Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p39
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 39/69)
Character Range: 465255–472802

PBS‑subsidised treatment where this benefit is extending treatment beyond 24 cumulative months from the first administered dose, once in a lifetime.
C13735              P13735         Pembrolizumab                                                                Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 13735
                                                                                                                Initial treatment
                                                                                                                The condition must be incurable by local therapies in the locally advanced setting; AND
                                                                                                                Patient must not have had systemic therapy for this condition in the recurrent or metastatic setting prior to initiating PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have experienced disease recurrence within 6 months of completion of systemic therapy if previously treated in the locally advanced setting; AND
                                                                                                                Patient must have had a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be either: (i) the sole PBS‑subsidised therapy where the condition expresses programmed cell death ligand 1 (PD‑L1) with a combined positive score (CPS) greater than or equal to 20 in the tumour sample, (ii) in combination with platinum‑based chemotherapy, unless contraindicated or not tolerated.
                                                                                                                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.
C13736              P13736         Pembrolizumab                                                                Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 13736
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must not have developed disease progression while being treated 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.
C13739              P13739         Pembrolizumab                                                                Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 13739
                                                                                                                Initial treatment
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                The condition must have progressed on or after prior platinum based chemotherapy; OR
                                                                                                                The condition must have progressed on or within 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;