ModifiedUnitedHealthcarePolicy 2026D0125E

Leqembi (lecanemab-irmb) intravenous infusion for Alzheimer's disease

Defines UnitedHealthcare medical benefit coverage criteria for Leqembi (lecanemab-irmb) administered by IV for treatment of early Alzheimer's disease (MCI due to AD or mild dementia due to AD) and requirements for initial and continuation authorization.

Policy Summary

PayerUnitedHealthcare

PolicyLeqembi (lecanemab-irmb) intravenous infusion for Alzheimer's disease

Policy CodePolicy 2026D0125E

Change TypeAdministrative update to applicable HCPCS codes

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, amyloid confirmation, baseline MRI within 12 months, prescriber specialty, and required cognitive test scores.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable HCPCS codes to reflect quarterly edits; revised description for J0174.

Archived previous policy version 2026D0125D.

12 monthsmaximum initial authorization duration

Baseline MRIrequired imaging before initiation

J0174listed HCPCS code

MMSE 20-30acceptable cognitive ranges

1,795

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participants in CLARITY AD

Coverage Criteria for Leqembi (lecanemab-irmb)

Initial Therapy — Covered when ALL of the following are met for 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.

Amyloid confirmation: Presence of amyloid beta pathology has been confirmed by positive amyloid PET OR CSF biomarker testing documenting abnormalities suggestive of beta-amyloid accumulation (e.g., Aβ42/40 ratio, ptau181/Aβ42, ttau/Aβ42).

Baseline imaging: Baseline brain magnetic resonance imaging (MRI) completed within 12 months prior to initiating treatment.within 12 months

Cognitive testing: Submission of medical records documenting one of: MMSE 20–30 OR MoCA 17–30 OR SLUMS 17–30.MMSE 20-30; MoCA 17-30; SLUMS 17-30

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

Hemorrhage history: No history of intracerebral hemorrhage within the previous year prior to initiating treatment.within 1 year

ARIA counseling and ApoE: Counseling has been provided regarding amyloid-related imaging abnormalities (ARIA) risks and offer of ApoE ε4 testing with prescriber attestation of shared decision-making regarding testing and treatment risks.

Prescriber and dosing: Prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia; dosing per FDA-approved labeling.

Initial authorization will be for no more than 12 months

No combination therapy: Not used in combination with other amyloid-beta monoclonal antibodies for Alzheimer's disease (e.g., Kisunla).

Continuation of Therapy — Covered when ALL of the following are met for continuation of therapy

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

Diagnosis of Alzheimer's disease (continuation applies to patients already receiving therapy).

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

ARIA findings and prescriber attestation: Either ARIA has not been observed on MRI OR (ARIA has been observed on MRI AND prescriber attests continuation is appropriate based on the severity of clinical symptoms AND either follow-up MRI demonstrates radiographic resolution/stabilization OR prescriber attests continuation is appropriate based on radiographic severity of ARIA).

Prescriber and dosing: Prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia; dosing per FDA-approved labeling.

Reauthorization will be for no more than 12 months

Initial therapy coverage (trial-aligned) — Covered when clinical circumstances align with trial populations and label

Covered when clinical circumstances align with trial populations and label:

Pivotal trial population match: Patient has mild cognitive impairment or mild dementia consistent with early Alzheimer's disease—the population enrolled in the pivotal trials (Study 201 and CLARITY AD).

Supported by FDA indication and trial inclusion criteria

Biomarker evidence: Presence of amyloid pathology documented by amyloid PET or CSF testing, as required in CLARITY AD and Study 201.

CLARITY AD required evidence of amyloid on PET or CSF

Dose matching trials: Planned dosing consistent with clinical trials (10 mg/kg IV every 2 weeks).

Dose evaluated in CLARITY AD and Study 201

Not Medically Necessary / Limitations

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

Use of Leqembi in combination with other amyloid-beta monoclonal antibodies for Alzheimer's disease (for example, Kisunla) is explicitly excluded. The policy requires that therapy not be administered concurrently with other Aβ-targeting mAbs for both initial and continuation authorizations, and requests that propose combination use will not meet the coverage criteria described for Leqembi.

Providers requesting authorization should ensure the treatment plan documents that Leqembi will be used as a single Aβ monoclonal antibody therapy and that no concurrent amyloid-targeting antibodies are planned or administered.

Coverage for Leqembi may be constrained by the member's specific benefit plan and applicable state mandates. Some certificates of coverage exclude experimental, investigational, or unproven treatments; others may permit them under defined circumstances. Additionally, certain state laws can require coverage for off‑label medication use in specific situations and would supersede plan exclusions where applicable.

Before submitting an authorization request, verify the member's certificate of coverage and plan document to determine whether the plan allows coverage of experimental or investigational therapies or is subject to state mandate exceptions that would change the coverage determination for Leqembi.

Leqembi (lecanemab-irmb) is considered unproven and not medically necessary for any indication other than Alzheimer's disease. Requests for use of Leqembi outside the FDA‑recognized indication for early symptomatic Alzheimer’s disease (mild cognitive impairment due to AD or mild dementia due to AD) do not meet the policy’s medical necessity criteria.

Use of Leqembi in patients without biomarker evidence of amyloid pathology is not supported by the clinical evidence and is excluded from coverage. Clinical trials and the rationale for anti‑Aβ therapies required demonstration of Aβ pathology; inclusion of patients without confirmed amyloid has been cited as a reason investigational antibodies failed to show benefit.

Similarly, use in later stages of Alzheimer's disease—where significant, irreversible neurodegeneration is present—was not the population studied in pivotal trials and is not supported by available evidence. The policy therefore excludes treatment of patients whose clinical stage indicates advanced, irreversible neurodegeneration or who lack documented amyloid pathology.

Coding: HCPCS and Diagnosis Codes, Test Ranges, Imaging

Applicable HCPCS CodesHCPCS

J0174

Lecanemab-irmb, for intravenous injection, 1 mg.

Applicable 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 codes (updated)HCPCS

J0174

Revised description for J0174 (specific description updated in applicable codes list)

Cognitive test score ranges — acceptable baseline values

MMSE (Mini-Mental State Examination)Score range accepted for baseline documentation: 20–30.

MoCA (Montreal Cognitive Assessment)Score range accepted for baseline documentation: 17–30.

SLUMS (Saint Louis University Mental Status)Score range accepted for baseline documentation: 17–30.

Baseline brain MRI — timing requirement

Required baseline MRI timingBaseline brain MRI must be completed within 12 months prior to initiating treatment.

Purpose

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Verify member eligibility and benefits with the member-specific plan prior to submission. Prior authorization requests must document the diagnosis of early Alzheimer's disease (mild cognitive impairment due to AD or mild dementia due to AD) and meet the policy's initial-therapy medical necessity criteria. Initial authorizations will be limited to no more than 12 months; reauthorization/continuation requests must meet the continuation criteria and will be authorized for no more than 12 months.

Verify member-specific benefit plan document — plan terms govern in the event of conflict; check for applicable federal or state mandates that may supersede policy.
Prior authorization required for initial and continuation therapy; initial authorization limited to ≤12 months.
Prescriber must be a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia (per policy requirements for some criteria).

Denial Risk

Definitions and Key Terms

Early symptomatic Alzheimer's disease — population description

Definition (NIA-AA alignment)Clinical presentation meeting NIA-AA criteria for either mild cognitive impairment (MCI) due to Alzheimer’s disease or mild dementia due to Alzheimer’s disease.

Clinical featuresSymptoms limited to early symptomatic stages (MCI or mild dementia) with preserved or only mildly impaired daily function consistent with trial populations.

Biomarker requirementTreatment initiation requires confirmation of amyloid beta pathology by amyloid PET or CSF biomarkers, consistent with trial enrollment.

ARIA — definition and monitoring requirements

DefinitionAmyloid-related imaging abnormalities (ARIA) include ARIA-E (edema/effusions) and ARIA-H (hemosiderin deposition/microhemorrhage).

Counseling requirement

Background on Alzheimer's Disease and Leqembi

Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized pathologically by extracellular accumulation of amyloid‑beta (Aβ) plaques and intracellular neurofibrillary tangles composed of hyperphosphorylated tau. These pathologic changes begin years to decades before clinical symptoms emerge, and the combination of Aβ deposition and tau‑related neurodegeneration drives progressive cognitive decline.

Leqembi (lecanemab‑irmb) is an IgG1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid‑beta and was studied in patients with early symptomatic AD (mild cognitive impairment due to AD or mild dementia due to AD). Clinical development—including Study 201 and the CLARITY AD Phase 3 trial—required biomarker confirmation of amyloid pathology (amyloid PET or CSF) and evaluated dosing consistent with the pivotal trials.

Because anti‑amyloid therapies can produce amyloid‑related imaging abnormalities (ARIA), monitoring with brain MRI and counseling about ARIA risk are integral to safe use. The policy aligns coverage with the trial populations and FDA labeling by requiring biomarker confirmation of amyloid, baseline and follow‑up MRI as specified, and use only in early symptomatic disease where potential benefit was demonstrated.

Policy Revision History and Changes

2026-04-01Administrative updateLatest

Updated list of applicable HCPCS codes to reflect quarterly edits and revised description for J0174.

2026-04-01Archival

Archived previous policy version 2026D0125D.

Policy Summary

PayerUnitedHealthcare

PolicyLeqembi (lecanemab-irmb) intravenous infusion for Alzheimer's disease

Policy CodePolicy 2026D0125E

Change TypeAdministrative update to applicable HCPCS codes

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization with documentation of diagnosis, amyloid confirmation, baseline MRI within 12 months, prescriber specialty, and required cognitive test scores.

SourceLink

On This Page

No combination therapy: Not used in combination with other amyloid-beta monoclonal antibodies for Alzheimer's disease (e.g., Kisunla).

Establishes imaging baseline for detection and monitoring of ARIA and other intracranial findings before treatment initiation.

DocumentationSubmit MRI report with prior authorization request as part of required medical records.

Benefit Plan Constraints and Coverage Limits

Coverage may be denied if the member’s benefit plan excludes experimental, investigational, or unproven treatments, or if state/federal mandates do not apply. Always consult the member-specific Certificate of Coverage; where mandates apply they supersede the policy. FDA approval alone is not a basis for coverage.

If the member-specific plan excludes experimental/investigational therapies, authorization may be denied.
Some Certificates of Coverage permit coverage of experimental/investigational therapies for life‑threatening illnesses when conditions are met — verify specifics in the benefit document.
Medicare Advantage: in absence of an NCD/LCD, MAO may create coverage determinations; check applicable Medicare guidance.

Denial Risk

Triggers for Denial

Requests lacking required documentation will be subject to denial or delay. Common triggers for denial include absence of documented amyloid confirmation, missing baseline or follow-up MRI, inadequate cognitive testing documentation, lack of prescriber attestation where required, or concurrent use with other Aβ monoclonal antibodies.

No documentation of amyloid beta pathology (positive amyloid PET or CSF biomarkers).
No baseline brain MRI completed within 12 months prior to treatment initiation.
No documentation of required baseline cognitive testing (MMSE, MoCA, or SLUMS within specified score ranges).
Use in combination with other Aβ monoclonal antibodies (e.g., Kisunla).
Lack of required prescriber attestation regarding anticoagulant counseling or ARIA management on continuation requests.

Documentation Required

Required Documentation

Submit complete medical records to support the request. Documentation must include baseline and, for continuation, follow-up clinical and imaging data as specified by the policy.

Baseline cognitive testing results documented in the medical record: MMSE 20–30, or MoCA 17–30, or SLUMS 17–30.
Documentation confirming presence of amyloid beta pathology via one of: positive amyloid PET scan; or CSF biomarker testing showing abnormalities consistent with β-amyloid accumulation (e.g., Aβ42/40 ratio, ptau181/Aβ42, ttau/Aβ42).
Baseline brain MRI completed within 12 months prior to initiating treatment.
For continuation: documentation of follow-up brain MRI after therapy initiation; documentation of ARIA status on MRI and prescriber attestation if ARIA observed that continuation is appropriate.
Medical record evidence that other differential diagnoses have been reasonably ruled out (e.g., DLB, FTD, vascular dementia, reversible causes).
If patient is on anticoagulant therapy, include counseling documentation and prescriber attestation regarding shared decision-making when proceeding with therapy.

Step Therapy

Step Therapy and Plan-Specific Requirements

No step therapy sequence is specified in this policy. Follow the member-specific plan rules and utilization management processes; if a plan imposes step therapy or alternative-therapy requirements, those requirements must be met.

Policy does not define a mandatory step-therapy sequence for Leqembi.
If the member's benefit plan includes step therapy or prior-line requirements, verify and comply with those plan-specific rules before submission.
Verify any quantity limits, dosing requirements, or specialty pharmacy routing in the member plan.

Counsel patients on ARIA risks and symptoms (headache, dizziness, visual disturbances, nausea, vomiting) prior to initiating therapy.

MonitoringObtain baseline MRI prior to treatment and follow-up MRI after initiation to monitor for ARIA as required for continuation decisions.

Early Alzheimer's disease (EAD) — clinical staging and target population

Clinical stagingEarly Alzheimer’s disease (EAD) encompasses mild cognitive impairment or mild dementia due to Alzheimer’s disease — the indicated population for lecanemab.

Trial-consistent dosingPivotal trials evaluated 10 mg/kg IV every 2 weeks (CLARITY AD and Study 201); dosing per FDA label should be followed.

Enrollment criteriaTrials required evidence of amyloid on PET or CSF to confirm underlying AD pathology before treatment enrollment.

ARIA (trial context) — ARIA-E and ARIA-H definitions and safety monitoring

ARIA-E (edema/effusion)Radiographic evidence of vasogenic edema or sulcal/ventricular effusion on MRI; observed and reported as an imaging adverse event in trials and requires monitoring.

ARIA-H (hemorrhage/hemosiderin)Microhemorrhages or superficial siderosis and hemosiderin deposition identified on MRI; part of safety assessments in study monitoring.

Trial safety contextCLARITY AD and Study 201 monitored for ARIA events with serial MRI; ARIA incidence (e.g., ARIA-E ~12.6% overall) informed counseling and management protocols.