Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p143
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 143/161)
Character Range: 14552258–14560044

lines for this condition, one of which must include rituximab-based chemotherapy; AND
                                                                                   Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy 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.
C13728              P13728         CN13728          Pembrolizumab                  Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   Patient must be untreated for this PBS indication (i.e untreated for each of:
                                                                                    (i) unresectable disease, (ii) metastatic disease); AND
                                                                                   Patient must not have received prior treatment for colorectal cancer with each of:
                                                                                    (i) a programmed cell death-1 (PD-1) inhibitor, (ii) a programmed cell death ligand-1 (PD-L1) inhibitor; AND
                                                                                   Patient must have a WHO performance status of 0 or 1; AND
                                                                                   Patient must have deficient mismatch repair (dMMR) colorectal cancer, as determined by immunohistochemistry test; 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.
C13730              P13730         CN13730          Pembrolizumab                  Unresectable or metastatic deficient mismatch repair (dMMR) colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must not have progressive disease 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.
C13731              P13731         CN13731          Pembrolizumab                  Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 13731
                                                                                   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 being treated 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