Recorlev — Blue Cross Blue Shield of Alabama

Initial criteria

• ONE of the following: • The requested agent is eligible for continuation of therapy AND ONE of the following: – The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days – The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR • The patient has a diagnosis of Cushing’s syndrome AND ALL of the following: – ONE of the following: • The patient had an inadequate response to pituitary surgery • The patient is NOT a candidate for pituitary surgery – The patient’s disease is persistent or recurrent as evidenced by ONE of the following: • The patient has a mean of three 24-hour urine free cortisol (UFC) greater than 1.5× ULN • Morning plasma ACTH above the lower limit of normal – ONE of the following: • The patient has tried and had an inadequate response to at least ONE of the following: mifepristone; Signifor/Signifor LAR (pasireotide); Isturisa (osilodrostat); cabergoline; metyrapone; Lysodren (mitotane) • The patient has an intolerance or hypersensitivity to mifepristone, pasireotide, or osilodrostat • The patient has an FDA labeled contraindication to mifepristone, pasireotide AND osilodrostat – ONE of the following: • The patient has tried and had an inadequate response to ketoconazole tablets • The patient has an intolerance or hypersensitivity to ketoconazole tablets that is NOT expected to occur with the requested agent (medical records required) • The patient has an FDA labeled contraindication to ketoconazole tablets that is NOT expected to occur with the requested agent (medical records required) – If the patient has an FDA labeled indication, then ONE of the following: • The patient’s age is within FDA labeling for the requested indication • There is support for using the requested agent for the patient’s age for the requested indication – The prescriber is a specialist in endocrinology (or has consulted with one) – 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 in endocrinology (or has consulted with one) • 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