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Recorlev — Blue Cross Blue Shield of Oklahoma

Cushing’s syndrome

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) greater than 1.5 times upper limit of normal OR B. Morning plasma adrenocorticotropic hormone (ACTH) above lower limit of normal AND
  • 4. ONE of the following: A. BOTH of the following regarding stage 4 metastatic cancer and documented use OR B. Patient is currently stable on the requested agent OR C. Patient has tried and had inadequate response to at least ONE conventional agent (mifepristone, Signifor/Signifor LAR (pasireotide), Isturisa (osilodrostat), cabergoline, metyrapone, Lysodren (mitotane)) OR D. Discontinued the above agents due to inefficacy or adverse event OR E. Intolerance/hypersensitivity to mifepristone, pasireotide, or osilodrostat OR F. Contraindication to mifepristone, pasireotide, and osilodrostat OR G. Those agents expected to be ineffective, cause adherence issues, worsen comorbidity, impair function, or cause harm OR H. Not in best interest of patient based on medical necessity OR I. Tried another drug in same class with discontinued due to inefficacy or adverse event AND
  • 5. ONE of the following: A. BOTH of the following regarding stage 4 metastatic cancer documentation OR B. Stable on requested agent OR C. Tried and had inadequate response to ketoconazole tablets OR D. Ketoconazole discontinued due to inefficacy or adverse event OR E. Intolerance or hypersensitivity to ketoconazole not expected with Recorlev OR F. Contraindication to ketoconazole not expected with Recorlev OR G. Ketoconazole expected to be ineffective, cause adherence issues or harm OR H. Ketoconazole not in best interest based on medical necessity OR I. Tried another prescription drug in same pharmacologic class as ketoconazole discontinued due to inefficacy or adverse event AND
  • 6. If the patient has an FDA labeled indication, ONE of: A. The patient’s age is within FDA labeling OR B. There is support for using the requested agent for the patient’s age AND
  • 7. Prescriber is a specialist in endocrinology or has consulted one AND
  • 8. Patient will NOT use Recorlev with glucocorticoid replacement therapy AND
  • 9. Patient does NOT have any FDA labeled contraindication to Recorlev
  • Alternate approval for Ohio residents if: 1. Member resides in Ohio AND 2. Plan is Fully Insured or HIM Shop AND A. No FDA labeled contraindications AND B. ONE of: another labeled indication OR compendia-supported indication OR prescriber-provided ≥2 peer-reviewed journal articles supporting use.

Reauthorization criteria

  • 1. Patient previously approved for Recorlev through the plan’s PA process AND
  • 2. Patient has had clinical benefit with Recorlev AND
  • 3. Prescriber is specialist or has consulted one AND
  • 4. Patient will NOT use in combination with glucocorticoid replacement therapy AND
  • 5. Patient does NOT have any FDA labeled contraindications

Approval duration

BCBSIL: 12 months; All Other Plans: 6 months; Renewal: 12 months