CurrentUnitedHealthcarePolicy IEXD00125.05

Leqembi (Lecanemab-irmb) — Medical Benefit Drug Policy (Individual Exchange)

Medical benefit drug policy governing coverage and medical necessity criteria for intravenous Leqembi (lecanemab-irmb) for treatment of Alzheimer's disease for Individual Exchange plans (except Nevada). Affects prescribers, infusion providers, and prior authorization reviewers.

Policy Summary

PayerUnitedHealthcare

PolicyLeqembi (Lecanemab-irmb) — Medical Benefit Drug Policy (Individual Exchange)

Policy CodePolicy IEXD00125.05

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, cognitive test scores, amyloid pathology evidence, baseline MRI, and prescriber specialty.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial authorization length

J0174HCPCS code

MMSE 20-30baseline cognitive scores

within 12 monthsbaseline MRI timing

Excludedcombination therapy

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-0.45CDR-SB difference

Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met for initial therapy

Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease OR mild dementia due to Alzheimer's disease based on NIA-AA criteria.

Cognitive testing: Submission of medical records documenting one of the following cognitive test results: MMSE 20–30, MoCA 17–30, or SLUMS 17–30.MMSE 20-30; MoCA 17-30; SLUMS 17-30

Amyloid pathology: Documentation of amyloid beta pathology by positive amyloid PET OR CSF biomarker testing demonstrating abnormalities suggestive of beta-amyloid accumulation (e.g., Aβ42/40 ratio, ptau181/Aβ42 ratio, ttau/Aβ42 ratio).

Rule out other causes: Other differential diagnoses (e.g., dementia with Lewy bodies, frontotemporal dementia, vascular dementia, pseudodementia due to mood disorder, vitamin B12 deficiency, encephalopathy) have been ruled out.

Anticoagulant status: Either patient is not currently taking an anticoagulant (e.g., warfarin, dabigatran) OR the patient is taking an anticoagulant and counseling has been provided about increased cerebral hemorrhage risk with prescriber attestation of shared decision-making to initiate therapy.

Hemorrhage history: No history of intracerebral hemorrhage within the previous year prior to initiating treatment.

ARIA counseling and ApoE: Counseling provided on risk of amyloid-related imaging abnormalities (ARIA-E and ARIA-H) and testing/offering of ApoE ε4 status with prescriber attestation of shared decision-making regarding initiation.

Baseline MRI: Baseline brain MRI completed within 12 months prior to initiating treatment.within 12 months

Monoclonal antibody combination: Not used in combination with other Aβ monoclonal antibodies for Alzheimer's disease.

Prescriber specialty: Prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia.

Dosing: Leqembi dosing is in accordance with the U.S. FDA–approved labeling.

Authorization length: Initial authorization will be for no more than 12 months.12 months

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy

Follow-up MRI: Submission of medical records confirming follow-up brain MRI has been completed after initiation of therapy.

ARIA absence or managed: Either ARIA has not been observed on MRI OR ARIA has been observed AND prescriber attests continuation is appropriate based on clinical severity, with either radiographic resolution/stabilization on follow-up MRI OR prescriber attestation that continuation is appropriate based on radiographic severity.

Monoclonal antibody combination: Not used in combination with other Aβ monoclonal antibodies for Alzheimer's disease.

Prescriber specialty: Prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia.

Not Medically Necessary

Other indications: Leqembi (lecanemab-irmb) is unproven and not medically necessary for any indication other than Alzheimer's disease.

Covered with criteria (pivotal trial-aligned population and monitoring)

Covered when ALL of the following reflect the trial and FDA-indicated population and considerations

Population: Patient has mild cognitive impairment or mild dementia due to Alzheimer's disease (early AD), matching the population enrolled in clinical trials and the FDA indication.

Matches trial inclusion and FDA indication

Biomarker confirmation: Evidence of amyloid pathology by PET or cerebrospinal fluid testing as required in CLARITY AD and Study 201.

CLARITY AD required amyloid on PET or CSF

Dosing: Plan to administer intravenous lecanemab 10 mg/kg every 2 weeks as used in CLARITY AD pivotal trial.

Dose used in pivotal trials

Risk counseling and monitoring:

Use of Leqembi (lecanemab-irmb) in combination with other amyloid-beta (Aβ) monoclonal antibodies for Alzheimer's disease is excluded. The policy explicitly states that Leqembi must not be used concurrently with other Aβ mAbs (for example, Kisunla) for both initial therapy and continuation of therapy.

Patients must have documented evidence of amyloid pathology by a positive amyloid PET scan or cerebrospinal fluid (CSF) biomarker abnormalities prior to initiation. Prior clinical trials that included patients without confirmed Aβ pathology failed to demonstrate benefit, and the policy requires amyloid confirmation as a condition of coverage.

Leqembi (lecanemab-irmb) is considered unproven and not medically necessary for any indication other than Alzheimer's disease. Requests for use in diagnoses outside of Alzheimer's disease do not meet the policy's coverage criteria.

Use of Leqembi in patients with later-stage Alzheimer's disease (beyond mild cognitive impairment or mild dementia) is not supported. The policy aligns coverage with the trial and FDA-indicated population and excludes treatment initiation in more advanced stages because prior studies suggest reduced likelihood of benefit when patients are enrolled at later disease stages.

Billing and Diagnosis Codes

HCPCS CodeHCPCS

J0174

Lecanemab-irmb, for intravenous injection, 1 mg

Diagnosis CodesICD-10

G30.0	Alzheimer's disease with early onset
G30.1	Alzheimer's disease with late onset
G30.8	Other Alzheimer's disease
G30.9	Alzheimer's disease, unspecified

Applicable HCPCS (examples/updated per policy history)HCPCS

J0174	revised description for J0174 (per policy history)
J3490	Unclassified drugs (mentioned as an example of HCPCS that may be applicable)
J3590	Unclassified biologics (example)

inv-12: Cognitive test score ranges — acceptable baseline ranges

MMSE (Mini-Mental State Examination)Score of 20 to 30 required for initiation

MoCA (Montreal Cognitive Assessment)Score of 17 to 30 required for initiation

SLUMS (Saint Louis University Mental Status)Score of 17 to 30 required for initiation

inv-13: Baseline brain MRI timing

Baseline brain MRI timingBaseline brain MRI completed within 12 months prior to initiating treatment

Follow-up MRIFollow-up MRI results required for continuation authorization per documentation requirements

Prior Authorization, Documentation, and Denials

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation and reauthorization of Leqembi (lecanemab-irmb). Requests must document that the patient meets diagnostic and clinical criteria (MCI or mild dementia due to Alzheimer’s disease per NIA-AA), baseline cognitive testing within required score ranges (e.g., MMSE 20–30; MoCA 17–30; SLUMS 17–30), confirmation of cerebral amyloid pathology (positive amyloid PET or CSF biomarkers), baseline brain MRI within 12 months prior to initiation, and that the prescriber is a dementia specialist (neurologist, geriatric psychiatrist, or geriatrician). Initial and reauthorization approvals are limited to a maximum 12-month duration.

Prior authorization required for both initial therapy and continuation (reauthorization)
Initial authorization: up to 12 months; Reauthorization: up to 12 months
Required prescriber specialty: neurologist, geriatric psychiatrist, or geriatrician

Documentation Required

Required Documentation for Authorization

Background and Rationale

Alzheimer's disease is characterized by accumulation of aggregated amyloid-beta (Aβ) plaques and neurofibrillary tau tangles, with Aβ deposition beginning years to decades before clinical symptoms. Leqembi (lecanemab-irmb) is a humanized IgG1 monoclonal antibody developed to target aggregated soluble and insoluble forms of Aβ and lower aggregated Aβ in the brain. Clinical development and pivotal trials (including Phase 2 Study 201 and the Phase 3 CLARITY AD trial) evaluated lecanemab in patients with early Alzheimer's disease (mild cognitive impairment or mild dementia) and required biomarker confirmation of amyloid; these trials informed the dosing, monitoring, and population for which the policy provides coverage with criteria.

Definitions and Key Terms

inv-23: Leqembi (lecanemab-irmb) — drug definition and mechanism

Generic name and brandLecanemab-irmb (brand name: Leqembi)

Agent classHumanized IgG1 monoclonal antibody targeting aggregated soluble and insoluble forms of amyloid beta

Therapeutic intentDeveloped to lower aggregated amyloid-beta plaques in the brain for treatment of Alzheimer’s disease

inv-25: Early Alzheimer's disease (EAD) — clinical population

Clinical definitionEarly Alzheimer’s disease (EAD) = mild cognitive impairment or mild dementia due to Alzheimer disease (population enrolled in trials and FDA-indicated initiation population)

Biomarker requirementEvidence of amyloid pathology by PET or CSF testing required to confirm AD pathology in EAD population

Policy Revision History

2026-04-01policy updateLatest

Updated applicable states language (removed exclusions for Massachusetts and New York), added instruction to refer to UnitedHealthcare Commercial policy for Nevada, and updated list of applicable HCPCS codes including a revised description for J0174; archived previous version IEXD00125.04.

policy history note

Prior edits reflected iterative updates to applicable states and HCPCS listings, and addition of Nevada guidance in earlier revisions (details in archived versions).

Policy Summary

PayerUnitedHealthcare

PolicyLeqembi (Lecanemab-irmb) — Medical Benefit Drug Policy (Individual Exchange)

Policy CodePolicy IEXD00125.05

Change TypeNo material clinical or coverage changes

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, cognitive test scores, amyloid pathology evidence, baseline MRI, and prescriber specialty.

SourceLink

On This Page

Dosing and reauthorization: Leqembi dosing per U.S. FDA labeling and reauthorization granted for no more than 12 months.12 months

Documentation of counseling about infusion reactions and amyloid-related imaging abnormalities (ARIA) and a plan for monitoring (e.g., MRI surveillance per product labeling), noting ARIA incidence and symptomatic rates observed in trials.

ARIA-E incidence ~12.5% (symptomatic ARIA-E ~2.8%); infusion reactions common

PurposeEstablishes baseline for ARIA surveillance and to rule out intracerebral hemorrhage prior to treatment

Requests must include complete supporting medical records: documentation of diagnosis, baseline cognitive test scores, amyloid confirmation (PET or CSF), prior and follow‑up MRI reports, notes addressing exclusion of alternative diagnoses, anticoagulant status and counseling if applicable, and documentation of shared decision‑making when anticoagulant therapy is continued with Leqembi.

Submit chart notes, lab values, imaging reports, and prescriber attestation as applicable
Baseline MRI within 12 months prior to initiation; follow‑up MRI post‑initiation for continuation requests
Documentation of ARIA findings and prescriber rationale for continuation when ARIA is observed

Denial Risk

Criteria-Related Denials

Coverage may be denied when requests do not meet the policy’s diagnostic, biomarker, cognitive testing, imaging, prescriber, dosing, or treatment‑setting criteria. Examples of grounds for denial include: absence of confirmed amyloid pathology, cognitive scores outside specified ranges, lack of baseline MRI, use in indications other than early Alzheimer’s disease (MCI or mild dementia), concurrent use with other anti‑amyloid monoclonal antibodies, or dosing that is not consistent with FDA labeling.

Denial risk if amyloid PET or CSF evidence of amyloid is not provided
Denial risk if MMSE/MoCA/SLUMS scores fall outside required ranges
Denial risk if prescriber is not a dementia specialist or if dosing deviates from FDA labeling
Requests for indications other than early AD (MCI or mild dementia) will be considered not medically necessary

Note

FDA Approval Is Not Sole Basis for Coverage

FDA approval alone does not guarantee coverage. UnitedHealthcare will consider FDA labeling but may require additional determinations based on the member specific benefit plan, applicable state or federal mandates, and utilization management criteria (including third‑party tools such as InterQual) when making coverage decisions.

FDA approval is informational — payer may require further eligibility review per the member specific benefit plan
Refer to the member specific benefit plan and any applicable mandates before approving coverage
UnitedHealthcare may apply InterQual or other criteria in benefit determinations

Documentation Required

Clinical Trial Evidence and Dosing Documentation

Clinical trial evidence should be documented in support of requests: include the dosing regimen consistent with trials and FDA labeling (10 mg/kg IV every 2 weeks), summary of efficacy endpoints (e.g., CDR‑SB, ADCOMS, ADAS‑Cog14 changes), and safety signals observed in trials (infusion reactions, ARIA‑E and ARIA‑H rates and symptomatic ARIA rates). Provide any patient‑specific risk factors (e.g., ApoE ε4 carrier status) that may affect safety monitoring or treatment decisions.

Ensure dosing aligns with FDA‑approved regimen (per labeling) — document actual administered dose and schedule
Document awareness and monitoring plan for ARIA (ARIA‑E and ARIA‑H) and infusion reactions
Include clinical rationale referencing CLARITY‑AD/Study 201 efficacy and safety outcomes when appropriate

Trial-aligned characteristicsParticipants typically 50-90 years with baseline mean CDR-SB around 3.2, matching CLARITY AD enrollment

inv-26: ED90 — dose-finding concept used in Study 201

Role in Study 201Study 201 used ED90 to identify the dose evaluated for clinical efficacy in the Phase 2b trial

Primary endpoint contextED90 selection informed Bayesian analysis of 12-month clinical change on ADCOMS for dose selection