National Health (Highly specialised drugs program for hospitals) Special Arrangement Amendment Instrument 2011 (No. 5) (No. PB 38 of 2011) (Cth)
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 |
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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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.
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