National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 7) (PB 73 of 2015) (Cth)

PB 73 of 2015

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 7)

National Health Act 1953

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I, Julianne Quaine, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this instrument under subsections 100(1) and (2) of the National Health Act 1953.

Dated 30 July 2015

JULIANNE QUAINE

Assistant Secretary

Pharmaceutical Access Branch       

Pharmaceutical Benefits Division

Department of Health

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1              Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No.7).

(2)This Instrument may also be cited as PB 73 of 2015.

2             Commencement

This Instrument commences on 1 August 2015.

3              Amendments to PB 79 of 2011

Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1       Amendments

1. Schedule 1, Part 1 after the entry for Mitozantrone:

insert:

Obinutuzumab Solution for I.V. infusion 1000 mg in 40 mL Injection Gazyva RO MP C5126 D

1. Schedule 1, Part 2 after the entry for Mitozantrone:

insert:

Obinutuzumab 1000 7

1. Schedule 2, after the entry for ‘Mesna’:

substitute:

Mesna	Solution for I.V. injection 400 mg in 4 mL ampoule	Injection	Uromitexan	BX	EMP	C5130	1	5
Solution for I.V. injection 1 g in 10 mL ampoule	Injection	Uromitexan	BX	EMP	C5130	1	5

1. Schedule 4, entry for Mesna:

substitute:

Mesna C5130 Urothelial toxicity Treatment Phase: Prophylaxis or reduction of toxicity
The treatment must be adjunctive therapy to ifosfamide or high dose cyclophosphamide.

1. Schedule 4, after entry for Methotrexate:

insert:

Obinutuzumab C5126 Chronic lymphocytic leukaemia (CLL)
Patient must require treatment for CD20 positive chronic lymphocytic leukaemia (CLL), AND
The condition must be previously untreated, AND
Patient must be inappropriate for fludarabine based chemo-immunotherapy, AND
The treatment must be in combination with chlorambucil, AND
Patient must have a creatinine clearance 30 mL/min or greater, AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.
Treatment must be discontinued in patients who experience disease progression while on treatment.
Applications for authorisation must be in writing and must include:
(a) a completed authority prescription form; AND
(b) a completed CD20 positive Chronic Lymphocytic Leukaemia PBS Authority Application  Supporting Information Form which includes:
i) documentation that the patient has CD20 positive CLL (flow cytometry pathology report from blood or bone marrow, noting that this may be from some time earlier); AND
ii) a statement that the patient is previously untreated, is inappropriate for fludarabine based chemo immunotherapy, that treatment will be in combination with chlorambucil; AND
iii) documentation that the patient has a creatinine clearance 30 mL/min or greater; AND
iv) One of the following, either:
- A completed cumulative illness rating scale (CIRS) score form demonstrating that the patient has a score of greater than 6 (excluding CLL-induced illness or organ damage) OR
- Documentation that the patient has a creatinine clearance less than 70 mL/min. Compliance with Written Authority Required procedures