National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 12) (PB 107 of 2019) (Cth)

PB 107 of 2019

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 12)

National Health Act 1953

___________________________________________________________________________

I, NATASHA PLOENGES, Assistant Secretary (Acting), 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         20 December 2019

NATASHA PLOENGES

Assistant Secretary (Acting)

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 2019 (No. 12).

(2)This Instrument may also be cited as PB 107 of 2019.

1. Commencement

This Instrument commences on 1 January 2020.

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 Avelumab

(a)omit from the column headed “Circumstances”: C8856

(b)insert in numerical order in the column headed “Circumstances”: C10023

1. Schedule 1, Part 1, entry for Cladribine in the form Injection 10 mg in 5 mL

omit from the column headed “Responsible Person”: OA          substitute: AS

1. Schedule 1, Part 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion 500 mg in 50 mL

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

Truxima EW MP C7399 C7400 C9451 C9542 PB

1. Schedule 1, Part 1, entry for Trastuzumab in the form Powder for I.V. infusion 150 mg

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

Ontruzant MK MP C9349 C9353 C9354 C9356 C9461 C9571 C9573 C9628 PB

1. Schedule 1, Part 2, entry for Avelumab [Maximum Amount: 1200; Number of Repeats: 11]

omit from the column headed “Purposes”: P8856       substitute: P10023

1. Schedule 3

omit:

OA Orphan Australia Pty Ltd 11 067 189 342

1. Schedule 4, entry for Avelumab

(a)omit:

C8856 P8856 Stage IV (metastatic) Merkel Cell Carcinoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a total of 12 doses at a maximum dose of 10 mg per kg every 2 weeks under this restriction. Compliance with Authority Required procedures - Streamlined Authority Code 8856

(b)insert in numerical order after existing text:

C10023 P10023 Stage IV (metastatic) Merkel Cell Carcinoma
Continuing treatment
The treatment must be the sole PBS-subsidised therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction. Compliance with Authority Required procedures - Streamlined Authority Code 10023