Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p76
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 76/312)
Character Range: 15911791–15920336

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         CN14818          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         CN14821          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         CN14825          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 Information, hospitalisation