Subject: Korlym 2160-A SGM P2021
Policy:
I. 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 Indication
Korlym is a cortisol receptor blocker 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.
All other indications are considered experimental/investigational and not medically necessary.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization review: pretreatment hemoglobin A1C level (for initial requests)
III. CRITERIA FOR INITIAL APPROVAL
Cushing’s syndrome/disease
Authorization of 6 months may be granted for treatment of Cushing’s syndrome/disease when all of the following criteria are met:
A. Member has type 2 diabetes mellitus or glucose intolerance
B. Korlym is being prescribed to control hyperglycemia secondary to hypercortisolism
C. Member has had surgery that was not curative OR member is not a candidate for surgery
D. If the member is able to become pregnant, a negative pregnancy test is required before initiating therapy
IV. CONTINUATION OF THERAPY
Cushing’s syndrome/disease
Authorization of 12 months for continuation of therapy may be granted if the member has achieved or maintained 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:
- Korlym [package insert]. Menlo Park, CA: Corcept Therapeutics Incorporated; November 2019.
- Nieman LK, Biller B, Findling JW, et al. Treatment of Cushing’s Syndrome: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2015;100:2807-2831.
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.
August 23, 2021
