National Health Act 1953 Amendment special arrangements under subsection 100(1) Highly Specialised Drugs Program (No. PB 21 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 21 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 5 March 2010

LINDA JACKSON

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 April 2010.

2              Amendment of PB 54 of 2009

Schedule 1 amends PB 54 of 2009.

Schedule 1                   Amendments

1. Paragraph 2(h)

insert as next entry after “lopinavir with ritonavir”:

maraviroc

1. Schedule 1, item dealing with Darunavir

omit from the column headed “Circumstances”:

Treatment, in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir twice daily, of HIV infection in an antiretroviral experienced patient with:

(a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and/or

(b) CD4 cell counts of less than 500 per cubic millimetre.

A patient must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens which have included:

(i) at least 1 non-nucleoside reverse transcriptase inhibitor; and

(ii) at least 1 nucleoside reverse transcriptase inhibitor; and

(iii) at least 2 protease inhibitors.

and substitute:

Treatment, in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir twice daily, of HIV infection in an antiretroviral experienced patient with:

(a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and/or

(b) CD4 cell counts of less than 500 per cubic millimetre.

A patient must have failed previous treatment with, or have resistance to, 1 antiretroviral regimen

1. Schedule 1, after item dealing with Lopinavir with Ritonavir

insert in the columns in the order indicated:

Maraviroc

In combination with other antiretrovirals, for the treatment of an antiretroviral experienced patient infected with only CCR5-tropic HIV-1 and:

(a) evidence of HIV replication (viral load greater than 5,000 copies per mL); and/or

(b) CD4 cell counts of less than 500 per cubic millimetre.

A patient must have virological failure of previous treatment with, or have resistance to, 3 different antiretroviral regimens, including regimens with:

(i) at least 1 non-nucleoside reverse transcriptase inhibitor; and

(ii) at least 1 nucleoside reverse transcriptase inhibitor; and

(iii) at least 2 protease inhibitors.

A tropism assay to determine CCR5 only strain status is required prior to initiation.  Individuals with CXCR4 tropism demonstrated at any time point are not eligible

Methoxy polyethylene glycol-epoetin beta

Treatment of anaemia requiring transfusion, defined as a haemoglobin level of less than 100 g per L, where intrinsic renal disease, as assessed by a nephrologist, is the primary cause of the anaemia

1. Schedule 2, after item dealing with Lopinavir with Ritonavir

insert in the columns in the order indicated:

Maraviroc	Tablet 300 mg	Oral	Celsentri
Tablet 150 mg	Oral	Celsentri
Methoxy polyethylene glycol-epoetin beta	Injection 30 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera
Injection 50 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera
Injection 75 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera
Injection 100 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera
Injection 120 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera
Injection 200 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera
Injection 360 micrograms in 0.3 mL pre-filled syringe	Injection	Mircera

1. Schedule 2, after item dealing with Nevirapine in the form Tablet 200 mg

insert in the columns in the order indicated:

Oral suspension 50 mg (as hemihydrate) per
5 mL, 240 mL Oral Viramune

1. Schedule 2, item dealing with Octreotide in the forms Injection 50 micrograms
   (as acetate) in 1 mL, Injection 100 micrograms (as acetate) in 1 mL and Injection
   500 micrograms (as acetate) in 1 mL

insert in alphabetical order in the column headed “Brand”:

Octreotide MaxRx