1 Name

(1) This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 12)

(2) This instrument may also be cited as PB 133 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 January 2024	1 January 2024

Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 Bortezomib in the form Powder for injection 3.5 mg

omit:

Bortezomib‑AFT

C11099 C13745

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

insert in numerical order in the column headed “Circumstances”: C14764

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

(a) omit from the column headed “Circumstances”: C10687

(b) omit from the column headed “Circumstances”: C10695

[4] Schedule 1, Part 2, entry for Obinutuzumab [Maximum Amount: 1000 mg; Number of Repeats: 5]

insert in numerical order in the column headed “Purposes”: P14764

[5] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200 mg; Number of Repeats: 7]

(a) omit from the column headed “Purposes”: P10687 P10695

(b) insert in numerical order in the column headed “Purposes”: P14770 P14786

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

omit:

APO‑Ondansetron ODT

C5743

[7] Schedule 2, entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate)

omit:

Ondansetron APOTEX

C5778

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

omit:

APO‑Ondansetron ODT

C5743

[9] Schedule 2, entry for Ondansetron in the form Tablet 8 mg (as hydrochloride dihydrate)

omit:

Ondansetron APOTEX

C5778

[10] Schedule 3

omit:

Apotex Pty Ltd

52 096 916 148

[11] Schedule 4, entry for Obinutuzumab

insert in numerical order after existing text:

C14764

P14764

Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)
For combination use with acalabrutinib from treatment cycles 2 to 7 inclusive in first-line therapy
The condition must be untreated; AND
The treatment must be in combination with PBS-subsidised acalabrutinib (refer to Product Information for timing of obinutuzumab and acalabrutinib doses).

Compliance with Authority Required procedures - Streamlined Authority Code 14764

[12] Schedule 4, entry for Pembrolizumab

(a) omit:

C10687

P10687

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Initial treatment ‑ 3 weekly treatment regimen
The treatment must be adjuvant to complete surgical resection; AND
Patient must have a WHO performance status of 1 or less; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must not have received prior PBS‑subsidised treatment for this condition; AND
The treatment must commence within 12 weeks of complete resection; AND
Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy.

Compliance with Authority Required procedures

(b) omit:

C10695

P10695

Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma
Continuing treatment ‑ 3 weekly treatment regimen
Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
Patient must not have experienced disease recurrence; AND
The treatment must be the sole PBS‑subsidised therapy for this condition; AND
Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy.

Compliance with Authority Required procedures

	C14770	P14770	Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Initial treatment - 3 weekly treatment regimen The treatment must be in addition to complete surgical resection; AND Patient must have a WHO performance status of 1 or less; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received prior PBS-subsidised treatment for this condition; AND The treatment must commence within 12 weeks of complete resection; AND Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).	Compliance with Authority Required procedures
	C14786	P14786	Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma Continuing treatment - 3 weekly treatment regimen Patient must be undergoing continuing PBS-subsidised treatment commenced through an 'Initial treatment' listing. Patient must not have experienced disease recurrence; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS-subsidised/non-PBS-subsidised).	Compliance with Authority Required procedures