Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p11
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 11/69)
Character Range: 252066–259457

PBS Authority Application ‑ Supporting Information Form; and
                                                                                                                (3) evidence that the condition is CD22‑positive; and
                                                                                                                (4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
                                                                                                                (5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.
                                                                                                                The treatment must not exceed 0.8mg per m2for the first dose of a treatment cycle (Day 1), and 0.5mg per m2for subsequent doses (Days 8 and 15) within a treatment cycle.
                                                                                                                Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.
C9519               P9519          Blinatumomab                                                                 Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                Induction treatment ‑ balance of supply
                                                                                                                The condition must be relapsed or refractory B‑precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
                                                                                                                The condition must not be present in the central nervous system or testis; AND
                                                                                                                Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
                                                                                                                Patient must have received insufficient therapy with this agent for this condition under the Induction treatment restriction to complete a maximum of 2 treatment cycles in a lifetime.
                                                                                                                According to the TGA‑approved Product Information, hospitalisation is recommended at minimum for the first 9 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re‑initiation (e.g. if treatment is interrupted for 4 or more hours), supervision by a health care professional or hospitalisation is recommended.
                                                                                                                An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in cycle 2.
                                                                                                                Blinatumomab is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
C9571               P9571          Trastuzumab                                                                  Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro‑oesophageal junction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 9571
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have progressive disease; AND
                                                                                                                The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
C9573               P9573          Trastuzumab                                                                  Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro‑oesophageal junction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 9573
                                                                                                                Initial treatment
                                                                                                                Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND
                                                                                                                Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in