Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p5
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 5/162)
Character Range: 14680914–14688036

with Authority Required procedures
                                                                                                         Continuing treatment - balance of supply
                                                                                                         Must be treated by a gastroenterologist (code 87); or
                                                                                                         Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                         Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                         The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restriction.
C13948              P13948         CN13948          Pembrolizumab                                        Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 13948
                                                                                                         Initial treatment
                                                                                                         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
                                                                                                         The condition must be untreated; AND
                                                                                                         Patient must have a WHO performance status of 2 or less; AND
                                                                                                         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.
C13949              P13949         CN13949          Pembrolizumab                                        Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance 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; AND
                                                                                                         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.
C13950              P13950         CN13950          Asciminib                                            Chronic Myeloid Leukaemia (CML)