National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 4) (Cth)

PB 38 of 2023

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 4)

National Health Act 1953

I, NIKOLAI TSYGANOV, Assistant Secretary, 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                 27 April 2023                               

NIKOLAI TSYGANOV

Assistant Secretary

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 2023 (No. 4)

(2)This instrument may also be cited as PB 38 of 2023.

1. 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 May 2023	1 May 2023

Note:          This table relates only to the provisions of this instrument as originally made.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.

1. Authority

This instrument is made under subsection 100(2) of the National Health Act 1953.

1. 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)

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

omit from the column headed “Circumstances”: C11394

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”: C8573

(b)omit from the column headed “Circumstances”: C11469

(c)insert in numerical order in the column headed “Circumstances”: C14001

1. Schedule 1, Part 1, entry for Pembrolizumab

insert in numerical order in the column headed “Circumstances”: C13948 C13949 C13986

1. Schedule 1, Part 1, entry for Sacituzumab govitecan

omit from the column headed “Circumstances”: C12670

1. Schedule 1, Part 2, entry for Ipilimumab [Maximum Amount: 120; Number of Repeats: 4]

omit from the column headed “Purposes”: P11394

1. Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 360; Number of Repeats: 3]

omit from the column headed “Purposes”: P8573          substitute: P14001

1. Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 360; Number of Repeats: 13]

omit from the column headed “Purposes”: P11469

1. Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 400; Number of Repeats: 6]

insert in numerical order in the column headed “Purposes”: P13948 P13949 P13986

1. Schedule 1, Part 2, entry for Sacituzumab govitecan [Maximum Amount: 1200; Number of Repeats: 13]

omit from the column headed “Purposes”: P12670

1. Schedule 2, entry for Daratumumab

substitute:

Daratumumab	Solution for subcutaneous injection containing daratumumab 1800 mg in 15 mL	Injection	Darzalex SC	JC	MP	C12691 C12842 C12845 C13752 C13774 C13944 C14015	P12845	1	4
MP	C12691 C12842 C12845 C13752 C13774 C13944 C14015	P12691 P13774	1	5
MP	C12691 C12842 C12845 C13752 C13774 C13944 C14015	P12842	1	7
MP	C12691 C12842 C12845 C13752 C13774 C13944 C14015	P13752	1	8
MP	C12691 C12842 C12845 C13752 C13774 C13944 C14015	P13944 P14015	1	15

1. Schedule 4, entry for Daratumumab

(a)omit:

C13744	P13744	Newly diagnosed systemic light chain amyloidosis Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather arrangements Patient must be continuing treatment with this drug that was commenced as non‑PBS‑subsidised supply prior to 1 January 2023; AND The condition must have histological evidence consistent with a diagnosis of systemic light‑chain amyloidosis; AND The condition must have been, prior to the first dose of the non‑PBS‑subsidised supply, untreated with drug therapy, including this drug, irrespective of whether the diagnosis had been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non‑PBS supply was initiated. Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information; AND Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first: (i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include: Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the date of the histology result, which was within 4 weeks prior to the commencement of non‑PBS‑subsidised therapy, (ii) the name of pathologist/pathology provider, (iii) the site of biopsy. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Determine an appropriate number of repeat prescriptions for this authority application in line with either: (i) Where the patient has received less than 10 non‑PBS‑subsidised doses, prescribe a number of repeat prescriptions up to the balance of: 15 doses less the number of non‑PBS‑subsidised doses; or (ii) Where the patient has received at least 10 non‑PBS‑subsidised doses, prescribe no more than 5 repeat prescriptions.	Compliance with Written Authority Required procedures
C13751	P13751	Newly diagnosed systemic light chain amyloidosis Initial treatment from week 0 to week 24 The condition must have histological evidence consistent with a diagnosis of systemic light‑chain amyloidosis; AND The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation. Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include: Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the date of the histology result, which is no older than 4 weeks at the time of making this authority application, (ii) the name of pathologist/pathology provider, (iii) the site of biopsy. If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures

(b)insert in numerical order after existing text:

C13944	P13944	Newly diagnosed systemic light chain amyloidosis Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements Patient must be continuing treatment with this drug that was commenced as non-PBS-subsidised supply prior to 1 January 2023; AND The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND The condition must have been, prior to the first dose of the non-PBS-subsidised supply, untreated with drug therapy, including this drug, irrespective of whether the diagnosis had been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND Patient must have had a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 2 at the time non-PBS supply was initiated. Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information; AND Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first: (i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include: Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the name of pathologist/pathology provider, (ii) the site of biopsy If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice). Determine an appropriate number of repeat prescriptions for this authority application in line with either: (i) Where the patient has received less than 10 non-PBS-subsidised doses, prescribe a number of repeat prescriptions up to the balance of: 15 doses less the number of non-PBS-subsidised doses; or (ii) Where the patient has received at least 10 non-PBS-subsidised doses, prescribe no more than 5 repeat prescriptions.	Compliance with Written Authority Required procedures
C14015	P14015	Newly diagnosed systemic light chain amyloidosis Initial treatment from week 0 to week 24 The condition must have histological evidence consistent with a diagnosis of systemic light-chain amyloidosis; AND The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation. Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information. The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include: Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the name of pathologist/pathology provider, (ii) the site of biopsy If the application is submitted through HPOS form upload or mail, it must include: (i) A completed authority prescription form; and (ii) A completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).	Compliance with Written Authority Required procedures

1. Schedule 4, entry for Ipilimumab

omit:

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

1. Schedule 4, entry for Nivolumab

(a)omit:

C8573 P8573 Stage IV clear cell variant renal cell carcinoma (RCC)
Induction treatment
The condition must not have previously been treated; AND
The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be in combination with PBS‑subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
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 8573

(b)omit:

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

(c)insert in numerical order after existing text:

C14001 P14001 Stage IV clear cell variant renal cell carcinoma (RCC)
Induction treatment
The condition must not have previously been treated; AND
Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must be in combination with PBS-subsidised treatment with ipilimumab as induction for this condition.
Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
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 14001

1. Schedule 4, entry for Pembrolizumab

insert in numerical order after existing text:

C13948	P13948	Stage IV clear cell variant renal cell carcinoma (RCC) Initial treatment Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records; AND The condition must be untreated; AND Patient must have a WHO performance status of 2 or less. Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 13948
C13949	P13949	Stage IV clear cell variant renal cell carcinoma (RCC) Continuing treatment Patient must have previously received 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. Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions; AND Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.	Compliance with Authority Required procedures - Streamlined Authority Code 13949
C13986	P13986	Stage IV clear cell variant renal cell carcinoma (RCC) Transitioning from non-PBS to PBS-subsided supply - Grandfather arrangements Patient must be currently receiving non-PBS-subsidised treatment with this drug for this condition, with treatment having commenced prior to 1 May 2023; AND Patient must have had a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records if not already documented; AND The treatment must be occurring in a patient where each of the following is true: (i) the patient's WHO performance status was no higher than 2 at treatment initiation, (ii) this drug is being prescribed in either: (a) a combination of pembrolizumab plus lenvatinib only, (b) as monotherapy where there was a contraindication/intolerance to the other drug in the combination - document the details in the patient's medical records, (iii) the condition was untreated at the time of treatment initiation, (iv) disease progression has not occurred whilst on treatment, (v) treatment is occurring with a dosing regimen specified in this drug's approved Australian Product Information, (vi) this prescription does not extend treatment beyond 24 months from the first administered dose. Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; OR Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.	Compliance with Authority Required procedures - Streamlined Authority Code 13986

1. Schedule 4, entry for Sacituzumab govitecan

omit:

C12670 P12670 Unresectable locally advanced or metastatic triple‑negative breast cancer
Transitioning from non‑PBS to PBS‑subsidised supply ‑ Grandfather treatment
Patient must must have received treatment with this drug for this PBS indication prior to 1 May 2022; AND
Patient must not have developed disease progression while being treated with this drug for this condition; AND
Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 1 prior to treatment initiation of non‑PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised therapy for this PBS indication. Compliance with Authority Required procedures ‑ Streamlined Authority Code 12670