Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p24
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 24/51)
Character Range: 78461–83746

CN16309  Faricimab              Central retinal vein occlusion with macular oedema                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                Initial treatment
                                                Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist.
                                                Patient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); AND
                                                Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; AND
                                                The condition must be diagnosed by optical coherence tomography; OR
                                                The condition must be diagnosed by fluorescein angiography; AND
                                                The treatment must be the sole PBS-subsidised therapy for this condition.
                                                Authority approval for initial treatment of each eye must be sought.
                                                The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
                                                (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
                                                If the application is submitted through HPOS form upload or mail, it must include:
                                                (a) details of the proposed prescription; and
                                                (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                All reports must be documented in the patient's medical records.
C16312  P16312  CN16312  Inclisiran             Non-familial hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16312
                                                Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 April 2024; AND
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                Patient must have had symptomatic atherosclerotic cardiovascular disease prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must have had an LDL cholesterol level in excess of 1.8 millimoles per litre prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must have had atherosclerotic disease in two or more vascular territories (coronary, cerebrovascular or peripheral vascular territories) prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have had severe multi-vessel coronary heart disease defined as at least 50% stenosis in at least two large vessels prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have had at least two major cardiovascular events (i.e. myocardial infarction, unstable angina, stroke or unplanned revascularisation) in the previous 5 years prior to starting non-PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have