Isturisa – NC Standard Criteria

Restricted Product(s):

• Isturisa® (osilodrostat)

FDA Approved Use:

• For the treatment of adult patients with Cushing’s disease for whom pituitary surgery is not an option or has not been curative.

Initial Coverage Criteria:

1. The patient is 18 years of age or older; AND
2. The patient has a diagnosis of Cushing’s disease (medical record documentation required); AND
3. The provider has submitted documentation demonstrating one of the following (medical record documentation required):
   1. Mean of at least two 24-hour urine free cortisol (UFC) levels greater than upper limit of normal for reference range; OR
   2. Late night salivary cortisol (two measurements) greater than upper limit of normal for reference range; OR
   3. 1 mg overnight dexamethasone suppression test (DST) > 1.8 mcg/dL; AND
4. The patient has persistent or recurrent disease despite pituitary gland surgery or is not a candidate for pituitary gland surgery (medical record documentation required); AND
5. The patient has tried and failed ONE of the following conventional agents (medical record documentation required);
   1. oral ketoconazole, oral cabergoline, oral Metopirone (metyrapone), oral Lysodren (mitotane); OR
   2. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to ALL conventional agents; AND
6. Both of the following baseline tests have been completed before initiation of treatment with continued monitoring as clinically appropriate:
   1. Electrocardiogram (ECG); AND
   2. Serum potassium and magnesium with correction if abnormal prior to initiation of treatment; AND
7. The patient is being managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., endocrinologist); AND
8. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Initial Duration of Approval:

180 days (6 months)

Continuation Coverage Criteria:

1. The patient has been previously approved with Blue Cross and Blue Shield of North Carolina (Blue Cross NC) or would have met initial criteria for approval upon the start of therapy; AND
2. There is documentation that the patient has shown improvement with the requested medication as indicated by improvement in 24-hour urine free cortisol (UFC), late night salivary cortisol, or 1 mg overnight dexamethasone suppression test (DST) (medical record documentation required); AND
3. The patient continues to be managed by or in consultation with a specialist in the area of the patient’s diagnosis (e.g., endocrinologist); AND
4. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Continuation Duration of Approval:

365 days (1 year)

Quantity Limitations:

Quantity limitations apply to brand and associated generic products

Quantity Limit Exception Criteria:

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90-day titration period); AND
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

References:

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information:

May 2023: Criteria change: Updated the quantity limit for Isturisa 5 mg tablets due to planned discontinuation of Isturisa 10 mg tablets.

July 2022: Criteria change: Added documentation of approved testing for Cushing’s diagnosis in initial and continuation criteria. Added endocrinologist must be involved in initial therapy and continuation therapy. Updated tried and failed agents. Updated baseline tests to be completed prior to treatment for initial criteria.

May 2020: Criteria change: Added requirement of trial and failure of one conventional agent.

Apr 2020: Original utilization management criteria issued.