Lecanemab (Leqembi) (Medicaid Expansion)

Policy ID: ME-I-9030-002-01

Section: Injections

Effective Date: August 01, 2023

Last Reviewed: July 26, 2023

Applies To: Medicaid Expansion Only

Description

Lecanemab-irmb (Leqembi™) is a recombinant human immunoglobulin gamma 1 (IgG1) monoclonal antibody, directed against aggregated soluble and insoluble forms of amyloid beta.

Criteria

Coverage is subject to the specific terms of the member's benefit plan.

The use of lecanemab-irmb (Leqembi) may be considered medically necessary when the following criteria are met:

The individual must have been diagnosed with mild cognitive impairment or mild Alzheimer's disease dementia, with documented evidence of beta-amyloid plaque on the brain; and
The individual has a physician who participates in a qualifying registry with an appropriate clinical team and follow-up care.

The use of lecanemab-irmb (Leqembi) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.

Procedure Code

J0174

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the United States Food and Drug Administration (U.S. FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines.

Diagnosis Code

G30.0

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 7-26-2023 - Effective August 01, 2023

Adopted Medicaid Expansion specific policy

Links

References (PDF)

Disclaimer

Current medical policy is to be used in determining a Member's contract benefits on the date that services are rendered. Contract language, including definitions and specific inclusions/exclusions, as well as state and federal law, must be considered in determining eligibility for coverage. Members must consult their applicable benefit plans or contact a Member Services representative for specific coverage information. Likewise, medical policy, which addresses the issue(s) in any specific case, should be considered before utilizing medical opinion in adjudication. Medical technology is constantly evolving, and the Company reserves the right to review and update medical policy periodically.

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