Recorlev — Blue Cross Blue Shield of Montana
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 (UFC) > 1.5× ULN OR (B) morning plasma ACTH above lower limit of normal AND
- ONE of the following regarding prior therapy or clinical condition: (A) advanced/metastatic cancer use consistent with evidence-based practice OR (B) currently treated and stable on requested agent OR (C) tried and inadequate response to ≥1 of mifepristone, Signifor/Signifor LAR (pasireotide), Isturisa (osilodrostat), cabergoline, metyrapone, Lysodren (mitotane) OR (D) discontinued any of these due to lack of efficacy/adverse event OR (E) intolerance/hypersensitivity to mifepristone, pasireotide, or osilodrostat OR (F) contraindication to all mifepristone, pasireotide, osilodrostat OR (G) expected ineffectiveness/adherence barrier/adverse reaction OR (H) not in patient’s best interest OR (I) tried another drug in same class and discontinued for lack of efficacy/adverse event AND
- ONE of the following regarding ketoconazole: (A) advanced/metastatic cancer use consistent with evidence-based practice OR (B) currently stable on requested agent OR (C) tried and inadequate response to ketoconazole tablets OR (D) discontinued ketoconazole for lack of efficacy/adverse event OR (E) intolerance/hypersensitivity to ketoconazole not expected with requested agent OR (F) FDA labeled contraindication to ketoconazole not expected with requested agent OR (G) expected ineffectiveness/adherence barrier/adverse reaction with ketoconazole OR (H) ketoconazole not in patient’s best interest OR (I) tried another drug in same class and discontinued for lack of efficacy/adverse event AND
- If FDA-labeled indication, patient’s age is within FDA labeling or supported for that indication AND
- Prescriber is a specialist (e.g., endocrinologist) or has consulted with one AND
- Patient will NOT use requested agent with glucocorticoid replacement therapy AND
- Patient does NOT have any FDA labeled contraindications to requested agent
Reauthorization criteria
- Patient was previously approved for requested agent through plan’s Prior Authorization process AND
- Patient has had clinical benefit with requested agent AND
- Prescriber is a specialist in the area of patient’s diagnosis (e.g., endocrinologist) or has consulted with specialist 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 6-12 months; renewal 12 months