National Health Act 1953 Amendment special arrangements under subsection 100(1) Highly Specialised Drugs Program (No. PB 83 of 2007) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 83 of 2007

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

I, STEPHEN DELLAR, Assistant Secretary, Pharmaceutical Evaluation Branch, Department of Health and Ageing, make this instrument under subsection 100(1) of the National Health Act 1953.

Dated 2 October 2007

STEPHEN DELLAR

Assistant Secretary

Pharmaceutical Evaluation Branch

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1              Commencement

This instrument commences on 1 November 2007.

2              Amendment of PB 53 of 2007

Schedule 1 amends PB 53 of 2007.

Schedule 1        Amendments

[1]           Schedule 1, item dealing with Etanercept

(a)  insert in the column headed ‘Circumstances’  immediately before the existing circumstances:

In respect of the injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL:

(b)    insert in the column headed ‘Circumstances’  immediately after the existing circumstances:

In respect of the injections 50 mg in 1 mL single use pre-filled syringes, 4:

Continuing PBS-subsidised treatment by a rheumatologist, or under the supervision of a paediatric rheumatology treatment centre, of severe active polyarticular course juvenile chronic arthritis in patients 18 years or older who have demonstrated an adequate response to treatment with etanercept as manifested by:

(a) an active joint count of fewer than 10 active (swollen and tender) joints; or

(b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or

(c) a reduction in the number of the following active joints, from at least 4, by at least 50%:

(i) elbow, wrist, knee or ankle (assessed as swollen and tender); or

(ii) shoulder, cervical spine or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth); and

where the following conditions apply:

the authority application includes sufficient information to determine the patient's eligibility according to the above criteria and the date of joint assessment; and

patients who have previously ceased treatment with etanercept due to failure to demonstrate an adequate response to treatment are not eligible to recommence treatment until a period of 12 months has elapsed since cessation of the previous treatment; and

applications for re-treatment of patients who have previously ceased treatment with etanercept due to having achieved and sustained complete remission of disease for 12 or more months are subject to the conditions applying to initial treatment and will not be authorised until a period of 12 months has elapsed since cessation of the previous treatment; and

authority applications for re-treatment with etanercept following a break in PBS-subsidised treatment with the drug include the reason for and date of cessation of the previous treatment course

[2]           Schedule 2, after item dealing with Atazanvir in the form Capsule 200 mg (as sulfate)

insert in the columns in the order indicated:

Capsule 300 mg (as sulfate) Oral Reyataz

[3]           Schedule 2, after item dealing with Etanercept in the form Injection set containing 4 vials powder for injection 25 mg and 4 pre-filled syringes solvent 1 mL

insert in the columns in the order indicated:

Injections 50 mg in 1 mL single use pre-filled syringes, 4 Injection Enbrel