Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p28
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 28/51)
Character Range: 94745–99719

medical records.
C16317  P16317  CN16317  Osilodrostat           Endogenous Cushing's syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                Continuing treatment
                                                Patient must have received PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must have demonstrated a complete response after at least 26 weeks of treatment with this drug; OR
                                                Patient must have demonstrated a partial response after at least 26 weeks of treatment with this drug.
                                                Must be treated by an endocrinologist.
                                                Patient must be at least 18 years of age.
                                                For the purposes of administering this restriction, a complete response is defined as a mean urinary free cortisol (UFC) level of less than or equal to the upper limit of normal (ULN).
                                                A partial response is defined as mean UFC level of greater than ULN but with at least 50% reduction from the baseline value. The mean UFC should be the average of at least two urine samples.
                                                At the time of authority application, medical practitioners must request the appropriate number of packs to provide sufficient drug, based on the prescribed dose of the patient, for 4 weeks of treatment.
                                                A separate authority prescription form must be completed for each strength requested. The dose must not exceed 30 mg twice daily. Up to a maximum of 5 repeats will be authorised.
                                                Where there is a current, approved PBS prescription with valid repeat prescriptions specified (i.e. where the dose is changing), mark the prescription that is intended for no further supply as 'Cancelled'.
                                                An application for the continuing treatment must be accompanied with the assessment of response conducted after 26 weeks from the first dose of osilodrostat and no later than 4 weeks from the date of completion of treatment. This will enable ongoing treatment for patients who meet the continuing restriction for PBS-subsidised treatment.
C16319  P16319  CN16319  Faricimab              Branch 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 branched retinal vein occlusion (BRVO); AND
                                                Patient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), 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