Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p53
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 53/69)
Character Range: 555119–563621

old at the time of application.
                                                                                                                Patients who fail to demonstrate a response to PBS‑subsidised treatment with this agent at the time where an assessment is required must cease PBS‑subsidised therapy with this agent.
C14676              P14676         Nivolumab                                                                    Advanced or metastatic gastro‑oesophageal cancers                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 14676
                                                                                                                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
C14708              P14708         Durvalumab                                                                   Locally advanced, metastatic or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 14708
                                                                                                                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.
C14727              P14727         Pembrolizumab                                                                Stage II or Stage III triple negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 14727
                                                                                                                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