National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 10) (Cth)
Case
PB 103 of 2022
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 10)
National Health Act 1953
I, NIKOLAI TSYGANOV, Assistant Secretary (Acting), Pricing and PBS Policy Branch, Technology Assessment and Access Division, Department of Health and Aged Care, delegate of the Minister for Health and Aged Care, make this Instrument under subsection 100(2) of the National Health Act 1953.
Date 28 October 2022
NIKOLAI TSYGANOV
Assistant Secretary (Acting)
Pricing and PBS 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 2011
(PB 79 of 2011) 2
Name
(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 10).
(2)This instrument may also be cited as PB 103 of 2022.
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 November 2022 | 1 November 2022 |
Note: This table relates only to the provisions of this instrument as originally made.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.
Authority
This instrument is made under subsection 100(2) of the National Health Act 1953.
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)
Schedule 1, Part 1, entry for Atezolizumab in the form Solution concentrate for I.V. infusion 840 mg in 14 mL
(a)omit from the column headed “Circumstances”: C10312
(b)omit from the column headed “Circumstances”: C10915
(c)insert in numerical order in the column headed “Circumstances”: C13446 C13451
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”: C10182
(b)omit from the column headed “Circumstances”: C10276
(c)omit from the column headed “Circumstances”: C10915
(d)insert in numerical order in the column headed “Circumstances”: C13442 C13443 C13448
Schedule 1, Part 1, entry for Bevacizumab in each of the forms: Solution for I.V. infusion 100 mg in 4 mL; and Solution for I.V. infusion 400 mg in 16 mL
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bevaciptin | LR | MP | D |
Schedule 1, Part 1, entry for Bortezomib in the form Powder for injection 3.5 mg
insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:
| Bortezomib Baxter | BX | MP | C11099 | D |
Schedule 1, Part 1, after entry for Carfilzomib in the form Powder for injection 60 mg
insert:
| Cemiplimab | Solution concentrate for I.V. infusion 350 mg in 7 mL | Injection | Libtayo | SW | MP | C13322 C13372 C13373 C13411 C13419 | D |
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”: C11392 C11434
(b)insert in numerical order in the column headed “Circumstances”: C13433 C13445
Schedule 1, Part 1, entry for Pembrolizumab
(a)omit from the column headed “Circumstances”: C10681 C10682
(b)omit from the column headed “Circumstances”: C10693
(c)omit from the column headed “Circumstances”: C10704
(d)insert in numerical order in the column headed “Circumstances”: C13431 C13432 C13436 C13437
Schedule 1, Part 2, entry for Atezolizumab
substitute:
| Atezolizumab | P10206 P10939 | 1200 | 3 |
| P10521 | 1200 | 4 | |
| P10125 P13443 P13448 | 1200 | 5 | |
| P10216 P10297 P13442 | 1200 | 7 | |
| P10917 | 1200 | 8 | |
| P10509 P13446 | 1680 | 3 | |
| P10215 P10257 P10972 P13451 | 1680 | 5 |
Schedule 1, Part 2, after entry for Carfilzomib
insert:
| Cemiplimab | P13419 | 350 | 2 |
| P13372 P13373 | 350 | 6 | |
| P13322 P13411 | 350 | 7 |
Schedule 1, Part 2, entry for Nivolumab
substitute:
| Nivolumab | P10195 | 120 | 3 |
| P8573 | 360 | 3 | |
| P11985 | 360 | 8 | |
| P11468 P11469 P13433 | 360 | 13 | |
| P10119 P10120 | 480 | 5 | |
| P9216 P9312 P10155 P13445 | 480 | 8 | |
| P9214 P9252 P9298 P9299 P9321 P11477 | 480 | 11 | |
| P13280 | 480 | 13 |
Schedule 1, Part 2, entry for Pembrolizumab
substitute:
| Pembrolizumab | P10696 | 200 | 5 |
| P12033 P12065 P13126 P13213 P13214 P13245 P13278 P13279 P13289 P13296 P13316 P13431 P13432 | 200 | 6 | |
| P10687 P10695 P10705 | 200 | 7 | |
| P10689 | 400 | 2 | |
| P10676 P10688 P10701 P13436 P13437 | 400 | 3 |
Schedule 3, after entry for Responsible Person SG
insert:
| SW | sanofi-aventis Australia Pty Ltd | 31 008 558 807 |
Schedule 4, entry for Atezolizumab
(a)omit:
| C10182 | P10182 | 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; 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 10182 |
(b)omit:
| C10276 | P10276 | Locally advanced or metastatic non‑small cell lung cancer Initial treatment ‑ 3 weekly treatment regimen 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. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10276 |
(c)omit:
| C10312 | P10312 | Locally advanced or metastatic non‑small cell lung cancer Initial treatment ‑ 4 weekly treatment regimen 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 this condition; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS‑subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10312 |
(d)omit:
| C10915 | P10915 | Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma Transitioning from non‑PBS‑subsidised to PBS‑subsidised supply ‑ Grandfather treatment ‑ 3 weekly treatment regimen (1,200 mg) or 4 weekly treatment regimen (1,680 mg where bevacizumab is discontinued) Patient must have commenced non‑PBS‑subsidised treatment with this drug for this PBS indication prior to 1 November 2020; AND Patient must have met all the PBS eligibility criteria applying to a non‑grandfather patient under the Initial treatment restriction for this PBS indication prior to having commenced non‑PBS‑subsidised treatment with this drug, which are: (i) WHO status score no greater than 1, (ii) Child Pugh class A chronic liver disease, (iii) the patient was unsuitable for transarterial chemoembolization, (iv) the condition was untreated with systemic therapy, unless an intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal had occurred; AND Patient must not have developed disease progression while being treated with this drug for this condition. Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated. A Grandfathered patient may qualify for PBS‑subsidised treatment under this restriction once only. For continuing PBS‑subsidised treatment, a Grandfathered patient must qualify under the continuing treatment criteria. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10915 |
(e)insert in numerical order after existing text:
| C13442 | P13442 | Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,200 mg administered once every 3 weeks Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR Patient must be continuing existing PBS-subsidised treatment with this drug; OR Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated. Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug. The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred. | Compliance with Authority Required procedures - Streamlined Authority Code 13442 |
| C13443 | P13443 | Locally advanced or metastatic non-small cell lung cancer Initial treatment - 3 weekly treatment regimen 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; OR The condition must have progressed after treatment with tepotinib. | Compliance with Authority Required procedures - Streamlined Authority Code 13443 |
| C13446 | P13446 | Locally advanced or metastatic non-small cell lung cancer Initial treatment - 4 weekly treatment regimen 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 this condition; AND Patient must have a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition; AND The condition must have progressed on or after prior platinum based chemotherapy; OR The condition must have progressed after treatment with tepotinib. | Compliance with Authority Required procedures - Streamlined Authority Code 13446 |
| C13448 | P13448 | 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 tepotinib; 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 13448 |
| C13451 | P13451 | Resected early stage (Stage II to IIIA) non-small cell lung cancer (NSCLC) 1,680 mg administered once every 4 weeks, or 840 mg every 2 weeks Patient must be both: (i) initiating treatment, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy; OR Patient must be continuing existing PBS-subsidised treatment with this drug; OR Patient must be both: (i) transitioning from existing non-PBS to PBS subsidised supply of this drug, (ii) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy at the time this drug was initiated. Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug. The treatment must be for the purpose of adjuvant therapy following all of: (i) surgical resection, (ii) platinum-based chemotherapy; AND The condition must have/have had, at treatment commencement, an absence of each of the following gene abnormalities confirmed via tumour material sampling: (i) an activating epidermal growth factor receptor (EGFR) gene mutation, (ii) an anaplastic lymphoma kinase (ALK) gene rearrangement; AND The condition must have/have had, at treatment commencement, confirmation of programmed cell death ligand 1 (PD-L1) expression on at least 50% of tumour cells; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition. Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) 12 months in total for this condition from the first administered dose; mark any remaining repeat prescriptions with the words 'cancelled' where (i)/(ii) has occurred. | Compliance with Authority Required procedures - Streamlined Authority Code 13451 |
Schedule 4, after entry for Carfilzomib
insert:
| Cemiplimab | C13322 | P13322 | Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must have received non-PBS-subsidised therapy with this drug for this condition prior to 1 November 2022; AND The condition must be unsuitable for each of: (i) curative surgical resection, (ii) curative radiotherapy; 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 treatment must be the sole PBS-subsidised therapy for this condition. 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 |
| C13372 | P13372 | 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; 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 express programmed cell death ligand 1 (PD-L1) with a tumour proportion score (TPS) of at least 50% in the tumour sample. 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 the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed a total of 7 doses under this restriction. | Compliance with Authority Required procedures - Streamlined Authority Code 13372 | |
| C13373 | P13373 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first. | Compliance with Authority Required procedures - Streamlined Authority Code 13373 | |
| C13411 | P13411 | Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Continuing treatment Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND The treatment must be the sole PBS-subsidised therapy for this condition. 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 | |
| C13419 | P13419 | Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) Initial treatment covering the first 3 treatment cycles The condition must be unsuitable for each of: (i) curative surgical resection, (ii) curative radiotherapy; AND Patient must have had a WHO performance status of 0 or 1; AND The treatment must be the sole PBS-subsidised therapy for this condition. | Compliance with Authority Required procedures |
Schedule 4, entry for Nivolumab
(a)omit:
| 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 |
(b)insert in numerical order after existing text:
| C13433 | P13433 | 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 tepotinib; 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 13433 |
| C13445 | P13445 | 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; OR The condition must have progressed after treatment with tepotinib. 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 13445 |
Schedule 4, entry for Pembrolizumab
(a)omit:
| C10681 | P10681 | 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; 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 10681 |
| C10682 | P10682 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Continuing treatment ‑ 3 weekly treatment regimen Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; 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 10682 |
(b)omit:
| C10693 | P10693 | Stage IV (metastatic) non‑small cell lung cancer (NSCLC) Continuing treatment ‑ 6 weekly treatment regimen Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; 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 10693 |
(c)omit:
| C10704 | P10704 | 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; 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 10704 |
(d)insert in numerical order after existing text:
| C13431 | P13431 | 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 tepotinib; 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 13431 |
| C13432 | P13432 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 3 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first. | Compliance with Authority Required procedures - Streamlined Authority Code 13432 |
| C13436 | P13436 | 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 tepotinib; 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 13436 |
| C13437 | P13437 | Stage IV (metastatic) non-small cell lung cancer (NSCLC) Continuing treatment - 6 weekly treatment regimen Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not have developed disease progression while being treated with this drug for this condition; AND The treatment must not exceed a total of 18 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first. | Compliance with Authority Required procedures - Streamlined Authority Code 13437 |
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