National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 3) (PB 21 of 2019) (Cth)

PB 21 of 2019

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2019 (No. 3)

National Health Act 1953

___________________________________________________________________________

I, BEN SLADIC, 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         27 March 2019

BEN SLADIC

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 2019 (No. 3).

(2)This Instrument may also be cited as PB 21 of 2019.

1. Commencement

This Instrument commences on 1 April 2019.

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 Brentuximab vedotin in the form Powder for I.V. infusion 50 mg

insert in numerical order in the column headed “Circumstances”: C8722 C8736

1. Schedule 1, Part 1, entry for Epirubicin in the form Solution for injection containing epirubicin hydrochloride 50 mg in 25 mL

omit:

Epirubicin SZ HX MP D

1. Schedule 1, Part 2, entry for Brentuximab vedotin

insert as first entry:

P8722	180	3
P8736	180	11

1. Schedule 4, entry for Bortezomib

omit from the column headed "Circumstances and Purposes" for circumstances code C7940: PBS subsidised              substitute: PBS-subsidised

1. Schedule 4, entry for Brentuximab vedotin

insert in numerical order after existing text:

C8722	P8722	CD30 positive cutaneous T-cell lymphoma Initial treatment Patient must have pathologically confirmed CD30 positive cutaneous T cell lymphoma; AND Patient must have CD30 positivity of at least 3% of malignant cells; AND Patient must have a diagnosis of mycosis fungoides; OR Patient must have a diagnosis of Sezary syndrome; OR Patient must have a diagnosis of primary cutaneous anaplastic large cell lymphoma; AND Patient must have received prior systemic treatment for this condition; AND The condition must be relapsed or refractory; AND The treatment must not exceed 4 cycles under this restriction; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. The authority application must be made in writing and must include: (a) a completed authority prescription form; and (b) a completed Cutaneous T-cell lymphoma (CTCL) Brentuximab vedotin PBS Authority Application Supporting Information Form which includes the following: (i) Evidence of a diagnosis of either mycosis fungoides, Sezary syndrome or primary cutaneous anaplastic large cell lymphoma; and (ii) Evidence of CD30 positivity of at least 3% of malignant cells, either from a histology report on the tumour sample or from a flow cytometric analysis of lymphoma cells of the blood; and (iii) Date of commencement and completion of the most recent prior systemic treatment.	Compliance with Written Authority Required procedures
C8736	P8736	CD30 positive cutaneous T-cell lymphoma Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must have achieved an objective response with this drug; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed 12 cycles under this restriction. An objective response is defined as the demonstration of response by clinical observation of skin lesions, or response by positron-emission tomography (PET) and/or computed tomography (CT) standard criteria. The treatment must not exceed a lifetime total of 16 cycles.	Compliance with Written Authority Required procedures

1. Schedule 4, entry for Nivolumab

(a)omit from the column headed "Circumstances and Purposes" for circumstances code C8143: PBS subsidised              substitute: PBS-subsidised

(b)omit from the column headed "Circumstances and Purposes" for circumstances code C8568: PBS subsidised              substitute: PBS-subsidised

1. Schedule 4, entry for Obinutuzumab

(a)omit from the column headed "Circumstances and Purposes" for circumstances code C7935: PBS subsidised              substitute: PBS-subsidised

(b)omit from the column headed "Circumstances and Purposes" for circumstances code C7950: PBS subsidised              substitute: PBS-subsidised