National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 10) (PB 116 of 2020) (Cth)

PB 116 of 2020

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 10)

National Health Act 1953

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I, THEA CONNOLLY, Assistant Secretary, Pricing and PBS Policy 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    26^th November 2020

THEA CONNOLLY

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health

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1. Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2020 (No. 10).

(2)This Instrument may also be cited as PB 116 of 2020.

1. Commencement

This Instrument commences on 1 December 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. Section 7, Note

substitute

(Note:          Each person mentioned in the column in Part 1 of Schedule 1 or in Schedule 2 headed ‘Authorised Prescriber’ is authorised by subsection 88(1) of the Act, or has been authorised by the Minister under section 88 of the Act, to prescribe the pharmaceutical benefit unless the pharmaceutical benefit is mentioned in Part 2 of Schedule 1 to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) (ready‑prepared pharmaceutical benefits for supply only).

1. Schedule 1, Part 1, entry for Arsenic

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

Arsenic Trioxide Juno JU MP C4793 C5997 C6018 D

1. Schedule 1, Part 1, entry for Obinutuzumab

(a)omit from the column headed “Circumstances”: C8184

(b)insert in numerical order in the column headed “Circumstances”: C11015 C11052

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

omit from the column headed “Responsible Person” for the brand “Ontruzant”: MK                   substitute: OQ

1. Schedule 1, Part 2, entry for Obinutuzumab [Maximum Amount: 1000; Number of Repeats: 7]

(a)omit from the column headed “Purposes”: P8184

(b)insert in numerical order in the column headed “Purposes”: P11052

1. Schedule 1, Part 2, after entry for Obinutuzumab [Maximum Amount: 1000; Number of Repeats: 7]

insert:

P11015 1000 8

1. Schedule 3, after details relevant to Responsible Person code OE

insert:

OQ Organon Pharma Pty Ltd 54 637 107 512

1. Schedule 4, entry for Obinutuzumab

(a)omit:

C8184 P8184 Chronic lymphocytic leukaemia (CLL)
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
Patient must be inappropriate for fludarabine based chemo‑immunotherapy; AND
The treatment must be in combination with chlorambucil; AND
Patient must have a creatinine clearance 30 mL/min or greater; AND
Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL‑induced illness or organ damage); OR
Patient must have a creatinine clearance less than 70 mL/min.
Treatment must be discontinued in patients who experience disease progression whilst on this treatment. Compliance with Authority Required procedures ‑ Streamlined Authority Code 8184

(b)insert in numerical order after existing text:

C11015	P11015	Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) For combination use with venetoclax treatment cycles 1 to 6 inclusive in first-line therapy The condition must be untreated; AND The treatment must be in combination with PBS-subsidised venetoclax.	Compliance with Authority Required procedures - Streamlined Authority Code 11015
C11052	P11052	Chronic lymphocytic leukaemia (CLL) Combination use with chlorambucil only The condition must be CD20 positive; AND The condition must be previously untreated; AND Patient must be inappropriate for fludarabine based chemo-immunotherapy; AND The treatment must be in combination with chlorambucil; AND Patient must have a creatinine clearance 30 mL/min or greater; AND Patient must have a total cumulative illness rating scale (CIRS) score of greater than 6 (excluding CLL-induced illness or organ damage); OR Patient must have a creatinine clearance less than 70 mL/min. Treatment must be discontinued in patients who experience disease progression whilst on this treatment.	Compliance with Authority Required procedures - Streamlined Authority Code 11052