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Recorlev — Blue Cross Blue Shield of Texas

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 UFC greater than 1.5 × ULN OR (B) Morning plasma ACTH above lower limit of normal AND
  • ONE of the following: (A) BOTH of (1) Evidence of stage IV advanced, metastatic cancer treated per FDA and best-practice standards OR (2) Documentation of such, OR (B) Patient currently stable on requested agent, OR (C) Patient tried and had inadequate response to ≥1 of mifepristone, pasireotide (Signifor/Signifor LAR), osilodrostat (Isturisa), cabergoline, metyrapone, or mitotane (Lysodren), OR (D) Discontinued those due to inefficacy/adverse event, OR (E) Has intolerance or hypersensitivity, OR (F) Has FDA-labeled contraindication to mifepristone, pasireotide, and osilodrostat, OR (G) Those agents expected ineffective or harmful, OR (H) Those agents not in best medical interest, OR (I) Tried another drug of same class which failed due to inefficacy/adverse event) AND
  • ONE of the following related to ketoconazole: (A) BOTH of (1) Evidence of stage IV cancer per above and (2) Use consistent with best practices, OR (B) Patient currently stable on Recorlev, OR (C) Tried and failed ketoconazole tablets, OR (D) Discontinued due to inefficacy/adverse event, OR (E) Intolerance/hypersensitivity to ketoconazole not expected with requested agent, OR (F) Has FDA labeled contraindication to ketoconazole not expected with requested agent, OR (G) Ketoconazole expected ineffective/harmful, OR (H) Ketoconazole not in best interest, OR (I) Tried another drug of same mechanism as ketoconazole discontinued due to inefficacy/adverse event) AND
  • If patient has FDA-labeled indication: (A) Age is within labeling OR (B) Use supported for patient’s age AND
  • Prescriber is endocrinologist or has consulted with endocrinologist AND
  • Patient will NOT use requested agent with glucocorticoid replacement therapy AND
  • Patient has no FDA-labeled contraindications to Recorlev

Reauthorization criteria

  • Patient previously approved through plan’s prior authorization process AND
  • Patient has had clinical benefit with Recorlev AND
  • Prescriber is or has consulted an endocrinologist AND
  • Patient will NOT use Recorlev with glucocorticoid replacement therapy AND
  • Patient has no FDA-labeled contraindications to Recorlev

Approval duration

BCBSIL: 12 months; others: 6 months initial, 12 months renewal