Subject: Endari 2208-A SGM P2021

Drug

ENDARI  (L-glutamine oral powder)

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
           Endari is indicated to reduce the acute complications of sickle cell
           disease in adult and pediatric patients 5 years of age and older.

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

 

     II.  CRITERIA FOR INITIAL APPROVAL

           Sickle cell disease, to reduce the acute complications
           Authorization of 12 months may be granted for use in reducing the
           acute complications of sickle cell disease in members 5 years of age or
           older when any of the following criteria are met:
           A.  The member experienced, at any time in the past, an inadequate
                response or intolerance to a trial of hydroxyurea.
           B.  The member has a contraindication to hydroxyurea.
           C.  The member will be using Endari with concurrent hydroxyurea
                 therapy.

   III.  CONTINUATION OF THERAPY

           Sickle cell disease, to reduce the acute complications
           Authorization of 12 months may be granted for continued treatment
           when the member experienced a reduction in acute complications of
           sickle cell disease (e.g., reduction in the number of painful vaso-
           occlusive episodes, acute chest syndrome episodes, fever, occurrences
           of priapism, splenic sequestration) since initiating therapy with Endari.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Endari [package insert]. Torrance, CA: Emmaus Medical, Inc; October 2020.
2. Niihara Y, Miller ST, et al. A phase 3 trial of l-glutamine in sickle cell disease. N Engl J Med. 2018;379(3):226-235.

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.

December 30, 2021