National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 2) (Cth)

PB 15 of 2022

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 2)

National Health Act 1953

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

Date     28^th February 2022

DAVID LAFFAN

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Contents

1......... Name............................................................................................................................... 1

2......... Commencement............................................................................................................... 1

3......... Authority......................................................................................................................... 1

4......... Schedules......................................................................................................................... 1

Schedule 1—Amendments  2

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011
(PB 79 of 2011)   2

1. Name

(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 2).

(2)This instrument may also be cited as PB 15 of 2022.

1. Commencement

(1)Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.

Commencement information
Column 1	Column 2	Column 3
Provisions	Commencement	Date/Details
1.  The whole of this instrument	1 March 2022	1 March 2022

Note:          This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.

(2)     Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

1. Schedules

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

Schedule 1—Amendments

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

1. Schedule 1, Part 1, entry for Cabazitaxel in the form Concentrated injection 60 mg (as acetone solvate) in 1.5 mL, with diluent

substitute:

Cabazitaxel	Concentrated injection 60 mg in 1.5 mL, with diluent	Injection	Cabazitaxel Juno	JU	MP	C4662	D
Jevtana	SW	MP	C4662	D
MSN Cabazitaxel	RQ	MP	C4662	D

1. Schedule 1, Part 1, entry for Etoposide in the form Solution for I.V. infusion 100 mg in 5 mL

omit:

Pfizer Australia Pty Ltd PF MP PB

1. Schedule 1, Part 1, after entry for Gemcitabine in the form Solution for injection 2 g (as hydrochloride) in 52.6 mL

insert:

Gemtuzumab ozogamicin Powder for injection 5 mg Injection Mylotarg PF MP C12559 C12566 D

1. Schedule 1, Part 2, after entry for Gemcitabine

insert:

Gemtuzumab ozogamicin	P12566	5	1
P12559	5	2

1. Schedule 3, after details relevant for Responsible Person code RO

insert:

RQ Reach Pharmaceuticals Pty Ltd 25 623 897 183

1. Schedule 4, after entry for Fotemustine

insert:

Gemtuzumab ozogamicin	C12559	P12559	Acute Myeloid Leukaemia Induction treatment Patient must have confirmed CD33-positive AML prior to initiation of treatment; AND The condition must be de novo; AND The condition must be previously untreated at the time of initiation (except for prior essential treatment with hydroxyurea or leukapheresis for patients with hyperleukocytic AML); AND Patient must have confirmed intermediate/favourable cytogenetic risk; OR Patient must have unknown cytogenetic risk due to inconclusive test results; AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND The condition must not be acute promyelocytic leukaemia; AND The treatment must be in combination with standard intensive remission induction chemotherapy for this condition, which must include cytarabine and an anthracycline; AND The treatment must not be used in combination with a tyrosine kinase inhibitor; AND The condition must not be internal tandem duplication (ITD) or tyrosine kinase domain (TKD) FMS tyrosine kinase 3 (FLT3) mutation positive; AND Patient must not receive more than 1 induction cycle under this restriction in a lifetime. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting.	Compliance with Authority Required procedures
C12566	P12566	Acute Myeloid Leukaemia Consolidation treatment Patient must have achieved a complete remission following induction treatment with this drug for this condition; AND The treatment must be in combination with standard intensive remission consolidation chemotherapy for this condition, which must include cytarabine and an anthracycline; AND Patient must not receive more than 2 consolidation cycles under this restriction in a lifetime. This drug is not PBS-subsidised if it is prescribed to an in-patient in a public hospital setting. A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug. Complete remission following induction is defined as fewer than 5% blasts in a normocellular marrow and an absolute neutrophil count of more than 1.0 x 109cells/L with a platelet count of 100 x 109/L or more in the peripheral blood in the absence of transfusion. Progressive disease is defined as the presence of any of the following: a) Leukaemic cells in the CSF; b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; d) Extramedullary leukaemia.	Compliance with Authority Required procedures