Subject: mifepristone-Korlym SGM 2160-A P2026

Drug

KORLYM  (mifepristone)

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-Approved Indications^1,2

Indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery.

Limitations of Use:

Should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing’s syndrome.

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

·        Pretreatment cortisol level as measured by one of the following tests:

§  Urinary free cortisol (UFC)

§  Late-night salivary cortisol (LNSC)

§  1 mg overnight dexamethasone suppression test (DST)

§  Longer, low dose DST (2 mg per day for 48 hours)

·        Pretreatment hemoglobin A1C level, fasting plasma glucose or 2-hour plasma glucose (for initial requests)

Prescriber Specialties

This medication must be prescribed by or in consultation with an endocrinologist or a prescriber specialized in the treatment of endogenous Cushing’s syndrome.

Coverage Criteria

Cushing’s Syndrome/Disease^1-4

Authorization of 12 months may be granted for treatment of Cushing’s syndrome/disease in adult members when all of the following criteria are met:

·        Member has a diagnosis of Cushing’s syndrome/disease as evidenced by hypercortisolism per one of the following tests:

§  Urinary free cortisol (UFC)

§  Late-night salivary cortisol (LNSC)

§  1 mg overnight dexamethasone suppression test (DST)

§  Longer, low dose DST (2 mg per day for 48 hours)

·        Member has type 2 diabetes mellitus or glucose intolerance

·        The requested drug is being prescribed to control hyperglycemia secondary to hypercortisolism

·        Member has had surgery that was not curative OR member is not a candidate for surgery

·        If the member is able to become pregnant, a negative pregnancy test is required before initiating therapy

Continuation of Therapy

Cushing’s Syndrome/Disease^1-4

Authorization of 12 months may be granted in adult  members who have achieved or maintained an adequate positive response, or there is improvement in signs and symptoms of the condition.

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Korlym [package insert]. Menlo Park, CA: Corcept Therapeutics Incorporated; September 2024.

2.     Mifepristone [package insert]. Menlo Park, CA: Corcept Therapeutics Incorporated; September 2024.

3.     Nieman LK, Biller BM, Findling JW, et al. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100(8):2807-2831. doi:10.1210/jc.2015-1818.

4.     Fleseriu M, Auchus R, Bancos I, et al. Consensus on Diagnosis and Management of Cushing’s Disease: A Guideline Update. Lancet Diabetes Endocrinol. 2021;9(12):847-875. doi:10.1016/S2213-8587(21)00235-7.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 29, 2026