Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p16
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 16/69)
Character Range: 292008–302535

condition; AND
                                                                                                                Patient must not have developed disease progression while being treated with this drug for this condition.
C10676              P10676         Pembrolizumab                                                                Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                Continuing treatment ‑ 6 weekly treatment regimen
                                                                                                                Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
                                                                                                                Patient must not have experienced disease recurrence; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy.
C10688              P10688         Pembrolizumab                                                                Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                Initial treatment ‑ 6 weekly treatment regimen
                                                                                                                The treatment must be adjuvant to complete surgical resection; AND
                                                                                                                Patient must have a WHO performance status of 1 or less; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must not have received prior PBS‑subsidised treatment for this condition; AND
                                                                                                                The treatment must commence within 12 weeks of complete resection; AND
                                                                                                                Patient must not receive more than 12 months of combined PBS‑subsidised and non‑PBS‑subsidised adjuvant therapy.
C10701              P10701         Pembrolizumab                                                                Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 10701
                                                                                                                Continuing treatment ‑ 6 weekly treatment regimen
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must have previously been issued with an authority prescription for this drug for this condition; AND
                                                                                                                Patient must have stable or responding disease.
C10705              P10705         Pembrolizumab                                                                Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 10705
                                                                                                                Continuing treatment ‑ 3 weekly treatment regimen
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must have previously been issued with an authority prescription for this drug for this condition; AND
                                                                                                                Patient must have stable or responding disease.
C10917              P10917         Atezolizumab                                                                 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 10917
                                                                                                                Continuing treatment of hepatocellular carcinoma ‑ 3 weekly treatment regimen
                                                                                                                Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated.
                                                                                                                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.
                                                                                                                PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time
C10939              P10939         Atezolizumab                                                                 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 10939