Commonwealth Coat of Arms of Australia

 

PB 59 of 2025

 

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (June Update) Instrument 2025

 

National Health Act 1953

 

I, REBECCA RICHARDSON, Assistant Secretary, Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health, Disability and Ageing, delegate of the Minister for Health and Ageing, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated 29 May 2025

REBECCA RICHARDSON

Assistant Secretary

Pricing and PBS Policy Branch

Technology Assessment and Access Division

 

 

1 Name

2 Commencement

3 Authority

4 Schedules

Schedule 1—Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024
(PB 31 of 2024) 2

 

 

 

  1.            This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (June Update) Instrument 2025.
  2.            This instrument may also be cited as PB 59 of 2025.
  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 June 2025

1 June 2025

Note: This table relates only to the provisions of this instrument as originally made.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

  1.             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.

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

Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.

 

 

 

 

  1.                      Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL
  1.            omit from the column headed “Circumstances”: C14676
  2.            insert in numerical order in the column headed “Circumstances”: C16657
  1.                      Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480 mg; Number of Repeats: 13]

omit from the column headed “Purposes”: P14676 substitute: P16657

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

omit:

 

 

 

Ondansetron Mylan Tablets

C5778

 

4

0

V5778

  1.                      Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 8 mg

omit:

 

 

 

Ondansetron Mylan ODT

C5743

 

4

0

V5743

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

omit:

 

 

 

Ondansetron Mylan Tablets

C5778

 

4

0

V5778

  1.                      Schedule 3, Part 1, omit entry for Circumstances Code “C14676”
  2.                      Schedule 3, Part 1, after entry for Circumstances Code “C16472”

insert:


C16657

P16657

Nivolumab

Advanced or metastatic gastro-oesophageal cancers

Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND

Patient must be untreated (up until initiating this drug) with programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for gastro-oesophageal cancer.

Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.

Compliance with Authority Required procedures - Streamlined Authority Code 16657