National Health Act 1953 Amendment special arrangements under subsection 100(1) Chemotherapy Pharmaceuticals Access Program (No. PB 60 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 60 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    7 June 2010

LINDA JACKSON

Assistant Secretary

Access and Systems Branch

Department of Health and Ageing

Amendment Special Arrangements — Chemotherapy Pharmaceuticals Access Program

1              Commencement

This instrument commences on 1 July 2010.

2              Amendment of PB 55 of 2009

Schedule 1 amends PB 55 of 2009.

Schedule 1   Amendments

[1]      Schedule 1, omit item dealing with Bevacizumab

and substitute in the columns in the order indicated:

Bevacizumab

In compliance with authority procedures set out in paragraph 14:

Initial PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with previously untreated metastatic colorectal cancer with a World Health Organisation performance status of 0 or 1, and where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks

Continuing PBS-subsidised treatment, in combination with first-line chemotherapy, of a patient with metastatic colorectal cancer who has previously been issued with an authority prescription for bevacizumab and who does not have progressive disease and who remains on first-line chemotherapy, and where the patient's dose of bevacizumab does not exceed 5 mg per kg every 2 weeks or 7.5 mg per kg every 3 weeks

[2]      Schedule 1, item dealing with Docetaxel

omit from the column headed “Circumstances”:

Advanced breast cancer after failure of prior therapy which includes an anthracycline

and substitute:

Advanced breast cancer after failure of prior therapy

[3]      Schedule 1, item dealing with Paclitaxel

omit from the column headed “Circumstances”:

Advanced breast cancer after failure of prior therapy which includes an anthracycline

and substitute:

Advanced breast cancer after failure of prior therapy

[4]      Schedule 1, item dealing with Paclitaxel, nanoparticle albumin-bound

omit from the column headed “Circumstances”:

Metastatic breast cancer after failure of prior therapy which includes an anthracycline

and substitute:

Metastatic breast cancer after failure of prior therapy

[5]      Schedule 2, omit item dealing with Docetaxel

and substitute:

Docetaxel	Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent	Injection	1	..	Taxotere
Injection set containing 1 single use vial concentrate for I.V. infusion 80 mg (anhydrous) in 2 mL with solvent	Injection	1	..	Taxotere

[6]      Schedule 2, item dealing with Oxaliplatin in the form Powder for I.V. infusion 50 mg

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

[7]      Schedule 2, item dealing with Paclitaxel in the forms Solution concentrate for I.V. infusion 30 mg in 5 mL, Solution concentrate for I.V. infusion 100 mg in 16.7 mL, Solution concentrate for I.V. infusion 150 mg in 25 mL and Solution concentrate for I.V. infusion 300 mg in 50 mL,

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

[8]      Schedule 3, omit item dealing with Docetaxel

and substitute:

Docetaxel Injection set containing 1 single use vial concentrate for I.V. infusion 20 mg (anhydrous) in 0.5 mL with solvent  In compliance with authority procedures set out in paragraph 14: Adjuvant treatment of node-positive breast cancer in combination with an anthracycline and cyclophosphamide Advanced breast cancer after failure of prior therapy Advanced metastatic ovarian cancer after failure of prior therapy which includes a platinum compound Locally advanced or metastatic non-small cell lung cancer Treatment of HER2 positive early breast cancer in combination with trastuzumab Treatment of androgen independent (hormone refractory) metastatic carcinoma of the prostate in a patient with a Karnofsky performance-status score of at least 60%, where docetaxel is used as first-line chemotherapy and administered in three weekly cycles Adjuvant treatment of operable breast cancer in combination with cyclophosphamide Injection 2 .. Taxotere