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

Endogenous Cushing's syndrome

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; AND

Must be treated by an endocrinologist; AND

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.