PB 117 of 2023
National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2023 (No. 11)
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 November 2023
NIKOLAI TSYGANOV
Assistant Secretary
Pricing and PBS Policy Branch
Technology Assessment and Access Division
Schedule 1—Amendments
National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011)
[1] Schedule 1, Part 1, entry for Carboplatin
omit:
[2] Schedule 1, Part 1, entry for Cyclophosphamide
substitute:
Cyclophosphamide | Powder for injection 500 mg (anhydrous) | Injection | CYCLOPHOSPHAMIDE-REACH | RQ | MP | | PB |
| | | Endoxan | BX | MP | | PB |
| Powder for injection 1 g (anhydrous) | Injection | CYCLOPHOSPHAMIDE-REACH | RQ | MP | | PB |
| | | Endoxan | BX | MP | | PB |
| Powder for injection 2 g (anhydrous) | Injection | Endoxan | BX | MP | | PB |
[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
omit from the column headed “Circumstances”: C10126 C12271 substitute: C10126 C10206 C10509 C12271 C14708
[4] Schedule 1, Part 1, entry for Fluorouracil in the form Injection 2500 mg in 50 mL
omit:
| | | DBL Fluorouracil Injection BP | PF | MP | C6266 C6297 | D |
[5] 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”: C13888
(b) insert in numerical order in the column headed “Circumstances”: C14676
[6] Schedule 1, Part 1, entry for Oxaliplatin in the form Solution concentrate for I.V. infusion 100 mg in 20 mL
omit:
| | | DBL Oxaliplatin Concentrate | PF | MP | | D |
[7] Schedule 1, Part 1, entry for Pembrolizumab
insert in numerical order in the column headed “Circumstances”: C14727
[8] Schedule 1, Part 1, entry for Pemetrexed in each of the forms: Powder for I.V. infusion 100 mg (as disodium); and Powder for I.V. infusion 500 mg (as disodium)
omit:
[9] Schedule 1, Part 2, entry for Durvalumab
substitute:
Durvalumab | P10206 | 1500 mg | 3 |
| P10126 P12271 | 1500 mg | 4 |
| P10509 P14708 | 1500 mg | 5 |
[10] Schedule 1, Part 2, entry for Nivolumab [Maximum Amount: 480 mg; Number of Repeats: 13]
omit from the column headed “Purposes”: P13888 substitute: P14676
[11] Schedule 1, Part 2, after entry for Pembrolizumab [Maximum Amount: 400 mg; Number of Repeats: 6]
insert:
[12] Schedule 2, entry for Ondansetron
omit:
| Wafer 8 mg | Oral | Zofran Zydis | AS | MP | C5743 | | 4 | 0 | C |
[13] Schedule 4, entry for Durvalumab
substitute:
Durvalumab | C10126 | P10126 | Unresectable Stage III non‑small cell lung cancer
Initial treatment
Patient must have received platinum based chemoradiation therapy; AND
The condition must not have progressed following platinum based chemoradiation therapy; AND
Patient must have a WHO performance status of 0 or 1; AND
Patient must not have previously received PBS‑subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS‑subsidised systemic anti‑cancer therapy for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 10126 |
| C10206 | P10206 | Extensive-stage small cell lung cancer
Initial treatment
The condition must be previously untreated; AND
Patient must have a WHO performance status of 0 or 1; AND
The treatment must be in combination with etoposide and a platinum-based antineoplastic drug. | Compliance with Authority Required procedures - Streamlined Authority Code 10206 |
| C10509 | P10509 | Extensive-stage small cell lung cancer
Continuing treatment - 4 weekly treatment regimen
The treatment must be as monotherapy; AND
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. | Compliance with Authority Required procedures - Streamlined Authority Code 10509 |
| C12271 | P12271 | Unresectable Stage III non‑small cell lung cancer
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 systemic anti‑cancer therapy for this condition; AND
The treatment must not exceed 12 months in total for this condition under the initial and continuing restriction combined; AND
The treatment must be once in a lifetime with this drug for this condition. | Compliance with Authority Required procedures ‑ Streamlined Authority Code 12271 |
| C14708 | P14708 | Locally advanced, metastatic or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer)
Patient must have either of the following at treatment initiation: (i) locally advanced biliary tract cancer that is untreated with systemic anti-cancer therapy in the unresectable setting, (ii) metastatic biliary tract cancer that is untreated with systemic anti-cancer therapy in the metastatic setting.
Patient must have/have had a WHO performance status score of no greater than 1 at treatment initiation with this drug.
The treatment must be/have been initiated with both: (i) gemcitabine, (ii) cisplatin (refer to Product Information of gemcitabine and cisplatin for dosing information); AND
Patient must not have developed disease progression while being treated with this drug for this condition. | Compliance with Authority Required procedures - Streamlined Authority Code 14708 |
[14] Schedule 4, entry for Nivolumab
(a) omit:
| 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 |
(b) insert in numerical order after existing text:
| C14676 | P14676 | Advanced or metastatic gastro-oesophageal cancers
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 (up until initiating this drug) 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.
Patient must be in one of the three population subsets described below.
Population 1
Conditions: gastric cancer, gastro-oesophageal junction cancer, oesophageal adenocarcinoma
Concomitant therapies: chemotherapy containing at least a fluoropyrimidine drug plus a platinum drug
Line of treatment: first-line drug treatment
Additional clinical finding: HER2 negative
Population 2
Condition: oesophageal squamous cell carcinoma (can be recurrent)
Concomitant therapies: chemotherapy containing at least a fluoropyrimidine drug plus a platinum drug
Line of treatment: first-line drug treatment
Additional clinical finding: unresectable
Population 3
Condition: oesophageal squamous cell carcinoma (can be recurrent)
Line of treatment: second-line drug treatment after chemotherapy containing at least a fluoropyrimidine drug plus a platinum drug
Additional clinical finding: unresectable | Compliance with Authority Required procedures - Streamlined Authority Code 14676 |
[15] Schedule 4, entry for Pembrolizumab
insert in numerical order after existing text:
| C14727 | P14727 | Stage II or Stage III triple negative breast cancer
The treatment must be initiated in combination with neoadjuvant chemotherapy; AND
The condition must not have progressed/recurred whilst on treatment with this drug.
Patient must not be undergoing treatment with this drug beyond 52 cumulative weeks under this restriction; AND
Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 7 repeat prescriptions; OR
Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 4 repeat prescriptions. | Compliance with Authority Required procedures - Streamlined Authority Code 14727 |
[16] Schedule 5
repeal the table and substitute:
Listed Drug | Form | Manner of Administration | Brand | Quantity or Number of Units | Approved Ex‑manufacturer Price | Claimed Ex‑manufacturer Price |
| | | | | | |
Note: There are currently no pharmaceutical benefits mentioned in Schedule 5.