National Health Act 1953 Amendment special arrangements under subsection 100(1) Highly Specialised Drugs Program (No. PB 123 of 2009) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 123 of 2009

Amendment special arrangements under subsection 100(1) of the National Health Act 1953

I, CHRIS BEDFORD, Acting Assistant Secretary, Access and Systems Branch, Department of Health and Ageing, delegate of the Minister for Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 8 December 2009

CHRIS BEDFORD

Acting Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1              Commencement

This instrument commences on 1 January 2010.

2              Amendment of PB 54 of 2009

Schedule 1 amends PB 54 of 2009.

Schedule 1                   Amendments

1. Subparagraph 2(h)

insert as next entry after “tenofovir with emtricitabine”:

tenofovir with emtricitabine and efavirenz

1. Schedule 1, item dealing with Abatacept

omit from the column headed “Circumstances” under the heading “Rheumatoid arthritis — initial treatment 1”:

(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 Infliximab

omit from the column headed “Circumstances” under the heading “Rheumatoid arthritis — initial treatment 1”:

(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, after item dealing with Tenofovir with Emtricitabine

insert in the columns in the order indicated:

Tenofovir with emtricitabine and efavirenz

Treatment of human immunodeficiency virus infection in patients with:

(a) CD4 cell counts of less than 500 per cubic millimetre; or

(b) viral load of greater than 10,000 copies per mL

[5]         Schedule 2, after item dealing with Tenofovir with Emtricitabine

insert in the columns in the order indicated:

Tenofovir with emtricitabine and efavirenz Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg Oral Atripla