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 (generic and brand Endari) for reducing acute complications of sickle cell disease in patients ≥5 years, including prior authorization and exception criteria for non-preferred product coverage.

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 TypeNo material change

Effective DateOct 1, 2025

Next Review DateAug 20, 2025

Key ActionProviders must document trial of the preferred generic l-glutamine and supply prescriber documentation if requesting Endari exception.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥5minimum indicated patient age

1 yearmax approval duration

Preferred = genericdesignation

Coverage Criteria

Endari (non-preferred) exception

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Endari exception criteria: A) Patient meets the standard Sickle Cell Disease - L-glutamine Prior Authorization Policy criteria; AND B) Patient has tried generic l-glutamine oral powder [documentation required]; AND C) 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].all three conditions required

Approvals are for 1 year

Alternate action: If the patient has met the standard Sickle Cell Disease - L-glutamine Prior Authorization Policy criteria (A) but has not met exception criteria B and/or C for brand Endari, approve generic l-glutamine oral powder.N/A

Fallback to preferred product

Requests for Endari that do not meet the specified non-preferred product exception criteria are considered not medically necessary. All requests for Endari are reviewed against the exception criteria and must also meet the standard Sickle Cell Disease - L-glutamine Prior Authorization Policy requirements; if those criteria are not met, coverage is not approved.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

All medications (Preferred and Non-Preferred) require meeting the standard Sickle Cell Disease - L‑glutamine Prior Authorization Policy. Requests for non-preferred products (e.g., Endari) are reviewed under the non-preferred product exception criteria and, if approved, authorizations are provided for 1 year.

Prior authorization required — See the standard Sickle Cell Disease - L‑glutamine Prior Authorization Policy (read‑with).

Step Therapy

Preferred Product Trial Required

Patient must try the Preferred Product (generic l‑glutamine oral powder) before approval of the non‑preferred product (Endari), unless there is documented intolerance or failure. If the standard prior authorization criteria are met but the patient has not tried the preferred product, approval will be authorized for the preferred product.

Preferred product trial required — generic l‑glutamine oral powder must be tried prior to Endari.
If exception criteria for Endari are not met (including documented trial of the generic), approve generic l‑glutamine oral powder.

Documentation Required

Required Documentation

Providers must supply documentation where indicated as [documentation required]. Acceptable documentation includes, but is not limited to, chart notes, prescription claims records, and prescription receipts. For non‑preferred product exception requests (Endari), documentation is required to show prior trial of the generic and evidence of inability to use the generic due to formulation differences causing allergy or serious adverse reaction per the prescriber.

Acceptable documentation: chart notes, prescription claims records, prescription receipts.
For Endari exception: documentation of trial of generic l‑glutamine and documentation of formulation‑related intolerance/allergic reaction as noted by prescriber.

Denial Risk

Claims submitted without covered diagnosis or procedure codes under the applicable coverage policy will be denied as not covered. Requests that do not meet the criteria in this policy (including failure to meet prior authorization requirements or exception criteria) are considered not medically necessary and will be denied.

Denial triggers — missing covered diagnosis/procedure codes; failure to meet prior authorization or exception criteria.

Definitions

inv-11: Preferred Product

Preferred productgeneric l-glutamine oral powder

IndicationReduce acute complications of sickle cell disease in patients ≥ 5 years

Role in programPreferred product that must be tried prior to consideration of Non-Preferred Endari (unless exception criteria met)

inv-12: Non-Preferred Product

Non-Preferred productEndari oral powder (brand)

Exception pathEndari may be approved only if patient meets the Non‑Preferred Product Exception Criteria (A, B, and C) and standard prior authorization criteria

Coverage stanceRequests for Endari that do not meet the exception criteria are considered not medically necessary