Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p56
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 56/69)
Character Range: 578530–586227

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 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; AND
                                                                                                                The treatment must not exceed a total of 3 doses under this restriction.
C14818              P14818         Pembrolizumab                                                                Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 14818
                                                                                                                Initial treatment ‑ 3 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 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; AND
                                                                                                                The treatment must not exceed a total of 6 doses under this restriction.
C14821              P14821         Tebentafusp                                                                  Advanced (unresectable or metastatic) uveal melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 14821
                                                                                                                Initial treatment ‑ day 8
                                                                                                                Patient must have HLA‑A*02:01‑positive disease; AND
                                                                                                                Patient must have previously received PBS‑subsidised initial day 1 treatment with this drug for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                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.
C14825              P14825         Tebentafusp                                                                  Advanced (unresectable or metastatic) uveal melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 14825
                                                                                                                Initial treatment ‑ day 15
                                                                                                                Patient must have HLA‑A*02:01‑positive disease; AND
                                                                                                                Patient must have previously received PBS‑subsidised initial day 8 treatment with this drug for this condition; AND
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                According to the TGA‑approved Product