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PB 38 of 2011 Arrangements as made
This instrument amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (No. PB 116 of 2010) to make changes to the list of pharmaceutical benefits supplied under the Special Arrangments for the treatment of chronic conditions which, because of their clinical use or other special features, may only be supplied to patients receiving treatment at or from a public or private hospital having access to appropriate specialised facilities.
Administered by: Health
Registered 31 May 2011
Tabling HistoryDate
Tabled HR14-Jun-2011
Tabled Senate15-Jun-2011
Date of repeal 19 Mar 2014
Repealed by Health (Spent and Redundant Instruments) Repeal Regulation 2014

 

PB 38 of 2011

National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 5)

 

National Health Act 1953

___________________________________________________________________________

 

 

I, FELICITY MCNEILL, Acting First Assistant Secretary, Pharmaceutical Benefits Division, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

Dated  27  May 2011

 

 

 

 

 

 

 

 

 

 

 

FELICITY MCNEILL

Acting First Assistant Secretary

Pharmaceutical Benefits Division

Department of Health and Ageing

 

___________________________________________________________________________

 

 

 

 


1              Name of Instrument

 

(1)                This Instrument is the National Health (Highly                    

             specialised drugs program for hospitals) Special Arrangement

            Amendment Instrument 2011 (No.5).

 

(2)                This Instrument may also be cited as PB 38 of 2011.

 

2             Commencement

                             This Instrument commences on 1 June 2011.

3              Amendments to PB 116 of 2010

                Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010)

.

 

 


Schedule 1                   Amendments

[1]           Schedule 1, entry for Abatacept

omit from the column headed ‘Circumstances’:

                C3556  C3557  C3558 

and substitute:

                C3558  C3712  C3713 

 

[2]           Schedule 1, entry for Infliximab

omit from the column headed ‘Circumstances’:

                C2996  C2997  C2998  C2999  C3000  C3001  C3002  C3003  C3004  C3005  C3007  C3008  C3259  C3260  C3261  C3262  C3263  C3264  C3492 C3493  C3494  C3513  C3514  C3515  C3571  C3572  C3581  C3585  C3691  C3692  C3693  C3694   

and substitute:

                C2996  C2997  C2998  C2999  C3000  C3001  C3002  C3003  C3004  C3005  C3007  C3008  C3259  C3260  C3261  C3262  C3263  C3264  C3492 C3493  C3494  C3513  C3514  C3515  C3572  C3585  C3691  C3692  C3693  C3694  C3710  C3711

 

[3]           Schedule 1, entry for Rituximab

omit from the column headed ‘Circumstances’:

                C3573  C3574  C3582 

and substitute:

                C3574  C3720  C3721 

 

[4]           Schedule 1, entry for Sirolimus

substitute:

 

Sirolimus

Tablet 0.5 mg

Oral

Rapamune (Pfizer Australia Pty Ltd)

PF

EMP

C1650 C3355

 

200

5

C

 

Tablet 1 mg

Oral

Rapamune

WX

EMP

C1650 C3355

 

200

5

C

 

Tablet 2 mg

Oral

Rapamune

WX

EMP

C1650 C3355

 

200

5

C

 

Oral solution 1 mg per mL, 60 mL

Oral

Rapamune

WX

EMP

C1650 C3355

 

2

5

C

 

 

 

 

 

[5]           Schedule 1, entry for Tocilizumab

omit from the column headed ‘Circumstances’ (all instances):

                C3480  C3559  C3560  C3561

and substitute:

                C3480  C3561  C3716  C3717

 

[6]           Schedule 3, entry for Abatacept

substitute:

Abatacept

C3558

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with abatacept; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with abatacept; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and 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 an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form, and a measurement of response to the most recent prior course of therapy with abatacept;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the cessation of the treatment course;
if the most recent course of abatacept therapy is a 16-week initial treatment course, the application for continuing treatment is accompanied by an assessment of response to a minimum of 12 weeks of treatment with that course;
if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 24 weeks of treatment;
if less than 24 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 24 weeks of treatment in total may be submitted by telephone

Compliance with modified  Authority Required procedures

 

C3712

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) 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:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with abatacept for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

 

C3713

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with abatacept, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with abatacept for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with abatacept are not eligible to commence treatment with abatacept until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with abatacept and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised abatacept treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised abatacept treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

 

[7]           Schedule 3 entry for Infliximab

omit:

 

C3571

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS‑subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS‑subsidised treatment with infliximab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with infliximab are not eligible to commence treatment with infliximab until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with infliximab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised infliximab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised infliximab treatment is a 22‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 22 weeks of treatment;
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

and insert in the columns in the order indicated, and in numerical order for the column headed “Circumstances Code”:

 

C3710

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) 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:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with infliximab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 22 weeks of treatment;
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

 

[8]           Schedule 3, entry for Infliximab

omit:

 

C3581

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial PBS‑subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include:
(i) 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:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with infliximab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 22 weeks of treatment;
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

 

and insert in the columns in the order indicated, and in numerical order for the column headed “Circumstances Code”:

 

C3711

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with infliximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with infliximab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with infliximab are not eligible to commence treatment with infliximab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with infliximab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised infliximab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised infliximab treatment is a 22-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 22 weeks of treatment;
if less than 22 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 22 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

 

[9]           Schedule 3, entry for Rituximab

substitute:

Rituximab

C3574

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — continuing treatment
Continuing PBS-subsidised treatment with rituximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults:
(a) who have a documented history of severe active rheumatoid arthritis; and
(b) who have demonstrated an adequate response to treatment with rituximab; and
(c) whose most recent course of PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment was with rituximab; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
an adequate response to treatment is defined as:
(a) an erythrocyte sedimentation rate no greater than 25 mm per hour or a C-reactive protein level no greater than 15 mg per L or either marker reduced by at least 20% from baseline; and
(b) either of the following:
(i) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
(ii) a reduction in the number of the following major joints which are active, from at least 4, by at least 50%:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is pain in passive movement and restriction of passive movement, and 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 an initial course of treatment are used to determine response to that course, and subsequent courses, of treatment;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
a patient is eligible to receive a further course of treatment (every 24 weeks) with this agent providing they have demonstrated an adequate response to treatment following a minimum of 12 weeks after the first infusion of their most recent treatment with rituximab, and the demonstration of response is submitted to the Medicare Australia CEO within 4 weeks of assessment;
if the response assessment to a course of treatment is not submitted to the Medicare Australia CEO within the timeframes specified above, the patient will be deemed to have failed that course of treatment;
a course of continuing treatment is limited to a maximum of 2 infusions;
a patient whose most recent course of PBS-subsidised therapy was with rituximab and whose response to this treatment is sustained for more than 12 months, is eligible to receive a further course of rituximab under the continuing treatment restriction

Compliance with modified Authority Required procedures

 

C3720

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 1
(patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with rituximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have failed to respond to at least 1 PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist; and
(c) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(d) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) 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:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with rituximab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 2 infusions

Compliance with modified Authority Required procedures

 

C3721

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with rituximab, in combination with methotrexate at a dose of at least 7.5 mg weekly, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have failed to respond to at least 1 PBS-subsidised tumour necrosis factor (TNF)-alfa antagonist; and
(c) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(d) have not failed previous PBS-subsidised treatment with rituximab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with rituximab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised rituximab treatment;
the response assessment included in the application is made at least 12 weeks after the first infusion of the course and is provided to the Medicare Australia CEO no later than 4 weeks from the date of assessment;
a course of initial treatment is limited to a maximum of 2 infusions

Compliance with modified Authority Required procedures

 

[10]         Schedule 3, entry for Tocilizumab

omit:

 

 

C3559

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 12 months)
Initial PBS‑subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS‑subsidised treatment with a biological disease modifying anti‑rheumatic drug (bDMARD) for this condition in the previous 12 months; and
(c) have failed to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti‑rheumatic drugs (DMARDs), which must include:
(i) 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:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or

Compliance with modified Authority Required procedures

(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)‑approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA‑approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS‑subsidised treatment with tocilizumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

 

C3560

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 12 months)
Initial PBS‑subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS‑subsidised biological disease modifying anti‑rheumatic drug (bDMARD) treatment for this condition within the previous 12 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS‑subsidised treatment with tocilizumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS‑subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS‑subsidised treatment with rituximab and who wish to transfer to treatment with tocilizumab are not eligible to commence treatment with tocilizumab until they have completed a period free from PBS‑subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application ‑ Supporting Information Form;
where a patient has received PBS‑subsidised treatment with tocilizumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS‑subsidised tocilizumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS‑subsidised tocilizumab treatment is a 16‑week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

and insert in the columns in the order indicated, and in numerical order for the column headed “Circumstances Code”:

 

C3716

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 1
(new patient or patient recommencing after a break of more than 24 months)
Initial PBS-subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have severe active rheumatoid arthritis; and
(b) have received no PBS-subsidised treatment with a biological disease modifying anti-rheumatic drug (bDMARD) for this condition in the previous 24 months; and
(c) have failed, in the 24 months immediately prior to the date of application, to achieve an adequate response to at least 6 months of intensive treatment with disease modifying anti-rheumatic drugs (DMARDs), which must include:
(i) 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:
— hydroxychloroquine at a dose of at least 200 mg daily; or
— leflunomide at a dose of at least 10 mg daily; or
— sulfasalazine at a dose of at least 2 g daily; or
(ii) if methotrexate is contraindicated according to the Therapeutic Goods Administration (TGA)-approved Product Information or cannot be tolerated at a 20 mg weekly dose — at least 3 months continuous treatment with each of at least 2 of the following DMARDs:
— hydroxychloroquine at a dose of at least 200 mg daily; and/or
— leflunomide at a dose of at least 10 mg daily; and/or
— sulfasalazine at a dose of at least 2 g daily; or
(iii) 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 — at least 3 months continuous treatment with each of at least 2 DMARDs, one or more of the following DMARDs being used in place of the DMARDS which are contraindicated or not tolerated:
— azathioprine at a dose of at least 1 mg/kg per day; and/or
— cyclosporin at a dose of at least 2 mg/kg/day; and/or
— sodium aurothiomalate at a dose of 50 mg weekly; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, infliximab, golimumab, rituximab or tocilizumab; and
where the following conditions apply:
if methotrexate is contraindicated according to the TGA-approved Product Information or cannot be tolerated at a 20 mg weekly dose, the authority application includes details of the contraindication or intolerance to methotrexate, and documents the maximum tolerated dose of methotrexate, if applicable;
the authority application includes 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, the authority application provides details of the contraindication or intolerance and dose for each DMARD;
failure to achieve an adequate response to the DMARD treatment specified above is demonstrated by the following:
(a) 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
(b) either:
(i) a total active joint count of at least 20 active (swollen and tender) joints; or
(ii) at least 4 active joints from the following list of major joints:
— elbow, wrist, knee and/or ankle (assessed as active if swollen and tender); and/or
— shoulder and/or hip (assessed as active if there is 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 are determined at the completion of the 6 month intensive DMARD trial, but prior to ceasing DMARD therapy, and all measures are 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 authority application states the reason this criterion cannot be satisfied;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form and a signed patient acknowledgement;
a patient is eligible for treatment if they have not failed previous PBS-subsidised treatment with tocilizumab for rheumatoid arthritis, and have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

 

C3717

 

Where the patient is receiving treatment at/from a private or public hospital

Rheumatoid arthritis — initial treatment 2
(change or recommencement after a break of less than 24 months)
Initial PBS-subsidised treatment with tocilizumab, by a rheumatologist or by a clinical immunologist with expertise in the management of rheumatoid arthritis, of adults who:
(a) have a documented history of severe active rheumatoid arthritis; and
(b) have received prior PBS-subsidised biological disease modifying anti-rheumatic drug (bDMARD) treatment for this condition within the previous 24 months and are eligible to receive further bDMARD therapy; and
(c) have not failed previous PBS-subsidised treatment with tocilizumab for this condition; and
where bDMARD means abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, rituximab or tocilizumab; and
where the following conditions apply:
patients are eligible to receive further bDMARD therapy for rheumatoid arthritis provided they have not already failed, or ceased to respond to, PBS-subsidised bDMARD treatment for this condition 5 times;
patients who demonstrate a response to a course of PBS-subsidised treatment with rituximab and who wish to transfer to treatment with tocilizumab are not eligible to commence treatment with tocilizumab until they have completed a period free from PBS-subsidised bDMARD treatment of at least 22 weeks duration, immediately following the second rituximab infusion;
the authority application is made in writing and includes a completed copy of the appropriate Rheumatoid Arthritis PBS Authority Application - Supporting Information Form;
where a patient has received PBS-subsidised treatment with tocilizumab and wishes to recommence therapy with this drug, the authority application is accompanied by evidence of a response to the patient's most recent course of PBS-subsidised tocilizumab treatment;
the response assessment included in the application is provided to the Medicare Australia CEO no later than 4 weeks from the date the course was ceased, and, where the most recent course of PBS-subsidised tocilizumab treatment is a 16-week initial treatment course, is made following a minimum of 12 weeks of therapy;
a course of initial treatment is limited to a maximum of 16 weeks of treatment;
if less than 16 weeks of treatment is authorised when the written application is made, subsequent authority applications for supplies sufficient to enable the patient to complete a course of 16 weeks of treatment in total may be submitted by telephone

Compliance with modified Authority Required procedures

 

 

 

 

 

 

[11]         Schedule 4

 

substitute:

 

Listed Drug

Form (strength, type, size, etc.)

Manner of Administration

Brand

Quantity or Number of Units

Approved

ex-manufacturer price

$

Claimed

ex-manfacturer price

$

Cyclosporin

Capsule 50 mg

Oral

Neoral 50

30

79.88

80.94

 

Capsule 100 mg

Oral

Neoral 100

30

162.77

164.16

Desferrioxamine

Powder for injection containing desferrioxamine mesylate 500 mg

Injection

Desferal 500 mg

10

93.14

100.86

 

Powder for injection containing desferrioxamine mesylate 2 g

Injection

Desferal 2 g

1

37.25

37.63

 

Note

All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. 

See http://www.frli.gov.au.