National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No.3) (Cth)

PB 29 of 2021

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No.3)

National Health Act 1953

___________________________________________________________________________

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.

Dated         31 March 2021

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

1. Name of Instrument

(1)This Instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2021 (No.3).

(2)This Instrument may also be cited as PB 29 of 2021.

1. Commencement

This Instrument commences on 1 April 2021.

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. Schedule 1, Part 1, entry for Cabazitaxel

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

Cabazitaxel Juno JU MP C4662 D

1. Schedule 1, Part 1, entry for Ipilimumab in the form Injection concentrate for I.V. infusion 50 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C11391 C11394 C11478

1. Schedule 1, Part 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL

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

Irinotecan Accord OC MP D

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

(a)omit from the column headed “Circumstances”: C10117

(b)omit from the column headed “Circumstances”: C10165

(c)insert in numerical order in the column headed “Circumstances”: C11392 C11434 C11468 C11469 C11477

1. Schedule 1, Part 1, entry for Rituximab in each of the forms: Solution for I.V. infusion 100 mg in 10 mL; and Solution for I.V. infusion 500 mg in
   50 mL

omit:

Mabthera RO MP C7399 C7400 C9451 C9542 C10227 PB

1. Schedule 1, Part 2, after entry for Ipilimumab [Maximum Amount: 120; Number of Repeats: 3]

insert:

P11391 P11394 P11478 120 4

1. Schedule 1, Part 2, entry for Nivolumab

substitute:

Nivolumab	P10156 P10195	120	3
P8573	360	3
P11392 P11468 P11469	360	13
P10118 P10119 P10120	480	5
P9216 P9312 P10155 P11434	480	8
P9214 P9252 P9298 P9299 P9321 P11477	480	11

1. Schedule 4, entry for Ipilimumab

insert in numerical order after existing text:

C11391	P11391	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing combination treatment (with nivolumab) of first-line drug therapy Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND The treatment must be in combination with nivolumab.	Compliance with Authority Required procedures - Streamlined Authority Code 11391
C11394	P11394	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment (treatment of a patient commenced on non-PBS-subsidised combination treatment as first-line drug therapy) Patient must have previously received non-PBS-subsidised treatment with this drug for this indication prior to 1 April 2021; AND The condition must be squamous type non-small cell lung cancer (NSCLC); AND Patient must not have been treated for this condition in the metastatic setting prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; 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 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND The treatment must be in combination with platinum-based chemotherapy for the first two cycles; AND The treatment must be in combination with nivolumab.	Compliance with Authority Required procedures - Streamlined Authority Code 11394
C11478	P11478	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Initial combination treatment (with nivolumab) 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; 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 nivolumab. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.	Compliance with Authority Required procedures - Streamlined Authority Code 11478

1. Schedule 4, entry for Nivolumab

(a)omit:

C10117 P10117 Locally advanced or metastatic non‑small cell lung cancer
Continuing treatment
Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
Patient must have stable or responding disease.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. Compliance with Authority Required procedures ‑ Streamlined Authority Code 10117

(b)omit:

C10165 P10165 Locally advanced or metastatic non‑small cell lung cancer
Initial treatment
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 treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition; AND
The condition must have progressed on or after prior platinum based chemotherapy.
The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen. Compliance with Authority Required procedures ‑ Streamlined Authority Code 10165

(c)insert in numerical order after existing text:

C11392	P11392	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; 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 11392
C11434	P11434	Locally advanced or metastatic non-small cell lung cancer Initial treatment as second-line drug therapy 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 treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. The patient's body weight must be documented in the patient's medical records at the time treatment is initiated. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.	Compliance with Authority Required procedures - Streamlined Authority Code 11434
C11468	P11468	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing combination treatment (with ipilimumab) of first-line drug therapy The condition must be squamous type non-small cell lung cancer (NSCLC); AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; AND The treatment must be in combination with ipilimumab.	Compliance with Authority Required procedures - Streamlined Authority Code 11468
C11469	P11469	Stage IV (metastatic) non-small cell lung cancer (NSCLC) Grandfather treatment (treatment of a patient commenced on non-PBS-subsidised combination treatment as first-line drug therapy) Patient must have previously received non-PBS-subsidised treatment with this drug for this indication prior to 1 April 2021; AND The condition must be squamous type non-small cell lung cancer (NSCLC); AND Patient must not have been treated for this condition in the metastatic setting prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND Patient must have had a WHO performance status of 0 or 1 prior to initiation of non-PBS-subsidised treatment with this drug for this condition; 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 Patient must not have received 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 prior to initiating treatment with this drug for this PBS indication; AND The treatment must not exceed 24 months in total, measured from the initial dose, or, must not extend beyond disease progression, whichever comes first; 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 11469
C11477	P11477	Locally advanced or metastatic non-small cell lung cancer Continuing treatment as second-line drug therapy Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND Patient must have stable or responding disease. Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.	Compliance with Authority Required procedures - Streamlined Authority Code 11477

1. Schedule 4, entry for Pembrolizumab

(a)omit entry for circumstances code "C10697" and substitute:

C10683 P10683 Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Grandfather treatment ‑ 6 weekly treatment regimen
Patient must have previously received non‑PBS subsidised treatment with this drug for this condition prior to 1 December 2019; 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 not have been treated for this condition in the metastatic setting prior to initiating non‑PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non‑PBS‑subsidised treatment with this drug for this condition; 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 18 cycles or up to 24 months of treatment under this restriction. Compliance with Authority Required procedures ‑ Streamlined Authority Code 10683

(b)omit entry for circumstances code "C10683" and substitute:

C10697 P10697 Stage IV (metastatic) non‑small cell lung cancer (NSCLC)
Grandfather treatment ‑ 3 weekly treatment regimen
Patient must have previously received non‑PBS subsidised treatment with this drug for this condition prior to 1 December 2019; 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 not have been treated for this condition in the metastatic setting prior to initiating non‑PBS-subsidised treatment with this drug for this condition; AND
Patient must have stable or responding disease; AND
Patient must have had a WHO performance status of 0 or 1 prior to initiation of non‑PBS‑subsidised treatment with this drug for this condition; 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 35 cycles or up to 24 months of treatment under this restriction. Compliance with Authority Required procedures ‑ Streamlined Authority Code 10697