mifepristone — Blue Cross Blue Shield of Texas

Initial criteria

• 1. The patient has a diagnosis of Cushing’s syndrome AND A. 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 using the requested agent for the patient’s age for the requested indication AND B. 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 C. 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 2. If the request is for a brand agent with an available generic equivalent (Korlym / mifepristone), then ONE of the following: A. The patient is currently being treated with and stable on the requested agent [chart notes required] OR B. The patient has tried and had inadequate response to the generic equivalent not expected to occur with the brand [chart notes required] OR C. The available generic equivalent was discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR D. The patient has intolerance or hypersensitivity to the available generic equivalent not expected to occur with the requested agent [chart notes required] OR E. The patient has an FDA labeled contraindication to an available generic equivalent not expected to occur with the requested agent [chart notes required] OR F. The available generic equivalent is expected to be ineffective based on clinical characteristics, or cause adherence barrier, worsen comorbid condition, reduce functional ability, cause adverse reaction or harm [chart notes required] OR G. The available generic equivalent is not in the best interest of the patient based on medical necessity [chart notes required] OR H. The patient has tried another drug in same pharmacologic class as an available generic equivalent and discontinued due to lack of efficacy or adverse event [chart notes required] AND 3. The prescriber is a specialist (e.g., endocrinologist) or has consulted with one AND 4. The patient has no FDA labeled contraindications to Korlym AND 5. The requested dose does not exceed 20 mg/kg/day
• For BCBS NM Fully Insured or NM HIM members: ALL of the following: A. The patient has no FDA labeled contraindications AND B. The requested indication is a rare disease AND C. ONE of the following: 1. The patient has another FDA labeled indication and route of administration OR 2. The patient has another compendia-supported indication and route of administration
• For Ohio Fully Insured or HIM Shop (SG) members: ALL of the following: A. Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND B. No FDA labeled contraindications AND C. ONE of the following: 1. FDA labeled indication and route of administration OR 2. Compendia-supported indication and route of administration OR 3. Two peer‑reviewed journal articles (JAMA, NEJM, Lancet) showing use safe and effective [journal articles required]

Reauthorization criteria

• 1. Patient previously approved through plan’s prior authorization process AND 2. Patient has had clinical benefit with the requested agent AND 3. For brand with generic equivalent (Korlym / mifepristone), ONE of the following: A-H same as initial evaluation criteria (stability, intolerance, lack of efficacy, medical necessity, etc.) [chart notes required] AND 4. Prescriber is a specialist or has consulted with one AND 5. No FDA labeled contraindications AND 6. Requested dose does not exceed 20 mg/kg/day

Approval duration

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