National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 8) (PB 78 of 2018) (Cth)

PB 78 of 2018

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 8)

National Health Act 1953

___________________________________________________________________________

I, NATASHA PLOENGES, Acting Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated 29 August 2018

NATASHA PLOENGES

Acting Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

1. Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2018 (No. 8).

(2)This Instrument may also be cited as PB 78 of 2018.

1. Commencement

This Instrument commences on 1 September 2018.

1. Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (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, entry for Carfilzomib

substitute:

Carfilzomib	Powder for injection 10 mg	Injection	Kyprolis	AN	MP	C7344 C7348 C7355	D
Powder for injection 30 mg	Injection	Kyprolis	AN	MP	C7344 C7348 C7355	D
Powder for injection 60 mg	Injection	Kyprolis	AN	MP	C7344 C7348 C7355	D

1. Schedule 1, Part 1, entry for Fluorouracil in each of the forms: Injection 1000 mg in 20 mL; Injection 2500 mg in 50 mL; and Injection 5000 mg in 100 mL

insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

Fluorouracil OC MP C6266 C6297 D

1. Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

(a)omit from the column headed “Circumstances”: C6996

(b)insert in numerical order in the column headed “Circumstances”: C7567

1. Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 360; Number of Repeats: 8]

(a)omit from the column headed “Purposes”: P6996

(b)insert in numerical order in the column headed “Purposes”: P7567

1. Schedule 3

omit:

DZ Medsurge Healthcare Pty Ltd 92 124 728 892

1. Schedule 4, entry for Nivolumab

(a)omit:

C6996 P6996 Locally advanced or metastatic non-small cell lung cancer Initial treatment Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. Compliance with Authority Required procedures - Streamlined Authority Code 6996

(b)insert in numerical order for the column headed “Circumstances Code”:

C7567 P7567 Locally advanced or metastatic non-small cell lung cancer Initial treatment Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be the sole PBS-subsidised treatment for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. Compliance with Authority Required procedures - Streamlined Authority Code 7567