National Health Act 1953 Amendment special arrangements under subsection 100(1) Highly Specialised Drugs Program (No. PB 10 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 10 of 2010

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

I, LINDA JACKSON, 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    23 February   2010

Signed

LINDA JACKSON

Assistant Secretary

Access and Systems Branch

Pharmaceutical Benefits Division

Department of Health and Ageing

Amendment Special Arrangements — Highly Specialised Drugs Program

1              Commencement

This instrument commences on 1 March 2010.

2              Amendment of PB 125 of 2009

Schedule 1 amends PB 125 of 2009.

Schedule 1                   Amendments

1. Schedule 1, item dealing with Infliximab

under the headings:

Chronic plaque psoriasis (whole body) — initial treatment 1

Chronic plaque psoriasis (whole body) — initial treatment 2

Chronic plaque psoriasis (whole body) — continuing treatment

Chronic plaque psoriasis (face, hand, foot) — initial treatment 1

Chronic plaque psoriasis (face, hand, foot) — initial treatment 2

Chronic plaque psoriasis (face, hand, foot) — continuing treatment

omit from the column headed “Circumstances”:

 where biological agent means adalimumab, etanercept, or infliximab; and

 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with each of the 3 biological agents once, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

and substitute:

 where biological agent means adalimumab, etanercept, infliximab or ustekinumab; and

 where a Biological Treatment Cycle is a period of treatment with successive biological agents which commences when an eligible patient (one who has not received PBS-subsidised treatment with a biological agent for chronic plaque psoriasis in at least the previous 5 years) receives an initial course of PBS-subsidised therapy with 1 biological agent, and which continues until the patient has tried, and either failed or ceased to respond to, PBS-subsidised treatment with 3 biological agents, at which point the patient is no longer eligible for treatment and the period of treatment ceases; and

1. Schedule 2, item dealing with Epoetin Beta

omit from the columns in the order indicated:

Injection 1,000 units in 0.3 mL pre-filled syringe Injection NeoRecormon

1. Schedule 2, item dealing with Thalidomide

omit from the column headed “Brand”:

Thalidomide Pharmion

and substitute:

Thalomid