Korlym — Blue Cross Blue Shield of Illinois

Initial criteria

• Patient has a diagnosis of Cushing’s syndrome AND
• If patient has an FDA labeled indication, then ONE of the following: (1) Patient’s age is within FDA labeling for the requested indication OR (2) There is support for using the requested agent for the patient’s age for the requested indication AND
• ONE of the following: (1) Patient has type 2 diabetes mellitus OR (2) Patient has glucose intolerance as defined by a 2-hour glucose tolerance test plasma glucose value of 140–199 mg/dL AND
• ONE of the following: (1) Patient has had an inadequate response to surgical resection OR (2) Patient is not a candidate for surgical resection AND
• If the request is for a brand agent with an available generic equivalent (Korlym / mifepristone), then ONE of the following: (A) Patient is currently stable on the requested agent OR (B) Patient has tried and had inadequate response to the generic equivalent OR (C) Generic equivalent discontinued due to lack of efficacy, diminished effect, or adverse event OR (D) Patient has intolerance or hypersensitivity to generic equivalent OR (E) Patient has an FDA labeled contraindication to generic equivalent OR (F) Generic equivalent expected to be ineffective or cause harm OR (G) Generic equivalent not in best interest based on medical necessity OR (H) Patient has tried another drug in same pharmacologic class that was discontinued due to lack of efficacy or adverse event AND
• Prescriber is a specialist in the area of diagnosis (e.g., endocrinologist) or has consulted with one AND
• Patient has no FDA labeled contraindications to the requested agent AND
• Requested dose does not exceed 20 mg/kg/day
• For BCBS NM Fully Insured or NM HIM members: no contraindications AND indication is a rare disease AND one of: (1) another FDA labeled indication for same route OR (2) another compendia-supported indication; OR, for Ohio Fully Insured or HIM Shop: same plus two peer-reviewed journal articles supporting requested use

Reauthorization criteria

• Patient has been previously approved for requested agent through plan prior authorization AND
• Patient has had clinical benefit with the requested agent AND
• If the request is for a brand agent with an available generic equivalent (Korlym / mifepristone), then ONE of the following: (A) Patient is currently stable on the requested agent OR (B) Patient has tried and had inadequate response to the generic equivalent OR (C) Generic equivalent discontinued due to lack of efficacy, diminished effect, or adverse event OR (D) Patient has intolerance or hypersensitivity to generic equivalent OR (E) Patient has an FDA labeled contraindication to generic equivalent OR (F) Generic equivalent expected to be ineffective or cause harm OR (G) Generic equivalent not in best interest based on medical necessity OR (H) Patient has tried another drug in same pharmacologic class that was discontinued due to lack of efficacy or adverse event AND
• Prescriber is a specialist in the area of diagnosis (e.g., endocrinologist) or has consulted with one AND
• Patient has no FDA labeled contraindications to the requested agent AND
• Requested dose does not exceed 20 mg/kg/day

Approval duration

BCBSIL/BCBSMT/BCBSNM: 12 months; others: 6 months; renewal: 12 months