PB 110 of 2025
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (October Update) Instrument 2025
I, REBECCA RICHARDSON, Assistant Secretary, PBS Listing, Pricing and 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 September 2025
REBECCA RICHARDSON
Assistant Secretary
PBS Listing, Pricing and Policy Branch
Technology Assessment and Access Division
Contents
1. Name...............................................1
2. Commencement.........................................1
3. Authority.............................................1
4. Schedules............................................1
Schedule 1—Amendments............................................2
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2024 (PB 31 of 2024) 2
1. Name
(1) This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (October Update) Instrument 2025.
(2) This instrument may also be cited as PB 110 of 2025.
2. Commencement
(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 October 2025 | 1 October 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Note: This table relates only to the provisions of this instrument as originally made.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.
(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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 2024 (PB 31 of 2024)
[1] Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 1200 mg in 20 mL
(a) omit from the column headed “Circumstances”: C13448
(b) insert in numerical order in the column headed “Circumstances”: C17127
[2] 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 HYDROCHLORIDE MEDSURGE | C7943 C7944 C7972 |
[3] Schedule 1, Part 1, entry for Cemiplimab
(a) omit from the column headed “Circumstances”: C15094
(b) insert in numerical order in the column headed “Circumstances”: C17359
[4] 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
(a) omit from the column headed “Circumstances”: C13433
(b) insert in numerical order in the column headed “Circumstances”: C17360
[5] Schedule 1, Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
[6] Schedule 1, Part 1, entry for Pembrolizumab
(a) omit from the column headed “Circumstances”: C16264 C16280
(b) insert in numerical order in the column headed “Circumstances”: C17357 C17361
[7] Schedule 1, Part 2, entry for Atezolizumab [Maximum Amount: 1200 mg; Number of Repeats: 5]
(a) omit from the column headed “Purposes”: P13448
(b) insert in numerical order in the column headed “Purposes”: P17127
[8] Schedule 1, Part 2, entry for Cemiplimab [Maximum Amount: 350 mg; Number of Repeats: 6]
(a) omit from the column headed “Purposes”: P15094
(b) insert in numerical order in the column headed “Purposes”: P17359
[9] Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 360 mg; Number of Repeats: 13]
(a) omit from the column headed “Purposes”: P13433
(b) insert in numerical order in the column headed “Purposes”: P17360
[10] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200 mg; Number of Repeats: 6]
(a) omit from the column headed “Purposes”: P16280
(b) insert in numerical order in the column headed “Purposes”: P17361
[11] Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 400 mg; Number of Repeats: 3]
(a) omit from the column headed “Purposes”: P16264
(b) insert in numerical order in the column headed “Purposes”: P17357
[12] Schedule 2, entry for Atezolizumab [Maximum Quantity: 1; Number of Repeats: 3]
(a) omit from the column headed “Circumstances”: C13448
(b) insert in numerical order in the column headed “Circumstances”: C17127
[13] Schedule 2, entry for Atezolizumab [Maximum Quantity: 1; Number of Repeats: 4]
(a) omit from the column headed “Circumstances”: C13448
(b) insert in numerical order in the column headed “Circumstances”: C17127
[14] Schedule 2, entry for Atezolizumab [Maximum Quantity: 1; Number of Repeats: 5]
(a) omit from the column headed “Circumstances”: C13448
(b) insert in numerical order in the column headed “Circumstances”: C17127
(c) omit from the column headed “Purposes”: P13448
(d) insert in numerical order in the column headed “Purposes”: P17127
[15] Schedule 2, entry for Atezolizumab [Maximum Quantity: 1; Number of Repeats: 7]
(a) omit from the column headed “Circumstances”: C13448
(b) insert in numerical order in the column headed “Circumstances”: C17127
[16] Schedule 2, entry for Atezolizumab [Maximum Quantity: 1; Number of Repeats: 8]
(a) omit from the column headed “Circumstances”: C13448
(b) insert in numerical order in the column headed “Circumstances”: C17127
[17] Schedule 2, entry for Ondansetron in the form Tablet (orally disintegrating) 4 mg
omit:
| | | Ondansetron Mylan ODT | C5743 | | 4 | 0 | V5743 |
[18] Schedule 3, Part 1, omit entry for Circumstances Code “C13433”
[19] Schedule 3, Part 1, omit entry for Circumstances Code “C13448”
[20] Schedule 3, Part 1, omit entry for Circumstances Code “C15094”
[21] Schedule 3, Part 1, omit entry for Circumstances Code “C16264”
[22] Schedule 3, Part 1, omit entry for Circumstances Code “C16280”
[23] Schedule 3, Part 1, after entry for Circumstances Code “C16962”
insert:
C17127 | P17127 | Atezolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment 1 Patient must be undergoing combination treatment with bevacizumab and platinum-doublet chemotherapy. The condition must be non-squamous type non-small cell lung cancer (NSCLC); AND Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with only one of: (i) tepotinib, (ii) selpercatinib, (iii) dabrafenib in combination with trametinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene mutation or an anaplastic lymphoma kinase (ALK) gene rearrangement in tumour material. | Compliance with Authority Required procedures - Streamlined Authority Code 17127 |
C17357 | P17357 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 6 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with only one of: (i) tepotinib, (ii) selpercatinib, (iii) dabrafenib in combination with trametinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 4 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 17357 |
C17359 | P17359 | Cemiplimab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 3 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with only one of: (i) tepotinib, (ii) selpercatinib, (iii) dabrafenib in combination with trametinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 17359 |
C17360 | P17360 | Nivolumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial combination treatment (with ipilimumab) as first-line drug therapy The condition must be squamous type non-small cell lung cancer (NSCLC); AND Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with only one of: (i) tepotinib, (ii) selpercatinib, (iii) dabrafenib in combination with trametinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must be in combination with platinum-based chemotherapy for the first two cycles; AND The treatment must be in combination with ipilimumab. | Compliance with Authority Required procedures - Streamlined Authority Code 17360 |
C17361 | P17361 | Pembrolizumab | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial treatment - 3 weekly treatment regimen Patient must not have previously been treated for this condition in the metastatic setting; OR The condition must have progressed after treatment with only one of: (i) tepotinib, (ii) selpercatinib, (iii) dabrafenib in combination with trametinib; AND Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND Patient must have a WHO performance status of 0 or 1; AND The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 17361 |