time of the authority application, medical practitioners should request the appropriate maximum quantity and number of repeats to provide for an initial course of omalizumab consisting of the recommended number of doses for the baseline IgE level and body weight of the patient (refer to the TGA-approved Product Information) to be administered every 2 or 4 weeks. A multidisciplinary severe asthma clinic team comprises of: (i) A respiratory physician; and (ii) A pharmacist, nurse or asthma educator. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) details of prior optimised asthma drug therapy (dosage, date of commencement, duration of therapy); and (b) If applicable, details of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to standard therapy according to the relevant TGA-approved Product Information; and (c) details of severe exacerbation/s experienced in the past 12 months while receiving optimised asthma therapy (date and treatment); and (d) the IgE result and date; and (e) Asthma Control Questionnaire (ACQ-5) score. | Compliance with Written Authority Required procedures |
| C15403 | | Uncontrolled severe allergic asthma Balance of supply in a patient aged 6 to 12 years Must be treated by a medical practitioner who is either a: (i) paediatric respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) paediatrician or general physician experienced in the management of patients with severe asthma, in consultation with a respiratory physician. Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete 28 weeks treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks treatment; AND The treatment must provide no more than the balance of up to 28 weeks treatment available under the Initial restriction or up to 24 weeks treatment available under the Continuing restriction. | Compliance with Authority Required procedures |
Onasemnogene abeparvovec | C12639 | | Spinal muscular atrophy (SMA)
Use in a patient untreated with disease modifying therapies for this condition
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
Patient must have experienced at least two of the defined signs/symptoms of Type 1 SMA specified below; OR
The condition must be pre‑symptomatic SMA, with genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND
The treatment must not be a PBS‑subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND
The treatment must be given concomitantly with best supportive care for this condition.
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND
Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND
Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND
Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.
Patient must be no older than 9 months of age; AND
Patient must have symptomatic Type 1 SMA; OR
Patient must have pre‑symptomatic SMA.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Prescribing Instructions:
In the relevant PBS Authority Application form, specify the following:
(i) the SMA type being treated: symptomatic Type 1 SMA, or, pre‑symptomatic SMA;
(ii) for Type 1 SMA, the signs/symptoms that the patient has experienced, together with the patient's age at the onset of these signs/symptoms.
State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.
Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:
(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or
(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.
If the condition is pre‑symptomatic SMA, confirm that there is genetic test finding that substantiates the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).
Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient.
Defined signs and symptoms of type I SMA are:
i) Onset before 6 months of age; and
ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age‑matched child. | Compliance with Written Authority Required procedures |
| C14468 | | Spinal muscular atrophy (SMA)
Use in a patient untreated with disease modifying therapies for this condition
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
The condition must be pre‑symptomatic SMA, with genetic confirmation that there are 3 copies of the survival motor neuron 2 (SMN2) gene; AND
The treatment must not be a PBS‑subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND
The treatment must be given concomitantly with best supportive care for this condition.
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND
Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND
Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND
Patient must not be undergoing treatment with this pharmaceutical benefit through this listing where prior treatment has occurred with any of: (i) nusinersen, (ii) risdiplam.
Patient must be no older than 9 months of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials.
Confirm that genetic testing has been completed to demonstrate the following in support of an SMA diagnosis:
(i) 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; or
(ii) deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variance in the remaining single copy of the SMN1 gene.
Confirm that there is a genetic test finding that substantiates the number of SMN2 gene copies to be 3 and has been determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA).
Quote the date, pathology provider name and any unique identifying serial number/code that links the genetic test result to the patient. | Compliance with Written Authority Required procedures |
| C15458 | | Spinal muscular atrophy (SMA) Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen to onasemnogene abeparvovec) The treatment must be given concomitantly with best supportive care for this condition; AND The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes. Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased. Patient must be no older than 9 months of age; AND Patient must have pre-symptomatic SMA with 3 copies of the SMN2 gene. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA. Confirm that a previous PBS authority application has been approved for pre-symptomatic SMA with 3 copies of SMN2 gene. State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials. Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit. | Compliance with Written Authority Required procedures |
| C15460 | | Spinal muscular atrophy (SMA) Use occurring after treatment with at least one disease modifying therapy for this condition (i.e. switching from nusinersen/risdiplam to onasemnogene abeparvovec) The treatment must be given concomitantly with best supportive care for this condition; AND The treatment must not be a PBS-subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes. Patient must be undergoing treatment with this pharmaceutical benefit following prior PBS-subsidised treatment with at least one other disease modifying therapy for this condition; AND Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; AND Must be treated in a treatment centre that is each of: (i) recognised in the management of SMA, (ii) accredited in the use of this gene technology by the relevant authority, (iii) will(has) source(d) this product from an accredited supplier, as specified in the administrative notes to this listing; AND Patient must be undergoing treatment with this pharmaceutical benefit once only in a lifetime; AND Patient must be undergoing treatment with this pharmaceutical benefit with the intent that treatment with the replaced disease modifying agent is/has ceased. Patient must be no older than 9 months of age; AND Patient must have symptomatic Type 1 SMA; OR Patient must have pre-symptomatic SMA with 1-2 copies of SMN2 gene. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA. Confirm that a previous PBS authority application has been approved for one of the following: (i) Symptomatic Type 1 SMA; or (ii) Pre-symptomatic SMA with 1-2 copies of SMN2 gene. State the weight of the patient in kilograms and request the appropriate product pack presentation with respect to the mix of 5.5 mL and 8.3 mL vials. Adhere to any Product Information or local treatment guidelines with respect to treatment-free ('wash out') periods prior to administering this benefit. | Compliance with Written Authority Required procedures |
Pamidronic Acid | C4433 | | Hypercalcaemia of malignancy Patient must have a malignancy refractory to anti‑neoplastic therapy | Compliance with Authority Required procedures – Streamlined Authority Code 4433 |
| C5218 | | Multiple Myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5218 |
| C5291 | | Bone metastases The condition must be due to breast cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5291 |
| C9234 | | Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9234 |
| C9315 | | Bone metastases
The condition must be due to breast cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9315 |
| C9335 | | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9335 |
Pasireotide | C9088 | | Acromegaly
Initial treatment
Patient must not have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have a mean growth hormone (GH) level greater than 1 microgram per litre or 3 mlU/L; OR
Patient must have an age‑ and sex‑adjusted insulin‑like growth factor 1 (IGF‑1) concentration greater than the upper limit of normal (ULN); AND
The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND
The treatment must not be given concomitantly with PBS‑subsidised pegvisomant.
Patient must be aged 18 years or older.
If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of contraindication.
If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.
Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:
1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR
2) IGF‑1 level is greater than the age‑ and sex‑adjusted ULN.
In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as:
1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR
2) normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1)
The authority application must be made in writing and must include:
a) a completed authority prescription form; and
b) a completed Acromegaly PBS Authority Application ‑ Supporting Information Form; and
c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; the date and result of GH or IGF‑1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided; and
d) a recent result of GH or IGF‑1 levels must be provided. | Compliance with Written Authority Required procedures |
| C9089 | | Acromegaly
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must not be given concomitantly with PBS‑subsidised pegvisomant.
Patient must be aged 18 years or older.
In a patient treated with radiotherapy, pasireotide should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pasireotide should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as:
1) Growth hormone (GH) levels of less than 1 mcg/L or 3 mlU/L; OR
2) normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1)
In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy and the GH and IGF‑1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of approval. | Compliance with Authority Required procedures |
Patisiran | C15453 | | Hereditary transthyretin amyloidosis Initial treatment Patient must have either: (i) stage 1 polyneuropathy, (ii) stage 2 polyneuropathy. Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication. Patient must be at least 18 years of age. The condition must be hereditary transthyretin amyloidosis confirmed by genetic testing; AND Patient must have a Polyneuropathy Disability (PND) score description of either I, II, IIIA, IIIB; OR Patient must have a Familial Amyloid Polyneuropathy (FAP) stage description of 1 or 2; AND Patient must not have previously undergone a liver transplant; AND Patient must not exhibit heart failure symptoms (defined as New York Heart Association NYHA class III or IV). Must be treated by a consultant with experience in the management of amyloid disorders or in consultation with a consultant with experience in the management of amyloid disorders; AND Patient must be undergoing treatment with this drug as a monotherapy (i.e. not in combination with any other disease modifying medicines for amyloidosis disorders). PND scores in the context of this PBS restriction are: Stage 0 - No symptoms; Stage I - Sensory disturbances but preserved walking capability; Stage II - Impaired walking capacity but able to walk without stick or crutches; Stage IIIA - Walking with help of one stick or crutch; Stage IIIB - Walking with help of two sticks or crutches; Stage IV - Confined to wheelchair or bedridden. FAP stage in the context of this PBS restriction are: Stage 0 - No symptoms; Stage 1 - Unimpaired ambulation; Stage 2 - Assistance with ambulation required; Stage 3 - Wheelchair-bound or bedridden. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C15478 | | Hereditary transthyretin amyloidosis Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received treatment with this drug for this condition prior to 1 August 2024; AND Patient must continue to demonstrate clinical benefit; AND Patient must not be permanently bedridden; OR Patient must not be receiving end-of-life care. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C15501 | | Hereditary transthyretin amyloidosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must continue to demonstrate clinical benefit; AND Patient must not be permanently bedridden; OR Patient must not be receiving end-of-life care. Applications for authorisation under this treatment phase must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
Pegcetacoplan | C13616 | | Paroxysmal nocturnal haemoglobinuria (PNH)
First continuing treatment
Patient must have received PBS‑subsidised treatment with this drug for this condition under the 'Initial' or 'Grandfather' treatment restriction; AND
The treatment must not be in combination with a Complement 5 (C5) inhibitor.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) | Compliance with Written Authority Required procedures |
| C13655 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment (new patient)
Patient must not have received prior treatment with this drug for this condition; AND
Patient must have PNH granulocyte clone size equal to or greater than 10% within the last 3 months; AND
Patient must have experienced an inadequate response to a complement 5 (C5) inhibitor demonstrated by a haemoglobin level of less than 105 g/L; OR
Patient must be intolerant to C5 inhibitors as determined by the treating physician; AND
Patient must have received treatment with at least one C5 inhibitor for at least 3 months before initiating treatment with this drug unless intolerance of severity necessitating permanent treatment withdrawal had occurred; AND
The treatment must be in combination with one PBS‑subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) | Compliance with Written Authority Required procedures |
| C13710 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Return from PBS‑subsidised eculizumab post pregnancy or from PBS‑subsidised Complement 5 (C5) inhibitor for reasons other than post pregnancy
Patient must have received prior PBS‑subsidised treatment with this drug for this condition; AND
Patient must have received prior PBS‑subsidised treatment with eculizumab through the 'Initial treatment ‑ Initial 3 (switching from PBS‑subsidised pegcetacoplan for pregnancy (induction doses)' criteria; OR
Patient must have received prior PBS‑subsidised treatment with at least one C5 inhibitor and returning to pegcetacoplan treatment for reasons other than post pregnancy; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
The treatment must be in combination with one PBS‑subsidised C5 inhibitor for a period of 4 weeks during initiation of therapy.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place)
For the purposes of family planning, patient may qualify under this treatment phase more than once. To return to pegcetacoplan treatment for reasons other than post pregnancy, patient may qualify under this treatment phase once only in any 12 consecutive months. Where long‑term continuing PBS‑subsidised treatment with pegcetacoplan is planned, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria of pegcetacoplan. | Compliance with Written Authority Required procedures |
| C13743 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Subsequent continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Return' criteria; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
The treatment must not be in combination with a Complement 5 (C5) inhibitor.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
Patient must be at least 18 years of age.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners must request the appropriate number of vials for 4 weeks supply per dispensing as per the Product Information. A maximum of 5 repeats may be requested. | Compliance with Written Authority Required procedures |
Pegfilgrastim | C7822 | | Chemotherapy‑induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7822 |
| C7843 | | Chemotherapy‑induced neutropenia Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 7843 |
| C9235 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must be at greater than 20% risk of developing febrile neutropenia; OR
Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9235 |
| C9303 | | Chemotherapy‑induced neutropenia
Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
Patient must have had a prior episode of febrile neutropenia; OR
Patient must have had a prior episode of prolonged severe neutropenia for more than or equal to seven days. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9303 |
Peginterferon
alfa‑2a | C5004 | | Chronic hepatitis C infection
Must be treated in an accredited treatment centre.
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child‑bearing age.
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
Patient must have a contraindication to ribavirin; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must be limited to a maximum duration of 48 weeks.
Evidence of chronic hepatitis C infection (repeatedly anti‑HCV positive and HCV RNA positive) must be documented in the patient’s medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5004 |
| C9603 | | Chronic hepatitis C infection
Must be treated in an accredited treatment centre.
Patient must be aged 18 years or older; AND
Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child‑bearing age.
Patient must have compensated liver disease; AND
Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C; AND
Patient must have a contraindication to ribavirin; AND
The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop; AND
The treatment must be limited to a maximum duration of 48 weeks.
Evidence of chronic hepatitis C infection (repeatedly anti‑HCV positive and HCV RNA positive) must be documented in the patient’s medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9603 |
Pegvisomant | C7087 | | Acromegaly Continuing treatment Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND The treatment must not be given concomitantly with a PBS‑subsidised somatostatin analogue; AND The treatment must cease if IGF‑1 is not lower after 3 months of pegvisomant treatment at the maximum tolerated dose. Somatostatin analogues include octreotide, lanreotide and pasireotide In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission. Biochemical evidence of remission is defined as normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1). In a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy must be provided; and a copy of IGF‑1 level taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy must be provided at the time of application. | Compliance with Authority Required procedures |
| C9041 | | Acromegaly
Initial treatment
Patient must not have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have an age‑ and sex‑adjusted insulin‑like growth factor 1 (IGF‑1) concentration greater than the upper limit of normal (ULN); AND
The treatment must be after failure to achieve biochemical control with a maximum indicated dose of either 30 mg octreotide LAR or 120 mg lanreotide ATG every 28 days for 24 weeks; unless contraindicated or not tolerated according to the TGA approved Product Information; AND
The treatment must not be given concomitantly with a PBS‑subsidised somatostatin analogue.
Somatostatin analogues include octreotide, lanreotide and pasireotide
Failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide is defined as:
1) Growth hormone level greater than 1 mcg/L or 3 mIU/L; OR
2) IGF‑1 level is greater than the age‑ and sex‑adjusted ULN.
If treatment with either octreotide or lanreotide is contraindicated according to the relevant TGA‑approved Product Information, the application must provide details of contraindication.
If intolerance to either octreotide or lanreotide treatment developed during the relevant period of use which is of a severity to necessitate withdrawal of the treatment, the application must provide details of the nature and severity of this intolerance.
In a patient treated with radiotherapy, pegvisomant should be withdrawn every 2 years in the 10 years after completion of radiotherapy for assessment of remission. Pegvisomant should be withdrawn at least 8 weeks prior to the assessment of remission.
Biochemical evidence of remission is defined as normalisation of sex‑ and age‑ adjusted insulin‑like growth factor 1 (IGF‑1).
Two completed authority prescriptions should be submitted with the initial application for this drug. One prescription should be for the loading dose of 80 mg for a quantity of 4 vials of 20 mg with no repeats. The second prescription should be for subsequent doses, starting from 10 mg daily, and allowing dose adjustments in increments of 5 mg based on serum IGF‑1 levels measured every 4 to 6 weeks in order to maintain the serum IGF‑1 level within the age‑adjusted normal range based on the dosage recommendations in the TGA‑approved Product Information.
The authority application must be made in writing and must include:
a) two completed authority prescription forms ; and
b) a completed Acromegaly Pegvisomant initial PBS Authority Application ‑ Supporting Information Form; and
c) in a patient who has been previously treated with radiotherapy for this condition, the date of completion of radiotherapy, the date and result of IGF‑1 levels taken at the most recent two yearly assessment in the 10 years after completion of radiotherapy; and
d) a recent result of the IGF‑1 level and the date of assessment ; and
e) demonstration of failure to achieve biochemical control after completion of a prior therapy with either octreotide or lanreotide
No increase in the maximum quantity or number of units may be authorised for the loading dose. | Compliance with Written Authority Required procedures |
Plerixafor | C4549 | | Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte‑colony stimulating factor (G‑CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G‑CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G‑CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient’s medical records | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4549 |
| C9329 | | Mobilisation of haematopoietic stem cells
The treatment must be in combination with granulocyte‑colony stimulating factor (G‑CSF); AND
Patient must have lymphoma; OR
Patient must have multiple myeloma; AND
Patient must require autologous stem cell transplantation; AND
Patient must have failed previous stem cell collection; OR
Patient must be undergoing chemotherapy plus G‑CSF mobilisation and their peripheral blood CD34+ count is less than 10,000 per millilitre or less than 10 million per litre on the day of planned collection; OR
Patient must be undergoing chemotherapy plus G‑CSF mobilisation and the first apheresis has yielded less than 1 million CD34+ cells/kg.
Evidence that the patient meets the PBS restriction criteria must be recorded in the patient’s medical records. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9329 |
Pomalidomide | C13746 | | Multiple myeloma
Initial treatment ‑ dual therapy in combination with dexamethasone
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have undergone or be ineligible for a primary stem cell transplant; AND
Patient must have experienced treatment failure with lenalidomide, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information; AND
Patient must have experienced treatment failure with bortezomib, unless contraindicated or not tolerated according to the Therapeutic Goods Administration (TGA) approved Product Information.
Bortezomib treatment failure is the absence of achieving at least a partial response or as progressive disease during treatment or within 6 months of discontinuing treatment with bortezomib. Lenalidomide treatment failure is progressive disease during treatment or within 6 months of discontinuing treatment with lenalidomide.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(1) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with lenalidomide, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to lenalidomide according to the relevant TGA‑approved Product Information; and
(2) details (date, unique identifying number/code or provider number) of the reports demonstrating the patient has failed treatment with bortezomib, including the dates of treatment or the details of the contraindication to or details of the nature and severity of the intolerance to bortezomib according to the relevant TGA‑approved Product Information.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C13755 | | Multiple myeloma
Continuing treatment ‑ dual therapy in combination with dexamethasone
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
The treatment must form part of dual combination therapy limited to: (i) this drug, (ii) dexamethasone.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause). | Compliance with Authority Required procedures |
| C13757 | | Multiple myeloma
Initial treatment with triple therapy (this drug, bortezomib and dexamethasone)
The condition must be confirmed by a histological diagnosis; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy that is either: (i) lenalidomide monotherapy, (ii) contains lenalidomide; AND
Patient must have undergone or be ineligible for a stem cell transplant.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C13768 | | Multiple myeloma
Continuing treatment with triple therapy (this drug, bortezomib and dexamethasone)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; AND
Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
Raltegravir | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Ravulizumab | C13459 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Return from PBS‑subsidised pegcetacoplan ‑ induction doses
Patient must have received PBS‑subsidised treatment with at least one Complement 5 (C5) inhibitor for this condition; AND
Patient must have received PBS‑subsidised treatment with pegcetacoplan for this condition; AND
Patient must have developed resistance or intolerance to pegcetacoplan; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
For continuing PBS‑subsidised treatment with this drug, a 'Returning' patient must proceed under the 'Subsequent Continuing Treatment' criteria. | Compliance with Written Authority Required procedures |
| C14476 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Subsequent Continuing Treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the 'First Continuing Treatment' or 'Return' criteria; AND
Patient must have experienced clinical improvement as a result of treatment with this drug; OR
Patient must have experienced a stabilisation of the condition as a result of treatment with this drug; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested. | Compliance with Written Authority Required procedures |
| C14477 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment ‑ Initial 1 (new patient) induction dose
Patient must not have received prior treatment with this drug for this condition; AND
Patient must have a diagnosis of PNH established by flow cytometry; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10%; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Written Authority Required procedures |
| C14530 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Grandfather (transition from non‑PBS‑subsidised treatment)
Patient must have received non‑PBS‑subsidised treatment with this drug for this condition prior to 1 March 2022; AND
Patient must have a diagnosis of PNH established by flow cytometry prior to commencing treatment with ravulizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to commencing treatment with ravulizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to commencing treatment with ravulizumab; AND
Patient must have demonstrated clinical improvement or stabilisation of condition, the details of which must be kept with the patient's record; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to commencing treatment with ravulizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to commencing treatment with ravulizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to commencing treatment with ravulizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to commencing treatment with ravulizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to commencing treatment with ravulizumab; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Written Authority Required procedures |
| C14531 | | Paroxysmal nocturnal haemoglobinuria (PNH)
First Continuing Treatment
Patient must have received PBS‑subsidised treatment with this drug for this condition under the 'Initial' or 'Grandfather' treatment restriction; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners should request the appropriate number of vials for a maintenance dose based on the patient's weight, as per the Product Information. A maximum of 2 repeats may be requested.
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) | Compliance with Written Authority Required procedures |
| C14565 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Initial treatment ‑ Initial 2 (switch from LSDP eculizumab) induction dose
Patient must have previously received eculizumab for the treatment of this condition funded under the Australian Government's Life Saving Drugs Program (LSDP); AND
Patient must have a diagnosis of PNH established by flow cytometry prior to LSDP‑funded treatment with eculizumab; AND
Patient must have a PNH granulocyte clone size equal to or greater than 10% prior to LSDP‑funded treatment with eculizumab; AND
Patient must have a raised lactate dehydrogenase value at least 1.5 times the upper limit of normal prior to LSDP‑funded treatment with eculizumab; AND
Patient must have experienced a thrombotic/embolic event which required anticoagulant therapy prior to LSDP‑funded treatment with eculizumab; OR
Patient must have been transfused with at least 4 units of red blood cells in the last 12 months prior to LSDP‑funded treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 70 g/L in the absence of anaemia symptoms prior to LSDP‑funded treatment with eculizumab; OR
Patient must have chronic/recurrent anaemia, where causes other than haemolysis have been excluded, together with multiple haemoglobin measurements not exceeding 100 g/L in addition to having anaemia symptoms prior to LSDP‑funded treatment with eculizumab; OR
Patient must have debilitating shortness of breath/chest pain resulting in limitation of normal activity (New York Heart Association Class III) and/or established diagnosis of pulmonary arterial hypertension, where causes other than PNH have been excluded prior to LSDP‑funded treatment with eculizumab; OR
Patient must have a history of renal insufficiency, demonstrated by an eGFR less than or equal to 60 mL/min/1.73m2, where causes other than PNH have been excluded prior to LSDP‑funded treatment with eculizumab; OR
Patient must have recurrent episodes of severe pain requiring hospitalisation and/or narcotic analgesia, where causes other than PNH have been excluded prior to LSDP‑funded treatment with eculizumab; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information
At the time of the authority application, details (result and date of result) of the following monitoring requirements must be provided:
(i) Haemoglobin (g/L)
(ii) Platelets (x109/L)
(iii) White Cell Count (x109/L)
(iv) Reticulocytes (x109/L)
(v) Neutrophils (x109/L)
(vi) Granulocyte clone size (%)
(vii) Lactate Dehydrogenase (LDH)
(viii) the upper limit of normal (ULN) for LDH as quoted by the reporting laboratory
(ix) the LDH:ULN ratio (in figures, rounded to one decimal place) must be at least 1.5 | Compliance with Written Authority Required procedures |
| C14586 | | Paroxysmal nocturnal haemoglobinuria (PNH)
Return from PBS‑subsidised eculizumab ‑ induction dose
Patient must have received prior PBS‑subsidised treatment with this drug for this condition; AND
Patient must have received prior PBS‑subsidised treatment with eculizumab through the 'Initial treatment ‑ Initial 2 (switching from PBS‑subsidised ravulizumab for pregnancy)' criteria; AND
The treatment must not be in combination with any of (i) another Complement 5 (C5) inhibitor, (ii) pegcetacoplan.
Must be treated by a haematologist; OR
Must be treated by a non‑specialist medical physician who has consulted a haematologist on the patient's drug treatment details.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
At the time of the authority application, medical practitioners should request the appropriate number of vials for a single loading dose based on the patient's weight, as per the Product Information
Patient may qualify under this treatment phase more than once for the purposes of family planning. Where long‑term continuing PBS‑subsidised treatment with this drug is planned, a 'Returning' patient may proceed under the 'Subsequent Continuing Treatment' criteria. | Compliance with Written Authority Required procedures |
| C14744 | | Atypical haemolytic uraemic syndrome (aHUS)
Switch from PBS-subsidised eculizumab (all phases) - loading dose
Patient must have previously received PBS-subsidised eculizumab under the 'Initial treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised eculizumab under the 'Continuing treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised eculizumab under the 'Extended continuing treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised eculizumab under the 'Recommencement of treatment' restriction for this condition; OR
Patient must have previously received PBS-subsidised eculizumab under the 'Continuing recommencement of treatment' restriction for this condition; AND
Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
Patient must not receive more than 2 weeks of treatment under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
The application must indicate the most recent treatment phase that the patient is switching from.
For patients who are switching C5 inhibitors, the next application should be sought under the next relevant treatment phase.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted. | Compliance with Written Authority Required procedures |
| C14746 | | Atypical haemolytic uraemic syndrome (aHUS)
Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
Patient must have previously received non-PBS-subsidised therapy with this drug for this condition; AND
Patient must have met all other PBS eligibility criteria that a non-'Grandfather' patient would ordinarily be required to meet, meaning that at the time non-PBS supply was commenced, the patient: (i) had active and progressing thrombotic microangiopathy (TMA) caused by aHUS; (ii) had ADAMTS-13 activity of greater than or equal to 10% on a blood sample not confounded by any plasma exchange or infusion; (iii) had a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days of commencing ravulizumab treatment; (iv) had clinical features of active organ damage or impairment; AND
Patient must have demonstrated ongoing treatment response with ravulizumab for this condition if received at least 26 weeks of initial non-PBS-subsidised therapy; AND
Patient must not have experienced treatment failure with ravulizumab for this condition if they have received at least 26 weeks of initial non-PBS-subsidised therapy.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
Evidence of active and progressing TMA is defined by the following:
(1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; or
(2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and
(3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one or more of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients;
(iv) a renal biopsy consistent with aHUS;
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment.
Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.
The prescriber's cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A detailed cover letter from the prescriber;
(4) A measurement of body weight at the time of application;
(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the two weeks prior to collection of the ADAMTS-13 assay;
(6) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days of initiating treatment with non-PBS-subsidised ravulizumab;
(7) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of commencement of non-PBS-subsidised ravulizumab;
(8) For patients who have received at least 26 weeks of ravulizumab treatment, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application. | Compliance with Written Authority Required procedures |
| C14747 | | Atypical haemolytic uraemic syndrome (aHUS)
Extended continuing treatment
Patient must have received PBS-subsidised ravulizumab under the continuing treatment phase for this condition; OR
Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; OR
Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the extended continuing treatment phase for this condition; AND
Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; AND
Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND
Patient must have a TMA-related cardiomyopathy as evidenced by left ventricular ejection fraction < 40% on current objective measurement; OR
Patient must have severe TMA-related neurological impairment; OR
Patient must have severe TMA-related gastrointestinal impairment; OR
Patient must have severe TMA-related pulmonary impairment on current objective measurement; OR
Patient must have grade 4 or 5 chronic kidney disease (eGFR of less than 30 mL/min); OR
Patient must have a high risk of aHUS recurrence in the short term in the absence of continued treatment with ravulizumab; AND
Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
(2) One of the following:
a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
A treatment failure is defined as a patient who is:
(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted;
(5) A family history of aHUS, if applicable;
(6) A history of multiple episodes of aHUS before commencing ravulizumab treatment, if applicable;
(7) A history of kidney transplant, if applicable (especially if required due to aHUS);
(8) An inclusion of the individual consequences of recurrent disease;
(9) A supporting statement with clinical evidence of severe TMA-related cardiomyopathy (including current LVEF result), neurological impairment, gastrointestinal impairment or pulmonary impairment;
(10) Evidence that the patient has had a treatment response including haematological results of no more than 4 weeks old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 4 weeks old at the time of application;
(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;
(12) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab. | Compliance with Written Authority Required procedures |
| C14748 | | Atypical haemolytic uraemic syndrome (aHUS)
Balance of Supply - maintenance doses
Patient must have received PBS-subsidised loading dose of ravulizumab for this condition for this current treatment phase; AND
Patient must have/had ADAMTS-13 activity of greater than or equal to 10% on a blood sample; AND
Patient must have received insufficient therapy to complete the maximum allowable treatment under their specified treatment phase; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the relevant treatment phase.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
ADAMTS-13 activity result must have been submitted to Services Australia. In the case that a sample for ADAMTS-13 activity taken prior to plasma exchange or infusion was not available at the time of application for Initial treatment, ADAMTS-13 activity must have been measured 7-10 days following the last plasma exchange or infusion and must have been submitted to Services Australia within 13 days of commencement of ravulizumab. The date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of the last, if any, plasma exchange or infusion that was undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay must also have been provided to Services Australia.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment. | Compliance with Written Authority Required procedures |
| C14749 | | Atypical haemolytic uraemic syndrome (aHUS)
Continuing treatment
Patient must have received PBS-subsidised ravulizumab under the initial treatment phase for this condition; OR
Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab in the continuing treatment phase for this condition; OR
Patient must have received PBS-subsidised ravulizumab under the grandfather restriction for this condition; AND
Patient must have demonstrated ongoing treatment response with PBS-subsidised ravulizumab for this condition; AND
Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND
Patient must not receive more than 72 weeks of ravulizumab treatment in total under this restriction; OR
Patient must not receive more than 104 weeks supply of a C5 inhibitor under the initial and continuing treatment restrictions if they had switched C5 inhibitors during the course of initial and continuing treatment; AND
Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
(2) One of the following:
a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
A treatment failure is defined as a patient who is:
(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted;
(5) A family history of aHUS, if applicable;
(6) A history of kidney transplant if applicable (especially if required due to aHUS);
(7) An inclusion of the individual consequences of recurrent disease, if applicable;
(8) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;
(9) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;
(10) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab. | Compliance with Written Authority Required procedures |
| C14780 | | Atypical haemolytic uraemic syndrome (aHUS)
Initial treatment - Initial (new patient) loading dose
Patient must have active and progressing thrombotic microangiopathy (TMA) caused by aHUS; AND
Patient must have ADAMTS-13 activity of greater than or equal to 10% on a blood sample taken prior to plasma exchange or infusion; or, if ADAMTS-13 activity was not collected prior to plasma exchange or infusion, patient must have platelet counts of greater than 30x10^9/L and a serum creatinine of greater than 150 mol/L; AND
Patient must have a confirmed negative STEC (Shiga toxin-producing E.Coli) result if the patient has had diarrhoea in the preceding 14 days; AND
Patient must have clinical features of active organ damage or impairment; AND
Patient must not receive more than 2 weeks of treatment under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
Evidence of active and progressing TMA is defined by the following:
(1) A platelet count of less than 150x10^9/L; and evidence of at least two of the following:
(i) presence of schistocytes on blood film;
(ii) low or absent haptoglobin;
(iii) lactate dehydrogenase (LDH) above normal range; or
(2) In recipients of a kidney transplant for end-stage kidney disease due to aHUS, a kidney biopsy confirming TMA; and
(3) Evidence of at least one of the following clinical features of active TMA-related organ damage or impairment is defined as below:
(a) kidney impairment as demonstrated by one or more of the following:
(i) a decline in estimated Glomerular Filtration Rate (eGFR) of greater than 20% in a patient who has pre-existing kidney impairment;
(ii) a serum creatinine (sCr) of greater than the upper limit of normal (ULN) in a patient who has no history of pre-existing kidney impairment;
(iii) a sCr of greater than the age-appropriate ULN in paediatric patients;
(iv) a renal biopsy consistent with aHUS;
(b) onset of TMA-related neurological impairment;
(c) onset of TMA-related cardiac impairment;
(d) onset of TMA-related gastrointestinal impairment;
(e) onset of TMA-related pulmonary impairment.
Claims of non-renal TMA-related organ damage should be made at the point of application for initial PBS-subsidised ravulizumab (where possible), and should be supported by objective clinical measures.
The prescriber's cover letter should establish that the observed organ damage is directly linked to active and progressing TMA, particularly when indirect causes such as severe thrombocytopenia, hypertension and acute renal failure are present at the time of the initial organ impairment.
Serial haematological results (every 3 months while the patient is receiving treatment) must be provided with every subsequent application for treatment.
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A detailed cover letter from the prescriber;
(4) A measurement of body weight at the time of application;
(5) The result of ADAMTS-13 activity on a blood sample taken prior to plasma exchange or infusion; the date and time that the sample for the ADAMTS-13 assay was collected, and the dates and times of any plasma exchanges or infusions that were undertaken in the 2 weeks prior to collection of the ADAMTS-13 assay;
(6) In the case that a sample for ADAMTS-13 assay was not collected prior to plasma exchange or infusion, measurement of ADAMTS-13 activity must be taken 7-10 days following the last plasma exchange or infusion. The ADAMTS-13 result must be submitted to Services Australia within 13 days of commencement of ravulizumab treatment in order for the patient to be considered as eligible for further PBS-subsidised C5 inhibitor treatment, under Initial balance of supply;
(7) A confirmed negative STEC result if the patient has had diarrhoea in the preceding 14 days;
(8) Evidence of active and progressing TMA, including pathology results where relevant. Evidence of the onset of TMA-related neurological, cardiac, gastrointestinal or pulmonary impairment requires a supporting statement with clinical evidence in patient records. All tests must have been performed within 4 weeks of application;
(9) For all patients, a recent measurement of eGFR, platelets and two of either LDH, haptoglobin or schistocytes of no more than 1 week old at the time of application.
Two authority prescription forms will be required to cover for the 26 weeks of initial therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply. | Compliance with Written Authority Required procedures |
| C14791 | | Atypical haemolytic uraemic syndrome (aHUS)
Recommencement of treatment
Patient must have demonstrated treatment response to previous treatment with a PBS-subsidised C5 inhibitor for this condition; AND
Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND
Patient must have the following clinical conditions prior to recommencing C5 inhibitor treatment: (i) either significant haemolysis as measured by low/absent haptoglobin; or presence of schistocytes on the blood film; or lactate dehydrogenase (LDH) above normal; AND (ii) either platelet consumption as measured by either 25% decline from patient baseline or thrombocytopenia (platelet count <150 x 10^9/L); OR (iii) TMA-related organ impairment including on recent biopsy.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
(2) One of the following:
a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
A treatment failure is defined as a patient who is:
(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted;
(5) A family history of aHUS if applicable;
(6) A history of multiple episodes of aHUS following the treatment break, if applicable;
(7) A history of kidney transplant if applicable (especially if required due to aHUS);
(8) An inclusion of the individual consequences of recurrent disease;
(9) A supporting statement with clinical evidence of TMA-related organ damage including current (within one week of application) haematological results (platelet count, haptoglobin and LDH), eGFR level, and, if applicable, on recent biopsy;
(10) Evidence that the patient has had a treatment response to their previous treatment with a C5 inhibitor;
(11) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;
(12) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
Two authority prescription forms will be required to cover for the 26 weeks of recommencement therapy with ravulizumab, one for the loading dose and one for the 24 week balance which can be sought under the Balance of Supply. | Compliance with Written Authority Required procedures |
| C14797 | | Atypical haemolytic uraemic syndrome (aHUS)
Continuing recommencement of treatment
Patient must have received PBS-subsidised ravulizumab under the 'Recommencement of treatment' restriction for this condition; OR
Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab 'Recommencement treatment' restriction for this condition; OR
Patient must have received PBS-subsidised ravulizumab under the switch from eculizumab 'Continuing recommencement treatment' restriction for this condition; AND
Patient must have demonstrated ongoing treatment response to 'Recommencement of treatment' with a C5 inhibitor for this condition; AND
Patient must not have experienced treatment failure with ravulizumab for this condition in the most recent treatment phase; AND
Patient must not receive more than 24 weeks of treatment with ravulizumab per continuing treatment course authorised under this restriction.
Must be treated by a prescriber who is either: (i) a haematologist, (ii) a nephrologist; OR
Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
Patient must be undergoing treatment with one C5 inhibitor therapy only at any given time.
This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.
A treatment response is defined as:
(1) Normalisation of haematology as demonstrated by at least 2 of the following: (i) platelet count, (ii) haptoglobin, (iii) lactate dehydrogenase (LDH); and
(2) One of the following:
a) an increase in eGFR of > 25% from baseline, where the baseline is the eGFR measurement immediately prior to commencing treatment with a C5 inhibitor; or
b) an eGFR within +/- 25% from baseline; or
c) an avoidance of dialysis-dependence but worsening of kidney function with a reduction in eGFR 25% from baseline.
PBS-subsidised treatment with ravulizumab will not be permitted if a patient has experienced treatment failure with ravulizumab in the most recent treatment phase prior to the treatment phase where this application is sought.
A treatment failure is defined as a patient who is:
(1) Dialysis-dependent at the time of application and has failed to demonstrate significant resolution of extra-renal complications if originally presented; or
(2) On dialysis and has been on dialysis for 4 months of the previous 6 months while receiving a PBS-subsidised C5 inhibitor, and has failed to demonstrate significant resolution of extra-renal complications if originally presented.
The authority application must include the following measures of response to the prior course of treatment, including serial haematological results (every 3 months while the patient is receiving treatment).
The authority application must be in writing and must include all of the following:
(1) A completed authority prescription form(s);
(2) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice);
(3) A measurement of body weight at the time of application;
(4) Results of genetic testing, if not previously submitted;
(5) A family history of aHUS, if applicable;
(6) A history of multiple episodes of aHUS before recommencing ravulizumab treatment, if applicable;
(7) A history of kidney transplant if applicable (especially if required due to aHUS);
(8) An inclusion of the individual consequences of recurrent disease, if applicable;
(9) Evidence that the patient has had a treatment response including haematological results of no more than 1 week old at the time of application (platelet count, haptoglobin and LDH); and an eGFR level of no more than 1 week old at the time of application;
(10) Evidence that the patient has not experienced treatment failure, including a supporting statement with clinical evidence that the patient does not require dialysis, unless the indication for continuing ravulizumab is severe extra-renal complications that have significantly improved;
(11) If the indication for continuing ravulizumab is severe extra-renal complications, then a supporting statement with clinical evidence that any initial extra-renal complications of TMA have significantly improved is required.
This assessment must be submitted no later than 4 weeks from the cessation of the prior treatment. Where a response assessment is not undertaken and submitted within these timeframes, the patient will be deemed to have failed to respond to treatment with ravulizumab | Compliance with Written Authority Required procedures |
Ribavirin | C5957 | | Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
Patient must not be pregnant or breastfeeding. Female partners of male patients must not be pregnant. Patients and their partners must each be using an effective form of contraception if of child‑bearing age. | Compliance with Authority Required procedures |
Rifabutin | C6350 | | Mycobacterium avium complex infection Patient must be human immunodeficiency virus (HIV) positive. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6350 |
| C6356 | | Mycobacterium avium complex infection The treatment must be for prophylaxis; AND Patient must be human immunodeficiency virus (HIV) positive; AND Patient must have CD4 cell counts of less than 75 per cubic millimetre. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6356 |
| C9560 | | Mycobacterium avium complex infection
Patient must be human immunodeficiency virus (HIV) positive. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9560 |
| C9622 | | Mycobacterium avium complex infection
The treatment must be for prophylaxis; AND
Patient must be human immunodeficiency virus (HIV) positive; AND
Patient must have CD4 cell counts of less than 75 per cubic millimetre. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9622 |
Rilpivirine | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Riociguat | C13502 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13514 | | Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2‑week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA‑approved Product Information. No repeats will be authorised for these prescriptions.
Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA‑approved Product Information, and a maximum of 4 repeats. | Compliance with Authority Required procedures |
| C13515 | | Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
Patient must have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
Approvals for prescriptions for dose titration will provide sufficient quantity for dose titrations by 0.5 mg increments at 2‑week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA‑approved Product Information. No repeats will be authorised for these prescriptions.
Approvals for subsequent authority prescription will be limited to 1 month of treatment, with the quantity approved based on the dosage recommendations in the TGA‑approved Product Information, and a maximum of 4 repeats. | Compliance with Written Authority Required procedures |
| C15271 | | Chronic thromboembolic pulmonary hypertension (CTEPH) Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must demonstrate stable or responding disease; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated in a centre with expertise in the management of CTEPH. Patient must be at least 18 years of age. Response to this drug is defined as follows: For patients with two or more baseline tests, response to treatment is defined as two or more tests demonstrating stability or improvement of disease. For patients with a RHC composite assessment alone at baseline, response to treatment is defined as a RHC result demonstrating stability or improvement of disease. For patients with an ECHO composite assessment alone at baseline, response to treatment is defined as an ECHO result demonstrating stability or improvement of disease. Test requirements to establish response to treatment for continuation of treatment are as follows: The following list outlines the preferred test combination, in descending order, for the purposes of continuation of PBS-subsidised treatment: (1) RHC plus ECHO composite assessments plus 6MWT; (2) RHC plus ECHO composite assessments; (3) RHC composite assessment plus 6MWT; (4) ECHO composite assessment plus 6MWT; (5) RHC composite assessment only; (6) ECHO composite assessment only. The results of the same tests as conducted at baseline should be documented in the patient's medical record with each continuing treatment application (i.e., every 6 months), except for patients who were able to undergo all 3 tests at baseline, and whose subsequent ECHO and 6MWT results demonstrate disease stability or improvement, in which case RHC can be omitted. In all other patients, where the same test(s) conducted at baseline cannot be performed for assessment of response on clinical grounds, a patient specific reason why the test(s) could not be conducted must be documented in the patient's medical records. The test results conducted for continuing treatment must be no more than 2 months old at the time of application. The assessment of the patient's response to the continuing 6 month courses of treatment should be made following the preceding 5 months of treatment, in order to allow sufficient time for a response to be demonstrated. The maximum quantity per prescription must be based on the dosage recommendations in the TGA-approved Product Information and be limited to provide sufficient supply for 1 month of treatment. A maximum of 5 repeats will be authorised. Patients who fail to demonstrate disease stability or improvement to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent. | Compliance with Authority Required procedures |
| C15272 | | Chronic thromboembolic pulmonary hypertension (CTEPH) Balance of supply Patient must have received insufficient therapy with this drug under the Initial treatment restriction to complete a maximum of 20 weeks of treatment; OR Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete a maximum of 24 weeks of treatment; AND The treatment must provide no more than the balance of up to 20 or 24 weeks of treatment available under the above respective restriction; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated in a centre with expertise in the management of CTEPH. Patient must be at least 18 years of age. | Compliance with Authority Required procedures |
| C15274 | | Chronic thromboembolic pulmonary hypertension (CTEPH) Initial treatment Patient must have WHO Functional Class II, III or IV CTEPH; AND The condition must be inoperable by pulmonary endarterectomy; OR The condition must be recurrent or persistent following pulmonary endarterectomy; AND The treatment must be the sole PBS-subsidised therapy for this condition. Must be treated in a centre with expertise in the management of CTEPH. Patient must be at least 18 years of age. CTEPH that is inoperable by pulmonary endarterectomy is defined as follows: (a) Right heart catheterisation (RHC) demonstrating pulmonary vascular resistance (PVR) of greater than 300 dyn*sec*cm-5measured at least 90 days after start of full anticoagulation; and (b) A mean pulmonary artery pressure (PAPmean) of greater than 25 mmHg at least 90 days after start of full anticoagulation. CTEPH that is recurrent or persistent subsequent to pulmonary endarterectomy is defined as follows: RHC demonstrating a PVR of greater than 300 dyn*sec*cm-5measured at least 180 days following pulmonary endarterectomy. Where a RHC cannot be performed due to right ventricular dysfunction, an echocardiogram demonstrating the dysfunction must be documented in the patient's medical records. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) a completed authority prescription form; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). The following must be provided at the time of application and documented in the patient's medical records: (a) the results from the 3 tests below, to establish baseline measurements, where available: (i) RHC composite assessment, and (ii) ECHO composite assessment, and (iii) 6 Minute Walk Test (6MWT); and (b) confirmation of evidence of inoperable CTEPH including the pulmonary vascular resistance (PVR) value, a mean pulmonary artery pressure (PAPmean) and the starting date of full anticoagulation; or (c) confirmation of evidence of recurrent or persistent CTEPH including the PVR value and the date that pulmonary endarterectomy was performed; or (d) confirmation of an echocardiogram demonstrating right ventricular dysfunction. Where it is not possible to perform all 3 tests above on clinical grounds, the expected test combination, in descending order of preference is: (1) RHC plus ECHO composite assessments; (2) RHC composite assessment plus 6MWT; (3) RHC composite assessment only. In circumstance where a RHC cannot be performed on clinical grounds, the expected test combinations, in descending order of preference is: (1) ECHO composite assessment plus 6MWT; (2) ECHO composite assessment only. Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be documented in the patient's medical records. The test results provided must not be more than 2 months old at the time of application. Prescriptions for dose titration must provide sufficient quantity for dose titrations by 0.5 mg increments at 2-week intervals to achieve up to a maximum of 2.5 mg three times daily based on the dosage recommendations for initiation of treatment in the TGA-approved Product Information. No repeats will be authorised for these prescriptions. Approvals for subsequent authority prescription will be limited to 1 month of treatment, The quantity approved must be based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 3 repeats. The assessment of the patient's response to the initial 20-week course of treatment should be made following the preceding 16 weeks of treatment, in order to allow sufficient time for a response to be demonstrated. Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent. | Compliance with Written Authority Required procedures |
Risdiplam | C14368 | | Spinal muscular atrophy (SMA)
Initial PBS‑subsidised treatment with this drug in an adult who did not initiate PBS subsidy with this drug during childhood
Patient must be at least 19 years of age at the time of this authority application, but never claimed PBS subsidy for a disease modifying treatment during childhood; AND
Patient must have SMA where the onset of signs/symptoms (at least one) of SMA first occurred prior to their 19th birthday (SMA symptom onset after this age will be considered type IV SMA, which is not PBS‑subsidised).
Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR
Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND
Patient must be undergoing initial PBS‑subsidised treatment with this drug for untreated disease; OR
Patient must be undergoing initial PBS‑subsidised treatment, but the patient has initiated treatment via non‑PBS supply (e.g. clinical trial, sponsor compassionate access); AND
Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.
Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:
(i) Failure to meet or regression in ability to perform age‑appropriate motor milestones,
(ii) Proximal weakness,
(iii) Hypotonia,
(iv) Absence of deep tendon reflexes,
(v) Failure to gain weight appropriate for age,
(vi) Any active denervation or chronic neurogenic changes found on electromyography,
(vii) A compound muscle action potential below normative values for an age‑matched child.
In this authority application, confirm:
(1) the patient's medical history is consistent with a diagnosis of childhood onset spinal muscular atrophy,
(2) which of the above (i to vii) (at least 1) were present during childhood,
(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed. | Compliance with Written Authority Required procedures |
| C14372 | | Symptomatic Type I, II or IIIa spinal muscular atrophy (SMA)
Initial treatment
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
Patient must have experienced at least two of the defined signs and symptoms of SMA type I, II or IIIa prior to 3 years of age; AND
The treatment must be given concomitantly with best supportive care for this condition; AND
The treatment must not be in combination with PBS‑subsidised treatment with nusinersen for this condition; AND
The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic.
Patient must be untreated with gene therapy.
Patient must be 18 years of age or under.
Defined signs and symptoms of type I SMA are:
i) Onset before 6 months of age; and
ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age‑matched child.
Defined signs and symptoms of type II SMA are:
i) Onset between 6 and 18 months; and
ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or
iii) Proximal weakness; or
iv) Weakness in trunk righting/derotation; or
v) Hypotonia; or
vi) Absence of deep tendon reflexes; or
vii) Failure to gain weight appropriate for age; or
viii) Any active chronic neurogenic changes; or
ix) A compound muscle action potential below normative values for an age‑matched child.
Defined signs and symptoms of type IIIa SMA are:
i) Onset between 18 months and 3 years of age; and
ii) Failure to meet or regression in ability to perform age‑appropriate motor milestones; or
iii) Proximal weakness; or
iv) Hypotonia; or
v) Absence of deep tendon reflexes; or
vi) Failure to gain weight appropriate for age; or
vii) Any active chronic neurogenic changes; or
viii) A compound muscle action potential below normative values for an age‑matched child.
Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:
i) specification of SMA type (I, II or IIIa); and
(ii) sign(s) and symptom(s) that the patient has experienced; and
(iii) patient's age at the onset of sign(s) and symptom(s).
The approved Product Information recommended dosing is as follows:
(i) 16 days to less than 2 months of age: 0.15 mg/kg
(ii) 2 months to less than 2 years of age: 0.20 mg/kg
(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
(iv) 2 years of age and older weighing 20 kg or more: 5 mg
In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:
1 unit where (i) applies;
2 units where (ii) applies;
3 units where (iii) applies;
3 units where (iv) applies. | Compliance with Written Authority Required procedures |
| C14392 | | Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)
Continuing/maintenance treatment in a child or adult, but where treatment was initiated during childhood
Patient must be undergoing continuation of existing PBS‑subsidised treatment with this drug; OR
Patient must be undergoing a change in prescribed SMA drug to this drug ‑ the drug treatment being replaced was a PBS benefit initiated prior to the patient's 19th birthday for SMA type IIIB/IIIC; AND
Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR
Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND
Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug.
Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.
The approved Product Information recommended dosing is as follows:
(i) 16 days to less than 2 months of age: 0.15 mg/kg
(ii) 2 months to less than 2 years of age: 0.20 mg/kg
(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
(iv) 2 years of age and older weighing 20 kg or more: 5 mg
In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:
1 unit where (i) applies;
2 units where (ii) applies;
3 units where (iii) applies;
3 units where (iv) applies. | Compliance with Authority Required procedures |
| C14408 | | Symptomatic type IIIB/IIIC spinal muscular atrophy (SMA)
Initial PBS‑subsidised treatment with this drug in a child
Patient must be of an age that is prior to their 19th birthday at the time of this authority application; AND
Patient must have SMA type III where the onset of signs/symptoms of SMA first occurred after their 3rd birthday, but before their 19th birthday (SMA type IIIB/IIIC).
Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR
Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND
Patient must be undergoing initial PBS‑subsidised treatment with this drug for untreated disease; OR
Patient must be undergoing initial PBS‑subsidised treatment, but the patient has initiated treatment via non‑PBS supply (e.g. clinical trial, sponsor compassionate access); AND
Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.
Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Signs and symptoms of spinal muscular atrophy in the context of this PBS restriction are:
(i) Failure to meet or regression in ability to perform age‑appropriate motor milestones,
(ii) Proximal weakness,
(iii) Hypotonia,
(iv) Absence of deep tendon reflexes,
(v) Any active denervation or chronic neurogenic changes found on electromyography,
(vi) A compound muscle action potential below normative values for an age‑matched child.
In this authority application, confirm:
(1) the patient's medical history is consistent with a diagnosis of type IIIB/IIIC spinal muscular atrophy,
(2) which of the above (i to vi) (at least 1) were present after their 3rd birthday, but before their 19th birthday,
(3) the age of the patient (rounded to the nearest year) when the first sign/symptom was observed.
The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.
The approved Product Information recommended dosing is as follows:
(i) 16 days to less than 2 months of age: 0.15 mg/kg
(ii) 2 months to less than 2 years of age: 0.20 mg/kg
(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
(iv) 2 years of age and older weighing 20 kg or more: 5 mg
In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:
1 unit where (i) applies;
2 units where (ii) applies;
3 units where (iii) applies;
3 units where (iv) applies. | Compliance with Written Authority Required procedures |
| C14420 | | Spinal muscular atrophy (SMA)
Continuing/maintenance treatment in an adult where treatment was initiated in adulthood
Patient must be undergoing continuation of existing PBS‑subsidised treatment with this drug; OR
Patient must be undergoing a change in prescribed SMA drug to this drug ‑ the drug treatment being replaced was a PBS benefit initiated after the patient's 19th birthday; AND
Must be treated by a specialist medical practitioner experienced in the diagnosis/management of SMA; OR
Must be treated by a medical practitioner who has been directed to prescribe this benefit by a specialist medical practitioner experienced in the diagnosis/management of SMA; AND
Patient must be undergoing concomitant treatment with best supportive care, but this benefit is the sole PBS‑subsidised disease modifying treatment.
The treatment must be each of: (i) occurring from week 104 onwards relative to the first administered dose, (ii) demonstrating a clinically meaningful response; OR
The treatment must be occurring within the first 104 weeks from the first administered dose; AND
Patient must not be receiving invasive permanent assisted ventilation in the absence of a potentially reversible cause while being treated with this drug.
Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day.
Where this authority application seeks to continue treatment beyond the first 104 weeks of treatment, comprehensive assessment must be undertaken periodically and documented, involving the patient and the treating physician to establish agreement that treatment is continuing to produce a clinically meaningful response.
A clinically meaningful response is present where an improvement, stabilisation or minimal decline in symptoms has occurred as a result of this drug treatment and where there is agreement between the treating physician and patient over what constitutes improvement, stabilisation, or minimal decline.
PBS subsidy must cease if there is no agreement on whether a clinically meaningful response is present.
Undertake re‑assessments for a clinically meaningful response at least every six months. Document these re‑assessments in the patient's medical records.
In undertaking comprehensive assessments, where practical, a clinically meaningful response assessment encompasses the patient's motor function as assessed using an instrument like the Revised Upper Limb Module (RULM), Hammersmith Functional Motor Scale ‑ Expanded (HFMSE) or 6‑minute walk test (6MWT), and the patient's quality of life including, but not limited to, level of independence. Quality of life may be informed by use of the SMA Health Index (SMA‑HI) or SMA Functional Rating Scale (SMAFRS). | Compliance with Authority Required procedures |
| C14435 | | Spinal muscular atrophy (SMA)
Initial treatment occurring after onasemnogene abeparvovec therapy in a patient with Type 1 SMA
Patient must have experienced a regression in a developmental state listed below (see 'Definition') despite treatment with gene therapy ‑ confirm that this: (i) not due to an acute concomitant illness; (ii) not due to non‑compliance to best‑supportive care, (iii) apparent for at least 3 months, (iv) verified by another clinician in the treatment team ‑ state the full name of this clinician plus their profession (e.g. medical practitioner, nurse, physiotherapist; this is not an exhaustive list of examples); AND
The treatment must not be a PBS‑subsidised benefit where the condition has progressed to a point where invasive permanent assisted ventilation (i.e. ventilation via tracheostomy tube for at least 16 hours per day) is required in the absence of potentially reversible causes; AND
The treatment must be given concomitantly with best supportive care for this condition; AND
The treatment must not be in combination with PBS‑subsidised treatment with nusinersen for this condition.
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND
Patient must be undergoing treatment under this Treatment phase listing once only ‑ for continuing treatment beyond this authority application, refer to the drug's relevant 'Continuing treatment' listing for the patient's SMA type.
Patient must have a prior authority approval for any drug PBS‑listed for symptomatic Type 1 SMA, with at least one approval having been for gene therapy.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
Do not resubmit previously submitted documentation concerning the diagnosis and type of SMA.
Confirm that a previous PBS authority application has been approved for symptomatic Type 1 SMA.
Definition:
Various childhood developmental states (1 to 9) are listed below, some followed by further observations (a up to d). Where at least one developmental state/observation is no longer present, that developmental state has regressed.
0. Absence of developmental states (1 to 9) listed below:
1. Rolls from side to side on back;
2. Child holds head erect for at least 3 seconds unsupported;
3. Sitting, but with assistance;
4. Sitting without assistance:
(a) Child sits up straight with the head erect for at least 10 seconds;
(b) Child does not use arms or hands to balance body or support position.
5. Hands and knees crawling:
(a) Child alternately moves forward or backwards on hands and knees;
(b) The stomach does not touch the supporting surface;
(c) There are continuous and consecutive movements at least 3 in a row.
6. Standing with assistance:
(a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;
(b)The body does not touch the stable object, and the legs support most of the body weight;
(c) Child thus stands with assistance for at least 10 seconds.
7. Standing alone:
(a) Child stands in upright position on both feet (not on the toes) with the back straight;
(b) The leg supports 100% of the child's weight;
(c) There is no contact with a person or object;
(d) Child stands alone for at least 10 seconds.
8. Walking with assistance:
(a) Child is in an upright position with the back straight;
(b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;
(c) One leg moves forward while the other supports part of the body weight;
(d) Child takes at least 5 steps in this manner.
9. Walking alone:
(a) Child takes at least 5 steps independently in upright position with the back straight;
(b) One leg moves forward while the other supports most of the body weight;
(c) There is no contact with a person or object.
Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 ‑ 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient's current overall developmental state (i.e. a number that is lower than stated in (i).
Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS‑subsidy of this benefit is not available.
The approved Product Information recommended dosing is as follows:
(i) 16 days to less than 2 months of age: 0.15 mg/kg
(ii) 2 months to less than 2 years of age: 0.20 mg/kg
(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
(iv) 2 years of age and older weighing 20 kg or more: 5 mg
In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:
1 unit where (i) applies;
2 units where (ii) applies;
3 units where (iii) applies;
3 units where (iv) applies. | Compliance with Written Authority Required procedures |
| C14458 | | Pre‑symptomatic spinal muscular atrophy (SMA)
Initial treatment with this drug of pre‑symptomatic spinal muscular atrophy (SMA)
Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA; or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic of a recognised hospital in the management of SMA.
The condition must have genetic confirmation of 5q homozygous deletion of the survival motor neuron 1 (SMN1) gene; OR
The condition must have genetic confirmation of deletion of one copy of the SMN1 gene in addition to a pathogenic/likely pathogenic variant in the remaining single copy of the SMN1 gene; AND
The condition must have genetic confirmation that there are 1 to 2 copies of the survival motor neuron 2 (SMN2) gene; AND
The condition must be pre‑symptomatic; AND
The treatment must be given concomitantly with best supportive care for this condition; AND
Patient must be untreated with gene therapy.
Patient must be aged under 36 months prior to commencing treatment.
Application for authorisation of initial treatment must be in writing (lodged via postal service or electronic upload) and must include:
(a) a completed authority prescription form; and
(b) a completed Spinal muscular atrophy PBS Authority Application Form which includes the following:
(i) confirmation of genetic diagnosis of SMA; and
(ii) a copy of the results substantiating the number of SMN2 gene copies determined by quantitative polymerase chain reaction (qPCR) or multiple ligation dependent probe amplification (MLPA)
The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing.
The approved Product Information recommended dosing is as follows:
(i) 16 days to less than 2 months of age: 0.15 mg/kg
(ii) 2 months to less than 2 years of age: 0.20 mg/kg
(iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
(iv) 2 years of age and older weighing 20 kg or more: 5 mg
In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to:
1 unit where (i) applies;
2 units where (ii) applies;
3 units where (iii) applies;
3 units where (iv) applies. | Compliance with Written Authority Required procedures |
| C15095 | | Spinal muscular atrophy (SMA) Continuing/maintenance treatment with this drug of either symptomatic Type I, II or IIIa SMA, or, pre-symptomatic SMA (1 or 2 copies of the SMN2 gene) Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR Patient must be eligible for continuing PBS-subsidised treatment with nusinersen for this condition; AND The treatment must not be in combination with PBS-subsidised treatment with nusinersen for this condition; AND The treatment must be ceased when invasive permanent assisted ventilation is required in the absence of a potentially reversible cause while being treated with this drug; AND The treatment must be given concomitantly with best supportive care for this condition. Must be treated by a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic, or in consultation with a specialist medical practitioner experienced in the diagnosis and management of SMA associated with a neuromuscular clinic; AND Patient must not be undergoing treatment through this 'Continuing treatment' listing where the most recent PBS authority approval for this PBS indication has been for gene therapy. Patient must have been 18 years of age or younger at the time of initial treatment with this drug. Invasive permanent assisted ventilation means ventilation via tracheostomy tube for greater than or equal to 16 hours per day. In a patient who wishes to switch from PBS-subsidised nusinersen to PBS-subsidised risdiplam for this condition a wash out period may be required. The quantity of drug and number of repeat prescriptions prescribed is to be in accordance with the relevant 'Note' attached to this listing. The approved Product Information recommended dosing is as follows: (i) 16 days to less than 2 months of age: 0.15 mg/kg (ii) 2 months to less than 2 years of age: 0.20 mg/kg (iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg (iv) 2 years of age and older weighing 20 kg or more: 5 mg In this authority application, state which of (i) to (iv) above applies to the patient. Based on (i) to (iv), prescribe up to: 1 unit where (i) applies; 2 units where (ii) applies; 3 units where (iii) applies; 3 units where (iv) applies. | Compliance with Authority Required procedures |
Ritonavir | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Romiplostim | C13396 | | Severe thrombocytopenia
Second or Subsequent Continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have previously received PBS‑subsidised treatment with this drug for this condition under first continuing or re‑initiation of interrupted continuing treatment restriction; AND
Patient must have demonstrated a continuing response to PBS‑subsidised treatment with this drug; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
Authority approval will not be given for doses higher than 10 micrograms/kg/week | Compliance with Authority Required procedures |
| C14098 | | Severe thrombocytopenia
Initial treatment ‑ New patient
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have failed to achieve an adequate response to, or be intolerant to, corticosteroid therapy; AND
Patient must have failed to achieve an adequate response to, or be intolerant to, immunoglobulin therapy; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
The following criteria indicate failure to achieve an adequate response to corticosteroid and/or immunoglobulin therapy and must be demonstrated at the time of initial application;
(a) a platelet count of less than or equal to 20,000 million per L; OR
(b) a platelet count of 20,000 million to 30,000 million per L, where the patient is experiencing significant bleeding or has a history of significant bleeding in this platelet range.
The medical practitioner should request 1 vial of the appropriate strength, to titrate therapy based on the weight of the patient. A maximum of 5 repeats will be authorised.
Once a patient's dose has been stable for a period of 4 weeks, authority approvals for sufficient vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) for up to 4 weeks of treatment, may be requested under the Balance of supply or change of therapy restriction. The total period of treatment authorised under this restriction must not exceed 24 weeks.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
The authority application must be made via the online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include:
(a) details of a platelet count supporting the diagnosis of ITP.
All reports must be documented in the patient's medical records.
If the application is submitted through HPOS form upload or mail, it must include:
(i) A completed authority prescription form; and
(ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The platelet count must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records. | Compliance with Written Authority Required procedures |
| C14099 | | Severe thrombocytopenia
First Continuing treatment or Re‑initiation of interrupted continuing treatment
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
Patient must have demonstrated a sustained platelet response to PBS‑subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
Patient must have changed treatment from either eltrombopag or avatrombopag to this drug under the Balance of Supply/Change of therapy restriction and demonstrated a sustained response; OR
Patient must have demonstrated a sustained platelet response to the most recent PBS‑subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition.
For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
The medical practitioner should request sufficient number of vials of appropriate strength based on the weight of the patient and dose (microgram/kg/week) to provide 4 weeks of treatment. Up to a maximum of 5 repeats may be authorised.
Authority approval will not be given for doses higher than 10 micrograms/kg/week
The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS‑subsidised course of treatment with this drug and must be documented in the patient's medical records. | Compliance with Authority Required procedures
|
| C14149 | | Severe thrombocytopenia
Balance of supply or change of therapy
The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
The treatment must be the sole PBS‑subsidised thrombopoietin receptor agonist (TRA) for this condition; AND
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re‑initiation of interrupted continuing treatment restriction; OR
Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
Patient must be changing therapy from eltrombopag or avatrombopag to this drug for this condition; AND
The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
Patients receiving treatment with eltrombopag or avatrombopag may change to romiplostim under this restriction. | Compliance with Authority Required procedures
|
Ruxolitinib | C13876 | P13876 | Grade II to IV acute graft versus host disease (aGVHD)
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non‑response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non‑response of aGVHD.
The assessment of response must be documented in the patient's medical records.
Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13876 |
| C13892 | P13892 | Grade II to IV acute graft versus host disease (aGVHD)
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have responding disease compared with baseline after 14 days of treatment demonstrated by either a: (i) partial response (ii) complete response.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non‑response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non‑response of aGVHD.
The assessment of response must be documented in the patient's medical records.
Tapering the dose of corticosteroids should be considered in patients with responding disease. Following successful tapering of corticosteroids, tapering the dose of ruxolitinib can be initiated.
This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13892 |
| C13907 | P13907 | Grade II to IV acute graft versus host disease (aGVHD)
Initial treatment
Patient must have received prior systemic steroid treatment for this condition; AND
Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).
Steroid‑refractory disease is defined as:
(a) progression after at least 3 days of high‑dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II‑IV aGVHD; or
(b) failure to achieve a partial response after 5 days at the time of initiation of high‑dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II‑IV aGVHD.
Steroid‑dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:
(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or
(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.
Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.
Details of prior steroid use should be documented in the patient's medical records.
A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non‑response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non‑response of aGVHD.
The assessment of response must be documented in the patient's medical records.
This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13907 |
| C13911 | P13911 | Grade II to IV acute graft versus host disease (aGVHD)
Initial treatment
Patient must have received prior systemic steroid treatment for this condition; AND
Patient must be one of the following: (i) refractory to steroid treatment, (ii) dependent on steroid treatment, (iii) intolerant to steroid treatment.
Must be treated by a haematologist; OR
Must be treated by an oncologist with allogeneic bone marrow transplantation experience; OR
Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types.
The severity of aGVHD is defined by the Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016).
Steroid‑refractory disease is defined as:
(a) progression after at least 3 days of high‑dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II‑IV aGVHD; or
(b) failure to achieve a partial response after 5 days at the time of initiation of high‑dose systemic corticosteroid (methylprednisolone 2 mg/kg/day [or equivalent prednisone dose 2.5 mg/kg/day]) with or without calcineurin inhibitors for the treatment of Grade II‑IV aGVHD.
Steroid‑dependent disease is defined as failed corticosteroid taper involving either one of the following criteria:
(a) an increase in the corticosteroid dose to methylprednisolone of at least 2 mg/kg/day (or equivalent prednisone dose of at least 2.5 mg/kg/day); or
(b) failure to taper the methylprednisolone dose to less than 0.5 mg/kg/day (or equivalent prednisone dose less than 0.6 mg/kg/day) for a minimum of 7 days.
Steroid intolerance is defined as a patient developing an intolerance of a severity necessitating treatment withdrawal.
Details of prior steroid use should be documented in the patient's medical records.
A patient must demonstrate a response 14 days after initiating treatment with ruxolitinib to be eligible for continuing treatment.
Response is defined as attaining a complete or partial response as assessed by Mount Sinai Acute GVHD International Consortium (MAGIC) criteria (Harris et al., 2016). Note that response is relative to the assessment of organ function affected by aGVHD prior to commencing initial treatment with ruxolitinib.
(a) complete response is defined as a score of 0 for the aGVHD grade in all evaluable organs, indicating a complete resolution of all signs and symptoms of aGVHD, without the administration of any additional systemic therapies for any earlier progression, mixed response or non‑response of aGVHD.
(b) partial response is defined as an improvement of one stage, in at least one of the evaluable organs involved with aGVHD signs or symptoms, without disease progression in other organs or sites and without the administration of additional systemic therapies for any earlier progression, mixed response, or non‑response of aGVHD.
The assessment of response must be documented in the patient's medical records.
This drug is not PBS‑subsidised if it is prescribed to an in‑patient in a public hospital setting. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 13911 |
Selexipag | C11193 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
For the purposes of administering this restriction, disease progression has developed if at least one of the following has occurred:
(i) Hospitalisation due to worsening PAH;
(ii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6‑Minute Walk Distance from baseline, combined with worsening of WHO functional class status;
(iii) Deterioration of aerobic capacity/endurance, consisting of at least a 15% decrease in 6‑Minute Walk Distance from baseline, combined with the need for additional PAH‑specific therapy;
(iv) Initiation of parenteral prostanoid therapy or long‑term oxygen therapy for worsening of PAH;
(v) Need for lung transplantation or balloon atrial septostomy for worsening of PAH. | Compliance with Authority Required procedures |
| C11195 | | Pulmonary arterial hypertension (PAH)
Initial treatment following dose titration
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
Patient must have completed the dose titration phase; AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS‑subsidised PAH agent prior to this authority application.
Select one appropriate strength (determined under the 'Initial treatment ‑ dose titration' phase) and apply under this treatment phase (Initial treatment following dose titration) once only. Should future dose adjustments be required, apply under the 'Continuing treatment' restriction.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function. | Compliance with Authority Required procedures |
| C11261 | | Pulmonary arterial hypertension (PAH)
Initial treatment ‑ dose titration
Patient must have failed to achieve/maintain a WHO Functional Class II status with PAH agents (other than this agent) given as dual therapy; AND
Patient must have WHO Functional Class III PAH at treatment initiation with this drug; OR
Patient must have WHO Functional Class IV PAH at treatment initiation with this drug; AND
The treatment must be for dose titration purposes with the intent of completing the titration within 12 weeks; AND
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) selexipag with one endothelin receptor antagonist, (ii) selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'); AND
The treatment must not be as monotherapy.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have had at least one PBS‑subsidised PAH agent prior to this authority application.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function. | Compliance with Authority Required procedures |
Selinexor | C14021 | P14021 | Relapsed and/or refractory multiple myeloma
Initial treatment ‑ Dose requirement of 80 mg, 60 mg or 40 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Details of: the histological diagnosis of multiple myeloma; prior treatments including name(s) of drug(s) and date of most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response, must be documented in the patient's medical records.
Confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:
(a) the level of serum monoclonal protein; or
(b) Bence‑Jones proteinuria ‑ the results of 24‑hour urinary light chain M protein excretion; or
(c) the serum level of free kappa and lambda light chains; or
(d) bone marrow aspirate or trephine; or
(e) if present, the size and location of lytic bone lesions (not including compression fractures); or
(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT‑scan; or
(g) if present, the level of hypercalcaemia, corrected for albumin concentration.
As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo‑secretory or non‑secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo‑secretory or non‑secretory multiple myeloma with free light chain assays, evidence of the oligo‑secretory or non‑secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
| C14023 | P14023 | Relapsed and/or refractory multiple myeloma
Continuing treatment ‑ Dose requirement of 100 mg per week
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C14024 | P14024 | Relapsed and/or refractory multiple myeloma
Initial treatment ‑ Dose requirement of 100 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
| C14031 | P14031 | Relapsed and/or refractory multiple myeloma
Continuing treatment ‑ Dose requirement of 160 mg per week
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
| C14039 | P14039 | Relapsed and/or refractory multiple myeloma
Initial treatment ‑ Dose requirement of 160 mg per week
The condition must be confirmed by a histological diagnosis; AND
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must have progressive disease after at least one prior therapy; AND
Patient must not have previously received this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy | Compliance with Authority Required procedures |
| C14045 | P14045 | Relapsed and/or refractory multiple myeloma
Continuing treatment ‑ Dose requirement of 80 mg, 60 mg or 40 mg per week
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must be undergoing triple combination therapy limited to: (i) this drug, (ii) bortezomib, (iii) dexamethasone; OR
Patient must be undergoing dual combination therapy limited to: (i) this drug, (ii) dexamethasone; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Progressive disease is defined as at least 1 of the following:
(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
(b) at least a 25% increase in 24‑hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
(c) in oligo‑secretory and non‑secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
Sevelamer | C5530 | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5530 |
| C9762 | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762 |
Sildenafil | C11229 | | Pulmonary arterial hypertension (PAH)
Triple therapy ‑ Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) PBS‑subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS‑subsidised selexipag with one endothelin receptor antagonist, (ii) PBS‑subsidised selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The authority application for selexipag must be approved prior to the authority application for this agent.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13482 | | Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH; AND
Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13484 | | Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current.
(5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The test results must not be more than 6 months old at the time of application.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Written Authority Required procedures |
| C13569 | | Pulmonary arterial hypertension (PAH)
Initial 3 ‑ changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13570 | | Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13572 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13573 | | Pulmonary arterial hypertension (PAH)
Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13629 | | Pulmonary arterial hypertension (PAH)
Initial 1 ‑ combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient
Patient must not have received prior PBS‑subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) a completed authority prescription form; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
(1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition:
(a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or
(b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function.
(2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted:
‑ RHC composite assessment; and
‑ ECHO composite assessment; and
‑ 6 Minute Walk Test (6MWT)
Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is:
‑ RHC plus ECHO composite assessments;
‑ RHC composite assessment plus 6MWT;
‑ RHC composite assessment only.
In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is:
‑ ECHO composite assessment plus 6MWT;
‑ ECHO composite assessment only.
(3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s:
(i) for why fewer than 3 tests are able to be performed on clinical grounds;
(ii) why RHC cannot be performed on clinical grounds ‑ confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records.
(4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. | Compliance with Written Authority Required procedures |
Siltuximab | C12585 | | Idiopathic multicentric Castleman disease (iMCD)
Initial treatment
Patient must have a diagnosis of iMCD consistent with the latest international, evidence‑based consensus diagnostic criteria for this condition with the relevant diagnostic findings documented in the patient's medical records; AND
The condition must not be, to the prescriber's best knowledge, any of the following diseases that can mimic iMCD: (i) human herpes virus‑8 infection, (ii) an Epstein‑Barr virus‑lymphoproliferative disorder, (iii) an acute/uncontrolled infection (e.g. cytomegalovirus, toxoplasmosis, human immunodeficiency virus, tuberculosis) leading to inflammation with adenopathy, (iv) an autoimmune/autoinflammatory disease, (v) a malignant/lymphoproliferative disorder.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist; AND
Patient must be undergoing treatment through this treatment phase once only in a lifetime, where the full number of repeats are prescribed; OR
Patient must be undergoing treatment through this treatment phase for up to the first 5 doses in a lifetime, where the full number of repeats was not prescribed with the first prescription.
Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum. | Compliance with Authority Required procedures |
| C12594 | | Idiopathic multicentric Castleman disease (iMCD)
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving treatment with this drug for this condition.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Prescribe the most efficient combination of vials/strengths based on the patient's body weight to keep any amount of unused drug to a minimum. | Compliance with Authority Required procedures |
Sirolimus | C5795 | | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection, AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5795 |
| C9914 | | Management of renal allograft rejection
Management (initiation, stabilisation and review of therapy)
Patient must be receiving this drug for prophylaxis of renal allograft rejection; AND
The treatment must be under the supervision and direction of a transplant unit. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9914 |
Sofosbuvir with velpatasvir | C5969 | | Chronic hepatitis C infection Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND The treatment must be limited to a maximum duration of 12 weeks. | Compliance with Authority Required procedures |
Sofosbuvir with velpatasvir and voxilaprevir | C10248 | | Chronic hepatitis C infection
Patient must meet the criteria set out in the General Statement for Drugs for the Treatment of Hepatitis C; AND
Patient must be taking this drug as part of a regimen set out in the matrix in the General Statement for Drugs for the Treatment of Hepatitis C, based on the hepatitis C virus genotype, patient treatment history and cirrhotic status; AND
The treatment must be limited to a maximum duration of 12 weeks.
The application must include details of the prior treatment regimen containing an NS5A inhibitor. | Compliance with Authority Required procedures |
Sucroferric oxyhydroxide | C5530 | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5530 |
| C9762 | | Hyperphosphataemia
Initiation and stabilisation
The condition must not be adequately controlled by calcium; AND
Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
Patient must be undergoing dialysis for chronic kidney disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762 |
Tacrolimus | C5569 | | Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit, AND
The treatment must include initiation, stabilisation, and review of therapy as required. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5569 |
| C9697 | | Management of rejection in patients following organ or tissue transplantation
The treatment must be under the supervision and direction of a transplant unit; AND
The treatment must include initiation, stabilisation, and review of therapy as required. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9697 |
Tadalafil | C11229 | | Pulmonary arterial hypertension (PAH)
Triple therapy ‑ Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) PBS‑subsidised selexipag (referred to as 'triple therapy'); OR
The treatment must form part of dual combination therapy consisting of either: (i) PBS‑subsidised selexipag with one endothelin receptor antagonist, (ii) PBS‑subsidised selexipag with one phosphodiesterase‑5 inhibitor, as triple combination therapy with selexipag‑an endothelin receptor antagonist‑a phoshodiesterase‑5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase‑5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy').
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
The authority application for selexipag must be approved prior to the authority application for this agent.
For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase‑5 inhibitor is one of: (d) sildenafil, (e) tadalafil.
PBS‑subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13482 | | Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH; AND
Patient must have had their most recent course of PBS‑subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re‑qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13569 | | Pulmonary arterial hypertension (PAH)
Initial 3 ‑ changing to this drug in combination therapy (dual or triple therapy)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Patient must be undergoing existing PBS‑subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13570 | | Pulmonary arterial hypertension (PAH)
Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag)
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid.
Patient must be undergoing continuing treatment of existing PBS‑subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C13572 | | Pulmonary arterial hypertension (PAH)
Continuing treatment
Patient must have received their most recent course of PBS‑subsidised treatment with this PAH agent for this condition; AND
The treatment must be the sole PBS‑subsidised PAH agent for this condition.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH.
A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat.
PAH agents are not PBS‑subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA‑approved Product Information.
A maximum of 5 repeats may be requested. | Compliance with Authority Required procedures |
| C13573 | | Pulmonary arterial hypertension (PAH)
Initial 2 ‑ starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application
Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND
Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS‑subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase‑5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND
The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase‑5 inhibitor; OR
The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase‑5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate.
Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. | Compliance with Authority Required procedures |
| C15463 | | Pulmonary arterial hypertension (PAH) Initial 3 - changing to this drug in combination therapy (dual or triple therapy) The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid. Patient must be undergoing existing PBS-subsidised combination therapy with at least this drug in the combination changing; combination therapy is not to commence through this Treatment phase listing; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days. | Compliance with Authority Required procedures |
| C15464 | | Pulmonary arterial hypertension (PAH) Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH. Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). (1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition: (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function. (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted: - RHC composite assessment; and - ECHO composite assessment; and - 6 Minute Walk Test (6MWT) Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is: - RHC plus ECHO composite assessments; - RHC composite assessment plus 6MWT; - RHC composite assessment only. In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is: - ECHO composite assessment plus 6MWT; - ECHO composite assessment only. (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s: (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days. | Compliance with Written Authority Required procedures |
| C15486 | | Pulmonary arterial hypertension (PAH) Initial 1 (new patients) Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent. Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH; AND The treatment must be the sole PBS-subsidised PAH agent for this condition. A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). (1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition: (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function. (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted: - RHC composite assessment; and - ECHO composite assessment; and - 6 Minute Walk Test (6MWT) Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is: - RHC plus ECHO composite assessments; - RHC composite assessment plus 6MWT; - RHC composite assessment only. In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is: - ECHO composite assessment plus 6MWT; - ECHO composite assessment only. (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s: (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current. (5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. The test results must not be more than 6 months old at the time of application. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days. | Compliance with Written Authority Required procedures |
| C15494 | | Pulmonary arterial hypertension (PAH) Initial 2 - starting combination therapy (dual or triple therapy, excluding selexipag) in a treated patient where a diagnosis of pulmonary arterial hypertension is established through a prior PBS authority application Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND Patient must have failed to achieve/maintain WHO Functional Class II status with at least one of the following PBS-subsidised therapies: (i) endothelin receptor antagonist monotherapy, (ii) phosphodiesterase-5 inhibitor monotherapy, (iii) prostanoid monotherapy; AND The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient in whom monotherapy/dual combination therapy has been inadequate. Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days. | Compliance with Authority Required procedures |
| C15495 | | Pulmonary arterial hypertension (PAH) Continuing treatment Patient must have received their most recent course of PBS-subsidised treatment with this PAH agent for this condition; AND The treatment must be the sole PBS-subsidised PAH agent for this condition. Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days. | Compliance with Authority Required procedures |
| C15505 | | Pulmonary arterial hypertension (PAH) Initial 2 (change) Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH; AND Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND The treatment must be the sole PBS-subsidised PAH agent for this condition. Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted. Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days. | Compliance with Authority Required procedures |
| C15508 | | Pulmonary arterial hypertension (PAH) Initial 1 (new patients) Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent. Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH; AND The treatment must be the sole PBS-subsidised PAH agent for this condition. A prior PAH agent is any of: ambrisentan, bosentan, macitentan, sildenafil, tadalafil, epoprostenol, iloprost, riociguat. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). (1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition: (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function. (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted: - RHC composite assessment; and - ECHO composite assessment; and - 6 Minute Walk Test (6MWT) Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is: - RHC plus ECHO composite assessments; - RHC composite assessment plus 6MWT; - RHC composite assessment only. In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is: - ECHO composite assessment plus 6MWT; - ECHO composite assessment only. (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s: (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that the test results are of a recency that the PAH physician making this authority application is satisfied that the diagnosis of PAH is current. (5) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. The test results must not be more than 6 months old at the time of application. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. | Compliance with Written Authority Required procedures |
| C15513 | | Pulmonary arterial hypertension (PAH) Continuing treatment of combination therapy (dual or triple therapy, excluding selexipag) The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid. Patient must be undergoing continuing treatment of existing PBS-subsidised combination therapy (dual/triple therapy, excluding selexipag), where this drug in the combination remains unchanged from the previous authority application; AND Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days. | Compliance with Authority Required procedures |
| C15515 | | Pulmonary arterial hypertension (PAH) Initial 1 - combination therapy (dual or triple therapy, excluding selexipag) in an untreated patient Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND Patient must currently have WHO Functional Class III PAH or WHO Functional Class IV PAH; AND The treatment must form part of dual combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of dual combination therapy consisting of: (i) one prostanoid, (ii) one phosphodiesterase-5 inhibitor; OR The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) one prostanoid; triple combination therapy is treating a patient with class IV PAH. Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail. If the application is submitted through HPOS form upload or mail, it must include: (a) details of the proposed prescription; and (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). (1) Confirm that the patient has a diagnosis of pulmonary arterial hypertension (PAH) in line with the following definition: (a) mean pulmonary artery pressure (mPAP) at least 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) no greater than 15 mmHg; or (b) where right heart catheterisation (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure assessed by echocardiography (ECHO) is greater than 40 mmHg, with normal left ventricular function. (2) Confirm that in forming the diagnosis of PAH, the following tests have been conducted: - RHC composite assessment; and - ECHO composite assessment; and - 6 Minute Walk Test (6MWT) Where it is not possible to perform all 3 tests on clinical grounds, the expected test combination, in descending order, is: - RHC plus ECHO composite assessments; - RHC composite assessment plus 6MWT; - RHC composite assessment only. In circumstances where RHC cannot be performed on clinical grounds, the expected test combination, in descending order, is: - ECHO composite assessment plus 6MWT; - ECHO composite assessment only. (3) Document the findings of these tests in the patient's medical records, including, where relevant only, the reason/s: (i) for why fewer than 3 tests are able to be performed on clinical grounds; (ii) why RHC cannot be performed on clinical grounds - confirm this by obtaining a second opinion from another PAH physician or cardiologist with expertise in the management of PAH; document that this has occurred in the patient's medical records. (4) Confirm that this authority application is not seeking subsidy for a patient with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. | Compliance with Written Authority Required procedures |
| C15525 | | Pulmonary arterial hypertension (PAH) Triple therapy - Initial treatment or continuing treatment of triple combination therapy (including dual therapy in lieu of triple therapy) that includes selexipag The treatment must form part of triple combination therapy consisting of: (i) one endothelin receptor antagonist, (ii) one phosphodiesterase-5 inhibitor, (iii) PBS-subsidised selexipag (referred to as 'triple therapy'); OR The treatment must form part of dual combination therapy consisting of either: (i) PBS-subsidised selexipag with one endothelin receptor antagonist, (ii) PBS-subsidised selexipag with one phosphodiesterase-5 inhibitor, as triple combination therapy with selexipag-an endothelin receptor antagonist-a phoshodiesterase-5 inhibitor is not possible due to an intolerance/contraindication to the endothelin receptor antagonist class/phosphodiesterase-5 inhibitor class (referred to as 'dual therapy in lieu of triple therapy'). Must be treated by a physician with expertise in the management of PAH, with this authority application to be completed by the physician with expertise in PAH. The authority application for selexipag must be approved prior to the authority application for this agent. For the purposes of PBS subsidy, an endothelin receptor antagonist is one of: (a) ambrisentan, (b) bosentan, (c) macitentan; a phosphodiesterase-5 inhibitor is one of: (d) sildenafil, (e) tadalafil. PBS-subsidy does not cover patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted. PAH (WHO Group 1 pulmonary hypertension) is defined as follows: (i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or (ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function. The results and date of the RHC, ECHO and 6 MWT as applicable must be included in the patient's medical record. Where a RHC cannot be performed on clinical grounds, the written confirmation of the reasons why must also be included in the patient's medical record. The maximum quantity authorised will be limited to provide sufficient supply for 1 month of treatment, based on the dosage recommendations in the TGA-approved Product Information. A maximum of 5 repeats may be requested. Tadalafil 20 mg with pack size of 60 tablets may be prescribed when used in a combination with endothelin receptor antagonist to provide sufficient supply of both medicines for the same number of days. | Compliance with Authority Required procedures |
Teduglutide | C11999 | | Type III Short bowel syndrome with intestinal failure Initial treatment ‑ balance of supply Must be treated by a gastroenterologist; OR Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit. Patient must have previously received PBS‑subsidised initial treatment with this drug for this condition; AND Patient must have received insufficient therapy with this drug under the initial treatment restriction to complete the maximum duration of 12 months of initial treatment; AND The treatment must provide no more than the balance of up to 12 months of treatment. | Compliance with Authority Required procedures |
| C14534 | | Type III Short bowel syndrome with intestinal failure
Initial treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have short bowel syndrome with intestinal failure following major surgery; AND
Patient must have a history of dependence on parenteral support for at least 12 months; AND
Patient must have received a stable parenteral support regimen for at least 3 days per week in the previous 4 weeks; AND
Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND
The treatment must not exceed 12 months under this restriction; AND
Patient must not have previously received PBS‑subsidised treatment with this drug for this condition.
Provide a baseline value in this authority application of the amount of parenteral support per week, expressed as either:
(i) for a patient of any age, the mean number of days of parenteral support per week
(ii) for a patient yet to turn 18 years of age, the mean volume of parenteral support per week in mL per kg.
Determine the mean over any given 4 week period prior to this authority application. For a patient yet to turn 18 years of age, both (i) and (ii) may be supplied, but provide at least (i).
Assessment of treatment response/non‑response in the 'Continuing treatment' authority application will be compared against the baseline value(s) submitted in this application.
A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
| C14632 | | Type III Short bowel syndrome with intestinal failure
Continuing treatment
Must be treated by a gastroenterologist; OR
Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
Patient must have previously received PBS‑subsidised initial treatment with this drug for this condition; AND
Patient must have a reduction in parenteral support frequency of at least one day per week compared to the mean number of days per week at baseline; OR
Patient must have, as a patient yet to turn 18 years of age, a reduction in the mean weekly parenteral support volume of at least 20% (mL per kg of body weight) relative to baseline; OR
The treatment must be resuming after a break in therapy, but before the break in therapy occurred, a reduction in parenteral support relative to baseline had been occurring to an extent as stated as above.
Refer to the measurement(s) stated in the Initial treatment authority application for the baseline dependence on parenteral support. Determine the current mean use per week of parental support in days (for a patient of any age) and/or the mean volume per week in mL per kg (for a patient yet to turn 18 years of age). State these values in this authority application.
The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.
The current mean weekly parenteral support volume is calculated as the mean mL per kg of body weight of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.
From 1 September 2021
Where the mean weekly volume of parenteral support in terms of mL per kg of body weight for 4 consecutive weeks has not been stated in an Initial treatment authority application for a patient yet to turn 18 years of age, provide in this authority application both:
(i) a known or estimated retrospective baseline value that would have applied to the patient immediately before commencing treatment with this drug, and
(ii) the current value (observed over a 4 week timeframe)
Provide these values for a child only where mean weekly volume is to be used as an alternative response assessment to mean days of parenteral support per week. Otherwise, continue to use mean days per week.
Where treatment is resuming after a break in treatment with this drug, state parenteral support days/volume values as occurring prior to the break instead of current values.
A patient who has turned 18 years of age since their last authority application may be assessed for response using either the mean number of days of parenteral support or mean volume of parenteral support. Any subsequent authority application after this application must be assessed using the mean number of days of parenteral support.
Patients who do not meet the clinical criteria with respect to demonstrating the minimum reduction in parenteral support must permanently discontinue PBS subsidy.
The authority application must be made in writing and must include:
(a) a completed authority prescription form(s); and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). | Compliance with Written Authority Required procedures |
Tenofovir | C6980 | P6980 | Chronic hepatitis B infection Patient must have cirrhosis; AND Patient must be nucleoside analogue naive; AND Patient must have detectable HBV DNA; AND The treatment must be the sole PBS‑subsidised therapy for this condition. Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6980 |
| C6982 | P6982 | HIV infection Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6982 |
| C6983 | P6983 | Chronic hepatitis B infection Patient must have cirrhosis; AND Patient must have failed antihepadnaviral therapy; AND Patient must have detectable HBV DNA. Patients with Child’s class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6983 |
| C6984 | P6984 | Chronic hepatitis B infection Patient must not have cirrhosis; AND Patient must have failed antihepadnaviral therapy; AND Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6984 |
| C6992 | P6992 | Chronic hepatitis B infection Patient must not have cirrhosis; AND Patient must be nucleoside analogue naive; AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND The treatment must be the sole PBS‑subsidised therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6992 |
| C6998 | P6998 | HIV infection Initial Patient must be antiretroviral treatment naive; AND The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6998 |
| C10362 | P10362 | Chronic hepatitis B infection
Patient must be in the third trimester of pregnancy; AND
Patient must have elevated HBV DNA levels greater than 200,000 IU/mL (1,000,000 copies/mL), in conjunction with documented hepatitis B infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10362 |
Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat | C4470 | | HIV infection
Continuing
Patient must have previously received PBS‑subsidised therapy for HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470 |
| C4522 | | HIV infection
Initial
Patient must be antiretroviral treatment naive. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522 |
Tenofovir with emtricitabine | C6985 | | HIV infection Initial Patient must be antiretroviral treatment naive; AND The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6985 |
| C6986 | | HIV infection Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 6986 |
Tenofovir with emtricitabine and efavirenz | C4470 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4470 |
| C4522 | | HIV infection
Initial Patient must be antiretroviral treatment naïve | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4522 |
Tezacaftor with ivacaftor and ivacaftor | C12609 | | Cystic fibrosis ‑ one residual function (RF) mutation
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS‑subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C12614 | | Cystic fibrosis ‑ homozygous for the F508del mutation
Continuing treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition.
Patient must be 12 years of age or older.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS‑subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C12630 | | Cystic fibrosis ‑ one residual function (RF) mutation
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must have at least one residual function (RF) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is responsive to tezacaftor with ivacaftor; AND
The treatment must be the sole PBS‑subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
Patient must be 12 years of age or older.
For the purposes of this restriction, the list of mutations considered to be responsive to tezacaftor with ivacaftor is defined in the TGA approved product information.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS‑subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient having at least one RF mutation on the CFTR gene ‑ quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient ; and
(4) CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
| C12635 | | Cystic fibrosis ‑ homozygous for the F508del mutation
Initial treatment
Must be treated by a specialist respiratory physician with expertise in cystic fibrosis or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be the sole PBS‑subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities.
Patient must be 12 years of age or older.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg and ivacaftor 150 mg tablets on alternate days if the patient is concomitantly receiving one of the following moderate CYP3A4 drugs inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil.
Dosage of tezacaftor with ivacaftor is tezacaftor 100 mg/ivacaftor 150 mg twice weekly (approximately 3 or 4 days apart) if the patient is concomitantly receiving one of the following strong CYP3A4 inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole.
Tezacaftor with ivacaftor is not PBS‑subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers:
Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort;
Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin;
Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide.
The authority application must be in writing and must include:
(1) a completed authority prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene ‑ quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics. | Compliance with Written Authority Required procedures |
Thalidomide | C5914 | | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5914 |
| C9290 | | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9290 |
Tocilizumab | C9380 | | Severe active juvenile idiopathic arthritis
Continuing Treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction. | Compliance with Authority Required procedures |
| C9386 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after break of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9407 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; OR
Patient must not have received PBS‑subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS‑subsidised biological medicine treatment 3 times in their last treatment cycle; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either (a) a total active joint count of at least 20 active (swollen and tender) joints; or (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count must be no more than 4 weeks old at the time of this application.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9417 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) ‑ balance of supply
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C9494 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient’s most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C9495 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
Patient must be aged 18 years or older.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) an active joint count of fewer than 10 active (swollen and tender) joints; or
(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 5 repeats will be authorised.
Where the most recent course of PBS‑subsidised treatment with this drug was approved under either Initial 1, Initial 2, or Initial 3 treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C10570 | | Systemic juvenile idiopathic arthritis
Balance of supply for Initial treatment ‑ Initial 1 (new patient) or Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) or Initial 3 (recommencement of treatment after a break of more than 12 months)
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (retrial or recommencement of treatment after a break of less than 12 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under Initial 3 (recommencement of treatment after a break of more than 12 months) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks therapy available under Initial 1, 2 or 3 treatment.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. | Compliance with Authority Required procedures |
| C12163 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have a documented history of severe active juvenile idiopathic arthritis with onset prior to the age of 18 years; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with each of at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly and one of which must be: (i) hydroxychloroquine at a dose of at least 200 mg daily; or (ii) leflunomide at a dose of at least 10 mg daily; or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with each of at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; and/or (ii) leflunomide at a dose of at least 10 mg daily; and/or (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are either contraindicated according to the relevant TGA‑approved Product Information or cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
If methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than one month old at the time of initial application.
If the above requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied.
The authority application must be made in writing and must include:
(1) completed authority prescription form(s); and
(2) a completed Juvenile Idiopathic Arthritis PBS Authority Application ‑ Supporting Information Form.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised.
An assessment of a patient's response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C12436 | | Severe active juvenile idiopathic arthritis Initial treatment ‑ Initial 4 (Temporary listing ‑ change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab) Must be treated by a paediatric rheumatologist; OR Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre. Patient must have been receiving PBS‑subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND Patient must have been receiving PBS‑subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be under 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. An adequate response to treatment is defined as: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C12450 | | Severe active juvenile idiopathic arthritis Initial treatment ‑ Initial 4 (Temporary listing ‑ change of treatment from another biological medicine to tocilzumab after resolution of the critical shortage of tocilizumab) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have been receiving PBS‑subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND Patient must have been receiving PBS‑subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) an active joint count of fewer than 10 active (swollen and tender) joints; or (b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or (c) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times (once with each agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Written Authority Required procedures |
| C12451 | | Severe active rheumatoid arthritis Initial treatment ‑ Initial 4 (Temporary listing ‑ change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab) Must be treated by a rheumatologist; OR Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis. Patient must have been receiving PBS‑subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND Patient must have been receiving PBS‑subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND Patient must not receive more than 16 weeks of treatment under this restriction. Patient must be aged 18 years or older. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided. If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved. A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. An adequate response to treatment is defined as: an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; AND either of the following: (a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or (b) a reduction in the number of the following active joints, from at least 4, by at least 50%: (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth). At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested. Up to a maximum of 3 repeats will be authorised. To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14082 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14082 |
| C14083 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 12 months or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Active joints are defined as:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measurements must be no more than 4 weeks old at the time of this application and must be documented in the patient's medical records.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of active joints, the response must be demonstrated on the total number of active joints.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) the date of the last continuing prescription.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14085 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break of more than 12 months)
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have had a break in treatment of 12 months or more from this drug for this condition; AND
Patient must have polyarticular course disease and the condition must have at least one of: (a) an active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active joints from the following list of major joints: i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); (ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); OR
Patient must have refractory systemic symptoms and the condition must have (a) an active joint count of at least 2 active joints; and (b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or (c) a C‑reactive protein (CRP) level and platelet count above the upper limits of normal (ULN); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must be under 18 years of age.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of application.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14091 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (retrial or recommencement of treatment after a break of less than 12 months)
Patient must have received prior PBS‑subsidised treatment with this drug for this condition in the previous 12 months; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug more than once during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to retrial or recommence therapy with this drug, must be accompanied by details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C14093 | | Systemic juvenile idiopathic arthritis
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14093 |
| C14145 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 12 months)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures |
| C14148 | | Systemic juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have polyarticular course disease which has failed to respond adequately to oral or parenteral methotrexate at a dose of at least 15 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; OR
Patient must have polyarticular course disease and have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have refractory systemic symptoms, demonstrated by an inability to decrease and maintain the dose of prednisolone (or equivalent) below 0.5 mg per kg per day following a minimum of 2 months of therapy; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
The following criteria indicate failure to achieve an adequate response to prior methotrexate therapy in a patient with polyarticular course disease and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response to prior therapy in a patient with refractory systemic symptoms and must be demonstrated in the patient at the time of the initial application:
(a) an active joint count of at least 2 active joints; and
(b) persistent fever greater than 38 degrees Celsius for at least 5 out of 14 consecutive days; and/or
(c) a C‑reactive protein (CRP) level and platelet count above the upper limits of normal (ULN).
The assessment of response to prior treatment must be documented in the patient's medical records.
The baseline measurements of joint count, fever and/or CRP level and platelet count must be performed preferably whilst on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be used to determine response for all subsequent continuing treatments.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with other treatments is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active systemic juvenile idiopathic arthritis; and
(b) the details of prior treatment including dose and duration of treatment.
The following reports must be documented in the patient's medical records where appropriate:
(a) pathology reports detailing C‑reactive protein (CRP) level and platelet count.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle. | Compliance with Authority Required procedures |
| C14162 | | Severe active juvenile idiopathic arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a paediatric rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have demonstrated severe intolerance of, or toxicity due to, methotrexate; OR
Patient must have demonstrated failure to achieve an adequate response to 1 or more of the following treatment regimens: (i) oral or parenteral methotrexate at a dose of at least 20 mg per square metre weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (ii) oral or parenteral methotrexate at a dose of 20 mg weekly, alone or in combination with oral or intra‑articular corticosteroids, for a minimum of 3 months; (iii) oral methotrexate at a dose of at least 10 mg per square metre weekly together with at least 1 other disease modifying anti‑rheumatic drug (DMARD), alone or in combination with corticosteroids, for a minimum of 3 months; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be under 18 years of age.
Severe intolerance to methotrexate is defined as intractable nausea and vomiting and general malaise unresponsive to manoeuvres, including reducing or omitting concomitant non‑steroidal anti‑inflammatory drugs (NSAIDs) on the day of methotrexate administration, use of folic acid supplementation, or administering the dose of methotrexate in 2 divided doses over 24 hours.
Toxicity due to methotrexate is defined as evidence of hepatotoxicity with repeated elevations of transaminases, bone marrow suppression temporally related to methotrexate use, pneumonitis, or serious sepsis.
If treatment with methotrexate alone or in combination with another DMARD is contraindicated according to the relevant TGA‑approved Product Information, details must be documented in the patient's medical records.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be documented in the patient's medical records.
The following criteria indicate failure to achieve an adequate response and must be demonstrated in all patients at the time of the initial application:
(a) an active joint count of at least 20 active (swollen and tender) joints; OR
(b) at least 4 active joints from the following list:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to prior treatment must be documented in the patient's medical records.
The joint count assessment must be performed preferably whilst still on DMARD treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
The following information must be provided by the prescriber at the time of application and documented in the patient's medical records:
(a) the date of assessment of severe active juvenile idiopathic arthritis; and
(b) details of prior treatment including dose and duration of treatment.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 3 repeats will be authorised.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Authority Required procedures |
| C14164 | | Severe active juvenile idiopathic arthritis
Continuing treatment
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
An adequate response to treatment is defined as:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurement of joint count provided with the initial treatment application.
At the time of authority application, medical practitioners must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for one infusion. A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
If a patient fails to respond to PBS‑subsidised biological medicine treatment 3 times they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14164 |
| C14179 | | Systemic juvenile idiopathic arthritis
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Must be treated by a rheumatologist; OR
Patient must be undergoing treatment under the supervision of a paediatric rheumatology treatment centre.
An adequate response to treatment is defined as:
(a) in a patient with polyarticular course disease:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major active joints, from at least 4, by at least 50%:
‑ elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
‑ shoulder, cervical spine and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
(b) in a patient with refractory systemic symptoms:
(i) absence of fever greater than 38 degrees Celsius in the preceding seven days; and/or
(ii) a reduction in the C‑reactive protein (CRP) level and platelet count by at least 30% from baseline; and/or
(iii) a reduction in the dose of corticosteroid by at least 30% from baseline.
The assessment of response to treatment must be documented in the patient's medical records.
Determination of whether a response has been demonstrated to initial and subsequent courses of treatment will be based on the baseline measurements of disease severity provided with the initial treatment application.
The most recent systemic juvenile idiopathic arthritis assessment must be no more than 4 weeks old at the time of prescribing and must be documented in the patient's medical records.
At the time of authority application, the medical practitioner must request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for two infusions (one month's supply). A separate authority approval is required for each strength requested. Up to a maximum of 5 repeats will be authorised.
The assessment of the patient's response to the most recent course of biological medicine must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed that most recent course of treatment in this treatment cycle.
The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
If a patient fails to demonstrate a response to 2 courses of treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition in the current treatment cycle. A serious adverse reaction of a severity requiring permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 12 months have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was prescribed in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14179 |
| C14485 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14485 |
| C14487 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Major joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14488 | | Severe active rheumatoid arthritis
Initial 1 (new patient) or Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) or Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions. | Compliance with Authority Required procedures |
| C14489 | | Severe active rheumatoid arthritis
First continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.
Up to a maximum of 5 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14491 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must not have received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs) which must include at least 3 months continuous treatment with at least 2 DMARDs, one of which must be methotrexate at a dose of at least 20 mg weekly plus one of the following: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 6 months of intensive treatment with DMARDs which, if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information/cannot be tolerated at a 20 mg weekly dose, must include at least 3 months continuous treatment with at least 2 of the following DMARDs: (i) hydroxychloroquine at a dose of at least 200 mg daily; (ii) leflunomide at a dose of at least 10 mg daily; (iii) sulfasalazine at a dose of at least 2 g daily; OR
Patient must have failed, in the 24 months immediately prior to the date of the application, to achieve an adequate response to a trial of at least 3 months of continuous treatment with a DMARD where 2 of: (i) hydroxychloroquine, (ii) leflunomide, (iii) sulfasalazine, are contraindicated according to the relevant TGA‑approved Product Information/cannot be tolerated at the doses specified above in addition to having a contraindication or intolerance to methotrexate: the remaining tolerated DMARD must be trialled at a minimum dose as mentioned above; OR
Patient must have a contraindication/severe intolerance to each of: (i) methotrexate, (ii) hydroxychloroquine, (iii) leflunomide, (iv) sulfasalazine; in such cases, provide details for each of the contraindications/severe intolerances claimed in the authority application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
If methotrexate is contraindicated according to the TGA‑approved product information or cannot be tolerated at a 20 mg weekly dose, the application must include details of the contraindication or intolerance including severity to methotrexate. The maximum tolerated dose of methotrexate must be documented in the application, if applicable.
The application must include details of the DMARDs trialled, their doses and duration of treatment, and all relevant contraindications and/or intolerances including severity.
The requirement to trial at least 2 DMARDs for periods of at least 3 months each can be met using single agents sequentially or by using one or more combinations of DMARDs, however the time on treatment must be at least 6 months.
If the requirement to trial 6 months of intensive DMARD therapy with at least 2 DMARDs cannot be met because of contraindications and/or intolerances of a severity necessitating permanent treatment withdrawal to all of the DMARDs specified above, details of the contraindication or intolerance including severity and dose for each DMARD must be provided in the authority application.
The following criteria indicate failure to achieve an adequate response to DMARD treatment and must be demonstrated in all patients at the time of the initial application:
an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour and/or a C‑reactive protein (CRP) level greater than 15 mg per L; AND either
(a) a total active joint count of at least 20 active (swollen and tender) joints; or
(b) at least 4 active joints from the following list of major joints:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The joint count and ESR and/or CRP must be determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy. All measures must be no more than 4 weeks old at the time of initial application.
If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Written Authority Required procedures |
| C14507 | | Severe active rheumatoid arthritis
First continuing treatment ‑ balance of supply
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment. | Compliance with Authority Required procedures |
| C14538 | | Severe active rheumatoid arthritis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months)
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; OR
Patient must have received prior PBS‑subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; AND
Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
Patients who have received PBS‑subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine, within the timeframes specified below.
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority prescription form must be completed for each strength requested.
Up to a maximum of 3 repeats will be authorised.
The authority application must be made in writing and must include:
(1) a completed authority prescription form; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition.
A patient who has demonstrated a response to a course of rituximab must have a PBS‑subsidised biological therapy treatment‑free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine. | Compliance with Written Authority Required procedures |
| C14621 | | Severe active rheumatoid arthritis
Subsequent continuing treatment
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition under the First continuing treatment restriction; OR
Patient must have received this drug under this treatment phase as their most recent course of PBS‑subsidised biological medicine; AND
Patient must have demonstrated an adequate response to treatment with this drug; AND
Patient must not receive more than 24 weeks of treatment under this restriction.
Patient must be at least 18 years of age.
An adequate response to treatment is defined as:
an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
AND either of the following:
(a) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(b) a reduction in the number of the following active joints, from at least 4, by at least 50%:
(i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
At the time of the authority application, medical practitioners should request the appropriate number of vials of appropriate strength to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 8 mg per kg. A separate authority approval is required for each strength requested.
If a patient has either failed or ceased to respond to a PBS‑subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS‑subsidised treatment with a biological medicine for this condition.
If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14621 |
Ustekinumab | C9655 | | Severe Crohn disease
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient’s condition, if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient’s weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy within the timeframes specified in the relevant restriction.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient’s response must have been conducted following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and submitted to the Department of Human Services no later than 4 weeks from the date of completion of treatment.
An assessment of a patient’s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C9656 | | Severe Crohn disease
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient’s condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient’s weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
An assessment of a patient’s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C9710 | | Severe Crohn disease
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
The treatment must not exceed a total of 2 doses to be administered at weeks 0 and 8 under this restriction; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient’s condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 2 vials of 45 mg and no repeats.
A maximum quantity of a weight based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg (2 vials of 45 mg) with no repeats provide for an initial 16 week course of this drug will be authorised.
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient’s weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
An assessment of a patient’s response to an initial course of treatment must be conducted following a minimum of 12 weeks of therapy. An application for the continuing treatment must be accompanied with the assessment of response and submitted to the Department of Human Services no later than 4 weeks from the date of completion of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where the response assessment is not submitted within this timeframe, the patient will be deemed to have failed to respond to treatment with this drug.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C13975 | | Moderate to severe ulcerative colitis Initial treatment ‑ Initial 1 (new patient) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND The treatment must not exceed a single dose to be administered at week 0 under this restriction. Patient must be at least 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application. If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre‑filled syringe of 90 mg and no repeats. | Compliance with Written Authority Required procedures |
| C13976 | | Moderate to severe ulcerative colitis Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND The treatment must not exceed a single dose to be administered at week 0 under this restriction. Patient must be at least 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre‑filled syringe of 90 mg and no repeats. Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Written Authority Required procedures |
| C14010 | | Moderate to severe ulcerative colitis Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) Must be treated by a gastroenterologist (code 87); OR Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]. Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND Patient must have a Mayo clinic score greater than or equal to 6; OR Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND The treatment must not exceed a single dose to be administered at week 0 under this restriction. Patient must be at least 18 years of age. The authority application must be made in writing and must include: (1) a completed authority prescription form; and (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes: (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and (ii) the details of prior biological medicine treatment including the details of date and duration of treatment. All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment. The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application. An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below. An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy. Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment. If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. A maximum of 16 weeks of treatment with this drug will be approved under this criterion. Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight‑based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for the subsequent first dose, containing a quantity of 1 pre‑filled syringe of 90 mg and no repeats. Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Written Authority Required procedures |
| C14758 | | Complex refractory Fistulising Crohn disease
Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed PBS-subsidised therapy with this drug for this condition more than once in the current treatment cycle.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted between 8 and 16 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
Applications for authorisation must be made in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes the following:
(i) a completed current Fistula Assessment Form including the date of assessment of the patient's condition; and
(ii) details of prior biological medicine treatment including details of date and duration of treatment.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.
The most recent fistula assessment must be no more than 4 weeks old at the time of application.
A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. | Compliance with Written Authority Required procedures |
| C14787 | | Complex refractory Fistulising Crohn disease
Initial treatment - Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years)
Patient must have confirmed Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have an externally draining enterocutaneous or rectovaginal fistula.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Applications for authorisation must be made in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 4 weeks old at the time of application.
Two completed authority prescriptions should be submitted with every initial application for this drug. One prescription should be written under S100 (Highly Specialised Drugs) for a weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.
An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised
Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period. | Compliance with Written Authority Required procedures |
| C14801 | | Complex refractory Fistulising Crohn disease
Initial 1 (new patient or recommencement of treatment after a break in biological medicine of more than 5 years), Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) - balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient or patient recommencing treatment after a break of 5 years or more) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break of less than 5 years) restriction to complete 16 weeks treatment; AND
The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)] | Compliance with Authority Required procedures |
Valaciclovir | C5975 | | Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5975 |
| C9267 | | Cytomegalovirus infection and disease
Prophylaxis
Patient must have undergone a renal transplant; AND
Patient must be at risk of cytomegalovirus disease. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9267 |
Valganciclovir | C4980 | | Cytomegalovirus retinitis
Patient must have HIV infection. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4980 |
| C15782 | | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15782 |
| C15784 | | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15784 |
| C15800 | | Cytomegalovirus infection and disease Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15800 |
| C15814 | | Cytomegalovirus infection and disease Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease. | Compliance with Authority Required procedures - Streamlined Authority Code 15814 |
Vedolizumab | C9738 | | Moderate to severe ulcerative colitis
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 3 doses therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. | Compliance with Authority Required procedures |
| C9771 | | Severe Crohn disease
Balance of supply
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete the 3 doses (the initial infusion regimen at 0, 2 and 6 weeks); OR
Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 14 weeks therapy available under Initial 1, 2 or 3 treatment; OR
The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment. | Compliance with Authority Required procedures |
| C12080 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have failed to achieve an adequate response to a 5‑aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; OR
Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation of initial treatment must be in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Written Authority Required procedures |
| C12083 | | Severe Crohn disease
Initial treatment ‑ Initial 1 (new patient)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have failed to achieve an adequate response to prior systemic therapy with a tapered course of steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period; AND
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with 6‑mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months; OR
Patient must have failed to achieve adequate response to prior systemic immunosuppressive therapy with methotrexate at a dose of at least 15 mg weekly for 3 or more consecutive months; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 300 as evidence of failure to achieve an adequate response to prior systemic therapy; OR
Patient must have short gut syndrome with diagnostic imaging or surgical evidence, or have had an ileostomy or colostomy; and must have evidence of intestinal inflammation; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below; OR
Patient must have extensive intestinal inflammation affecting more than 50 cm of the small intestine as evidenced by radiological imaging; and must have a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220; and must have evidence of failure to achieve an adequate response to prior systemic therapy as specified below.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy]; and
(iii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iv) the date of the most recent clinical assessment.
Evidence of failure to achieve an adequate response to prior therapy must include at least one of the following:
(a) patient must have evidence of intestinal inflammation;
(b) patient must be assessed clinically as being in a high faecal output state;
(c) patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
All assessments, pathology tests and diagnostic imaging studies must be made within 1 month of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 1 month following cessation of the most recent prior treatment
If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA‑approved Product Information, please provide details at the time of application.
If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
Details of the accepted toxicities including severity can be found on the Services Australia website.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure. | Compliance with Written Authority Required procedures |
| C12135 | | Moderate to severe ulcerative colitis
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the vedolizumab subcutaneous form continuing restriction; AND
Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Patients who have failed to maintain a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 with continuing treatment with this drug, will not be eligible to receive further PBS‑subsidised treatment with this drug.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Authority Required procedures |
| C12137 | | Severe Crohn disease
Continuing treatment
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must be aged 18 years or older.
Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR
Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the vedolizumab subcutaneous form continuing restriction; AND
Patient must not receive more than 24 weeks of treatment under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment; AND
Patient must have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; OR
Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by: (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C‑reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of the assessment of the patient's condition, if relevant; or
(ii) the reports and dates of the pathology test or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment.
All assessments, pathology tests, and diagnostic imaging studies must be made within 1 month of the date of application.
An application for the continuing treatment must be accompanied with the assessment of response following a minimum of 12 weeks of therapy with this drug and submitted no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS‑subsidised treatment.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain a response.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide sufficient for a single infusion of 300 mg vedolizumab per dose. Up to a maximum of 2 repeats will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete 24 weeks treatment may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for continuing authority applications, or for treatment that would otherwise extend the continuing treatment period. | Compliance with Written Authority Required procedures |
| C12179 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have already failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
At the time of the authority application, medical practitioners should request the appropriate number of vials, to provide for a single infusion of 300 mg per dose.
Up to a maximum of 2 repeats will be authorised.
Authority approval for sufficient therapy to complete a maximum of 3 initial doses of treatment may be requested by telephone by contacting the Department of Human Services.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab and submitted no later than 4 weeks from the date of completion of treatment.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS‑subsidised treatment with this drug in this treatment cycle. A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C12219 | | Moderate to severe ulcerative colitis
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have had a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have a Mayo clinic score greater than or equal to 6; OR
Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Application for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Ulcerative Colitis PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
(ii) the details of prior biological medicine treatment including the details of date and duration of treatment.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
The most recent Mayo clinic or partial Mayo clinic score must be no more than 4 weeks old at the time of application.
A partial Mayo clinic assessment of the patient's response to this initial course of treatment must be following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under either Initial 1, Initial 2, Initial 3 or continuing treatment restrictions, an assessment of a patient's response must have been conducted following a minimum of 12 weeks of therapy and submitted no later than 4 weeks from the date of completion of treatment.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
Details of the accepted toxicities including severity can be found on the Services Australia website. | Compliance with Written Authority Required procedures |
| C12220 | | Severe Crohn disease
Initial treatment ‑ Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
Patient must not have failed, or ceased to respond to, PBS‑subsidised treatment with this drug for this condition during the current treatment cycle; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or
(ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
(iii) the date of clinical assessment; and
(iv) the details of prior biological medicine treatment including the details of date and duration of treatment.
An application for a patient who has received PBS‑subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised biological medicine treatment, within the timeframes specified below.
Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that course following a minimum of 12 weeks of therapy for adalimumab or ustekinumab and up to 12 weeks after the first dose (6 weeks following the third dose) for infliximab and vedolizumab and this assessment must be submitted no later than 4 weeks from the date that course was ceased.
If the response assessment to the previous course of biological medicine treatment is not submitted as detailed above, the patient will be deemed to have failed therapy with that particular course of biological medicine.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
| C12221 | | Severe Crohn disease
Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
Must be treated by a gastroenterologist (code 87); OR
Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; OR
Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)].
Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition; AND
Patient must have a break in treatment of 5 years or more from the most recently approved PBS‑subsidised biological medicine for this condition; AND
Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than 4 weeks old at the time of application; OR
Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; OR
Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
Patient must have evidence of intestinal inflammation; OR
Patient must be assessed clinically as being in a high faecal output state; OR
Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; AND
The treatment must not exceed a total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction; AND
Patient must be appropriately assessed for the risk of developing progressive multifocal leukoencephalopathy whilst on this treatment.
Patient must be aged 18 years or older.
Applications for authorisation must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form which includes the following:
(i) the completed current Crohn Disease Activity Index (CDAI) calculation sheet including the date of assessment of the patient's condition if relevant; and
(ii) the reports and dates of the pathology or diagnostic imaging test(s) nominated as the response criterion, if relevant; and
(iii) the date of the most recent clinical assessment.
Evidence of intestinal inflammation includes:
(i) blood: higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C‑reactive protein (CRP) level greater than 15 mg per L; or
(ii) faeces: higher than normal lactoferrin or calprotectin level; or
(iii) diagnostic imaging: demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
A maximum quantity and number of repeats to provide for an initial course of this drug consisting of one vial of 300 mg per dose, with one dose to be administered at weeks 0, 2 and 6, will be authorised.
If fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete the 3 doses of this drug may be requested by telephone and authorised through the Balance of Supply treatment phase PBS restriction. Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS‑subsidised therapy.
The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction. | Compliance with Written Authority Required procedures |
Zidovudine | C4454 | | HIV infection
Continuing Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4454 |
| C4512 | | HIV infection
Initial Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents | Compliance with Authority Required procedures ‑ Streamlined Authority Code 4512 |
Zoledronic acid | C5605 | P5605 | Bone metastases
The condition must be due to breast cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5605 |
| C5703 | P5703 | Bone metastases
The condition must be due to castration‑resistant prostate cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5703 |
| C5704 | P5704 | Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 5704 |
| C5735 | P5735 | Multiple myeloma
| Compliance with Authority Required procedures ‑ Streamlined Authority Code 5735 |
| C9268 | P9268 | Multiple myeloma | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9268 |
| C9304 | P9304 | Bone metastases
The condition must be due to castration‑resistant prostate cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9304 |
| C9317 | P9317 | Hypercalcaemia of malignancy
Patient must have a malignancy refractory to anti‑neoplastic therapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9317 |
| C9328 | P9328 | Bone metastases
The condition must be due to breast cancer. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 9328 |
| C14729 | P14729 | Adjuvant management of breast cancer
Patient must be post‑menopausal.
Patient must not be undergoing PBS‑subsidised treatment with this drug for this indication for more than 36 months. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14729 |
| C14735 | P14735 | Adjuvant management of breast cancer
Patient must be post‑menopausal.
Patient must not be undergoing PBS‑subsidised treatment with this drug for this indication for more than 36 months. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 14735 |
