Subject: Xermelo 1670-A SGM P2023

Drug

XERMELO  (telotristat ethyl)

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
          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.

    II.  CRITERIA FOR INITIAL APPROVAL
          Carcinoid syndrome diarrhea
          Authorization of 3 months may be granted for adult members for
          treatment of carcinoid syndrome diarrhea when both of the
          following criteria are met:
          1.  The member has had an inadequate response to
               somatostatin analog (SSA) therapy alone
          2.  The requested medication will be used in combination with
               SSA therapy


  III.  CONTINUATION OF THERAPY

          Authorization of 6 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.

 

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.

March 28, 2024