National Health Act 1953 Amendment declaration under subsections 85(2) and 85(2AA) Amendment determination under subsection 85(2A) drugs and medicinal preparations (No. PB 118 of 2009) (Cth)
COMMONWEALTH OF AUSTRALIA
Instrument number PB 118 of 2009
Amendment declaration under subsections 85(2) and 85(2AA) of the National Health Act 1953
Amendment determination under subsection 85(2A) of the National Health Act 1953
I, LINDA JACKSON, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsections 85(2), 85(2A) and 85(2AA) of the National Health Act 1953.
Dated 4 December 2009
LINDA JACKSON
Assistant Secretary
Pharmaceutical Evaluation Branch
Department of Health and Ageing
Amendment declaration and determination — drugs and medicinal preparations
1 Commencement
This instrument commences on 1 January 2010.
2 Amendment of PB 113 of 2008
Schedule 1 amends PB 113 of 2008.
Schedule 1 Amendments
[1] Schedule 1, item dealing with Adalimumab
omit from the column headed “Circumstances” under the first instance of the heading “Rheumatoid arthritis”:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
and substitute:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
[2] Schedule 1, item dealing with Anakinra
omit from the column headed “Circumstances” under the first instance of the heading “Rheumatoid arthritis”:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
and substitute:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
[3] Schedule 1, item dealing with Etanercept
omit from the column headed “Circumstances” under the first instance of the heading “Rheumatoid arthritis”:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or with leflunomide in combination with methotrexate or with cyclosporin alone, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
and substitute:
| (c) have failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, have failed to achieve an adequate response to methotrexate (at a dose of at least 7.5 mg weekly) in combination with 2 other non-biological disease modifying anti-rheumatic drugs (DMARDs) for a minimum of 3 months, and have failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless the patient has had a break in PBS-subsidised bDMARD treatment of at least 5 years, in which case the patient is required to demonstrate failure to achieve an adequate response to treatment with at least 1 non-biological DMARD, at an adequate dose, for a minimum of 3 months; and |
[4] Schedule 1, item dealing with Etanercept
omit from the column headed “Circumstances” under the third instance of the heading “Rheumatoid arthritis”:
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide alone or leflunomide in combination with methotrexate or cyclosporin alone, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
and substitute:
| where the patient has failed to achieve an adequate response to methotrexate at a dose of at least 20 mg weekly, has failed to achieve an adequate response to methotrexate in combination with 2 other disease modifying anti-rheumatic drugs for a minimum of 3 months, and has subsequently failed to achieve an adequate response following a minimum of 3 months' treatment with leflunomide or cyclosporin, unless treatment with any of the above-mentioned drugs is contraindicated according to the relevant Therapeutic Goods Administration-approved Product Information, or intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use, in which case the patient is exempted from demonstrating an inadequate response to the above treatment regimens; and |
[5] Schedule 1, omit item dealing with Glucose Indicator—Blood
and substitute:
| Glucose Indicator—Blood | In respect of the test strips, 25 (On-Call Plus), test strips, 50 (Accu-Chek Active), test strips, 50 (Accu-Chek Go), test strips, 51 (Accu-Chek Integra), test strips, 50 (Advantage II), test strips, 50 (Betachek), test strips, 50 (Betachek G5), test strips, 50 (CareSens), test strips, 50 (FreeStyle), test strips, 50 (Freestyle Papillon), test strips, 50 (Glucoboy), test strips, 50 (Glucocard 01 Sensor), test strips, 50 (Glucoflex-R), test strips, 50 (GlucoOz), test strips, 50 (Glucostix), test strips, 50 (Lifeline Attest), test strips, 50 (MWD Pen Sensor Strips), test strips, 50 (MyGlucoHealth), test strips, 50 (Omnitest EZ), test strips, 50 (Omnitest Plus), test strips, 50 (Optium Omega), test strips, 50 (SensoCard), test strips, 50 (TrueTrack), test strips, 100 (Accu-Chek Performa), test strips, 100 (FreeStyle Lite), test strips, 100 (Optium glucose) and test strips, 100 (SofTact): — |
| In respect of the test strips, 100 (Precision Plus): In compliance with authority procedures set out in subparagraph 14 (d): | |
| 1769 | Patients who have previously received this product as a pharmaceutical benefit |
| 1770 | Patients who have purchased a meter to be used with this product prior to 1 August 2003 |
[6] Schedule 3, after item dealing with Dydrogesterone
insert in the columns in the order indicated:
| Efavirenz | Tenofovir with Emtricitabine and Efavirenz |
[7] Schedule 3, item dealing with Emtricitabine
insert in the column headed “Allowable compounds” below the existing entry:
Tenofovir with Emtricitabine and Efavirenz
[8] Schedule 3, item dealing with Tenofovir
insert in the column headed “Allowable compounds” below the existing entry:
Tenofovir with Emtricitabine and Efavirenz
[9] Schedule 6, after item dealing with Tenofovir with Emtricitabine
insert as next entry:
Tenofovir with Emtricitabine and Efavirenz
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