National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 1) (PB 5 of 2021) (Cth)

PB 5 of 2021

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No. 1)

National Health Act 1953

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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 January 2021

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 2021 (No. 1).

(2)This Instrument may also be cited as PB 5 of 2021.

1. Commencement

This Instrument commences on 1 February 2021.

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 in each of the forms: Powder for injection 10 mg; Powder for injection 30 mg; and Powder for injection 60 mg

omit from the column headed “Circumstances”: C7348 C10855             substitute: C11196 C11197 C11198 C11291

1. Schedule 1, Part 2, entry for Carfilzomib

substitute:

Carfilzomib	P11196 P11197	120	17
P11198 P11291	160	8

1. Schedule 2, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

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

Zotren 4 RF MP C5778 4 0 C

1. Schedule 2, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

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

Zotren 8 RF MP C5778 4 0 C

1. Schedule 4, entry for Carfilzomib

substitute:

Carfilzomib	C11196	P11196	Multiple myeloma Initial treatment - twice weekly treatment regimen The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not have previously received 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 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 in 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.	Compliance with Authority Required procedures - Streamlined Authority Code 11196
C11197	P11197	Multiple myeloma Continuing treatment - twice weekly treatment regimen 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. 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 in 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.	Compliance with Authority Required procedures - Streamlined Authority Code 11197
C11198	P11198	Multiple myeloma Initial treatment - once weekly treatment regimen The condition must be confirmed by a histological diagnosis; AND The treatment must be in combination with dexamethasone; AND Patient must have progressive disease after at least one prior therapy; AND Patient must have undergone or be ineligible for a stem cell transplant; AND Patient must not have previously received 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 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 in 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.	Compliance with Authority Required procedures - Streamlined Authority Code 11198
C11291	P11291	Multiple myeloma Continuing treatment - once weekly treatment regimen 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. 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 in 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.	Compliance with Authority Required procedures - Streamlined Authority Code 11291