Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p43
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 43/51)
Character Range: 158477–162902

have demonstrated a complete response if they have received at least 26 weeks of initial non-PBS-subsidised therapy; OR
                                                Patient must have demonstrated a partial response if they have received at least 26 weeks of initial non-PBS-subsidised therapy.
                                                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.
                                                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.
                                                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.
C16350  P16350  CN16350  Evolocumab             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 16350
                                                Continuing treatment with this drug or switching treatment from any of: (i) another drug that belongs to the same pharmacological class as this drug, (ii) inclisiran
                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have received PBS-subsidised treatment for this PBS indication with any of: (i) a drug from the same pharmacological class as this drug (ii) inclisiran; AND
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                Patient must not be receiving concomitant PBS-subsidised treatment with any of: (i) another drug that belongs to the same pharmacological class as this drug,