
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.
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 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Note: This table relates only to the provisions of this instrument as originally made.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.
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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 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
[2] 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 |
[3] Schedule 1, Part 1, entry for Cabazitaxel in the form Concentrated injection 60 mg in 1.5 mL, with diluent
omit:
[4] Schedule 1, Part 1, entry for Nivolumab in each of the forms: Injection concentrate for I.V. infusion 40 mg in 4 mL; and Injection concentrate for I.V. infusion 100 mg in 10 mL
insert in numerical order in the column headed “Circumstances”: C13280
[5] 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
[6] 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 |
[7] Schedule 1, Part 2, entry for Avelumab
substitute:
Avelumab | P13303 P13313 | 800 | 7 |
| P13290 | 800 | 11 |
| P8947 | 1200 | 8 |
| P10023 | 1200 | 11 |
[8] 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 |
[9] 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
[10] Schedule 1, Part 2, entry for Rituximab
substitute:
[11] Schedule 3,
omit:
SW | sanofi‑aventis Australia Pty Ltd | 31 008 558 807 |
[12] 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 |
[13] 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 |
[14] 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 |
[15] Schedule 4, omit entry for Rituximab