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Levoketoconazole — Blue Cross Blue Shield of Illinois

Cushing’s syndrome

Preferred products

  • ketoconazole tablets

Initial criteria

  • 1. The patient has a diagnosis of Cushing’s syndrome AND
  • 2. ONE of the following: (A) The patient had an inadequate response to pituitary surgery OR (B) The patient is NOT a candidate for pituitary surgery AND
  • 3. The patient’s disease is persistent or recurrent as evidenced by ONE of the following: (A) Mean of three 24-hour urine free cortisol (UFC) > 1.5× upper limit of normal OR (B) Morning plasma ACTH above lower limit of normal AND
  • 4. ONE of the following: (A) Stage four advanced/metastatic cancer criteria as outlined OR (B) Currently treated and stable on requested agent OR (C) Tried and inadequate response to ONE of: mifepristone OR Signifor/Signifor LAR (pasireotide) OR Isturisa (osilodrostat) OR cabergoline OR metyrapone OR Lysodren (mitotane) OR (D–I) Discontinued/contraindication/intolerance/best interest exceptions related to these conventional agents as specified AND
  • 5. ONE of the following: (A) Stage four advanced/metastatic cancer criteria as outlined OR (B) Currently treated and stable on requested agent OR (C) Tried and inadequate response or intolerance/contraindication to ketoconazole tablets or equivalents as specified AND
  • 6. If the patient has an FDA labeled indication, then ONE of the following: (A) Age is within FDA labeling OR (B) There is support for using the requested agent for the patient’s age for the requested indication AND
  • 7. The prescriber is a specialist in the area of the diagnosis (e.g., endocrinologist) or has consulted with a specialist AND
  • 8. The patient will NOT use the requested agent with glucocorticoid replacement therapy AND
  • 9. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s prior authorization process AND
  • 2. The patient has had clinical benefit with the requested agent AND
  • 3. The prescriber is a specialist in the area of the diagnosis (e.g., endocrinologist) or has consulted with a specialist AND
  • 4. The patient will NOT use the requested agent with glucocorticoid replacement therapy AND
  • 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months