National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 9) (Cth)

Case

PB 90 of 2022

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2022 (No. 9)

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     29 September 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. 9).

(2)This instrument may also be cited as PB 90 of 2022.

  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 October 2022 1 October 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Note:          This table relates only to the provisions of this instrument as originally made.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.

  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 Avelumab

insert in numerical order in the column headed “Circumstances”: C13290 C13303 C13313

  1. Schedule 1, Part 1, entry for Bortezomib in each of the forms: Solution for injection 2.5 mg in 1 mL; and Solution for injection 3.5 mg in 1.4 mL

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

Bortezomib Accord OC MP C11099 D

  1. Schedule 1, Part 1, entry for Cabazitaxel in the form Concentrated injection 60 mg in 1.5 mL, with diluent

omit:

Jevtana SW MP C13207 D

  1. Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C13280

  1. Schedule 1, Part 1, entry for Pembrolizumab

(a)omit from the column headed “Circumstances”: C9894 C9921

(b)insert in numerical order in the column headed “Circumstances”: C13278 C13279 C13289 C13296 C13316

  1. Schedule 1, Part 1, entry for Rituximab

substitute:

Rituximab Solution for I.V. infusion 100 mg in 10 mL Injection Riximyo SZ MP D
Ruxience PF MP D
Truxima EW MP D
Solution for I.V. infusion 500 mg in 50 mL Injection Riximyo SZ MP D
Ruxience PF MP D
Truxima EW MP D

  1. Schedule 1, Part 2, entry for Avelumab

substitute:

Avelumab P13303 P13313 800 7
P13290 800 11
P8947 1200 8
P10023 1200 11

  1. Schedule 1, Part 2, entry for Nivolumab

substitute:

Nivolumab P10195 120 3
P8573 360 3
P11985 360 8
P11392 P11468 P11469 360 13
P10119 P10120 480 5
P9216 P9312 P10155 P11434 480 8
P9214 P9252 P9298 P9299 P9321 P11477 480 11
P13280 480 13

  1. Schedule 1, Part 2, entry for Pembrolizumab [Maximum Amount: 200; Number of Repeats: 6]

(a)omit from the column headed “Purposes”: P9894 P9921

(b)insert in numerical order in the column headed “Purposes”: P13278 P13279 P13289 P13296 P13316

  1. Schedule 1, Part 2, entry for Rituximab

substitute:

Rituximab 800 11

  1. Schedule 3,

omit:

SW sanofi‑aventis Australia Pty Ltd 31 008 558 807

  1. Schedule 4, entry for Avelumab

insert in numerical order after existing text:

C13290 P13290 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - 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 being treated with this drug for this condition; AND
The treatment must be the sole PBS-subsidised therapy for this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 13290
C13303 P13303 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - Grandfathering treatment
Patient must have received non-PBS-subsidised treatment with this drug for this PBS indication prior to 1 October 2022; AND
Patient must have received first-line platinum-based chemotherapy prior to initiation of non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have progressive disease following first-line platinum-based chemotherapy; 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
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 therapy for this condition.
A 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 13303
C13313 P13313 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Maintenance therapy - Initial treatment
Patient must have received first-line platinum-based chemotherapy; AND
Patient must not have progressive disease following first-line platinum-based chemotherapy; 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. 		Compliance with Authority Required procedures - Streamlined Authority Code 13313

  1. Schedule 4, entry for Nivolumab

insert in numerical order after existing text:

C13280 P13280 Advanced or metastatic gastro-oesophageal cancers
The condition must be a gastro-oesophageal cancer type as specified in the drug's 'Indications' section of the approved Australian Product Information; AND
The treatment must be prescribed in accordance with the drug's 'Indications' section of the approved Australian Production Information with respect to each of: (i) concomitant drugs/therapies, (ii) line of therapy (i.e. prior treatments, if any); AND
Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1.
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 - Streamlined Authority Code 13280

  1. Schedule 4, entry for Pembrolizumab

(a)omit:

C9894 P9894 Locally advanced (Stage III) or metastatic (Stage IV) urothelial 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 therapy for this condition; AND
Patient must have stable or responding disease; 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 9894
C9921 P9921 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Initial treatment
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 on or within 12 months of completion of adjuvant platinum‑containing chemotherapy following cystectomy for localised muscle‑invasive urothelial cancer; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum‑containing chemotherapy prior to cystectomy for localised muscle‑invasive urothelial cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not exceed a total of 7 doses under this restriction. 		Compliance with Authority Required procedures ‑ Streamlined Authority Code 9921

(b)insert in numerical order after existing text:

C13278 P13278 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Initial treatment
The condition must be incurable by local therapies in the locally advanced setting; AND
Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS-subsidised treatment with this drug for this condition; AND
Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND
Patient must have had a WHO performance status of 0 or 1; AND
The treatment must be either: (i) the sole PBS-subsidised therapy where the condition expresses programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND
The treatment must not exceed a total of 7 doses under this restriction. 		Compliance with Authority Required procedures - Streamlined Authority Code 13278
C13279 P13279 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
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 being treated with this drug for this condition; AND
The treatment must not exceed a total of 35 doses or up to 24 months of combined initial and continuing treatment in a lifetime for this condition whichever comes first. 		Compliance with Authority Required procedures - Streamlined Authority Code 13279
C13289 P13289 Locally advanced (Stage III) or metastatic (Stage IV) urothelial 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 therapy 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 13289
C13296 P13296 Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer
Initial treatment
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 on or within 12 months of completion of adjuvant platinum-containing chemotherapy following cystectomy for localised muscle-invasive urothelial cancer; OR
The condition must have progressed on or within 12 months of completion of neoadjuvant platinum-containing chemotherapy prior to cystectomy for localised muscle-invasive urothelial cancer; AND
Patient must have a WHO performance status of 2 or less; AND
The treatment must not exceed a total of 7 doses under this restriction; 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 this condition. 		Compliance with Authority Required procedures - Streamlined Authority Code 13296
C13316 P13316 Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx
Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 October 2022; AND
Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating non-PBS-subsidised treatment with this drug for this condition; AND
Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if treated in the locally advanced setting prior to non-PBS-subsidised treatment with this drug for this condition; AND
The treatment must have been initiated as non-PBS-subsidised therapy as either: (i) the sole therapy where the condition expressed programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum-based chemotherapy, unless contraindicated or not tolerated; AND
Patient must not have developed disease progression while being treated 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 treatment must not exceed a total of 35 doses, or up to 24 months, of combined non-PBS-subsidised and PBS-subsidised treatment under the Grandfather and Continuing treatment restrictions in a lifetime. 		Compliance with Authority Required procedures - Streamlined Authority Code 13316

  1. Schedule 4, omit entry for Rituximab

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