Isturisa — 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 OR 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 BOTH of the following:
• ONE of the following: 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 surgery OR the patient is NOT a candidate for surgery AND the patient’s disease is persistent or recurrent as evidenced by ONE of the following: mean of three 24-hour urine free cortisol (UFC) >1.3 x upper limit of normal OR morning plasma ACTH above lower limit of normal
• AND ONE of the following: patient has tried and had an inadequate response to at least ONE of the following conventional agents: mifepristone, Signifor/Signifor LAR (pasireotide), Recorlev (levoketoconazole), cabergoline, metyrapone, Lysodren (mitotane) OR patient has intolerance or hypersensitivity to mifepristone, pasireotide, or levoketoconazole OR patient has an FDA labeled contraindication to mifepristone, pasireotide, and levoketoconazole
• AND ONE of the following: patient has tried and had an inadequate response to ketoconazole tablets OR patient has intolerance or hypersensitivity to ketoconazole tablets (medical records required) OR patient has an FDA labeled contraindication to ketoconazole tablets (medical records required)
• OR the patient has another FDA labeled indication for the requested agent and route of administration
• AND if the patient has an FDA labeled indication, then ONE of the following: patient’s age is within FDA labeling for the requested indication OR there is support for using the requested agent for the patient’s age for the requested indication
• AND the prescriber is a specialist in endocrinology (or has consulted with a specialist)
• AND the patient will NOT be using the requested agent in combination with glucocorticoid replacement therapy
• AND 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 a specialist)
• 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