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PB 71 of 2012 Other as amended, taking into account amendments up to National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 1) (PB 1 of 2020)
This instrument revokes and replaces the National Health (Listing of Pharmaceutical Benefits) Instrument 2010 (No. PB 108 of 2010) to determine the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands, and provides for related matters (responsible persons, prescribing circumstances, maximum quantities, numbers of repeats, and whether the pharmaceutical benefit is to be available only under special arrangements).
Administered by: Health
Registered 13 Feb 2020
Start Date 01 Feb 2020
End Date 29 Feb 2020
Table of contents.

Commonwealth Coat of Arms of Australia

National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the

National Health Act 1953

Compilation No. 88

Compilation date:                              1 February 2020

Includes amendments up to:            PB 1 of 2020

Registered:                                         13 February 2020

This compilation is in 6 volumes

Volume 1:       sections 1–26 and Schedule 1 (A–C)

Volume 2:       Schedule 1 (D–K)

Volume 3:       Schedule 1 (L–P)

Volume 4:       Schedule 1 (Q–Z), Schedules 2 and 3

Volume 5:       Schedule 4 (Part 1: A–R)

Volume 6:       Schedule 4 (Part 1: S–Z, Part 3), Schedule 5 and
                        Endnotes

Each volume has its own contents

 

About this compilation

This compilation

This is a compilation of the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) that shows the text of the law as amended and in force on 1 February 2020 (the compilation date).

The notes at the end of this compilation (the endnotes) include information about amending laws and the amendment history of provisions of the compiled law.

Uncommenced amendments

The effect of uncommenced amendments is not shown in the text of the compiled law. Any uncommenced amendments affecting the law are accessible on the Legislation Register (www.legislation.gov.au). The details of amendments made up to, but not commenced at, the compilation date are underlined in the endnotes. For more information on any uncommenced amendments, see the series page on the Legislation Register for the compiled law.

Application, saving and transitional provisions for provisions and amendments

If the operation of a provision or amendment of the compiled law is affected by an application, saving or transitional provision that is not included in this compilation, details are included in the endnotes.

Editorial changes

For more information about any editorial changes made in this compilation, see the endnotes.

Modifications

If the compiled law is modified by another law, the compiled law operates as modified but the modification does not amend the text of the law. Accordingly, this compilation does not show the text of the compiled law as modified. For more information on any modifications, see the series page on the Legislation Register for the compiled law.

Self‑repealing provisions

If a provision of the compiled law has been repealed in accordance with a provision of the law, details are included in the endnotes.

  

  

  


Contents

Schedule 4—Circumstances, purposes and conditions codes                     1

Part 1—Circumstances, purposes and conditions                                                                        1


Schedule 4Circumstances, purposes and conditions codes

(sections 10‑15,17, 18, 20 and 21)

Part 1Circumstances, purposes and conditions

 

Listed Drug

Circumstances Code

Purposes Code

Conditions Code

Circumstances and Purposes

Authority Requirements
(part of Circumstances;
or Conditions)

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 naive; AND
The treatment must be in combination with other antiretroviral agents.

Compliance with Authority Required procedures - Streamlined Authority Code 4512

Abacavir with lamivudine

C4527

 

 

HIV infection
Initial
Patient must be antiretroviral treatment naive; 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

Abacavir with lamivudine and zidovudine

C4480

 

 

HIV infection
Continuing
Patient must have previously received PBS-subsidised therapy for HIV infection.
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more.

Compliance with Authority Required procedures - Streamlined Authority Code 4480

C4495

 

 

HIV infection
Initial
Patient must be antiretroviral treatment naive.
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more.

Compliance with Authority Required procedures - Streamlined Authority Code 4495

Abatacept

C8627

P8627

 

Severe active rheumatoid 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

C8638

P8638

 

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

C8651

P8651

 

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 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 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; 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 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 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.
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 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) 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 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 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(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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 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.
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

C8652

P8652

 

Severe active rheumatoid arthritis
Initial treatment - Initial 3 (re-commencement 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 , or 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; or (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 aged 18 years or older.
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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 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.
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

 

C8655

P8655

 

Severe active rheumatoid 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 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 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) 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 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) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
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 provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced 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

 

C8746

P8746

 

Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement 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; 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 , or 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 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) 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 has received PBS-subsidised treatment with this drug and who wishes to re-commence 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.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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 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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
Initial treatment with an I.V. loading dose: Two completed authority prescriptions must be submitted with the initial application. One prescription must be for the I.V. loading dose for sufficient vials for one dose based on the patient's weight with no repeats. The second prescription must be written for the subcutaneous formulation, with a maximum quantity of 4 and up to 3 repeats.
Initial treatment with no loading dose: One completed authority prescription must be submitted with the initial application. The prescription must be written with a maximum quantity of 4 and up to 3 repeats.
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

Abemaciclib

C10019

 

 

Locally advanced or metastatic breast cancer
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
The treatment must be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with palbociclib or ribociclib.
Patient must not be premenopausal.
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

 

C10032

 

 

Locally advanced or metastatic breast cancer
Initial treatment
Patient must not have previously been treated with an aromatase inhibitor for advanced or metastatic breast cancer; AND
Patient must not have previously been treated with palbociclib or ribociclib; OR
Patient must have developed an intolerance to palbociclib or ribociclib of a severity necessitating permanent treatment withdrawal; AND
The condition must be hormone receptor positive; AND
The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
The condition must be inoperable; 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 be in combination with anastrozole or letrozole; AND
The treatment must not be in combination with palbociclib or ribociclib.
Patient must not be premenopausal.

Compliance with Authority Required procedures

Abiraterone

C6944

 

 

Castration resistant metastatic carcinoma of the prostate
The treatment must be used in combination with a corticosteroid; AND
The treatment must not be used in combination with chemotherapy; AND
Patient must have failed treatment with docetaxel due to resistance or intolerance; OR
Patient must be unsuitable for docetaxel treatment on the basis of predicted intolerance to docetaxel; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not receive PBS-subsidised abiraterone if progressive disease develops while on abiraterone; AND
Patient must not have received prior treatment with enzalutamide; OR
Patient must have developed intolerance to enzalutamide of a severity necessitating permanent treatment withdrawal.

Compliance with Authority Required procedures

Acamprosate

C5366

 

 

Alcohol dependence
The treatment must be part of a comprehensive treatment program with the goal of maintaining abstinence.

Compliance with Authority Required procedures - Streamlined Authority Code 5366

Aciclovir

C5936

P5936

 

Initial moderate to severe genital herpes
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

Compliance with Authority Required procedures - Streamlined Authority Code 5936

C5942

P5942

 

Recurrent moderate to severe genital herpes
Episodic treatment or suppressive therapy
Microbiological confirmation of diagnosis [viral culture, antigen detection or nucleic acid amplification by polymerase chain reaction (PCR)] is desirable but need not delay treatment.

Compliance with Authority Required procedures - Streamlined Authority Code 5942

C5959

 

 

Herpes zoster ophthalmicus

Compliance with Authority Required procedures - Streamlined Authority Code 5959

C5964

 

 

Herpes simplex keratitis

 

C5965

 

 

Herpes simplex keratitis

 

C5967

 

 

Herpes zoster
The treatment must be administered within 72 hours of the onset of the rash.

Compliance with Authority Required procedures - Streamlined Authority Code 5967

Acitretin

C5727

 

 

Severe disorders of keratinisation

Compliance with Authority Required procedures - Streamlined Authority Code 5727

C5789

 

 

Severe intractable psoriasis

Compliance with Authority Required procedures - Streamlined Authority Code 5789

Aclidinium

C4516

 

 

Chronic obstructive pulmonary disease (COPD)

 

Aclidinium with formoterol

C7798

 

 

Chronic obstructive pulmonary disease (COPD)
Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting muscarinic antagonist (LAMA); OR
Patient must have COPD symptoms that persist despite regular bronchodilator treatment with a long acting beta 2 agonist (LABA); OR
Patient must have been stabilised on a combination of a LAMA and a LABA.

Compliance with Authority Required procedures - Streamlined Authority Code 7798

Adalimumab

C6696

P6696

 

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 continuing treatment, Whole body restriction to complete 24 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the continuing treatment, 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

C6946

P6946

 

Moderate to severe hidradenitis suppurativa
Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment – balance of supply
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment 1 - New patient restriction to complete a maximum of 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial treatment 2 - Recommencement of treatment restriction to complete a maximum of 16 weeks treatment.
Must be treated by a dermatologist.
A maximum of 12 weeks of treatment will be authorised under this restriction.

Compliance with Authority Required procedures

C6951

 

 

Moderate to severe hidradenitis suppurativa
Initial treatment 1 - New patient
Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND
Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; AND
The treatment must be limited to a maximum duration of 16 weeks.
Must be treated by a dermatologist.
Assessment of disease severity must be no more than 1 month old at the time of application.
An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment.
At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count; and
(iii) the name of the antibiotic/s received for two separate courses each of three months; or
(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics
(v) a signed patient acknowledgement.

Compliance with Authority Required procedures

C6963

 

 

Moderate to severe hidradenitis suppurativa
Initial treatment 2 - Recommencement of treatment
Patient must have, at the time of application, a Hurley stage II or III grading with an abscess and inflammatory nodule (AN) count greater than or equal to 3; AND
Patient must have demonstrated a response to the most recent PBS-subsidised treatment with this drug for this condition; AND
The treatment must be limited to a maximum duration of 16 weeks.
Must be treated by a dermatologist.
Assessment of disease severity must be no more than 1 month old at the time of application.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
An assessment of the patient's response to this recommencement course of treatment must be made following a minimum of 12 weeks of treatment.
At the time of authority application the prescriber must request the first 4 weeks of treatment under this restriction; and weeks 5 to 16 of treatment under Initial treatment 1 - New patient or Initial treatment 2 - Recommencement of treatment - balance of supply
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count.

Compliance with Authority Required procedures

C6971

P6971

 

Moderate to severe hidradenitis suppurativa
Continuing treatment
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must have demonstrated a response to treatment with this drug for this condition.
Must be treated by a dermatologist.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and provided to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
A maximum of 24 weeks treatment will be authorised under this restriction per continuing treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) a completed hidradenitis suppurativa PBS authority application supporting Information form which must include the Hidradenitis Suppurativa Clinical Response (HiSCR) result.

Compliance with Authority Required procedures

C6972

P6972

 

Moderate to severe hidradenitis suppurativa
Initial treatment 3 - Grandfathered patient
Patient must have been receiving treatment with this drug for this condition prior to 1 July 2017; AND
Patient must have had a Hurley stage II or III with an abscess and inflammatory nodule (AN) count greater than or equal to 3 prior to starting treatment with this drug; AND
Patient must have demonstrated a response to treatment by achieving Hidradenitis Suppurativa Clinical Response (HiSCR) after 12 weeks of treatment if the patient has been treated with this drug for this condition for 12 weeks or longer; AND
Patient must have failed to achieve an adequate response to 2 courses of different antibiotics each for 3 months prior to initiation of PBS subsidised treatment with this drug for this condition; OR
Patient must have had an adverse reaction to an antibiotic of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition; OR
Patient must be contraindicated to treatment with an antibiotic due to an allergic reaction of a severity necessitating permanent treatment withdrawal resulting in the patient being unable to complete treatment with 2 different courses of antibiotics each for 3 months prior to initiation of PBS-subsidised treatment with this drug for this condition.
Must be treated by a dermatologist.
A response to treatment is defined as:
Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) of a 50% reduction in AN count compared to baseline with no increase in abscesses or draining fistulae.
For the first application for continuing treatment a Hidradenitis Suppurativa Clinical Response (HiSCR) assessment must be made following a minimum of 12 weeks of treatment. For subsequent continuing treatment a HiSCR assessment must be made every 24 weeks.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and provided to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, to treatment with this drug.
Assessment of disease severity must be no more than 1 month old at the time treatment with this drug was initiated.
A maximum of 24 weeks treatment will be authorised under this restriction.
A patient may qualify for PBS-subsidised treatment under this restriction once only.
For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria or recommencement of treatment criteria where there is a break in treatment.
The authority application must be made in writing and must include:
(a) a completed authority prescription form; and
(b) completed hidradenitis suppurativa PBS authority application supporting Information form which must include:
(i) the Hurley stage grading; and
(ii) the AN count; and
(iii) the name of the antibiotic/s received for two separate courses each of three months; or
(iv) confirmation that the adverse reaction or allergy to an antibiotic necessitated permanent treatment withdrawal resulting in the patient being unable to complete a three month course of antibiotics. The name of the one course of antibiotics of three months duration must be provided. Where the patient is unable to be treated with any courses of antibiotics the prescriber must confirm that the patient has a history of adverse reaction or allergy necessitating permanent treatment withdrawal to two different antibiotics
(v) the Hidradenitis Suppurativa Clinical Response (HiSCR) result if the patient has received 12 weeks or more of treatment
(vi) a signed patient acknowledgement.

Compliance with Authority Required procedures

 

C8608

P8608

 

Complex refractory Fistulising Crohn disease

Continuing treatment - 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 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

 

C8627

P8627

 

Severe active rheumatoid 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

 

C8631

P8631

 

Severe active rheumatoid arthritis
Initial treatment - Initial 3 (re-commencement 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 , or 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; 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.
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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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 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.
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

 

C8638

P8638

 

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

 

C8678

P8678

 

Severe active rheumatoid arthritis
Initial treatment - Initial 2 (change or re-commencement 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; 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 , or 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 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) 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 has received PBS-subsidised treatment with this drug and who wishes to re-commence 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.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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 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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
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

 

C8702

P8702

 

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 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 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; 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 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.
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 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) 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 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.
The authority application must be made in writing and must include:
(1) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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 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.
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

 

C8725

P8725

 

Severe active rheumatoid 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) 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 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) a completed authority prescription form(s); and
(2) a completed Rheumatoid Arthritis PBS Authority Application - Supporting Information Form.
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 provided, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced 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

 

C8804

P8804

 

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 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, cyclosporin 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, cyclosporin 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, cyclosporin, 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 1 month 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 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
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].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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. Demonstration of response should be provided within this timeframe.
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

 

C8808

P8808

 

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 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 1 month old at the time of application.
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.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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. Demonstration of response should be provided within this timeframe.
The PASI assessment for 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

 

C8809

P8809

 

Severe chronic plaque psoriasis
Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement 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 16 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 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 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 16 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 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 16 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 16 weeks treatment available under the above restrictions.
Must be treated by a dermatologist.

Compliance with Authority Required procedures

 

C8811

P8811

 

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Whole body (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, 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 therapy with this drug for this condition in the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 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.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence 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.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. 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. Demonstration of response should be provided within this timeframe.
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.
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

 

C8830

P8830

 

Severe chronic plaque psoriasis
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 per 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 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

 

C8836

P8836

 

Severe chronic plaque psoriasis
Initial treatment - Initial 2, Face, hand, foot (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, 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 therapy with this drug for this condition in the current treatment cycle; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 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.
An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to re-commence 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.
Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, or continuing treatment restrictions, it is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy. 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. Demonstration of response should be provided within this timeframe.
The PASI assessment for 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.
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

 

C8851

P8851

 

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 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
The most recent PASI assessment must be no more than 1 month old at the time of application.
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.
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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. Demonstration of response should be provided within this timeframe.
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

 

C8867

P8867

 

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 4 treatments: (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; and/or (ii) methotrexate at a dose of at least 10 mg weekly for at least 6 weeks; and/or (iii) cyclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; and/or (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; AND
The treatment must be as systemic monotherapy (other than methotrexate); AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
Must be treated by a dermatologist.
Where treatment with methotrexate, cyclosporin 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, cyclosporin 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, cyclosporin, 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 1 month 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 1 month 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 1 month following cessation of each course of treatment.
(c) The most recent PASI assessment must be no more than 1 month old at the time of application.
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].
It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. 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. Demonstration of response should be provided within this timeframe.
The PASI assessment for 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

 

C8892

P8892

 

Severe chronic plaque psoriasis
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 per 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 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 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

 

C9063

P9063

 

Severe psoriatic arthritis
Continuing treatment - balance of supply
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.
Must be treated by a rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9064

P9064

 

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
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 5 years) 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 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 rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of psoriatic arthritis.

Compliance with Authority Required procedures

 

C9069

P9069

 

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 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
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.
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 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

 

C9078

P9078

 

Severe psoriatic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after a break in 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 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 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 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 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 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

 

C9105

P9105

 

Severe psoriatic arthritis
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.
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

 

C9155

P9155

 

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 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
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.
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

 

C9380

P9380

 

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

P9386

 

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

 

C9409

P9409

 

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.
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

 

C9414

P9414

 

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, 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.
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:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis 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.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 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 supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old at the time of 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. 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

 

C9428

P9428

 

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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or 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; or (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); or (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 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
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:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment 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

 

C9429

P9429

 

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 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 5 years) 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 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 rheumatologist; OR
Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.

Compliance with Authority Required procedures

 

C9430

P9430

 

Ankylosing spondylitis
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 aged 18 years or older.
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:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form.
An adequate response is defined as an improvement from baseline of at least 2 of the BASDAI and 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 supplied in all subsequent continuing treatment applications.
All measurements provided must be no more than 1 month old at the time 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 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

 

C9431

P9431

 

Ankylosing spondylitis
Continuing treatment - balance of supply
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 24 weeks treatment available under the above restriction.
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

 

C9498

P9498

 

Severe active juvenile idiopathic arthritis
Initial treatment - Initial 2 (change or recommencement of treatment after 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).
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

 

C9503

P9503

 

Ankylosing spondylitis
Initial treatment - Initial 1 (new patient)
The condition must be radiographically (plain X-ray) confirmed Grade II bilateral sacroiliitis or 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; or (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); or (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 16 weeks of treatment under this restriction.
Patient must be aged 18 years or older.
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 BASDAI must be determined at the completion of the 3 month NSAID and exercise trial, but prior to ceasing NSAID treatment. The BASDAI must be no more than 1 month old at the time of initial application.
Both ESR and CRP measures should be provided with the initial treatment application and both must be no more than 1 month old. 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:
(a) a completed authority prescription form; and
(b) a completed Ankylosing Spondylitis PBS Authority Application - Supporting Information Form which includes the following:
(i) a copy of the radiological report confirming Grade II bilateral sacroiliitis or Grade III unilateral sacroiliitis; and
(ii) a completed BASDAI Assessment Form; and
(iii) a completed Exercise Program Self Certification Form included in the 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

 

C9564

P9564

 

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 6 months of intensive treatment with DMARDs which, if 3 or more of methotrexate, hydroxychloroquine, leflunomide and sulfasalazine are contraindicated according to the relevant TGA-approved Product Information or cannot be tolerated at the doses specified above, must include at least 3 months continuous treatment with each of at least 2 DMARDs, with one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated: (i) azathioprine at a dose of at least 1 mg/kg per day; and/or (ii) cyclosporin at a dose of at least 2 mg/kg/day; and/or (iii) sodium aurothiomalate at a dose of 50 mg weekly; 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.
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

 

C9631

P9631

 

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.
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

 

C9658

P9658

 

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.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
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.
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.
A maximum of 16 weeks of treatment with this drug will be approved under this criterion.
Two completed authority prescriptions must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.

Compliance with Written Authority Required procedures

 

C9661

P9661

 

Complex refractory Fistulising 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 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 for this condition.
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.
To demonstrate a response to treatment the application must be accompanied by the results of the most recent course of biological medicine therapy following a minimum of 12 weeks of therapy.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
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.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
A maximum of 24 weeks treatment will be authorised under this restriction.

Compliance with Written Authority Required procedures

 

C9662

P9662

 

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.
Applications for authorisation of change or recommencement treatment must be in writing and must include:
(a) two completed authority prescription forms; 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) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
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.
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.
The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
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 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.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9663

P9663

 

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.
Patient must be 6 years of age or older.
Applications for authorisation must be in writing and must include:
(a) two completed authority prescription forms; 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.
For patients weighing 40 kg or greater, a maximum quantity and number of repeats to provide for an initial 16 weeks course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
For patients weighing less than 40 kg, a maximum quantity and number of repeats to provide for an initial 16 weeks of this drug consisting of a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14 will be authorised.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
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.
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 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.
Details of the accepted toxicities including severity can be found on the Department of Human Services website.

Compliance with Written Authority Required procedures

 

C9666

P9666

 

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 previously received PBS-subsidised treatment with this drug for this condition; 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 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 eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request sufficient quantity for up to 24 weeks of treatment under this restriction.
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 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

 

C9672

P9672

 

Severe Crohn disease
Initial treatment - Initial 1 (new patient)
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, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40 preferably whilst still on treatment, but no longer than 1 month following cessation of the most recent prior conventional treatment and which is no more than 1 month old at the time of application; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
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.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] 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; and
(ii) details of previous systemic drug therapy [dosage, date of commencement and duration of therapy] or dates of enteral nutrition.
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, please provide details of the degree of this toxicity at the time of application. Details of the accepted toxicities including severity can be found on the Human Services website (www.humanservices.gov.au).
A maximum quantity and number of repeats to provide for an initial 16 week course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 for patients 40 kg or greater (for patients 40 kg or less, the course is a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14) will be authorised.
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) 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 following a minimum of 12 weeks therapy 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

 

C9673

P9673

 

Severe 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 a documented history of severe Crohn disease; AND
Patient must in this treatment cycle, have received prior PBS-subsidised treatment with this drug for this condition; OR
Patient must in this treatment cycle, have received prior PBS-subsidised treatment with infliximab for this condition and have a current PCDAI score of 40 or greater; 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
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
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.
Applications for authorisation of initial treatment must be in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed paediatric Crohn Disease PBS Authority Application -Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] which includes the following:
(i) the completed current Paediatric Crohn Disease Activity Index (PCDAI) Score calculation sheet; and
(ii) details of prior TNF-alfa antagonist treatment including details of date and duration of treatment.
The PCDAI assessment must be no more than 1 month old at the time of application.
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) 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.
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 PCDAI assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks therapy 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

 

C9674

P9674

 

Severe Crohn disease
Continuing treatment of Crohn disease in a paediatric patient assessed by PCDAI
Patient must have a documented history of severe Crohn disease; AND
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 40 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.
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.
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.
An application for continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
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.
Patients are only eligible to receive subsequent continuing PBS-subsidised treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

 

C9679

P9679

 

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 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 5 years) 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 5 years) restriction to complete 16 weeks treatment; OR
Patient must have received insufficient therapy with this drug under the Continuing treatment restriction to complete 24 weeks of 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; 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

 

C9713

P9713

 

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) two completed authority prescription forms; and
(b) a completed Fistulising Crohn Disease PBS Authority Application - Supporting Information Form which includes a completed current Fistula Assessment Form including the date of assessment of the patient's condition of no more than 1 month old 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 must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
The assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of therapy so that there is adequate time for a response to be demonstrated.
It is recommended that an application for continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of this initial course of treatment to ensure continuity of treatment for those patients who meet the continuation criterion for PBS-subsidised treatment with this drug for this condition.
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

 

C9714

P9714

 

Complex refractory Fistulising Crohn disease
Initial 1 (new patient or Recommencement of treatment after more than 5 years break in therapy ), Initial 2 (Change or Recommencement of treatment after a break in therapy of less than 5 years) - 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 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.

Compliance with Authority Required procedures

 

C9715

P9715

 

Moderate to severe ulcerative colitis
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 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 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 5 years) 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 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.

Compliance with Authority Required procedures

 

C9717

P9717

 

Moderate to severe ulcerative colitis
Continuing treatment - 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 under the Continuing treatment restriction to complete 24 weeks of treatment; AND
The treatment must provide no more than the balance of up to 24 weeks treatment available under this restriction.

Compliance with Authority Required procedures

 

C9722

P9722

 

Severe Crohn disease
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 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
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, consultant physician, paediatrician or specialist paediatric gastroenterologist; AND
Patient must have, at the time of application, disease severity considered to be severe as demonstrated by a Paediatric Crohn Disease Activity Index (PCDAI) Score greater than or equal to 40; AND
Patient must not receive more than 16 weeks of treatment under this restriction.
Patient must be aged 6 to 17 years inclusive.
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.
Applications for authorisation must be made in writing and must include:
(a) two completed authority prescription forms; and
(b) a completed paediatric Crohn Disease PBS Authority Application - Supporting Information Form [may be downloaded from the Department of Human Services website (www.humanservices.gov.au)] 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.
The PCDAI 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 16 week course of this drug consisting of a 160 mg dose at week 0, 80 mg dose at week 2 and 40 mg dose at weeks 4, 6, 8, 10, 12 and 14 for patients 40 kg or greater (for patients 40 kg or less, the course is a 80 mg dose at week 0, 40 mg dose at week 2 and a 20 mg dose at weeks 4, 6, 8, 10, 12 and 14) will be authorised.
Two completed authority prescriptions should be submitted with every initial application for this drug. For patients weighing 40 kg or greater: one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription should be written for 2 doses of 40 mg and 2 repeats. For patients weighing less than 40 kg: one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
If fewer than 2 repeats (for patients 40 kg or greater) or 3 repeats (for patients less than 40 kg) are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with this drug may be requested by telephone by contacting the Department of Human Services on 1800 700 270 (hours of operation 8 a.m. to 5 p.m. EST Monday to Friday) 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 following a minimum of 12 weeks therapy 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 Authority Required procedures

 

C9735

P9735

 

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
Patient must not receive more than 16 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) 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 must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested by telephone by contacting the Department of Human Services.
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

 

C9748

P9748

 

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.
Applications for authorisation must be in writing and must include:
(a) two completed authority prescription forms; 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.
Two completed authority prescriptions must be submitted with every initial application for this drug.For patients weighing 40 kg or greater, one prescription should be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats and the second prescription must be written for 2 doses of 40 mg and 2 repeats.
For patients weighing less than 40 kg, one prescription should be written for 2 doses of 40 mg with no repeats and the second prescription should be written for 2 doses of 20 mg with 3 repeats.
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 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 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

 

C9789

P9789

 

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
Patient must not receive more than 16 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) 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 must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested by telephone by contacting the Department of Human Services.
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.

Compliance with Written Authority Required procedures

 

C9790

P9790

 

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 have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; 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 continuing treatment with this drug must include a measurement of response to the most recent course of PBS-subsidised therapy. This assessment must be conducted no later than 4 weeks from the cessation of that treatment course. If the application is the first application for continuing treatment with this drug, it must be accompanied by an assessment of response to a minimum of 12 weeks of treatment with the initial treatment course.
The assessment of the patient's response to a continuing course of therapy must be made within the 4 weeks prior to completion of that course and posted to the Department of Human Services no less than 2 weeks prior to the date the next dose is scheduled, in order to ensure continuity of treatment for those patients who meet the continuation criterion.
Where an assessment is not submitted to the Department of Human Services within these timeframes, patients will be deemed to have failed to respond, or to have failed to sustain a response, 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.
Patients are eligible to receive continuing treatment with this drug in courses of up to 24 weeks providing they continue to sustain the response.
At the time of the authority application, medical practitioners should request the appropriate quantity and number of repeats to provide sufficient dose. Up to a maximum of 5 repeats will be authorised.
Where fewer than 5 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 24 weeks of treatment with this drug may be requested through the balance of supply restriction.

Compliance with Written Authority Required procedures

 

C9798

P9798

 

Severe Crohn disease
Balance of supply for paediatric patient
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 5 years) 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 5 years) restriction to complete 16 weeks treatment; 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 16 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.
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.

Compliance with Authority Required procedures

 

C9837

P9837

 

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
Patient must not receive more than 16 weeks of treatment 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 must be submitted with every initial application for adalimumab. One prescription must be for the induction pack containing a quantity of 6 doses of 40 mg and no repeats. The second prescription must be written for 2 doses of 40 mg and 2 repeats.
Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested by telephone by contacting the Department of Human Services.
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

Adapalene with benzoyl peroxide

C4898

P4898

 

Severe acne vulgaris
The treatment must be maintenance therapy.

 

C4961

P4961

 

Severe acne vulgaris
Acute treatment
The treatment must in combination with an oral antibiotic.

 

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

Adrenaline (epinephrine)

C4909

 

 

Acute allergic reaction with anaphylaxis
Initial sole PBS-subsidised supply for anticipated emergency treatment
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a clinical immunologist; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with an allergist; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a paediatrician; OR
Patient must have been assessed to be at significant risk of anaphylaxis by, or in consultation with a respiratory physician.
The name of the specialist consulted must be provided at the time of application for initial supply.

Compliance with Authority Required procedures

C4947

 

 

Acute allergic reaction with anaphylaxis
Continuing sole PBS-subsidised supply for anticipated emergency treatment
Patient must have previously been issued with an authority prescription for this drug.

Compliance with Authority Required procedures

 

C8734

 

 

Acute allergic reaction with anaphylaxis

Initial sole PBS-subsidised supply for anticipated emergency treatment
Patient must have been discharged from hospital or an emergency department after treatment with adrenaline (epinephrine) for acute allergic reaction with anaphylaxis.

Compliance with Authority Required procedures

Afatinib

C4473

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must not have received previous PBS-subsidised treatment with another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI); OR
Patient must have developed intolerance to another epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal; AND
Patient must have a WHO performance status of 2 or less.
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.

Compliance with Authority Required procedures

C7613

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition.
Patient must have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation known to confer sensitivity to treatment with EGFR tyrosine kinase inhibitors in tumour material.

Compliance with Authority Required procedures - Streamlined Authority Code 7613

Aflibercept

C7517

P7517

 

Diabetic macular oedema (DMO)
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

Compliance with Authority Required procedures

C7536

P7536

 

Central retinal vein occlusion with macular oedema
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

Compliance with Authority Required procedures

C7553

P7553

 

Diabetic macular oedema (DMO)
Initial treatment
Patient must have visual impairment due to diabetic macular oedema; AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be as monotherapy; OR
The treatment must be in combination with laser photocoagulation; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

Compliance with Written Authority Required procedures

C7564

P7564

 

Subfoveal choroidal neovascularisation (CNV)
Initial treatment
The condition must be due to age-related macular degeneration (AMD); AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.

Compliance with Written Authority Required procedures

C7570

P7570

 

Branch retinal vein occlusion with macular oedema
Continuing treatment
Patient must have previously been issued with an authority prescription for this drug for the same eye; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

Compliance with Authority Required procedures

C7571

P7571

 

Central retinal vein occlusion with macular oedema
Initial treatment
Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

Compliance with Written Authority Required procedures

C7587

P7587

 

Branch retinal vein occlusion with macular oedema
Initial treatment
Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); AND
Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; AND
The condition must be diagnosed by optical coherence tomography; OR
The condition must be diagnosed by fluorescein angiography; AND
The treatment must be the sole PBS-subsidised therapy for this condition.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.
Authority approval for initial treatment of each eye must be sought.
The first authority application for each eye must be made in writing or by telephone.
A written application must include:
a) a completed authority prescription form;
b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; and
c) a copy of the optical coherence tomography or fluorescein angiogram report.
A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.

Compliance with Written Authority Required procedures

C7592

P7592

 

Subfoveal choroidal neovascularisation (CNV)
Continuing treatment
The condition must be due to age-related macular degeneration (AMD); AND
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously been granted an authority prescription for the same eye.
Must be treated by an ophthalmologist or in consultation with an ophthalmologist.

Compliance with Authority Required procedures

Albendazole

C5607

 

 

Hydatid disease
The treatment must be in conjunction with surgery; OR
The treatment must be used when a surgical cure cannot be achieved; OR
The treatment must be used when surgery cannot be used.

Compliance with Authority Required procedures - Streamlined Authority Code 5607

C5680

P5680

 

Tapeworm infestation

Compliance with Authority Required procedures - Streamlined Authority Code 5680

C5712

P5712

 

Strongyloidiasis

Compliance with Authority Required procedures - Streamlined Authority Code 5712

C5797

P5797

 

Hookworm infestation

Compliance with Authority Required procedures - Streamlined Authority Code 5797

C5817

P5817

 

Whipworm infestation
Patient must be an Aboriginal or a Torres Strait Islander person.

Compliance with Authority Required procedures - Streamlined Authority Code 5817

Alectinib

C7345

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less.
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.

Compliance with Authority Required procedures

C7346

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be as monotherapy; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not develop disease progression while receiving PBS-subsidised treatment with this drug for this condition.

Compliance with Authority Required procedures

C7353

 

 

Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Grandfathering treatment
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 January 2018; AND
The treatment must be as monotherapy; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must not have progressive disease while receiving treatment with this drug for this condition.
Patient must have evidence of an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material, defined as 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing.
A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

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 a 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 a 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 a 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 a 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

Alendronic acid

C6310

 

 

Osteoporosis
Patient must be aged 70 years or older.
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 

C6323

 

 

Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

 

C6327

 

 

Established osteoporosis
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

 

Alendronic acid with colecalciferol

C6306

 

 

Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6306

C6307

 

 

Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6307

C6315

 

 

Established osteoporosis
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

Compliance with Authority Required procedures - Streamlined Authority Code 6315

C6319

 

 

Established osteoporosis
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

Compliance with Authority Required procedures - Streamlined Authority Code 6319

C6320

 

 

Osteoporosis
Patient must be aged 70 years or older.
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6320

C6325

 

 

Osteoporosis
Patient must be aged 70 years or older.
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6325

Alendronic acid with colecalciferol and calcium

C6306

 

 

Corticosteroid-induced osteoporosis
Patient must currently be on long-term (at least 3 months), high-dose (at least 7.5 mg per day prednisolone or equivalent) corticosteroid therapy; AND
Patient must have a Bone Mineral Density (BMD) T-score of -1.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The duration and dose of corticosteroid therapy together with the date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6306

C6319

 

 

Established osteoporosis
Patient must have fracture due to minimal trauma; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
A vertebral fracture is defined as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.

Compliance with Authority Required procedures - Streamlined Authority Code 6319

C6325

 

 

Osteoporosis
Patient must be aged 70 years or older.
Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.

Compliance with Authority Required procedures - Streamlined Authority Code 6325

Alogliptin

C4349

 

 

Diabetes mellitus type 2
The treatment must be in combination with metformin; OR
The treatment must be in combination with a sulfonylurea; AND
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with either metformin or a sulfonylurea; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with either metformin or a sulfonylurea.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin or a sulfonylurea does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with alogliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 4349

Alogliptin with metformin

C4423

 

 

Diabetes mellitus type 2
Patient must have, or have had, a HbA1c measurement greater than 7% despite treatment with metformin; OR
Patient must have, or have had, where HbA1c measurement is clinically inappropriate, blood glucose levels greater than 10 mmol per L in more than 20% of tests over a 2 week period despite treatment with metformin.
The date and level of the qualifying HbA1c measurement must be, or must have been, documented in the patient's medical records at the time treatment with a dipeptidyl peptidase 4 inhibitor (gliptin), a thiazolidinedione (glitazone), a glucagon-like peptide-1 or a sodium-glucose co-transporter 2 (SGLT2) inhibitor is initiated.
The HbA1c must be no more than 4 months old at the time treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor was initiated.
Blood glucose monitoring may be used as an alternative assessment to HbA1c levels in the following circumstances:
(a) A clinical condition with reduced red blood cell survival, including haemolytic anaemias and haemoglobinopathies; and/or
(b) Had red cell transfusion within the previous 3 months.
The results of the blood glucose monitoring, which must be no more than 4 months old at the time of initiation of treatment with a gliptin, a glitazone, a glucagon-like peptide-1 or an SGLT2 inhibitor, must be documented in the patient's medical records.
A patient whose diabetes was previously demonstrated unable to be controlled with metformin does not need to requalify on this criterion before being eligible for PBS-subsidised treatment with this fixed dose combination.

Compliance with Authority Required procedures - Streamlined Authority Code 4423

C4427

 

 

Diabetes mellitus type 2
Continuing
Patient must have previously received and been stabilised on a PBS-subsidised regimen of oral diabetic medicines which includes metformin and alogliptin.

Compliance with Authority Required procedures - Streamlined Authority Code 4427

Alprazolam

C6773

 

 

Panic disorder
The treatment must be for use when other treatments have failed; OR
The treatment must be for use when other treatments are inappropriate.

Compliance with Authority Required procedures

Amantadine

C5132

 

 

Parkinson disease
The condition must not be drug induced.

 

Amino acid formula supplemented with prebiotics, probiotics and long chain polyunsaturated fatty acids

C4305

P4305

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4312

P4312

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides).
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4323

P4323

 

Cows' milk protein enteropathy
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4330

P4330

 

Cows' milk anaphylaxis
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.
Patient must be up to the age of 24 months.
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4337

P4337

 

Cows' milk protein enteropathy
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4338

P4338

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4339

P4339

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4345

P4345

 

Severe cows' milk protein enteropathy with failure to thrive
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must have had failure to thrive prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4352

P4352

 

Severe cows' milk protein enteropathy with failure to thrive
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4368

P4368

 

Eosinophilic oesophagitis
Initial treatment for up to 3 months
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must require an amino acid based formula as a component of a dietary elimination program.
Patient must be 18 years of age or less.
Treatment with oral steroids should not be commenced during the period of initial treatment.
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
The date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4414

P4414

 

Eosinophilic oesophagitis
Continuing treatment
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must have responded to an initial course of PBS-subsidised treatment.
Patient must be 18 years of age or less.
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.

Compliance with Authority Required procedures

C4415

P4415

 

Severe intestinal malabsorption including short bowel syndrome
Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition.

Compliance with Authority Required procedures

Amino acid formula with carbohydrate, vitamins, minerals and trace elements without phenylalanine

C4295

 

 

Phenylketonuria

 

Amino acid formula with fat, carbohydrate, vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine and supplemented with docosahexaenoic acid

C4295

 

 

Phenylketonuria

 

Amino acid formula with fat, carbohydrate, vitamins, minerals, and trace elements, without methionine and supplemented with docosahexanoic acid

C5534

 

 

Pyridoxine non-responsive homocystinuria

 

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine

C5970

 

 

Phenylketonuria

 

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine

C5533

 

 

Tyrosinaemia

 

Amino acid formula with fat, carbohydrate, vitamins, minerals and trace elements without phenylalanine and tyrosine, and supplemented with docosahexanoic acid

C5533

 

 

Tyrosinaemia

 

Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

C4305

 

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4312

 

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides).
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4323

 

 

Cows' milk protein enteropathy
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4330

 

 

Cows' milk anaphylaxis
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.
Patient must be up to the age of 24 months.
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4337

 

 

Cows' milk protein enteropathy
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4338

 

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4339

 

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4345

 

 

Severe cows' milk protein enteropathy with failure to thrive
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must have had failure to thrive prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4352

 

 

Severe cows' milk protein enteropathy with failure to thrive
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4415

 

 

Severe intestinal malabsorption including short bowel syndrome
Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition.

Compliance with Authority Required procedures

C5945

 

 

Eosinophilic oesophagitis
Initial treatment for up to 3 months
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must require an amino acid based formula as a component of a dietary elimination program.
Patient must be 18 years of age or less.
Treatment with oral steroids should not be commenced during the period of initial treatment.
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
The date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C5974

 

 

Eosinophilic oesophagitis
Continuing treatment
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must have responded to an initial course of PBS-subsidised treatment.
Patient must be 18 years of age or less.
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.

Compliance with Authority Required procedures

Amino acid formula with fat, carbohydrate without phenylalanine

C5970

 

 

Phenylketonuria

 

Amino acid formula without phenylalanine

C4295

 

 

Phenylketonuria

 

Amino acid formula without valine, leucine and isoleucine

C5571

 

 

Maple syrup urine disease

 

Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid

C4295

 

 

Phenylketonuria

 

Amino acid formula with vitamins and minerals without lysine and low in tryptophan

C5323

 

 

Proven glutaric aciduria type 1

 

C6007

 

 

Proven glutaric aciduria type 1

 

Amino acid formula with vitamins and minerals without methionine

C5534

 

 

Pyridoxine non-responsive homocystinuria

 

C5559

 

 

Pyridoxine non-responsive homocystinuria
Patient must be an infant or a very young child.

 

C6038

 

 

Pyridoxine non-responsive homocystinuria

 

Amino acid formula with vitamins and minerals without methionine, threonine and valine and low in isoleucine

C5542

 

 

Propionic acidaemia

 

C5560

 

 

Methylmalonic acidaemia

 

C5986

 

 

Propionic acidaemia

 

C6055

 

 

Methylmalonic acidaemia

 

Amino acid formula with vitamins and minerals without phenylalanine

C4295

 

 

Phenylketonuria

 

C4964

 

 

Phenylketonuria

 

Amino acid formula with vitamins and minerals without phenylalanine and tyrosine

C4923

 

 

Tyrosinaemia

 

C5533

 

 

Tyrosinaemia

 

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine

C4954

 

 

Maple syrup urine disease

 

C5571

 

 

Maple syrup urine disease

 

Amino acid formula with vitamins and minerals without valine, leucine and isoleucine with fat, carbohydrate and trace elements and supplemented with docosahexanoic acid

C5571

 

 

Maple syrup urine disease

 

Amino acid formula with vitamins, minerals and long chain polyunsaturated fatty acids without phenylalanine

C4295

 

 

Phenylketonuria

 

Amino acids-synthetic, formula

C4305

P4305

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4312

P4312

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides).
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4323

P4323

 

Cows' milk protein enteropathy
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4330

P4330

 

Cows' milk anaphylaxis
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.
Patient must be up to the age of 24 months.
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4337

P4337

 

Cows' milk protein enteropathy
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4338

P4338

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4339

P4339

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4345

P4345

 

Severe cows' milk protein enteropathy with failure to thrive
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must have had failure to thrive prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4352

P4352

 

Severe cows' milk protein enteropathy with failure to thrive
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4368

P4368

 

Eosinophilic oesophagitis
Initial treatment for up to 3 months
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must require an amino acid based formula as a component of a dietary elimination program.
Patient must be 18 years of age or less.
Treatment with oral steroids should not be commenced during the period of initial treatment.
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
The date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4414

P4414

 

Eosinophilic oesophagitis
Continuing treatment
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must have responded to an initial course of PBS-subsidised treatment.
Patient must be 18 years of age or less.
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.

Compliance with Authority Required procedures

C4415

P4415

 

Severe intestinal malabsorption including short bowel syndrome
Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition.

Compliance with Authority Required procedures

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids

C4305

 

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4312

 

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides).
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4323

 

 

Cows' milk protein enteropathy
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4330

 

 

Cows' milk anaphylaxis
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.
Patient must be up to the age of 24 months.
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4337

 

 

Cows' milk protein enteropathy
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4338

 

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4339

 

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4345

 

 

Severe cows' milk protein enteropathy with failure to thrive
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must have had failure to thrive prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4352

 

 

Severe cows' milk protein enteropathy with failure to thrive
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4415

 

 

Severe intestinal malabsorption including short bowel syndrome
Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition.

Compliance with Authority Required procedures

Amino acid synthetic formula supplemented with long chain polyunsaturated fatty acids and medium chain triglycerides

C4305

P4305

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4312

P4312

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides).
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4323

P4323

 

Cows' milk protein enteropathy
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4330

P4330

 

Cows' milk anaphylaxis
Must be treated by a specialist allergist or clinical immunologist, or in consultation with a specialist allergist or clinical immunologist.
Patient must be up to the age of 24 months.
Anaphylaxis is defined as a severe and/or potentially life threatening allergic reaction.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4337

P4337

 

Cows' milk protein enteropathy
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must be intolerant to both soy protein and protein hydrolysate formulae, as demonstrated when the child has failed to respond to a strict cows' milk protein free and strict soy protein free diet with a protein hydrolysate (with or without medium chain triglycerides) as the principal formula.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4338

P4338

 

Combined intolerance to cows' milk protein, soy protein and protein hydrolysate formulae
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist at intervals not greater than 12 months.
The condition must not be isolated infant colic or reflux.
Patient must be older than 24 months of age.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4339

P4339

 

Proven combined immunoglobulin E (IgE) mediated allergy to cows' milk protein and soy protein
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
Patient must have failed a trial of protein hydrolysate formulae (with or without medium chain triglycerides) prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4345

P4345

 

Severe cows' milk protein enteropathy with failure to thrive
Continuing treatment
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or have been assessed at least once or have an appointment to be assessed by one of these specialists.
The condition must not be isolated infant colic or reflux; AND
Patient must have had failure to thrive prior to commencement with initial treatment.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4352

P4352

 

Severe cows' milk protein enteropathy with failure to thrive
Initial treatment for up to 6 months
Must be treated by a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist, or in consultation with a specialist allergist, clinical immunologist or specialist paediatric gastroenterologist and hepatologist.
The condition must not be isolated infant colic or reflux.
Patient must be up to the age of 24 months.
The name of the specialist and the date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4368

P4368

 

Eosinophilic oesophagitis
Initial treatment for up to 3 months
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must require an amino acid based formula as a component of a dietary elimination program.
Patient must be 18 years of age or less.
Treatment with oral steroids should not be commenced during the period of initial treatment.
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
The date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C4414

P4414

 

Eosinophilic oesophagitis
Continuing treatment
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must have responded to an initial course of PBS-subsidised treatment.
Patient must be 18 years of age or less.
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.

Compliance with Authority Required procedures

C4415

P4415

 

Severe intestinal malabsorption including short bowel syndrome
Patient must have failed to respond to protein hydrolysate formulae; OR
Patient must have been receiving parenteral nutrition.

Compliance with Authority Required procedures

C5945

 

 

Eosinophilic oesophagitis
Initial treatment for up to 3 months
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must require an amino acid based formula as a component of a dietary elimination program.
Patient must be 18 years of age or less.
Treatment with oral steroids should not be commenced during the period of initial treatment.
Eosinophilic oesophagitis is demonstrated by the following criteria:
(i) Chronic symptoms of reflux that persisted despite a 2-month trial of a proton pump inhibitor or chronic dysphagia; and
(ii) A lack of demonstrable anatomic abnormality with the exception of stricture, which can be attributable to eosinophilic oesophagitis; and
(iii) Eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy and where the most densely involved oesophageal biopsy had 20 or more eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies.
The date of birth of the patient must be included in the authority application.

Compliance with Authority Required procedures

C5974

 

 

Eosinophilic oesophagitis
Continuing treatment
Must be treated by a clinical immunologist, suitably qualified allergist or gastroenterologist.
Patient must have responded to an initial course of PBS-subsidised treatment.
Patient must be 18 years of age or less.
Response to initial treatment is demonstrated by oesophageal biopsy specimens obtained by endoscopy, where the most densely involved oesophageal biopsy had 5 or less eosinophils in any single 400 x high powered field, along with normal antral and duodenal biopsies. The response criteria will not be deemed to have been met if oral steroids were commenced during initial treatment.

Compliance with Authority Required procedures

Amiodarone

C5665

 

 

Severe cardiac arrhythmias

 

Amisulpride

C4246

 

 

Schizophrenia

Compliance with Authority Required procedures - Streamlined Authority Code 4246

Amlodipine with valsartan

C4373

 

 

Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy; AND
The condition must be inadequately controlled with an angiotensin II antagonist; OR
The condition must be inadequately controlled with a dihydropyridine calcium channel blocker.

 

Amlodipine with valsartan and hydrochlorothiazide

C4311

 

 

Hypertension
The treatment must not be for the initiation of anti-hypertensive therapy; AND
The condition must be inadequately controlled with concomitant treatment with two of the following: an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.

 

Amoxicillin

C5843

 

 

Chronic bronchitis
Patient must have acute exacerbations of the condition.

 

 

P5863

CN5863

Infection suspected or proven to be due to a susceptible organism
The treatment must be for patients who require a liquid formulation and in whom the syrup formulations are unsuitable.

Compliance with Authority Required procedures

Amoxicillin with clavulanic acid

C5832

 

 

Infections where resistance to amoxicillin is proven

 

C5833

 

 

Infection where resistance to amoxicillin is suspected

 

C5893

 

 

Infection where resistance to amoxicillin is suspected

 

C5894

 

 

Infections where resistance to amoxicillin is proven

 

Amylopectin, modified long chain

C5561

 

 

Glycogen storage disease

 

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

Anastrozole

C5464

 

 

Breast cancer
The condition must be hormone receptor positive.

 

Apixaban

C4098

P4098

 

Deep vein thrombosis
Initial treatment
Patient must have confirmed acute symptomatic deep vein thrombosis; AND
Patient must not have symptomatic pulmonary embolism.

Compliance with Authority Required procedures - Streamlined Authority Code 4098

C4099

P4099

 

Deep vein thrombosis
Continuing treatment
Patient must have confirmed acute symptomatic deep vein thrombosis; AND
Patient must not have symptomatic pulmonary embolism.

Compliance with Authority Required procedures - Streamlined Authority Code 4099

C4132

P4132

 

Prevention of recurrent venous thromboembolism
Continuing treatment
Patient must have a history of venous thromboembolism.

Compliance with Authority Required procedures - Streamlined Authority Code 4132

C4269

P4269

 

Prevention of stroke or systemic embolism
Patient must have non-valvular atrial fibrillation; AND
Patient must have one or more risk factors for developing stroke or systemic embolism.
Risk factors for developing stroke or systemic ischaemic embolism are:
(i) Prior stroke (ischaemic or unknown type), transient ischaemic attack or non-central nervous system (CNS) systemic embolism;
(ii) age 75 years or older;
(iii) hypertension;
(iv) diabetes mellitus;
(v) heart failure and/or left ventricular ejection fraction 35% or less.

Compliance with Authority Required procedures - Streamlined Authority Code 4269

C4359

P4359

 

Prevention of venous thromboembolism
Patient must be undergoing total hip replacement.
Patient must require up to 10 days supply to complete a course of treatment.

Compliance with Authority Required procedures - Streamlined Authority Code 4359

C4381