CurrentHealth NetPolicy CP PMN.116

L-glutamine (Endari) for sickle cell disease

This policy governs prior authorization and coverage criteria for Endari (L-glutamine) to reduce acute complications of sickle cell disease for Health Net members across specified lines of business.

Policy Summary

PayerHealth Net

PolicyL-glutamine (Endari) for sickle cell disease

Policy CodePolicy CP PMN.116

Change TypeClarified inclusion of generic L‑glutamineadministrative revision to approval duration

Effective DateAug 22, 2017

Next Review Date

Key ActionSubmit prior authorization with documentation demonstrating diagnosis, age ≥5 years, prior hydroxyurea trial (unless contraindicated), and weight‑based dosing not exceeding 30 g/day.

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 yearsminimum patient age

30 g/daymax daily dose

12 monthstypical approval duration

Oral powder 5 gproduct availability

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Initial Therapy

Initial Approval — Covered when ALL of the following are met

Initial Approval

Diagnosis of sickle cell disease.
Patient is age 5 years or older.
For Endari requests, member must use L-glutamine unless contraindicated or clinically significant adverse effects are experienced.
Failure of hydroxyurea at up to maximally tolerated doses unless hydroxyurea is contraindicated or clinically significant adverse effects are experienced.
Requested dose does not exceed the maximum of 30 g per day based on weight (see dosing by weight).30 g/day
Dosing by weight: Weight >65 kg: 15 g PO BID; Weight 30–65 kg: 10 g PO BID.

Operational Note: Provider must submit documentation (e.g. office chart notes, lab results) supporting that the member meets all approval criteria. Prior authorization may be required for L-glutamine/Endari.

Continuation Therapy

Continued Therapy — Covered when ALL of the following are met

Continued Therapy

Member status
- Member is currently receiving medication via the Health Net/Centene benefit or has previously met initial approval criteria.
- Member is currently receiving medication and is enrolled in a state/product with continuity of care regulations (state-specific addendums apply).
Member is responding positively to therapy.
For Endari requests, member must use L-glutamine unless contraindicated or clinically significant adverse effects are experienced.

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

Use of Endari for conditions that are neither FDA‑approved nor supported by the off‑label use policies referenced in this document is generally considered not authorized and is likely not covered unless the provider provides the documentation required by those off‑label policies demonstrating acceptable evidence of efficacy and safety.

Product Coding and Dosing Information

Product codes (not specified)NDC

NDC(s) not listed

No NDC codes provided in document

inv-06: Maximum daily dose — 30 g/day (weight-based).

Maximum daily dose30 g/day (maximum dose based on weight)

ContextMaximum dose applies to sickle cell disease dosing regimen for L-glutamine/Endari

Policy thresholdDose must not exceed 30 g/day for initial or continued therapy per coverage criteria

inv-07: Dosing by weight — weight-based BID dosing (e.g. >65 kg and 30–65 kg splits).

Weight >65 kg15 g orally twice daily (3 packets PO BID)

Weight 30–65 kg10 g orally twice daily (2 packets PO BID)

Dosing frequencyOral administration twice daily (BID) based on weight strata

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization may be required. Provider must obtain prior authorization when applicable and demonstrate the member meets all approval criteria for L‑glutamine (Endari).

Applies to L‑glutamine / Endari requests

Denial Risk

Non‑FDA Indications Risk

Requests for non‑FDA approved (off‑label) indications that are not specifically addressed in this policy may be denied unless the provider submits sufficient supporting documentation of efficacy and safety. When requesting coverage for an off‑label use, reference and provide evidence per the applicable off‑label use policies: CP CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace), or CP PMN.53 (Medicaid).

If sufficient documentation of efficacy and safety is provided, coverage may be considered per the referenced off‑label use policies.

Prior Authorization

Hydroxyurea Failure Requirement

For Endari (L‑glutamine) requests, the provider must document that the member has tried hydroxyurea at maximally tolerated doses and experienced treatment failure, unless hydroxyurea is contraindicated or caused clinically significant adverse effects. Include dosing, duration, response, and reasons for discontinuation if applicable.

Document hydroxyurea dosing and duration (maximally tolerated dose).
If hydroxyurea was not used, provide documentation of contraindication or significant adverse effects.

Documentation Required

Required Documentation

Provider must submit supporting documentation such as office chart notes, laboratory results, or other clinical information demonstrating the member meets all approval criteria.

Include relevant chart notes, labs, and evidence supporting diagnosis of sickle cell disease and prior therapies.
For off‑label requests, include literature or other evidence per off‑label use policies.

Background on Endari (L‑glutamine)

Endari (L‑glutamine) is indicated to reduce acute complications of sickle cell disease in adult and pediatric patients 5 years of age and older. Dosing is weight‑based with typical regimens of 15 g (3 packets) PO twice daily for patients >65 kg and 10 g (2 packets) PO twice daily for patients 30–65 kg, and the maximum recommended daily dose is 30 g/day. Providers should follow these dosing parameters when requesting coverage and submit clinical documentation showing the patient meets indication and dosing criteria.