Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p23
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 23/51)
Character Range: 74118–79429

application of this drug.
                                                Must be treated by an endocrinologist.
                                                Patient must be at least 18 years of age.
                                                For the purposes of administering this restriction, the mean UFC is the average of at least two values being 1.3 times greater than the ULN.
                                                Patient must undergo a dose titration period whereby responses must be assessed every 1-2 weeks until the mean UFC levels are within the normal range.
                                                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 6 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'.
                                                The condition is inappropriate for surgery if the patient:
                                                (i) has a medical contraindication for surgery;
                                                (ii) has inoperable tumours;
                                                (iii) has been determined that surgery is unlikely to reduce hypercortisolism;
                                                (iv) refuses surgery;
                                                (v) cannot access surgical treatment.
C16308  P16308  CN16308  Blinatumomab           Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                Continuing treatment of Pre-B-cell ALL in complete haematological remission (CR)
                                                Must be treated by a physician experienced in the treatment of haematological malignancies.
                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                Patient must have achieved a complete remission; AND
                                                The condition must be negative for measurable residual disease (MRD) using the same method used to establish initial MRD status; AND
                                                Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
                                                For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.
                                                An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.
                                                Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
C16309  P16309  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