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PB 103 of 2022 Arrangements as made
This instrument amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) to add, delete and make changes to drugs, forms, manners of administration, brands, responsible person codes, authorised prescribers, maximum quantities/amounts and repeats and the circumstances for prescribing various pharmaceutical benefits (including authority requirements).
Administered by: Health and Aged Care
Registered 31 Oct 2022
Tabling HistoryDate
Tabled HR07-Nov-2022
Tabled Senate21-Nov-2022
Date of repeal 08 Mar 2023
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003
Table of contents.

 

Commonwealth Coat of Arms of Australia

 

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

 

 

 


1        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.

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 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.

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 1Amendments

National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)

[1]        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

[2]        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

[3]        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

[4]        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

[5]        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

[6]        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

[7]        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

[8]        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

[9]        Schedule 1, Part 2, after entry for Carfilzomib

insert:

Cemiplimab

P13419

350

2

 

P13372 P13373

350

6

 

P13322 P13411

350

7


 

[10]      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

[11]      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


 

[12]      Schedule 3, after entry for Responsible Person SG

insert:

SW

sanofi-aventis Australia Pty Ltd

31 008 558 807

[13]      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

[14]      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

[15]      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

[16]      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