Isturisa (osilodrostat phosphate) — Blue Cross Blue Shield of Illinois

Initial criteria

• 1. The patient has a diagnosis of Cushing’s syndrome AND the patient had an inadequate response to surgery OR is NOT a candidate for surgery AND the disease is persistent or recurrent as evidenced by ONE of the following: mean of three 24-hour urine free cortisol > 1.3 times upper limit of normal OR morning plasma ACTH above lower limit of normal.
• 2. ONE of the following: (A) If applicable, use is for stage 4 advanced metastatic cancer or associated condition supported by literature and FDA criteria; OR (B) The patient is currently stable on Isturisa; OR (C) The patient meets plan-specific coverage (BCBS IL Fully Insured or specified ASO/HIM/non-ERISA) OR has tried and had inadequate response/intolerance/contraindication/lack of efficacy/adverse event to at least ONE conventional Cushing’s agent: mifepristone, Signifor/Signifor LAR (pasireotide), Recorlev (levoketoconazole), cabergoline, metyrapone, or Lysodren (mitotane); OR (D–H) patient cannot use or is not a candidate for those conventional agents due to expected ineffectiveness, adherence barriers, comorbidities, adverse events, medical necessity, or similar.
• 3. ONE of the following: (A) Plan category requirement met (Fully Insured or HIM Shop etc.) OR (B) The patient has tried and had inadequate response/intolerance/contraindication/lack of efficacy/adverse event to ketoconazole tablets; OR similar ineffectiveness or appropriateness criteria.
• 4. The patient has another FDA labeled indication for the requested agent and route of administration AND, if applicable, age is within FDA labeling or supported by clinical evidence.
• 5. The prescriber is an endocrinologist or has consulted one.
• 6. The patient will NOT be using Isturisa with glucocorticoid replacement therapy.
• 7. The patient does NOT have any FDA labeled contraindications to Isturisa.
• For Ohio members (Fully Insured or HIM Shop): approval if no contraindication AND has FDA labeled, compendia-supported, or two peer-reviewed journal–supported indications.

Reauthorization criteria

• 1. The patient was previously approved for Isturisa through the plan’s PA process.
• 2. The patient has had clinical benefit with Isturisa.
• 3. The prescriber is an endocrinologist or has consulted one.
• 4. The patient will NOT be using Isturisa in combination with glucocorticoid replacement therapy.
• 5. The patient does NOT have any FDA labeled contraindications to Isturisa.

Approval duration

BCBSIL: 12 months; BCBSOK: 36 months; BCBSMT: 12 months; others: 6 months (initial) / 12 months (renewal)