Levoketoconazole — Blue Cross Blue Shield of Kansas
Cushing’s syndrome
Initial criteria
- ONE of the following: A. The requested agent is eligible for continuation of therapy AND ONE of (the patient has been treated with the requested agent within the past 90 days OR the prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed) OR B. The patient has a diagnosis of Cushing’s syndrome AND ALL of the following:
 - 1. 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
 - 2. The patient’s disease is persistent or recurrent as evidenced by ONE of the following: mean of three 24‑hour urine free cortisol (UFC) > 1.5 × ULN OR morning plasma ACTH above the lower limit of normal
 - 3. ONE of the following: (A) The patient has tried and had an inadequate response to at least ONE of mifepristone, Signifor/Signifor LAR (pasireotide), Isturisa (osilodrostat), cabergoline, metyrapone, or Lysodren (mitotane) OR (B) Intolerance or hypersensitivity to mifepristone, pasireotide, or osilodrostat OR (C) FDA labeled contraindication to mifepristone, pasireotide, AND osilodrostat
 - 4. ONE of the following regarding ketoconazole tablets: (A) tried and inadequate response OR (B) intolerance or hypersensitivity not expected to occur with requested agent (medical records required) OR (C) FDA labeled contraindication not expected to occur with requested agent (medical records required)
 - 5. If the patient has an FDA labeled indication then ONE of (A) patient’s age is within FDA labeling for indication OR (B) support for use at that age
 - The prescriber is a specialist (e.g., endocrinologist) or has consulted with a specialist
 - The patient will NOT be using the requested agent in combination with glucocorticoid replacement therapy
 - The patient does NOT have any FDA labeled contraindications to the requested agent
 
Reauthorization criteria
- The patient has been previously approved for the requested agent through the plan’s prior authorization process
 - The patient has had clinical benefit with the requested agent
 - The prescriber is a specialist (e.g., endocrinologist) or has consulted with a specialist
 - The patient will NOT be using the requested agent in combination with glucocorticoid replacement therapy
 - The patient does NOT have any FDA labeled contraindications to the requested agent
 
Approval duration
initial 6 months; renewal 12 months