Subject: Endari 2208-A SGM P2023

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

          This medication 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 has 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, Kanter J, 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 09, 2023