1 Name

(1) This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 8)

(2) This instrument may also be cited as PB 85 of 2023.

(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 September 2023	1 September 2023

Note: This table relates only to the provisions of this instrument as originally made.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.

3 Authority

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

4 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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 Bendamustine in each of the forms: Powder for injection containing bendamustine hydrochloride 25 mg; and Powder for injection containing bendamustine hydrochloride 100 mg

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

Bendamustine Juno

C7943 C7944 C7972

[2] Schedule 1, Part 1, entry for Methotrexate in the form Injection 50 mg in 2 mL vial

omit:

Methotrexate Accord

[3] Schedule 1, Part 1, entry for Obinutuzumab

(a) omit from the column headed “Circumstances”: C11052

(b) insert in numerical order in the column headed “Circumstances”: C14326

[4] Schedule 1, Part 1, entry for Pembrolizumab

insert in numerical order in the column headed “Circumstances”: C14324

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

omit:

Ontruzant

C9349 C9353 C9571 C9573 C10213 C10293 C10294 C10296

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

(a) omit from the column headed “Purposes”: P11052

(b) insert in numerical order in the column headed “Purposes”: P14326

[7] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Quantity: 400; Number of Repeats: 6]

insert in numerical order in the column headed “Purposes”: P14324

[8] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg

omit:

Ondansetron ODT Lupin

C5743

[9] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg

omit:

Ondansetron ODT Lupin

C5743

[10] Schedule 2, entry for Ondansetron

omit:

Wafer 4 mg

Oral

Zofran Zydis

C5743

[11] Schedule 3,

omit:

Generic Health Pty Ltd

93 110 617 859

[12] Schedule 3,

omit:

Organon Pharma Pty Ltd

54 637 107 512

[13] Schedule 4, entry for Obinutuzumab

(a) omit:

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

(b) insert in numerical order after existing text:

C14326

P14326

Chronic lymphocytic leukaemia (CLL)
Combination use with chlorambucil only
The condition must be CD20 positive; AND
The condition must be previously untreated; AND
The treatment must be in combination with chlorambucil; AND
The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.
Treatment must be discontinued in patients who experience disease progression whilst on this treatment.

Compliance with Authority Required procedures - Streamlined Authority Code 14326

[14] Schedule 4, entry for Pembrolizumab

insert in numerical order after existing text:

C14324

P14324

Recurrent, unresectable or metastatic triple negative breast cancer
The condition must have been (up until this drug therapy) untreated in the unresectable/metastatic disease stage; AND
The condition must have been (up until this drug therapy) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy in breast cancer; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
The treatment must be in combination with chemotherapy; AND
The condition must have both: (i) programmed cell death ligand 1 (PD-L1) expression confirmed by a validated test, (ii) a Combined Positive Score (CPS) of at least 10 at treatment initiation.
Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; OR
Patient must be undergoing continuing treatment with this drug - both the following are true: (i) the condition has not progressed on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose; AND
Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR
Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.

Compliance with Authority Required procedures - Streamlined Authority Code 14324

[15] Schedule 5, entry for Ondansetron

omit:

Ondansetron	Wafer 4 mg	Oral	Zofran Zydis	4	$3.41	$5.69