Contents
1. Name#
(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (November Update) Instrument 2026.
(2)This instrument may also be cited as PB 131 of 2026.
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 2026 | 1 November 2026 |
Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
[1] Schedule 1, Part 1, entry for Brentuximab vedotin
(a) omit from the column headed “Circumstances”: C17757
(b) insert in numerical order in the column headed “Circumstances”: C19460
[2] Schedule 1, Part 1, after entry for Cyclophosphamide in the form Powder for injection 1 g (NorthStar, USA) (s19A)
insert:
| Powder for injection 1 g (Seacross Pharmaceuticals, UK) (s19A) | Injection | Cyclophosphamide (Seacross Pharmaceuticals, UK) |
[3] Schedule 1, Part 1, after entry for Cyclophosphamide in the form Powder for injection 2 g (Sagent, USA) (s19A)
insert:
| Powder for injection 2 g (Seacross Pharmaceuticals, UK) (s19A) | Injection | Cyclophosphamide (Seacross Pharmaceuticals, UK) |
[4] Schedule 1, Part 1, entry for Tislelizumab
omit from the column headed “Circumstances”: C16375 substitute: C19495
[5] Schedule 1, Part 2, entry for Brentuximab vedotin
substitute:
| Brentuximab vedotin | P18300 | 180 mg | 3 |
| P13181 P19460 | 180 mg | 11 | |
| P13212 | 200 mg | 1 | |
| P17438 P17508 P18503 | 200 mg | 3 | |
| P18301 | 200 mg | 5 | |
| P13261 P17440 P17507 | 200 mg | 11 |
[6] Schedule 2, after entry for Ondansetron in the form Tablet 4 mg (as hydrochloride dihydrate) [Ondansetron Tablets Viatris]
insert:
| Ondansetron VTRS | C5778 | 4 | 0 | V5778 |
[7] Schedule 3, Part 1, omit entry for Circumstances Code “C16375”
[8] Schedule 3, Part 1, entry for Circumstances Code “C17661”
substitute:
| C17661 | P17661 | Daratumumab | Untreated multiple myelomaTransitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangementsPatient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2025, ANDPatient must have met all initial treatment PBS eligibility criteria applying to a non-grandfathered patient prior to having commenced treatment with this drug, which are: (a) the condition was newly diagnosed, (b) the condition was confirmed by a histological diagnosis, (c) the patient was/is ineligible for a stem cell transplant, (d) the treatment is being given as triple combination therapy limited only to: (i) this drug, (ii) lenalidomide, (iii) dexamethasone, (e) patient is not receiving concomitant PBS-subsidised treatment with bortezomib, carfilzomib, elotuzumab, pomalidomide, selinexor or thalidomide, ANDPatient must not have developed disease progression while receiving treatment with this drug for this condition.Patient must be undergoing PBS-subsidised treatment with this drug once per lifetime. Meaning, patient must access this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been re-classified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 24 weeks of treatment for the same PBS indication.Details of the histological diagnosis of multiple myeloma, record of ineligibility for stem cell transplant and confirmation of eligibility for treatment with current diagnostic reports of at least one of the following must be documented in the patient's medical records:(a) the level of serum monoclonal protein; or(b) Bence-Jones proteinuria - the results of 24-hour urinary light chain M protein excretion; or(c) the serum level of free kappa and lambda light chains; or(d) bone marrow aspirate or trephine; or(e) if present, the size and location of lytic bone lesions (not including compression fractures); or(f) if present, the size and location of all soft tissue plasmacytomas by clinical or radiographic examination i.e. MRI or CT-scan; or(g) if present, the level of hypercalcaemia, corrected for albumin concentration.As these parameters must be used to determine response, results for either (a) or (b) or (c) should be documented for all patients. Where the patient has oligo-secretory or non-secretory multiple myeloma, either (c) or (d) or if relevant (e), (f) or (g) must be documented in the patient's medical records. Where the prescriber plans to assess response in patients with oligo-secretory or non-secretory multiple myeloma with free light chain assays, evidence of the oligo-secretory or non-secretory nature of the multiple myeloma (current serum M protein less than 10 g per L) must be documented in the patient's medical records.Progressive disease is defined as at least 1 of the following:(a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or(b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or(c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or(d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or(e) an increase in the size or number of lytic bone lesions (not including compression fractures); or(f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or(g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein. | Compliance with Authority Required procedures |
[9] Schedule 3, Part 1, omit entry for Circumstances Code “C17757”
[10] Schedule 3, Part 1, entry for Circumstances Code “C19060”
substitute:
| C19060 | P19060 | Enfortumab vedotin | Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerGrandfather arrangement - Transitioning from non-PBS to PBS-subsidised treatmentPatient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 September 2026, ANDPatient must have/have had a WHO performance status score of no greater than 2 prior to initiation of non-PBS-subsidised treatment with this drug for this condition, ANDPatient must not have developed disease progression while being treated with this drug for this condition.Patient must be undergoing combination therapy consisting of no more than 24 months of: (i) enfortumab vedotin, (ii) pembrolizumab; ORPatient must be undergoing monotherapy with this drug after exceeding a lifetime total of 24 cumulative months of combination therapy consisting of: (i) enfortumab vedotin, (ii) pembrolizumab, from the first administered dose; ORPatient must be undergoing monotherapy with this drug due to a contraindication/intolerance to pembrolizumab, requiring temporary/permanent discontinuation; document the details in the patient's medical records. | Compliance with Authority Required procedures - Streamlined Authority Code 19060 |
[11] Schedule 3, Part 1, after entry for Circumstances Code “C19222”
insert:
| C19460 | P19460 | Brentuximab vedotin | Advanced Stage CD30 positive Hodgkin lymphomaThe treatment must be for first line therapy for this condition, ANDThe treatment must be for curative intent, ANDThe treatment must be in combination with a multi-drug chemotherapy regimen, ANDThe treatment must not be more than 6 treatment cycles under this restriction in a lifetime. | Compliance with Authority Required procedures |
| C19495 | Tislelizumab | Advanced or metastatic gastro-oesophageal cancerPatient must be untreated (up until initiating this drug) with programmed cell death-1/ligand-1 (PD-1/PD-L1) inhibitor therapy for gastro-oesophageal cancer, ANDPatient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1, ANDPatient must not have developed disease progression while receiving treatment for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 19495 |
Sourced from the Federal Register of Legislation at legislation.gov.au, © Commonwealth of Australia, licensed under CC BY 4.0. Compilations may have been reformatted.