Subject: L-glutamine powder-Endari SGM 2208-A P2025

Drug

L-glutamine powder-Endari

EMDARI  (L-glutamine oral powder)

Policy:

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^1,2

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.

Prescriber Specialties

This medication must be prescribed by or in consultation with a hematologist or specialist in sickle cell disease.

Coverage Criteria

Sickle cell disease, to reduce acute complications^1-3

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:

• Member has sickle hemoglobin C (HbSC), sickle β⁺-thalassemia (HbSβ⁺), or other genotypic variants of sickle cell disease (e.g., HbS-O Arab, HbS-Lepore).
• Member has homozygous hemoglobin S (HbSS) or sickle β⁰-thalassemia (HbSβ⁰) genotype AND meets any of the following:
  • Has experienced, at any time in the past, an inadequate response or intolerance to a trial of hydroxyurea
  • Has a contraindication to hydroxyurea
  • Will be using the requested medication with concurrent hydroxyurea therapy

Continuation of Therapy

Sickle cell disease, to reduce acute complications^1-3

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 the requested medication.

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. L-glutamine [package insert]. East Windsor, NJ: Novitium Pharma LLC; July 2024.
3. 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.

January 01, 2026