CurrentCentenePolicy CP.PMN.116

L-glutamine (Endari) for sickle cell disease

Defines medical necessity criteria, dosing, and authorization requirements for Endari and generic L-glutamine to reduce acute complications of sickle cell disease for affected Centene lines of business.

Policy Summary

PayerCentene

PolicyL-glutamine (Endari) for sickle cell disease

Policy CodePolicy CP.PMN.116

Change TypeAdded generic L‑glutaminerevised approval duration

Effective DateAug 22, 2017

Next Review Date

Key ActionSubmit prior authorization with clinical documentation showing diagnosis, age ≥5, and failure of hydroxyurea at maximally tolerated doses.

SourceLink

POLICY UPDATE CHANGES

Policy/criteria section revised to also include generic L-glutamine and added redirection to L-glutamine.

Approval duration for Commercial line of business revised to 12 months or duration of request, whichever is less.

≥5 yrsminimum age

30 g/daymax daily dose

12 moapproval duration

weight-baseddosing

Coverage Criteria for L-glutamine (Endari)

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Initial Therapy

Covered when ALL of the following are met:

Initial Sickle Cell Criteria: 1. Diagnosis of sickle cell disease;

Initial Sickle Cell Criteria: 2. Age ≥ 5 years;

Initial Sickle Cell Criteria: 3. Failure of hydroxyurea at up to maximally tolerated doses, unless contraindicated or clinically significant adverse effects are experienced;

Initial Sickle Cell Criteria: 4. For Endari requests, member must use L-glutamine, unless contraindicated or clinically significant adverse effects are experienced;

Initial Sickle Cell Criteria: 5. Dose does not exceed 30 grams per day based on weight.

Continuation Therapy

Covered for continuation when ALL of the following are met:

Continued Therapy Sickle Cell

a or b: a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
a or b: b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations;

Continued Therapy Sickle Cell: 2. Member is responding positively to therapy;

Continued Therapy Sickle Cell: 3. For Endari requests, member must use L-glutamine, unless contraindicated or clinically significant adverse effects are experienced;

Other/Unlisted Indications

If requested use is not addressed under initial/continued therapy:

Other Indications: 1. If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to the applicable formulary/no-coverage or non-formulary policy for the relevant line of business as specified in policy (e.g., CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16);

Other Indications: 2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business (CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, CP.PMN.53 for Medicaid).

Non–FDA approved indications for L‑glutamine (Endari) that are not specifically addressed within this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy (see CP.CPA.09 for Commercial, HIM.PA.154 for Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents.

Requests for use outside the FDA‑approved indications that do not include adequate supporting documentation (for example, office notes, laboratory results, or other clinical information demonstrating efficacy and safety) will be considered not authorized per the off‑label use policies. Providers must supply the documentation required to show the member meets the rationale and evidence standards referenced by the applicable off‑label policy.

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization may be required for L‑glutamine (Endari). Providers should be prepared to document that the member meets the initial or continuation criteria listed in the policy and to justify ongoing therapy when requesting renewals.

Applies to initial and renewal requests for L‑glutamine (Endari).
Provider must demonstrate criteria for initial or continued approval are met.

Step Therapy

Hydroxyurea Requirement

Providers must document a trial and failure of hydroxyurea at maximally tolerated doses unless hydroxyurea is contraindicated or the member experienced clinically significant adverse effects. Therapeutic alternatives are listed in Appendix B; hydroxyurea dosing examples include 15 mg/kg PO QD up to a maximum of 35 mg/kg/day.

Document trial of hydroxyurea and reason for discontinuation if applicable (toxicity, contraindication, or lack of efficacy).
If hydroxyurea is contraindicated or intolerable, include supporting clinical rationale.

Documentation Required

Required Documentation

Provider must submit supporting documentation such as office chart notes, laboratory results, and other relevant clinical information to demonstrate the member meets all approval criteria (diagnosis, age, prior therapies, response to therapy, and dosing).

Examples: clinic notes documenting diagnosis of sickle cell disease, age verification, documentation of hydroxyurea trial and tolerability, L‑glutamine treatment records, and labs as applicable.
For dose increases, include documentation that new dose does not exceed 30 grams/day based on weight.

Denial Risk

Documentation Insufficiency / Non‑FDA Uses — Denial Risk

Requests lacking sufficient supporting documentation or requests for non‑FDA approved (off‑label) indications without evidence per applicable off‑label policies may be denied. Providers should reference Centene off‑label use policies and submit evidence of efficacy and safety when seeking coverage for indications not addressed by this policy.

Non‑FDA approved indications require sufficient supporting evidence per CP.CPA.09 (commercial), HIM.PA.154 (exchange), or CP.PMN.53 (Medicaid) as applicable.
Insufficient documentation of hydroxyurea trial, contraindication, or intolerance may lead to denial.

Revision History

2017-08-22policy_effective

Policy originally effective as Clinical Policy L-glutamine (Endari).

2021-02-22approval_duration_revision

Revised Commercial approval duration from length of benefit to 12 months or duration of request, whichever is less (P&T approval recorded).

2021-10-18approval_duration_revision

Revised Commercial approval duration from length of benefit to 12 months or duration of request, whichever is less (operational date).

2024-07-19material_change_generic_redirect

Revised policy/criteria to include generic L-glutamine and added redirection to L-glutamine (operational date).

2024-11-24material_change_generic_redirect

Revised policy/criteria to include generic L-glutamine and added redirection to L-glutamine (P&T approval recorded).

2025-07-15annual_reviewLatest

4Q 2025 annual review: no significant clinical changes; references reviewed and updated.

OpenPayer

L-glutamine (Endari) for sickle cell disease

Coverage Criteria for L-glutamine (Endari)

Coding and Dosing Details

Provider Requirements and Prior Authorization

Definitions

Background

Revision History