Subject: Xermelo SGM 1670-A P2026

Drug

XERMELO  (telotristat ethyl)

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 Indications¹

Xermelo is indicated for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy.

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

Coverage Criteria

Carcinoid Syndrome Diarrhea^1-4

Authorization of 12 months may be granted for treatment of carcinoid syndrome diarrhea in adult members when both of the following criteria are met:

·        The member has had an inadequate response to somatostatin analog (SSA) therapy alone.

·        The requested medication will be used in combination with SSA therapy.

Continuation of Therapy

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for carcinoid syndrome diarrhea in combination with SSA therapy and who achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition (e.g., reduction in the number of daily bowel movements).

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Xermelo [package insert]. Deerfield, IL: TerSera Therapeutics LLC; September 2022.

2.     Kulke MH, Hörsch D, Caplin ME, et al. Telotristat ethyl, a tryptophan hydroxylase inhibitor for the treatment of carcinoid syndrome. J Clin Oncol. 2017;35(1):14-23.

3.     Anthony LB, Kulke MH, Caplin ME, et al. Long-term safety experience with telotristat ethyl across five clinical studies in patients with carcinoid syndrome. Oncologist. 2019;24(8):e662-e670.

4.     The NCCN Drugs & Biologics Compendium® © 2026 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed March 13, 2026.

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 16, 2026