ModifiedUnitedHealthcarePolicy IEXD00125.05

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

Defines UnitedHealthcare Individual Exchange medical benefit drug policy criteria for coverage of Leqembi (lecanemab-irmb) administered by intravenous infusion for treatment of early Alzheimer's disease in applicable Individual Exchange plans (except Nevada).

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy IEXD00125.05

Change TypeHCPCS code description updatestate routing clarification

Effective DateApr 1, 2026

Next Review Date

Key ActionObtain prior authorization (initial and reauthorization limited to no more than 12 months) and submit medical records documenting cognitive scores, amyloid biomarker evidence, and baseline/follow-up MRI per policy.

SourceLink

POLICY UPDATE CHANGES

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

Added instruction to refer to the UnitedHealthcare Commercial policy version for the state of Nevada.

Removed language indicating this Medical Benefit Drug Policy does not apply to Massachusetts and New York.

12 monthsmax initial auth

J0174HCPCS

MMSE 20-30cognitive score range

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

All states except NVapplicability

Coverage Criteria for Leqembi (lecanemab-irmb)

Initial Therapy

Covered when ALL of the following are met for initial therapy

Initial therapy — overall: Member meets all listed criteria for initiation

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 scores: MMSE 20-30 OR MoCA 17-30 OR SLUMS 17-30MMSE 20-30; MoCA 17-30; SLUMS 17-30

Amyloid pathology: Documentation of amyloid beta pathology by positive amyloid PET OR cerebrospinal fluid (CSF) biomarker abnormalities suggestive of beta-amyloid accumulation

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 if patient is taking an anticoagulant, counseling provided about increased risk of cerebral macrohemorrhage and prescriber attests shared decision-making to initiate Leqembi

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

ARIA counseling and ApoE testing: Counseling provided on risk of amyloid-related imaging abnormalities (ARIA) and how ApoE ε4 status informs ARIA risk; ApoE ε4 testing offered and prescriber documents shared decision-making

Baseline MRI: Baseline brain MRI completed within 12 months prior to initiating treatmentwithin 12 months

Monotherapy: Not used in combination with other amyloid-beta monoclonal antibodies for Alzheimer's disease

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

Dosing: Leqembi dosing must be in accordance with the FDA-approved labeling

Initial authorization period: Initial authorization will be for no more than 12 months12 months

Continuation Therapy

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

Follow-up MRI and ARIA assessment: Submission of medical records confirming follow-up brain MRI after initiation of therapy AND either ARIA not observed on MRI OR (ARIA observed on MRI AND prescriber attests continuation is appropriate based on clinical severity AND either follow-up MRI demonstrates radiographic resolution/stabilization OR prescriber attests continuation appropriate based on radiographic severity)

Monotherapy: Not used in combination with other amyloid-beta monoclonal antibodies for Alzheimer's disease

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

Dosing for continuation: Leqembi dosing must be in accordance with the FDA-approved labeling

Not Medically Necessary / Unproven Uses

Other indications: Leqembi is unproven and not medically necessary for any indication other than Alzheimer's disease

Initial coverage criteria

Covered when ALL of the following are met

Population and diagnosis: Patient has mild cognitive impairment or mild dementia due to Alzheimer's disease (early AD), consistent with populations enrolled in clinical trials (Study 201, CLARITY AD)

Biomarker confirmation: Objective evidence of amyloid pathology via positive amyloid PET OR cerebrospinal fluid testing

Initiation setting: Treatment is initiated in the disease stage studied in clinical trials (MCI or mild dementia)

FDA indication and trial populations

Prior authorization and benefit verification: Authorization obtained per member-specific benefit plan and any applicable state or federal mandates; provider followed UnitedHealthcare instructions for state-specific commercial policy where applicable

Leqembi must not be administered concurrently with any other amyloid‑beta monoclonal antibody (Aβ mAb) for the treatment of Alzheimer’s disease. The policy explicitly prohibits use in combination with other Aβ mAbs (for example, Kisunla) for both initiation and continuation of therapy; monotherapy with Leqembi is required and documented in the medical record.

Coverage decisions and any exceptions are determined by the member’s specific benefit plan and by applicable federal or state mandates. Where a member-specific benefit document or a state mandate conflicts with this policy, the plan document or mandate governs and supersedes the policy language; providers must check the member’s benefit document and applicable mandates before relying on this policy for coverage determinations.

Leqembi is considered unproven and not medically necessary for any indication other than Alzheimer’s disease. Use for other diagnoses or conditions is not covered under this policy.

FDA approval alone does not guarantee coverage. Coverage requires that treatment be consistent with the patient population studied in clinical trials: initiation in patients with mild cognitive impairment or mild dementia due to Alzheimer’s disease, and documentation that the patient matches the trial population and meets policy clinical criteria. Providers should use the FDA indication for informational purposes but must still verify that the member meets the plan’s coverage criteria and any state or federal requirements.

Coding and Diagnostic 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 quarterly)HCPCS

J0174

Updated description for J0174 as reflected in quarterly edits

Cognitive test score ranges — accepted for documentation

MMSE (Mini-Mental State Examination)Score range 20–30 accepted for documentation of cognitive status

MoCA (Montreal Cognitive Assessment)Score range 17–30 accepted for documentation of cognitive status

SLUMS (Saint Louis University Mental Status)Score range 17–30 accepted for documentation of cognitive status

ED90 probability threshold (Study 201 primary prespecified Bayesian endpoint)

Prespecified Bayesian primary endpoint (Study 201)80% probability of ≥25% clinical reduction in decline versus placebo on ADCOMS at 12 months

Endpoint context

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Leqembi (lecanemab-irmb, HCPCS J0174) for both initial and continuation therapy. Initial and reauthorization approvals will be for no more than 12 months.

Prior authorization required for Leqembi (HCPCS J0174).
Initial authorization: up to 12 months. Reauthorization (continuation): up to 12 months.

Billing Rule

Prior Authorization and Applicable HCPCS Codes

Follow the member-specific benefit plan document and any applicable UnitedHealthcare commercial/state plan versions when determining coverage and billing. Applicable HCPCS code for Leqembi infusion is J0174. Verify member benefits and state/federal mandates prior to submission.

Background and Rationale

Alzheimer’s disease is a neurodegenerative disorder characterized by progressive cognitive decline associated with accumulation of amyloid‑beta plaques and neurofibrillary tau tangles. Amyloid accumulation begins decades before symptoms and is detected by biomarkers (amyloid PET or CSF Aβ testing). Leqembi (lecanemab‑irmb) is a humanized IgG1 monoclonal antibody that targets aggregated amyloid‑beta and is indicated for treatment in the early symptomatic stages of disease (mild cognitive impairment or mild dementia) when biomarker evidence of amyloid pathology is present.

Definitions and Key Terms

MCI due to Alzheimer's disease — definition and criteria

DefinitionMild cognitive impairment (MCI) due to Alzheimer's disease: symptomatic cognitive impairment with minimal functional impact consistent with NIA‑AA criteria for early symptomatic AD

Diagnostic basisDiagnosis must be made using National Institute on Aging and the Alzheimer's Association (NIA‑AA) criteria

Differential diagnosisOther causes (DLB, FTD, vascular dementia, mood disorders, B12 deficiency, encephalopathy, etc.) must be ruled out

ApoE ε4 status — genetic risk factor and testing guidance

RoleApolipoprotein E (ApoE) ε4 status is a genetic risk factor that informs increased risk of ARIA with anti‑amyloid therapies

Testing guidanceTesting for ApoE ε4 should be offered and counseling provided on how results inform ARIA risk; prescriber documents shared decision‑making

Revision History and Policy Changes

2026-04-01operational_updateLatest

Updated applicable HCPCS codes to reflect quarterly edits and revised the description for J0174; archived previous policy version IEXD00125.04.

2026-04-01operational_update

Removed language indicating the policy does not apply to Massachusetts and New York.

2026-04-01operational_update

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy IEXD00125.05

Change TypeHCPCS code description updatestate routing clarification

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

Reauthorization period: Reauthorization granted for no more than 12 months12 months

Primary endpoint evaluated for the ED90 dose in Study 201 using Bayesian analysis of 12‑month clinical change on ADCOMS

Study enrollment relevanceStudy 201 enrolled 854 patients; primary analysis conducted at Month 12

Applicable HCPCS: J0174 (lecanemab infusion).
Check member-specific benefit plan and any applicable mandates prior to authorization and billing.

Denial Risk

Denial Triggers for Unmet Criteria

Coverage may be denied if initiation or continuation criteria are not met. Common denial triggers include missing documentation of diagnosis (MCI or mild dementia due to AD), absence of documented cognitive test scores within specified ranges, lack of evidence of amyloid pathology, missing baseline or follow-up MRI reports, use in combination with other Aβ monoclonal antibodies, prescribing clinician not in an approved specialty, or failure to document counseling/testing (e.g., ApoE ε4 counseling/offering and ARIA risk discussion).

Denial triggers: failure to meet diagnosis criteria (NIA-AA for MCI or mild dementia due to AD).
Denial triggers: missing cognitive test scores (MMSE 20–30, MoCA 17–30, or SLUMS 17–30).
Denial triggers: lack of documented amyloid pathology (positive PET or CSF biomarkers).
Denial triggers: no baseline MRI within 12 months prior to initiation or no required follow-up MRI for continuation.
Denial triggers: concurrent use of other Aβ mAbs or prescribing clinician not a neurologist, geriatric psychiatrist, or geriatrician specializing in dementia.

Documentation Required

Required Clinical Documentation for Lecanemab

Submit complete clinical documentation with prior authorization requests: medical records/chart notes documenting diagnosis per NIA-AA criteria, cognitive testing scores (MMSE, MoCA, or SLUMS) within required ranges, objective evidence of amyloid beta pathology (positive amyloid PET or CSF biomarker abnormalities), baseline brain MRI within 12 months, documentation of counseling regarding ARIA risks and ApoE ε4 testing (testing offered and shared decision-making attested), medication list showing anticoagulant status and counseling if applicable, and attestation that prescriber is a qualifying specialist and dosing follows FDA labeling.

Required: documentation of diagnosis consistent with NIA-AA (MCI or mild dementia due to AD).
Required: cognitive test scores — MMSE 20–30, MoCA 17–30, or SLUMS 17–30.
Required: evidence of amyloid pathology — positive amyloid PET or CSF biomarker abnormalities (e.g., Aβ42/40 ratio, p-tau181/Aβ42, t-tau/Aβ42).
Required: baseline MRI within 12 months prior to initiating treatment and follow-up MRI after initiation for continuation.
Required: documentation of counseling on ARIA risks and offering ApoE ε4 testing with prescriber attestation of shared decision-making.
Required: medication reconciliation showing anticoagulant use (and counseling/attestation if anticoagulant use and treatment pursued).
Required: prescriber specialty (neurologist, geriatric psychiatrist, or geriatrician specializing in dementia) and dosing per FDA labeling.

Study contextIn Study 201, 71.4% of enrollees were ApoE ε4 carriers; protocol amendments affected randomization of carriers to the 10 mg/kg q2w dose

Early Alzheimer's disease (EAD) — patient population and biomarker evidence

PopulationPatients with early Alzheimer's disease (EAD): mild cognitive impairment or mild dementia due to Alzheimer's disease, typically ages 50–90

Biomarker requirementBiomarker evidence of amyloid required (positive amyloid PET OR CSF biomarker abnormalities suggestive of β‑amyloid accumulation)

Trial consistencyPopulation and biomarker requirements align with CLARITY AD and Study 201 trial inclusion criteria

Effective dose 90% (ED90) — definition

ED90 definitionDose achieving ≥90% of the maximum treatment effect as defined in Study 201

PurposeED90 was the analytic target used to identify the simplest dose expected to achieve near‑maximal effect in Study 201

Primary endpoint linkED90 determination tied to the Study 201 Bayesian primary endpoint for 12‑month ADCOMS change

Added instruction to refer to the UnitedHealthcare Commercial policy version for the state of Nevada.