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.
2 Commencement
This Instrument commences on 1 April 2021.
3 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 |
[2] 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
[3] 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 |
[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”: C10117
(b) omit from the column headed “Circumstances”: C10165
(c) insert in numerical order in the column headed “Circumstances”: C11392 C11434 C11468 C11469 C11477
[5] 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 |
[6] Schedule 1, Part 2, after entry for Ipilimumab [Maximum Amount: 120; Number of Repeats: 3]
insert:
| | P11391 P11394 P11478 | 120 | 4 |
[7] 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 |
[8] 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 |
[9] 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 |
[10] 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 |