Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p54
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 54/69)
Character Range: 563012–572025

be initiated in combination with neoadjuvant chemotherapy; AND
                                                                                                                The condition must not have progressed/recurred whilst on treatment with this drug.
                                                                                                                Patient must not be undergoing treatment with this drug beyond 52 cumulative weeks under this restriction; AND
                                                                                                                Patient must be undergoing treatment with this drug administered once every 3 weeks ‑ prescribe up to 7 repeat prescriptions; OR
                                                                                                                Patient must be undergoing treatment with this drug administered once every 6 weeks ‑ prescribe up to 4 repeat prescriptions.
C14764              P14764         Obinutuzumab                                                                 Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 14764
                                                                                                                For combination use with acalabrutinib from treatment cycles 2 to 7 inclusive in first‑line therapy
                                                                                                                The condition must be untreated; AND
                                                                                                                The treatment must be in combination with PBS‑subsidised acalabrutinib (refer to Product Information for timing of obinutuzumab and acalabrutinib doses).
C14770              P14770         Pembrolizumab                                                                Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                Initial treatment ‑ 3 weekly treatment regimen
                                                                                                                The treatment must be in addition 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 have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS‑subsidised/non‑PBS‑subsidised).
C14786              P14786         Pembrolizumab                                                                Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                Continuing treatment ‑ 3 weekly treatment regimen
                                                                                                                Patient must be undergoing continuing PBS‑subsidised treatment commenced through an 'Initial treatment' listing.
                                                                                                                Patient must not have experienced disease recurrence; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must not have received more than 12 months of therapy (irrespective of whether therapy has been partly PBS‑subsidised/non‑PBS‑subsidised).
C14808              P14808         Ipilimumab                                                                   Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 14808
                                                                                                                Induction treatment
                                                                                                                Patient must not have received prior treatment with nivolumab plus relatlimab, ipilimumab or a PD‑1 (programmed cell death‑1) inhibitor for the treatment of unresectable Stage III or Stage IV malignant melanoma; AND
                                                                                                                Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
                                                                                                                The condition must not be ocular or uveal melanoma; AND
                                                                                                                The treatment must be in combination with PBS‑subsidised treatment with nivolumab as induction therapy for this condition.
                                                                                                                Induction treatment with nivolumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
                                                                                                                Induction treatment with ipilimumab must not exceed a total