mifepristone — Blue Cross Blue Shield of Montana

Initial criteria

• The patient has a diagnosis of Cushing’s syndrome AND
• IF the patient has an FDA labeled indication THEN ONE of the following: The patient’s age is within FDA labeling for the indication OR There is support for use at the patient’s age
• AND ONE of the following: The patient has type 2 diabetes mellitus OR The patient has glucose intolerance defined by 2-hr glucose tolerance test plasma glucose 140–199 mg/dL
• AND ONE of the following: The patient has had inadequate response to surgical resection OR Is not a candidate for surgical resection
• If the request is for a brand agent with available generic (Korlym/mifepristone) then ONE of the following: patient stable on brand; tried and had inadequate response to generic not expected with brand; generic discontinued due to inefficacy, adverse event, or diminished effect; intolerance or hypersensitivity to generic not expected with brand; FDA labeled contraindication to generic not expected with brand; generic expected ineffective or harmful or barrier to adherence; brand is in best interest (medical necessity); or tried another drug in same class discontinued due to lack of efficacy or adverse event
• Prescriber is a specialist in the area of the patient’s diagnosis (e.g., endocrinologist) or has consulted with one
• Patient has no FDA labeled contraindications to requested agent
• Requested dose does not exceed 20 mg/kg/day
• Length of approval: BCBSIL/BCBSMT/BCBSNM 12 months; others 6 months
• Additional approval path for BCBS NM Fully Insured or NM HIM or Ohio members if no contraindications and indication is rare disease and one of: another FDA labeled indication or compendia‑supported indication (per listed compendia levels) or two peer‑reviewed journal articles supporting proposed use

Reauthorization criteria

• Patient previously approved for requested agent through plan’s prior authorization process
• Patient has had clinical benefit with the requested agent
• If brand has available generic (Korlym/mifepristone) then one of: patient stable on brand; tried and had inadequate response to generic not expected with brand; generic discontinued due to inefficacy, adverse event, or diminished effect; intolerance or hypersensitivity to generic not expected with brand; FDA contraindication to generic not expected with brand; generic expected ineffective or harmful or barrier to adherence; brand is in best interest (medical necessity); or tried another drug in same class discontinued due to lack of efficacy or adverse event
• Prescriber is a specialist in the area of the patient’s diagnosis or has consulted with one
• Patient has no FDA labeled contraindications to requested agent
• Requested dose does not exceed 20 mg/kg/day
• Length of approval: 12 months

Approval duration

Initial 6–12 months; Renewal 12 months