Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p42
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 42/51)
Character Range: 154484–158837

(ii) shoulder and/or hip (assessed as pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                The authority application must be made in writing and 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).
                                                (c) the date of commencement of this drug; and
                                                (d) results of the baseline patient assessment prior to initiation of non-PBS-subsidised therapy with this drug.
                                                The same indices of disease severity used to establish baseline at the commencement of treatment with each initial treatment application must be provided for all continuing treatment applications.
                                                The assessment of the patient's response to this PBS-subsidised course of therapy must be conducted no later than 4 weeks from the cessation of the treatment course.
                                                An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                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.
C16349  P16349  CN16349  Osilodrostat           Endogenous Cushing's syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                Transitioning from non-PBS to PBS-subsidised treatment - Grandfather arrangements
                                                Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 March 2025; AND
                                                The condition must have been, at least one of: (i) persistent hypercortisolism after surgery, (ii) recurrent hypercortisolism after surgery, (iii) inappropriate for surgery, prior to commencing non-PBS-subsidised treatment with this drug; AND
                                                Patient must have had 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) prior to commencing non-PBS-subsidised treatment with this drug; AND
                                                Patient must 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