CurrentCignaPolicy:Sickle Cell Disease - L-glutamine Preferred Specialty Management Policy

Sickle Cell Disease - L-glutamine Preferred Specialty Management Policy

Defines Cigna's preferred specialty management program for L-glutamine oral powder for sickle cell disease, requiring trial of a preferred generic product before coverage of non-preferred Endari brand and specifying exception criteria and documentation requirements. Applies to health benefit plans administered by Cigna companies.

Policy Summary

PayerCigna

PolicySickle Cell Disease - L-glutamine Preferred Specialty Management Policy

Policy CodePolicy Policy:Sickle Cell Disease - L-glutamine Preferred Specialty Management Policy

Change TypeNew policy

Effective DateOct 1, 2025

Next Review Date

Key ActionAll medications require meeting the standard Sickle Cell Disease - L-glutamine Prior Authorization Policy criteria; document trial of generic l-glutamine and prescriber justification if requesting Endari.

SourceLink

POLICY UPDATE CHANGES

New policy effective 10/01/2025 establishing preferred specialty management for L-glutamine with Endari as non-preferred requiring exception criteria.

1Preferred product (generic)

1Non-preferred product (Endari) with exception criteria

Coverage Summary

Defines Cigna's preferred specialty management program for L-glutamine oral powder for sickle cell disease, requiring trial of a preferred generic product before coverage of the non-preferred Endari brand and specifying exception criteria and documentation requirements. Applies to health benefit plans administered by Cigna companies. Effective date: 10/01/2025. Policy number: Policy:Sickle Cell Disease - L-glutamine Preferred Specialty Management Policy.

Policy metadata

Policy numberPolicy:Sickle Cell Disease - L-glutamine Preferred Specialty Management Policy

Policy titleSickle Cell Disease - L-glutamine Preferred Specialty Management Policy

PayerCigna

Effective date2025-10-01

Last review2025-08-20

StatusCURRENT

Scope summaryDefines Cigna's preferred specialty management program for L-glutamine oral powder for sickle cell disease, requiring trial of a preferred generic product before coverage of non-preferred Endari brand and specifying exception criteria and documentation requirements. Applies to health benefit plans administered by Cigna companies.

Coverage Criteria and Exception Rules

Default Approval When Exception Criteria Not Met

Endari is covered as medically necessary when ALL of the following are met:

ALL of the following

1A: Patient meets the standard Sickle Cell Disease - L-glutamine Prior Authorization Policy criteria
Reference to separate standard PA policy
1B: Patient has tried generic l-glutamine oral powder
Documentation required
1C: Patient cannot continue to use the generic l-glutamine oral powder due to a formulation difference in the inactive ingredient(s) (e.g., difference in dyes, fillers, preservatives) between the brand and bioequivalent generic product which, per the prescriber, would result in a significant allergy or serious adverse reaction
Documentation required (prescriber justification)

ref.BUTTON_OR_REF_PLACEHOLDER_ERROR?__fix_ref?__b1_0?__invalid?__ignore?__replace?__b1_0?__EOF?__FIXED?__b1_0

title": "Non-Preferred Product (Endari) Exception Criteria"}

ref": "b1_0

title": "Non-Preferred Product (Endari) Exception Criteria"

Provider Actions & Documentation Requirements

Prior Authorization

Prior authorization required

All medications (preferred and non-preferred) require meeting the respective standard Sickle Cell Disease - L-glutamine Prior Authorization Policy criteria. Approvals are provided for 1 year in duration.

Documentation Required

Document prior trial of generic

Provider must supply documentation that the patient has tried generic l-glutamine oral powder when requesting Endari.

Documentation Required

Document clinical intolerance to generic inactive ingredients

Provider must document prescriber justification that the patient cannot continue to use the generic l-glutamine oral powder due to a formulation difference in the inactive ingredient(s) (e.g., dyes, fillers, preservatives) which would, per the prescriber, result in a significant allergy or serious adverse reaction.

Background & Evidence

L-glutamine oral powder is indicated to reduce the acute complications of sickle cell disease in patients aged ≥ 5 years. The preferred specialty management program encourages use of a preferred generic product prior to approval of a non-preferred brand product (Endari), requires meeting the standard prior authorization criteria for all medications, directs trying a preferred product before a non-preferred product, and requires documentation when noted in the criteria.

Source	Citation
[{"text":"FDA prescribing information","status":""},{"text":"Endari oral powder prescribing information, Emmaus Medical, October 2020","status":""}
[{"text":"Guideline citation","status":""},{"text":"American Society of Hematology 2020 guidelines for sickle cell disease (Brandow et al., Blood Adv. 2020)","status":""}

Definitions

Preferred Productgeneric l-glutamine oral powder

Non-Preferred ProductEndari oral powder (brand)

Policy Summary

PayerCigna

PolicySickle Cell Disease - L-glutamine Preferred Specialty Management Policy

Policy CodePolicy Policy:Sickle Cell Disease - L-glutamine Preferred Specialty Management Policy

Change TypeNew policy

Effective DateOct 1, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Sickle Cell Disease - L-glutamine Preferred Specialty Management Policy

Coverage Summary

Coverage Criteria and Exception Rules

Product Codes and References

Provider Actions & Documentation Requirements

Background & Evidence

Revision History

Endari	Endari oral powder (brand - Emmaus Medical)
generic l-glutamine oral powder	Preferred generic L-glutamine oral powder