Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Endogenous Cushing's syndrome

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; AND

Must be treated by an endocrinologist; AND

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.