Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p44
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 44/69)
Character Range: 495860–502827

with Authority Required procedures ‑ Streamlined Authority Code 13949
                                                                                                                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 treatment with this drug for this condition.
                                                                                                                Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR
                                                                                                                Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND
                                                                                                                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.
C14001              P14001         Nivolumab                                                                    Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 14001
                                                                                                                Induction treatment
                                                                                                                The condition must not have previously been treated; AND
                                                                                                                Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at treatment initiation with this drug of either: (i) 1 to 2 (intermediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient's medical records; AND
                                                                                                                Patient must have a WHO performance status of 2 or less; AND
                                                                                                                The treatment must be in combination with PBS‑subsidised treatment with ipilimumab as induction for this condition.
                                                                                                                Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C14015              P14015         Daratumumab                                                                  Newly diagnosed systemic light chain amyloidosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                                Initial treatment from week 0 to week 24
                                                                                                                The condition must have histological evidence consistent with a diagnosis of systemic light‑chain amyloidosis; AND
                                                                                                                The condition must be untreated with drug therapy, including this drug, irrespective of whether the diagnosis has been reclassified (i.e. the diagnosis changes between multiple myeloma/amyloidosis); AND
                                                                                                                Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of no higher than 2 at treatment initiation.
                                                                                                                Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND
                                                                                                                Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the