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Isturisa — Blue Cross Blue Shield of Texas

other FDA labeled indications for Isturisa (osilodrostat phosphate) and route of administration

Initial criteria

  • Diagnosis of Cushing’s syndrome AND EITHER (inadequate response to surgery OR not a candidate for surgery) AND disease is persistent or recurrent as evidenced by EITHER (mean of three 24-hour urine free cortisol >1.3 times upper limit of normal OR morning plasma ACTH above the lower limit of normal)
  • AND ONE of the following applies:
  • A. The patient has stage four advanced, metastatic cancer and the requested agent is used to treat the cancer or an associated condition, consistent with best practices and FDA approval OR
  • B. The patient is currently stable and treated with the requested agent OR
  • C. The patient is a BCBS IL Fully Insured, ASO Cost/BBF, HIM, or Non-ERISA ASO/Self-insured Municipalities/Counties member OR
  • D. The patient has tried and had an inadequate response to at least ONE of: mifepristone, Signifor/Signifor LAR (pasireotide), Recorlev (levoketoconazole), cabergoline, metyrapone, or Lysodren (mitotane); OR discontinued due to lack of efficacy, diminished effect, or adverse event; OR has intolerance or hypersensitivity; OR has FDA labeled contraindication; OR therapy expected ineffective or not in best interest based on medical necessity
  • AND ONE of the following regarding ketoconazole tablets: tried and inadequate response; discontinued due to lack of efficacy/AE; intolerance/hypersensitivity; contraindication; expected to be ineffective; not in best interest; or tried another drug of same mechanism discontinued due to efficacy or AE
  • Patient has another FDA labeled indication for requested agent and route of administration
  • If FDA labeled indication, age within labeling OR has supporting evidence for use in the patient’s age
  • Prescriber is specialist (e.g., endocrinologist) or has consulted with one
  • Patient will NOT be using the requested agent with glucocorticoid replacement therapy
  • Patient has NO FDA labeled contraindications to requested agent
  • OR the member resides in Ohio and plan is Fully Insured or HIM Shop (SG) AND patient has no contraindications AND indication is either FDA labeled, compendia supported, or supported by two peer-reviewed journal articles

Reauthorization criteria

  • Previously approved through plan’s Prior Authorization process
  • Has had clinical benefit with requested agent
  • Prescriber is a specialist in area of diagnosis or has consulted with one
  • Patient will NOT use with glucocorticoid replacement therapy
  • No FDA labeled contraindications to requested agent

Approval duration

BCBSOK: 36 months; BCBSIL/BCBSMT: 12 months; other plans: 6 months; Renewal: BCBSOK 36 months, others 12 months