Lecanemab (Leqembi)

Policy ID: I-9030-002

Section: Injections

Effective Date: January 15, 2023

Revised Date: March 07, 2024

Revision Effective Date: April 01, 2024

Last Reviewed: March 19, 2024

Applies To: Commercial 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.

Policy Criteria

All claims submitted for this policy will be processed according to the policy effective date and associated revision effective dates in effect on the date of service.

Criteria

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

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

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, as evidenced by ONE of the following
- A positron emission tomography (PET) scan confirming the presence of amyloid pathology; or
- Have results for a lumbar puncture confirming the presence of elevated phosphorylated tau (P-tau) protein and/or elevated total tau (T-tau) protein, and reduced beta amyloid-42 (AB42) OR a low AB42/AB40 ratio as determined by the lab assay detected in cerebrospinal fluid (CSF); 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

Diagnosis Codes

G30.0

G30.1

G30.8

G30.9

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-26-2023 Effective January 15, 2023

Adopted policy with effective date 1/15/2023, full review of drug policy criteria will occur during March 2023 IMPC meeting

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

No Change to clinical content; and
Updated description

Internal Medical Policy Committee 7-26-2023 Effective July 06, 2023

Added new code J0174 to the policy

Internal Medical Policy Committee 3-19-2024 Effective April 01, 2024

Adopted medically necessary criteria

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.

Policy ID: I-9030-001

Section: Injections

Effective Date: January 15, 2023

Revised Date: March 13, 2023

Revision Effective Date: May 01, 2023

Last Reviewed: March 23, 2023

Archived Date: March 31, 2024

Applies To: Commercial 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. The accelerated approval of lecanemab-irmb (Leqembi) is based on a surrogate endpoint of reduction in brain amyloid plaques, which is a biomarker with little evidence that proves an association with clinical benefit, such as improvement in cognition. Continued approval of this agent by the FDA is contingent upon demonstrating clinical benefit in confirmatory trials.

Criteria

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

Lecanemab-irmb (Leqembi) for any indication is considered experimental and investigational because of lack of sufficient clinical evidence supporting its use.

Procedure Code

J3590

Diagnosis Codes

Not Applicable for this Policy

Professional Statements and Societal Positions Guidelines

Not Applicable

ND Committee Review

Internal Medical Policy Committee 1-26-2023 Effective January 15, 2023

Adopted policy with effective date 1/15/2023, full review of drug policy criteria will occur during March 2023 IMPC meeting

Internal Medical Policy Committee 3-23-2023 Effective May 01, 2023

No Change to clinical content
Updated description

Medical Policies Quick Search

Lecanemab (Leqembi)

Description

Policy Criteria

Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer

Description

Criteria

Diagnosis Codes

Professional Statements and Societal Positions Guidelines

ND Committee Review

Links

Disclaimer