CurrentCignaPolicy IP0475

Sickle Cell Disease - Endari (L‑glutamine) for Individual and Family Plans

Coverage policy for L‑glutamine oral powder (Endari and generic) for treatment of sickle cell disease for members covered under Cigna Individual and Family Plans; describes prior authorization, medical necessity criteria, and exclusions.

Policy Summary

PayerCigna

PolicySickle Cell Disease - Endari (L‑glutamine) for Individual and Family Plans

Policy CodePolicy IP0475

Change TypeMaterial changes: preferred product criterion addedgeneric product added

Effective Date4/15/2025

Next Review Date

Key ActionObtain prior authorization and ensure prescription is by or in consultation with a hematology specialist.

SourceLink

POLICY UPDATE CHANGES

Added Preferred Product Criterion for patients who are not candidates for a hydroxyurea product.

Generic L‑glutamine oral powder was added to the policy.

Updated coverage policy title from 'L-glutamine Oral Powder for Individual and Family Plans' to 'Sickle Cell Disease - Endari for Individual and Family Plans.'

Annual Revision on 4/15/2025 states 'No criteria changes.'

≥5Minimum patient age

1 yearApproval duration

IP0475Policy ID

2Products listed

Policy Summary

PayerCigna

PolicySickle Cell Disease - Endari (L‑glutamine) for Individual and Family Plans

Policy CodePolicy IP0475

Change TypeMaterial changes: preferred product criterion addedgeneric product added

Effective Date4/15/2025

Next Review Date

Key ActionObtain prior authorization and ensure prescription is by or in consultation with a hematology specialist.

SourceLink

On This Page

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Coverage Criteria

COVERAGE CRITERIA

Covered when ALL of the following are met:

FDA‑Approved Indication

Prescriber: Medication is prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., hematologist).
Preferred product criterion: For Individual and Family Plans, ONE of the following: (1) failure, contraindication, or intolerance to ONE of hydroxyurea or Droxia; OR (2) prescriber documents patient is not a candidate for hydroxyurea (e.g., planning pregnancy, pregnant, or has an immunosuppressive condition).

Operational note: Receipt of sample product does not satisfy any criteria requirements for coverage.

Any use of L‑glutamine oral powder other than the FDA‑approved indication for sickle cell disease in patients aged ≥ 5 years is considered experimental, investigational, or unproven and is not supported by this policy.

Uses that do not meet the specified coverage criteria in this policy are not covered and are considered experimental, investigational, or unproven until sufficient published evidence becomes available.

Coding and Product Identifiers

Covered productsmixedCovered

Endari	L‑glutamine oral powder - Emmaus Medical
generic	L‑glutamine (generic)

Notesmixed

Policy

Coverage policy number IP0475; effective 4/15/2025

Minimum age

Minimum patient age>= 5 years

Approval duration when criteria metApprove for 1 year

Indication contextFor FDA‑approved indication: sickle cell disease

Provider Actions and Requirements

Prior Authorization

Prior authorization required; 1‑year approval and specialist prescriber

Prior authorization is recommended for prescription benefit coverage of L‑glutamine oral powder. Approvals are provided for 1 year when criteria are met. The medication must be prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., a hematologist).

Approval duration: 1 year when patient meets FDA‑approved indication and other criteria.
Prescriber requirement: prescribed by or in consultation with a specialist in the condition (hematologist).

Step Therapy

Preferred product / step‑therapy requirement for Endari

For Individual and Family Plans, Endari (L‑glutamine oral powder) is covered only if ONE of the following is met: (1) failure, contraindication, or intolerance to ONE of hydroxyurea or Droxia; OR (2) the prescriber documents the patient is not a candidate for hydroxyurea (e.g., planning pregnancy, pregnant, or has an immunosuppressive condition).

Step requirement applies to Individual and Family Plans for Endari.

Definitions

L‑glutamine oral powder (Endari)

Product descriptionL‑glutamine oral powder (Endari) is an amino acid oral powder indicated to reduce acute complications of sickle cell disease.

FDA‑approved indicationIndicated for treatment to reduce acute complications of sickle cell disease in patients >= 5 years of age.

Mechanism/contextPrecursor to pyridine nucleotides involved in regulation and prevention of oxidative damage in red blood cells.

Prescriber requirementMedication should be prescribed by or in consultation with a physician who specializes in sickle cell disease (e.g., hematologist).

Background

L‑glutamine oral powder (Endari and generic L‑glutamine) is an amino acid‑based oral therapy indicated to reduce acute complications of sickle cell disease in patients aged ≥ 5 years. This policy addresses coverage, prior authorization, and documentation requirements for use under Cigna Individual and Family Plans.