Subject: Endari 2208-A SGM P2022

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.  PRESCRIBER SPECIALITIES
           Endari must be prescribed by or in consultation with a
           hematologist or specialist in sickle cell disease.

 
   III.  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 either of the following criteria is
           met:
           A.  Member has sickle hemoglobin C (HbSC) or sickle β⁺-
                thalassemia (HbSβ⁺) genotype
           B.  Member has homozygous hemoglobin S (HbSS) or sickle β⁰-
                thalassemia (HbSβ⁰) genotype AND meets any of the
                following:
                1.  Has experienced, at any time in the past, an inadequate
                     response or intolerance to a trial of hydroxyurea.
                2.  Has a contraindication to hydroxyurea.
                3.  Will be using Endari with concurrent hydroxyurea
                     therapy.

 
      IV.  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.

January 31, 2023