Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p77
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 77/312)
Character Range: 15919547–15927191

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         CN14830          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.
C14837              P14837         CN14837          Olmesartan with amlodipine and hydrochlorothiazide                     Hypertension
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           The treatment must not be for the initiation of anti-hypertensive therapy; AND
                                                                                                                           The condition must be inadequately controlled with concomitant treatment with two of the following:
                                                                                                                            an angiotensin II antagonist, a dihydropyridine calcium channel blocker or a thiazide diuretic.
C14839              P14839         CN14839          Olmesartan with amlodipine                                             Hypertension
                                                                                                                           The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient; AND
                                                                                                                           The treatment must not be for the initiation of anti-hypertensive therapy; AND
                                                                                                                           The condition must be inadequately controlled with an angiotensin II antagonist.  or
                                                                                                                           The condition must be inadequately controlled with a dihydropyridine calcium channel blocker.
C14841              P14841         CN14841          Eprosartan                                                             Drug interactions expected to occur with all of the base-priced drugs                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                           The condition must be stable for