National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (September Update) Instrument 2026

law://au/li/2026/f2026l01142@2026-11-13

Contents

1. Name #

(1)This instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (September Update) Instrument 2026.

(2)This instrument may also be cited as PB 104 of 2026.

(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 September 2026	1 September 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Note: This table relates only to the provisions of this instrument as originally made.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Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.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 Bortezomib in the form Powder for injection 3.5 mg

omit:

Bortezomib Baxter

C11099 C13745

[2] Schedule 1, Part 1, after entry for Cyclophosphamide in the form Powder for injection 2 g (NorthStar, USA) (s19A)

insert:

Powder for injection 2 g (Sagent, USA) (s19A)

Injection

Cyclophosphamide (Sagent, USA)

[3] Schedule 1, Part 1, entry for Durvalumab in each of the forms: Solution concentrate for I.V. infusion 120 mg in 2.4 mL; and Solution concentrate for I.V. infusion 500 mg in 10 mL

insert in numerical order in the column headed “Circumstances”: C19159 C19222

[4] Schedule 1, Part 1, entry for Enfortumab vedotin in each of the forms: Powder for I.V. infusion 20 mg; and Powder for I.V. infusion 30 mg

omit from the column headed “Circumstances”: C14416 substitute: C19059 C19060 C19195

[5] Schedule 1, Part 1, entry for Oxaliplatin

omit:

Solution concentrate for I.V. infusion 200 mg in 40 mL

Injection

Oxaliplatin SUN

[6] Schedule 1, Part 1, entry for Pembrolizumab

(a) omit from the column headed “Circumstances”: C10701 C10705 C13432 C13437 C13726 C13727 C13728 C13730 C13731 C13732 C13736 C13739 C13741 C13949 C14027 C14044 C14324

(b) omit from the column headed “Circumstances”: C16933 C16950 C17901

(d) omit from the column headed “Circumstances”: C18372 C18373

(e) omit from the column headed “Circumstances”: C18452 C18453

(f) insert in numerical order in the column headed “Circumstances”: C19192

[7] Schedule 1, Part 2, after entry for Durvalumab [Maximum Amount: 1120 mg; Number of Repeats: 5]

insert:

P19222

1500 mg

[8] Schedule 1, Part 2, entry for Durvalumab [Maximum Amount: 1500 mg; Number of Repeats: 5]

insert in numerical order in the column headed “Purposes”: P19159

[9] Schedule 1, Part 2, entry for Enfortumab vedotin

substitute:

Enfortumab vedotin	P19060 P19195	125 mg	7
	P19059	125 mg	8

[10] Schedule 1, Part 2, entry for Pembrolizumab

substitute:

Pembrolizumab	P14770 P14786	200 mg	7
	P10676 P10688	400 mg	3
	P14727 P17992 P18371 P18413 P18450 P19192	400 mg	7

[11] Schedule 3, Part 1, omit entry for Circumstances Code “C10701”

[12] Schedule 3, Part 1, omit entry for Circumstances Code “C10705”

[13] Schedule 3, Part 1, omit entry for Circumstances Code “C13432”

[14] Schedule 3, Part 1, omit entry for Circumstances Code “C13437”

[15] Schedule 3, Part 1, omit entry for Circumstances Code “C13726”

[16] Schedule 3, Part 1, omit entry for Circumstances Code “C13727”

[17] Schedule 3, Part 1, omit entry for Circumstances Code “C13728”

[18] Schedule 3, Part 1, omit entry for Circumstances Code “C13730”

[19] Schedule 3, Part 1, omit entry for Circumstances Code “C13731”

[20] Schedule 3, Part 1, omit entry for Circumstances Code “C13732”

[21] Schedule 3, Part 1, omit entry for Circumstances Code “C13736”

[22] Schedule 3, Part 1, omit entry for Circumstances Code “C13739”

[23] Schedule 3, Part 1, omit entry for Circumstances Code “C13741”

[24] Schedule 3, Part 1, omit entry for Circumstances Code “C13949”

[25] Schedule 3, Part 1, omit entry for Circumstances Code “C14027”

[26] Schedule 3, Part 1, omit entry for Circumstances Code “C14044”

[27] Schedule 3, Part 1, omit entry for Circumstances Code “C14324”

[28] Schedule 3, Part 1, omit entry for Circumstances Code “C14416”

[29] Schedule 3, Part 1, omit entry for Circumstances Code “C16933”

[30] Schedule 3, Part 1, omit entry for Circumstances Code “C16950”

[31] Schedule 3, Part 1, omit entry for Circumstances Code “C17901”

[32] Schedule 3, Part 1, omit entry for Circumstances Code “C18310”

[33] Schedule 3, Part 1, omit entry for Circumstances Code “C18372”

[34] Schedule 3, Part 1, omit entry for Circumstances Code “C18373”

[35] Schedule 3, Part 1, omit entry for Circumstances Code “C18452”

[36] Schedule 3, Part 1, omit entry for Circumstances Code “C18453”

[37] Schedule 3, Part 1, after entry for Circumstances Code “C19052”

insert:

C19059	P19059	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerThe condition must have progressed on/following both: (i) platinum-based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD-1/PD-L1) inhibitor therapy; ORThe condition must have progressed on/following platinum-based chemotherapy, whilst PD-1/PD-L1 inhibitor therapy resulted in an intolerance that required treatment cessation; ANDPatient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.Patient must not have previously received PBS-subsidised treatment with this drug for this indication in any prior line of treatment; ANDThe treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.Patient must be undergoing treatment with this drug for the first time; ORPatient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.	Compliance with Authority Required procedures - Streamlined Authority Code 19059
C19060	P19060	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerGrandfather arrangement - Transitioning from non-PBS to PBS-subsided 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
C19159	P19159	Durvalumab	Resected gastric and gastroesophageal junction adenocarcinomaAdjuvant treatmentPatient must have previously received PBS-subsidised neoadjuvant treatment with this drug for this condition; ORPatient must be both: (i) transitioning from existing non-PBS to PBS-subsidised supply of this drug, (ii) treated with combined therapy with durvalumab and FLOT as neoadjuvant treatment for this condition; ANDThe treatment must be for the purposes of adjuvant use following surgical resection; ANDThe treatment must be/have been initiated in combination with adjuvant FLOT for up to 2 cycles unless intolerant to FLOT requiring permanent discontinuation; ANDThe treatment must be sole PBS-subsidised systemic anti-cancer therapy from cycles 3-12 of adjuvant treatment; ANDPatient must not have developed disease progression while being treated with this drug for this condition.Patient must be undergoing treatment that does not occur beyond the following, whichever comes first: (i) the first instance of disease progression/recurrence, (ii) maximum of 12 cycles of adjuvant treatment for this condition from the first administered dose following surgery, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.Where 'FLOT' is referenced in this restriction, it refers to the combination therapy of fluorouracil (5-FU) in combination with leucovorin (folinic acid), oxaliplatin and docetaxel.	Compliance with Authority Required procedures
C19192	P19192	Pembrolizumab	Immunotherapy sensitive advanced or metastatic cancerPatient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for the condition which treatment was commenced for.Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; ORPatient 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 19192
C19195	P19195	Enfortumab vedotin	Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancerPatient must not have received prior systemic therapy for this condition at the initiation of treatment with this drug, with the exception of neoadjuvant/adjuvant chemotherapy; ANDPatient must have/have had a WHO performance status score of no greater than 2 at treatment initiation with this drug.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; ANDPatient must be undergoing treatment with this drug for the first time; ORPatient must be undergoing continuing treatment with this drug, with each of the following being true: (i) all other PBS eligibility criteria in this restriction are met, (ii) disease progression is absent.	Compliance with Authority Required procedures - Streamlined Authority Code 19195
C19222	P19222	Durvalumab	Resectable gastric and gastroesophageal junction adenocarcinomaNeoadjuvant treatmentPatient must be initiating treatment with this drug for this condition; ORPatient must be transitioning from existing non-PBS to PBS-subsidised supply of this drug; ANDThe condition must be Stage II or higher; ANDThe condition must be resectable; ANDThe treatment must be for the purpose of neoadjuvant use in a patient preparing for surgery; ANDPatient must have a WHO performance status no greater than 1; ANDThe treatment must be initiated in combination with neoadjuvant FLOT; ANDThe condition must have been untreated with systemic therapy.Patient must not be undergoing PBS-subsidised treatment where this prescription extends treatment beyond whichever comes first: (i) 2 cycles of neoadjuvant treatment from treatment initiation, irrespective of whether initial treatment was PBS-subsidised/non-PBS-subsidised, (ii) disease progression/recurrence despite treatment with this drug, (iii) unacceptable toxicity; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.Where 'FLOT' is referenced in this restriction, it refers to the combination therapy of fluorouracil (5-FU) in combination with leucovorin (folinic acid), oxaliplatin and docetaxel.	Compliance with Authority Required procedures

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.

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (September Update) Instrument 2026

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment (September Update) Instrument 2026

1. Name #

2. Commencement #

3. Authority #

4. Schedules #

Key facts

History · 1 version

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2. Commencement #

3. Authority #

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