National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 9) (No. PB 78 of 2014) (Cth)

PB 78 of 2014

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2014 (No. 9)

National Health Act 1953

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I, Tony Wynd, Acting 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 23 September 2014

TONY WYND

Acting 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 2014 (No.9).

(2)This Instrument may also be cited as PB 78 of 2014.

2             Commencement

This Instrument commences on 1 October 2014.

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 Epirubicin;

insert:

Eribulin Solution for I.V. injection containing eribulin mesilate 1 mg in 2 mL Injection Halaven EI MP C4646 C4649 D

1. Schedule 1, Part 2 after the entry for Epirubicin;

insert:

Eribulin 3 13

1. Schedule 3, Responsible Person codes, after entry for EA:

insert:

EI Eisai Australia Pty Ltd  73 117 970 993

1. Schedule 4, after the entry for Doxorubicin ‑ Pegylated Liposomal;

insert in the columns in the order indicated:

Eribulin	C4646	Locally advanced or metastatic breast cancer Patient must have progressive disease, Patient must have failed at least two prior chemotherapeutic regimens for this condition, The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures
C4649	Locally advanced or metastatic breast cancer Patient must have progressive disease, Patient must have failed at least two prior chemotherapeutic regimens for this condition, The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Authority Required procedures - Streamlined Authority Code 4649