Subject: Xermelo 1670-A SGM P2022

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
           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.


     II.  CRITERIA FOR INITIAL APPROVAL

           Carcinoid syndrome diarrhea
           Authorization of 3 months may be granted for the treatment of
           carcinoid syndrome diarrhea in members 18 years of age or
           older when both of the following criteria are met:
           1.  The member has had an inadequate response to
                somatostatin analog (SSA) therapy alone
           2.  Xermelo will be used in combination with SSA therapy

 
   III.  CONTINUATION OF THERAPY

           Authorization of 6 months may be granted for continued
           treatment in members requesting reauthorization for an
           indication listed in Section II when all of the following criteria
           are met:
           1.  The member is currently receiving the requested medication
                through a paid pharmacy or medical benefit
           2.  The member is receiving the requested medication in
                combination with SSA therapy
           3.  The member is experiencing benefit from therapy as
                evidenced by disease stability or disease improvement (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; October 2020.

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, 2023