National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 12) (PB 105 of 2017) (Cth)

PB 105 of 2017

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 12)

National Health Act 1953

I, JULIANNE QUAINE, Assistant Secretary, Private Health Insurance and 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 14 December 2017

JULIANNE QUAINE

Assistant Secretary

Private Health Insurance and Pharmacy Branch

Technology Assessment and Access Division

Department of Health

Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2017 (No. 12).

(2)This Instrument may also be cited as PB 105 of 2017.

Commencement

This Instrument commences on 1 January 2018.

Amendment of National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

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

Schedule 1 Amendments

Schedule 1, Part 1, after entry for Carboplatin in the form Solution for I.V. injection 450 mg in 45 mL [Brand: Hospira Pty Limited]

insert:

Carfilzomib	Powder for I.V. infusion 30 mg	Injection	Kyprolis	AN	MP	C7344 C7348 C7355	D
Powder for I.V. infusion 60 mg	Injection	Kyprolis	AN	MP	C7344 C7348 C7355	D

Schedule 1, Part 1, entry for Docetaxel

omit:

Solution concentrate for I.V. infusion 140 mg in 7 mL

Injection

Oncotaxel 140

EA

MP

D

Schedule 1, Part 1, entry for Gemcitabine

omit:

Powder for I.V. infusion 2 g (as hydrochloride)

Injection

Gemcitabine Actavis 2000

EA

MP

D

Schedule 1, Part 1, entry for Irinotecan

omit:

I.V. injection containing irinotecan hydrochloride trihydrate 300 mg in 15 mL

Injection

Irinotecan Ebewe

SZ

MP

D

Schedule 1, Part 2, after entry for Carboplatin

insert:

Carfilzomib

120

17

Schedule 4, after entry for Cabazitaxel

insert:

Carfilzomib

C7344

Multiple myeloma

Grandfathering

Patient must have received treatment with this drug for this condition prior to 1 January 2018; AND

Patient must have a documented histological diagnosis; AND

The treatment must be in combination with dexamethasone; AND

Patient must have had documented progressive disease after at least one prior therapy prior to commencing non-PBS subsidised treatment with this drug for this condition; AND

Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND

Patient must have undergone or be ineligible for a stem cell transplant; AND

Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND

Patient must not receive more than three cycles of treatment under this restriction.

Progressive disease is defined as at least 1 of the following:

(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or

(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or

(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase of the difference between involved free light chain and uninvolved free light chain; or

(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or

(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or

(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or

(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).

Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.

A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria.

Compliance with Authority Required procedures

C7348

Multiple myeloma

Continuing treatment

Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND

The treatment must be in combination with dexamethasone; AND

Patient must not develop disease progression while receiving treatment with this drug for this condition; AND

Patient must not be receiving concomitant PBS-subsidised bortezomib, thalidomide or its analogues; AND

Patient must not receive more than 3 cycles of treatment per continuing treatment course authorised under this restriction.