Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p22
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 22/51)
Character Range: 70386–74487

made in writing and must include:
                                                (1) details of the proposed prescription; and
                                                (2) 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).
                                                An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
                                                To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C16306  P16306  CN16306  Osilodrostat           Endogenous Cushing's syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                Initial treatment
                                                The condition must be at least one of: (i) persistent hypercortisolism after surgery, (ii) recurrent hypercortisolism after surgery, (iii) inappropriate for surgery; AND
                                                Patient must have active endogenous Cushing's Syndrome determined by a mean urinary free cortisol (UFC) level greater than 1.3 times the upper limit of normal (ULN); OR
                                                Patient must have undergone treatment for this condition with conventional therapies to control cortisol production resulting in an improved UFC level prior to applying for the initial authority 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