National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 3) (Cth)
PB 25 of 2023
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 3)
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 30 March 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
Name
(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 3)
(2)This instrument may also be cited as PB 25 of 2023.
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 April 2023 | 1 April 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Note: This table relates only to the provisions of this instrument as originally made.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.
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 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”: C13280
(b)insert in numerical order in the column headed “Circumstances”: C13888 C13900
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480; Number of Repeats: 5]
insert in numerical order in the column headed “Purposes”: P13900
Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480; Number of Repeats: 13]
omit from the column headed “Purposes”: P13280 substitute: P13888
Schedule 4, entry for Nivolumab
(a)omit:
| 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 |
(b)insert in numerical order after existing text:
| C13888 | P13888 | 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; AND Patient must be untreated with programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for gastro-oesophageal cancer. 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 13888 |
| C13900 | P13900 | Adjuvant treatment of stage II or III oesophageal cancer or gastro-oesophageal junction cancer The condition must have histological evidence confirming a diagnosis of a least one of: (i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient's medical records; AND The condition must have been treated with neoadjuvant platinum-based chemoradiotherapy; AND The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug; AND The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either: (i) at least ypT1, (ii) at least ypN1; document this evidence in the patient's medical records; AND Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND The treatment must be the sole PBS-subsidised therapy for this condition. Patient must be undergoing treatment with a dosing regimen as set out in the drug's approved Australian Product Information; AND Patient must not be undergoing PBS-subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first: (i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs. | Compliance with Authority Required procedures |
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