Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p33
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 33/69)
Character Range: 421004–430718

with Authority Required procedures
                                                                                                                Continuing treatment
                                                                                                                Patient must not have developed disease progression while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must not exceed 12 cycles under this restriction in a lifetime.
C13290              P13290         Avelumab                                                                     Locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 13290
                                                                                                                Maintenance therapy ‑ 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
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
C13411              P13411         Cemiplimab                                                                   Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS‑subsidised therapy with this drug for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                Patient must not be undergoing treatment with this drug as a PBS benefit where the treatment duration extends beyond the following, whichever comes first: (i) disease progression despite treatment with this drug, (ii) 24 months from treatment initiation; annotate any remaining repeat prescriptions with the word 'cancelled' where this occurs.
C13419              P13419         Cemiplimab                                                                   Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Initial treatment covering the first 3 treatment cycles
                                                                                                                The condition must be unsuitable for each of: (i) curative surgical resection, (ii) curative radiotherapy; AND
                                                                                                                Patient must have had a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
C13432              P13432         Pembrolizumab                                                                Stage IV (metastatic) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 13432
                                                                                                                Continuing treatment ‑ 3 weekly treatment regimen
                                                                                                                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
                                                                                                                The treatment must not exceed a total of 35 cycles or up to 24 months of treatment under both initial and continuing treatment restrictions, whichever comes first.
C13433              P13433         Nivolumab                                                                    Stage IV (metastatic) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 13433
                                                                                                                Initial combination treatment (with ipilimumab) as first‑line drug therapy
                                                                                                                The condition must be squamous type non‑small cell lung cancer (NSCLC); AND
                                                                                                                Patient must not have previously been treated for this condition in the metastatic setting; OR
                                                                                                                The condition must have progressed after treatment with tepotinib; AND
                                                                                                                Patient must not have received prior treatment with a programmed cell death‑1 (PD‑1) inhibitor or a programmed