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Recorlev — Blue Cross Blue Shield of New Mexico

Cushing’s syndrome

Initial criteria

  • The patient has a diagnosis of Cushing’s syndrome AND
  • 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
  • The patient’s disease is persistent or recurrent as evidenced by ONE of the following: (A) mean of three 24-hour urine free cortisol >1.5× ULN OR (B) morning plasma ACTH above lower limit of normal AND
  • ONE of the following conventional or clinical history requirements (chart notes required): (A) both conditions related to advanced, metastatic cancer use as described OR (B) currently stable on requested agent OR (C) tried and inadequate response to at least ONE of: mifepristone, Signifor/Signifor LAR (pasireotide), Isturisa (osilodrostat), cabergoline, metyrapone, or Lysodren (mitotane) OR (D) discontinued these agents due to adverse event or lack of efficacy OR (E) intolerance or hypersensitivity to mifepristone, pasireotide, or osilodrostat OR (F) FDA labeled contraindication to mifepristone, pasireotide, and osilodrostat OR (G) expected ineffective, adverse, or contraindicated use as defined OR (H) not in best interest based on medical necessity OR (I) tried another drug in same class or mechanism discontinued due to issues AND
  • ONE of the following related to ketoconazole: (A) advanced, metastatic cancer as above OR (B) currently stable on requested agent OR (C) tried and inadequate response to ketoconazole tablets OR (D) discontinued due to lack of efficacy or adverse event OR (E) intolerance/hypersensitivity to ketoconazole tablets not expected with requested agent OR (F) FDA contraindication to ketoconazole tablets not expected with requested agent OR (G) expected ineffective or harmful ketoconazole use OR (H) not in patient’s best interest OR (I) tried another drug in same class with discontinuation for efficacy/adverse event AND
  • If FDA-labeled indication: (A) age within labeling OR (B) supported age use AND
  • The prescriber is or has consulted an endocrinologist AND
  • The requested agent will NOT be used with glucocorticoid replacement therapy AND
  • The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • Patient previously approved for requested agent through plan PA process AND
  • Patient has had clinical benefit with requested agent AND
  • Prescriber is or has consulted an endocrinologist AND
  • Patient will NOT use requested agent with glucocorticoid replacement therapy AND
  • Patient does NOT have any FDA labeled contraindications to requested agent

Approval duration

initial 6 months; renewal 12 months (BCBSIL 12 months)