mifepristone — Blue Cross Blue Shield of New Mexico

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: (1) The patient’s age is within FDA labeling for the requested indication OR (2) There is support for use in the patient’s age for the requested indication AND
• ONE of the following: (1) The patient has type 2 diabetes mellitus OR (2) The patient has glucose intolerance as defined by a 2‑hr glucose tolerance test plasma glucose value of 140‑199 mg/dL AND
• ONE of the following: (1) The patient has had an inadequate response to surgical resection OR (2) The patient is NOT a candidate for surgical resection AND
• If the request is for one of the brand agents with available generic equivalent (Korlym/mifepristone), then ONE of the following: (A) The patient is currently stable on the requested brand agent [chart notes required] OR (B) The patient has tried and had an inadequate response to the generic OR (C) The generic was discontinued due to lack of efficacy, diminished effect, or adverse event OR (D) The patient has intolerance or hypersensitivity to the generic OR (E) The patient has FDA labeled contraindication to the generic OR (F) The generic is expected to be ineffective, cause barrier to adherence, worsen comorbidity, decrease function, or cause harm [chart notes required] OR (G) The generic is NOT in best interest of patient based on medical necessity OR (H) The patient has tried another agent in same pharmacologic class or same mechanism and discontinued for lack of efficacy, diminished effect, or adverse event [chart notes required]
• The prescriber is a specialist in the area of diagnosis (e.g., endocrinologist) or has consulted with a specialist
• The patient does NOT have any FDA labeled contraindications to the requested agent
• The requested dose does NOT exceed 20 mg/kg/day
• Special coverage notes: For BCBS NM Fully Insured or NM HIM member – approval if no FDA‑labeled contraindications AND the indication is a rare disease AND ONE of the following: (a) Has another FDA labeled indication for requested agent/route OR (b) Has another indication supported in compendia for requested agent/route. OR For Ohio Fully Insured or HIM Shop members – residence in Ohio, fully insured plan, no FDA‑labeled contraindications, and ONE of: (a) Another FDA labeled indication, (b) Another compendia‑supported indication, or (c) Two peer‑reviewed journal articles supporting the proposed use.

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s PA process
• The patient has had clinical benefit with the requested agent
• If the request is for a brand agent with available generic equivalent (Korlym/mifepristone), then ONE of the following: (A) Patient currently stable on requested brand [chart notes required] OR (B) Tried and had inadequate response to generic OR (C) Generic discontinued due to lack of efficacy/diminished effect/adverse event OR (D) Intolerance or hypersensitivity to generic OR (E) FDA labeled contraindication to generic OR (F) Generic expected to be ineffective, cause adherence barrier, worsen comorbid condition, decrease function, or cause harm [chart notes required] OR (G) Generic not in best interest based on medical necessity [chart notes required] OR (H) Tried another drug in same class or mechanism and discontinued for lack of efficacy/diminished effect/adverse event [chart notes required]
• The prescriber is a specialist or has consulted with a specialist in the diagnosis area
• The patient does NOT have FDA labeled contraindications to requested agent
• The requested dose does NOT exceed 20 mg/kg/day

Approval duration

12 months (Initial: BCBSIL/MT/NM 12 months; others 6 months; Renewal 12 months)