Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p57
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 57/69)
Character Range: 585497–593231

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 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.
C14830              P14830         Nivolumab                                                                    Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures ‑ Streamlined Authority Code 14830
                                                                                                                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 ipilimumab as induction 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.
C15063              P15063         Cemiplimab                                                                   Stage IV (metastatic) non‑small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures ‑ Streamlined Authority Code 15063
                                                                                                                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.
C15085              P15085         Tebentafusp                                                                  Advanced (unresectable or metastatic) uveal melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 15085
                                                                                                                Continuing treatment
                                                                                                                The treatment must be the sole PBS‑subsidised therapy for this condition; AND
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; OR
                                                                                                                Patient must have previously received inpatient treatment with this drug for this condition in the public hospital setting; AND
                                                                                                                Patient must not receive PBS‑subsidised treatment with this drug