Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p50
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 50/69)
Character Range: 536798–544396

must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The condition must not have progressed while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3‑weekly dose regimen), (iii) 17 doses (based on a 6‑weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non‑PBS subsidised.
                                                                                                                Patient must be undergoing treatment with this drug administered once every 3 weeks ‑ prescribe up to 6 repeat prescriptions; OR
                                                                                                                Patient must be undergoing treatment with this drug administered once every 6 weeks ‑ prescribe up to 3 repeat prescriptions.
C14416                             Enfortumab vedotin                                                           Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 14416
                                                                                                                The condition must have progressed on/following both: (i) platinum‑based chemotherapy, (ii) programmed cell death 1/ligand 1 (PD‑1/PD‑L1) inhibitor therapy; OR
                                                                                                                The condition must have progressed on/following platinum‑based chemotherapy, whilst PD‑1/PD‑L1 inhibitor therapy resulted in an intolerance that required treatment cessation; AND
                                                                                                                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 the sole PBS‑subsidised systemic anti‑cancer therapy for this PBS indication.
                                                                                                                Patient must be undergoing treatment with this drug for the first time; OR
                                                                                                                Patient 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.
C14443                             Netupitant with Palonosetron                                                 Nausea and vomiting                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures ‑ Streamlined Authority Code 14443
                                                                                                                The treatment must be in combination with dexamethasone, unless contraindicated; AND
                                                                                                                The treatment must be for prevention of nausea and vomiting associated with moderate to highly emetogenic anti‑cancer therapy.
C14587              P14587         Blinatumomab                                                                 Measurable residual disease of precursor B‑cell acute lymphoblastic leukaemia (Pre‑B‑cell ALL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                Continuing treatment of previously measurable residual disease of Pre‑B‑cell ALL
                                                                                                                Must be treated by a physician experienced in the treatment of haematological malignancies.
                                                                                                                Patient must have previously received PBS‑subsidised initial treatment with this drug for this condition; AND
                                                                                                                Patient must have achieved a complete remission; AND
                                                                                                                The condition must be negative for measurable residual disease using the same method used to determine initial PBS eligibility; AND
                                                                                                                Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
                                                                                                                For all subsequent cycle starts and re‑initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.