Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p25
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 25/38)
Character Range: 84646–90035

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.
C16189  P16189  CN16189  Methylphenidate               Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                       Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
                                                       Patient must require continuous coverage over 12 hours; AND
                                                       The treatment must not exceed a maximum daily dose of 72 mg of PBS-subsidised treatment with this drug.
                                                       Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.
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  P16191  CN16191  Molnupiravir                  SARS-CoV-2 infection                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 16191
                                                       The treatment must be for use when nirmatrelvir (&) ritonavir is contraindicated;