Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p40
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 40/69)
Character Range: 472360–479389

12 months of completion of adjuvant platinum‑containing chemotherapy following cystectomy for localised muscle‑invasive urothelial cancer; OR
                                                                                                                The condition must have progressed on or within 12 months of completion of neoadjuvant platinum‑containing chemotherapy prior to cystectomy for localised muscle‑invasive urothelial cancer; AND
                                                                                                                Patient must have a WHO performance status of 2 or less; AND
                                                                                                                Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed cell death ligand‑1 (PD‑L1) inhibitor for this condition.
                                                                                                                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.
C13741              P13741         Pembrolizumab                                                                Relapsed or Refractory Hodgkin lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 13741
                                                                                                                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 receiving PBS‑subsidised treatment with this drug for this condition.
                                                                                                                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; AND
                                                                                                                Patient must not be undergoing continuing PBS‑subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.
C13745                             Bortezomib                                                                   Newly diagnosed systemic light chain amyloidosis
                                                                                                                Administration on Days 1, 8, 15 and 22 of six treatment cycles (28 days per cycle) in total
                                                                                                                Patient must be undergoing concurrent treatment with PBS‑subsidised daratumumab for this PBS indication.
C13752              P13752         Daratumumab                                                                  Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                Initial treatment as second‑line drug therapy for weeks 1 to 9 (administered once weekly)
                                                                                                                The condition must be confirmed by a histological diagnosis; AND
                                                                                                                The treatment must be in combination with bortezomib and dexamethasone; AND
                                                                                                                Patient must have progressive disease after only one prior therapy (i.e. use must be as second‑line drug therapy; use as third‑line drug therapy or beyond is not PBS‑subsidised).
                                                                                                                Patient must be undergoing treatment with this drug in one of the following situations: (i) for the first time, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis has changed between multiple myeloma/amyloidosis), (ii) changing the drug's form (intravenous/subcutaneous) within the first 9 weeks of treatment for the same PBS indication.
                                                                                                                Progressive disease is defined as at least 1 of the following:
                                                                                                                (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                                                (b) at least a 25% increase in 24‑hour