Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p43
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 43/69)
Character Range: 489726–496490

Authority Required procedures
                                                                                                                The condition must have histological evidence confirming a diagnosis of a least one of: (i) adenocarcinoma, (ii) squamous cell cancer; document this evidence in the patient's medical records; AND
                                                                                                                The condition must have been treated with neoadjuvant platinum‑based chemoradiotherapy; AND
                                                                                                                The treatment must be for the purposes of adjuvant use following complete surgical resection that occurred within 16 weeks prior to initiating this drug; AND
                                                                                                                The condition must have evidence, through resected specimen, that residual disease meets the Tumour Nodes Metastases (TNM) staging system (as published by the Union for International Cancer Control) of either: (i) at least ypT1, (ii) at least ypN1; document this evidence in the patient's medical records; AND
                                                                                                                Patient must have/have had, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                Patient must be undergoing treatment with a dosing regimen as set out in the drug's approved Australian Product Information; AND
                                                                                                                Patient must not be undergoing PBS‑subsidised treatment with this drug where this prescription extends treatment beyond whichever comes first: (i) 12 months from treatment initiation, irrespective of whether initial treatment was PBS‑subsidised/non‑PBS‑subsidised, (ii) disease recurrence despite treatment with this drug; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.
C13948              P13948         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.
                                                                                                                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         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