Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p55
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 55/69)
Character Range: 571573–579029

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 of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
                                                                                                                The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C14813              P14813         Tebentafusp                                                                  Advanced (unresectable or metastatic) uveal melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                Initial treatment ‑ day 1
                                                                                                                Patient must have HLA‑A*02:01‑positive disease; AND
                                                                                                                Patient must have uveal melanoma that has been confirmed either (i) histologically, (ii) cytologically; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must not have received prior systemic therapy for metastatic disease.
                                                                                                                Patient must be at least 18 years of age.
                                                                                                                According to the TGA‑approved Product Information, hospitalisation is recommended at minimum for the first 3 doses (on Days 1, 8 and 15) and for at least 16 hours after each infusion is completed. If the patient does not experience hypotension that is Grade 2 or worse (requiring medical intervention) with the third dose, subsequent doses can be administered in an appropriate outpatient/ambulatory care setting. Supervision by a health care professional is recommended for a minimum of 30 minutes following each infusion.
                                                                                                                This drug is not PBS‑subsidised if it is administered to an in‑patient in a public hospital setting.
                                                                                                                Positive HLA‑A*02:01 assessment must be documented in the patient's medical records.
C14816              P14816         Nivolumab                                                                    Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 14816
                                                                                                                Initial 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 not have experienced disease progression whilst on adjuvant PD‑1 inhibitor treatment or disease recurrence within 6 months of completion of adjuvant PD‑1 inhibitor treatment if treated for resected Stage IIIB, IIIC, IIID or IV melanoma; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C14817              P14817         Pembrolizumab                                                                Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 14817
                                                                                                                Initial treatment ‑ 6 weekly treatment regimen
                                                                                                                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 not have experienced disease