CurrentUnitedHealthcarePolicy N/A

Endari (L‑glutamine) prior authorization — Coverage Criteria

Defines prior authorization and medical necessity criteria for coverage of Endari (L‑glutamine powder for solution) for members; applies to prescribers and pharmacy/medical reviewers managing sickle cell disease therapy.

Policy Summary

PayerUnitedHealthcare

PolicyEndari (L‑glutamine) prior authorization — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

Key ActionObtain prior authorization demonstrating diagnosis of sickle cell disease, documentation of ≥2 painful crises in past 12 months, concurrent hydroxyurea use or documented intolerance, and history of failure of non-prescription L‑glutamine.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5+minimum patient age

5-15 g BIDdosing range

>=2required crises (12 mo)

12 moauth duration

Coverage Criteria for Endari (L‑glutamine)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

inv-01: Initial Authorization

Covered when ALL of the following are met:

Initial Authorization

Core diagnosis and intent: Diagnosis of sickle cell disease AND used to reduce acute complications of sickle cell disease

Supported by indication statement

Hydroxyurea requirement: Patient is using Endari with concurrent hydroxyurea therapy OR patient is unable to take hydroxyurea due to a contraindication or intolerance

One of these must be present

Clinical history: Patient has had 2 or more painful sickle cell crises within the past 12 months>=2 in 12 months

Required for initial approval

Supplementation failure: History of failure to non-prescription L-glutamine supplementation

Required prior to coverage

inv-02: Reauthorization

Reauthorization covered when the following is documented:

Reauthorization: Documentation of positive clinical response to Endari therapy

Authorization will be issued for 12 months

Coverage may be affected by external requirements and the member's specific benefits. State mandates, applicable federal regulatory requirements, and the terms of the member benefit plan can modify coverage determinations. Additionally, other payer policies and utilization management programs may apply and influence authorization decisions.

Initial Therapy

inv-11: Initial Therapy

Initial therapy coverage requirements

Initial therapy: Diagnosis of sickle cell disease; used to reduce acute complications; concurrent hydroxyurea use or documented contraindication/intolerance to hydroxyurea; ≥2 painful sickle cell crises in past 12 months; history of failure to non-prescription L-glutamine supplementation

Authorization for 12 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Initial approvals are granted when all required criteria are documented: diagnosis of sickle cell disease, use to reduce acute complications, evidence of ≥2 painful sickle cell crises in the prior 12 months, and history of failure to non-prescription L‑glutamine supplementation. Authorization period: 12 months.

Authorization duration: 12 months
Required diagnosis: sickle cell disease
Required indication: reduce acute complications of sickle cell disease

Step Therapy

Hydroxyurea Concurrency or Intolerance

Patient must be currently using hydroxyurea concurrently with Endari OR have documented contraindication or intolerance to hydroxyurea. Include clinical notes and medication history to support concurrency or documentation of intolerance/contraindication.

Hydroxyurea concurrency documented in med list or clinic notes
If not using hydroxyurea, include documentation of contraindication or intolerance

Documentation Required

Reauthorization Documentation

For reauthorization, submit documentation demonstrating a positive clinical response to Endari (e.g., reduction in painful sickle cell crises, decreased healthcare utilization, or other clinical outcome measures). Reauthorizations will be reviewed and, if criteria are met, approved for 12 months.

Provide objective clinical response data (crisis frequency, ER visits, hospitalizations)
Reauthorization period: 12 months

Denial Risk

Triggers for Denial

Requests may be denied if required documentation or criteria are missing. Common triggers for denial include absence of a sickle cell disease diagnosis, failure to document the indication (reducing acute complications), fewer than 2 painful sickle cell crises in the past 12 months, lack of history of trial/failure of non‑prescription L‑glutamine, or missing evidence of hydroxyurea use or documented intolerance.

Missing diagnosis of sickle cell disease
<2 painful sickle cell crises in prior 12 months
No documentation of L‑glutamine trial/failure
No documentation of hydroxyurea use or intolerance

Step	Requirement
1	Patient must be using Endari with concurrent hydroxyurea therapy OR be unable to take hydroxyurea due to a documented contraindication or intolerance (one of these required prior to approval).

Background

Indication: Endari (L‑glutamine powder for solution) is indicated to reduce acute complications of sickle cell disease in patients age 5 years and older.

Recommended dosing: The typical dosing range is 5 to 15 grams orally twice daily, with dose selection based on body weight.

Clinical benefit: Endari has been shown to reduce acute sickle cell–related complications and is intended for use as part of disease management to decrease the frequency of painful crises and other acute events.

Policy Summary

PayerUnitedHealthcare

PolicyEndari (L‑glutamine) prior authorization — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2026

Next Review DateFeb 1, 2026

SourceLink

On This Page

OpenPayer

Endari (L‑glutamine) prior authorization — Coverage Criteria

Coverage Criteria for Endari (L‑glutamine)

Initial Therapy

Reauthorization / Continuation

Provider Actions and Documentation Requirements

Coding and Clinical Thresholds

Step Therapy Requirements

Background

Definitions