National Health Act 1953 Amendment special arrangements under subsection 100(1) Chemotherapy Pharmaceuticals Access Program (No. PB 76 of 2010) (Cth)

COMMONWEALTH OF AUSTRALIA

Instrument number PB 76 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 July 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 August 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 Aprepitant

and substitute in the columns in the order indicated:

Aprepitant

In compliance with authority procedures set out in subparagraph 14 (d):

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where any 1 of the following chemotherapy agents are to be administered:

 (a) altretamine;

 (b) carmustine;

 (c) cisplatin, when a single dose constitutes a cycle of chemotherapy;

 (d) cyclophosphamide, at a dose of 1500 mg per square metre per day or greater;

 (e) dacarbazine;

 (f) procarbazine, when a single dose constitutes a cycle of chemotherapy;

 (g) streptozocin; and

 where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy

Management of nausea and vomiting associated with cytotoxic chemotherapy being used to treat breast cancer, in combination with a 5-hydroxytryptamine type 3 receptor antagonist and dexamethasone, where cyclophosphamide and an anthracycline are to be co-administered, and where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy

Management of nausea and vomiting associated with moderately emetogenic cytotoxic chemotherapy being used to treat malignancy, in combination with a 5-hydroxytryptamine type 3 receptor (5HT3) antagonist and dexamethasone on day 1, where the patient has had a prior episode of chemotherapy induced nausea or vomiting where any 1 of the following intravenous chemotherapy agents is to be administered:

 (a) arsenic trioxide;

 (b) azacitidine;

 (c) carboplatin;

 (d) cyclophosphamide, at a dose of less than 1500 mg per square metre per day;

 (e) cytarabine, at a dose of greater than 1 g per square metre per day;

 (f) dactinomycin;

 (g) daunorubicin;

 (h) doxorubicin;

 (i) epirubicin;

 (j) fotemustine;

 (k) idarubicin;

 (l) ifosfamide;

 (m) irinotecan;

 (n) melphalan;

 (o) methotrexate, at a dose of 250 mg to 1 g per square metre;

 (p) oxaliplatin;

 (q) raltitrexed; and

 where treatment with aprepitant is limited to an initial dose of 125 mg and 2 subsequent doses of 80 mg per cycle of cytotoxic chemotherapy, and where concomitant use of a 5HT3 antagonist should not occur with aprepitant on days 2 and 3 of any chemotherapy cycle

[2]      Schedule 1, omit item dealing with Oxaliplatin

and substitute in the columns in the order indicated:

Oxaliplatin	In compliance with authority procedures set out in subparagraph 14 (d):
Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with capecitabine
Metastatic colorectal cancer in a patient with a World Health Organisation performance status of 2 or less, when used in combination with fluorouracil and folinic acid
Adjuvant treatment of stage III (Dukes C) colon cancer, in combination with fluorouracil and calcium folinate, following complete resection of the primary tumour

[3]      Schedule 2, item dealing with Oxaliplatin in the forms Solution concentrate for I.V. infusion 50 mg in 10 mL and Solution concentrate for I.V. infusion 100 mg in 20 mL

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

1. Schedule 4, item dealing with Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U. (Hospira Pty Limited)

(a)	omit from the column headed “Approved price”:
42.58
and substitute:
41.72

(b)	omit from the column headed “Price claimed by manufacturer”:
80.87
and substitute:
79.26

1. Schedule 4, item dealing with Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U. (Blenamax)

(a)	omit from the column headed “Approved price”:
425.74
and substitute:
417.22
(b)	omit from the column headed “Price claimed by manufacturer”:
808.74
and substitute:
792.56

1. Schedule 4, item dealing with Bleomycin in the form Powder for injection containing bleomycin sulfate 15,000 I.U. (Blenoxane)

(a)	omit from the column headed “Approved price”:
425.74
and substitute:
417.22
(b)	omit from the column headed “Price claimed by manufacturer”:
808.74
and substitute:
857.24

1. Schedule 4, item dealing with Folinic acid in the form Injection containing calcium folinate equivalent to 50 mg folinic acid in 5 mL

(a)	omit from the column headed “Approved price”:
197.05
and substitute:
193.30
(b)	omit from the column headed “Price claimed by manufacturer”:
197.25
and substitute:
193.31