Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p291
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 291/312)
Character Range: 17315933–17323646

or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 16188
                                                                                                                           Initial treatment
                                                                                                                           Patient must not have received prior treatment with 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
                                                                                                                           Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
                                                                                                                           The condition must not be uveal melanoma; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                           Patient must weigh 40 kg or more; AND
                                                                                                                           Patient must be at least 12 years of age.
                                                                                                                           Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.
                                                                                                                           The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.
                                                                                                                           The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy, the maximum amount requested is based on the nivolumab dose only. The prescribed amount of nivolumab must be expressed in milligrams.
C16190              P16190         CN16190          Molnupiravir                                                           SARS-CoV-2 infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 16190
                                                                                                                           The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated; AND
                                                                                                                           Patient must have received a positive nucleic acid test result; OR
                                                                                                                           Patient must have received a positive rapid antigen test (RAT) result; AND
                                                                                                                           Patient must not require hospitalisation for COVID-19 infection at the time of prescribing; AND
                                                                                                                           The treatment must be initiated within 5 days of symptom onset; OR
                                                                                                                           The treatment must be initiated as soon as possible after a diagnosis is confirmed where asymptomatic.
                                                                                                                           Patient must be at least 70 years of age.
                                                                                                                           Access to this drug through this restriction is permitted irrespective of vaccination status.
                                                                                                                           Where nucleic acid testing is used to confirm diagnosis, the result, testing date, location and test provider must be recorded on the patient record.
                                                                                                                           Where a RAT is used to confirm diagnosis, available information about the test result, testing date, location and test provider (where relevant) must be recorded on the patient record.
                                                                                                                           This drug is not PBS-subsidised for pre-exposure or post-exposure prophylaxis for the prevention of SARS-CoV-2 infection.
                                                                                                                           For the purpose of administering this restriction, the contraindications to nirmatrelvir (&) ritonavir can be found using the Liverpool COVID-19 Drug interaction checker or the TGA-approved Product Information for Paxlovid.
                                                                                                                           Details/reasons of contraindications to nirmatrelvir (&) ritonavir must be documented in the patient's medical records.
C16191