Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p144
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 144/161)
Character Range: 14559716–14567272

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.
C13732              P13732         CN13732          Pembrolizumab                  Relapsed or refractory primary mediastinal B-cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 13732
                                                                                   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; 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.
C13735              P13735         CN13735          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; 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.
C13736              P13736         CN13736          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