ModifiedUnitedHealthcarePolicy 2026D0125D

Leqembi (lecanemab-irmb) — Medical Benefit Drug Policy

Medical benefit policy governing intravenous Leqembi (lecanemab-irmb) administration for treatment of Alzheimer's disease, including initial and continuation authorization criteria and documentation requirements; affects providers prescribing or administering Leqembi under UnitedHealthcare commercial medical benefit.

Policy Summary

PayerUnitedHealthcare

PolicyLeqembi (lecanemab-irmb) — Medical Benefit Drug Policy

Policy CodePolicy 2026D0125D

Change TypeMaterial revisions to authorization duration and continuation criteria

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for intravenous Leqembi with initial authorization limited to no more than 12 months and submit required documentation (diagnosis per NIA-AA, baseline cognitive scores, amyloid confirmation, baseline MRI).

SourceLink

POLICY UPDATE CHANGES

Changed initial authorization duration from 'no more than 6 months' to 'no more than 12 months'.

Revised coverage criteria for continuation of therapy and removed requirement that continuation be limited to patients with MCI due to AD or mild dementia due to AD or who progressed to moderate/severe dementia with shared decision-making attestation.

Archived previous policy version 2025D0125C.

12 momaximum initial authorization period

J0174listed HCPCS code

within 12 morequired baseline MRI

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MMSE 20-30acceptable baseline cognitive scores

12.5%ARIA-E incidence (CLARITY AD)

Coverage Criteria for Leqembi (lecanemab-irmb)

Initial Therapy

Covered when ALL of the following are met for initial therapy

Initial therapy - diagnostic and baseline requirements: Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease OR mild dementia due to Alzheimer's disease based on NIA-AA criteria; presence of amyloid beta pathology confirmed (positive amyloid PET or CSF biomarker testing); baseline brain MRI completed within 12 months prior to initiating treatment; submission of cognitive testing documented as one of: MMSE 20–30 OR MoCA 17–30 OR SLUMS 17–30; other differential diagnoses (e.g., DLB, FTD, vascular dementia, pseudodementia, B12 deficiency, encephalopathy) ruled out.

Document supporting medical records (chart notes, laboratory values, imaging), per policy

Initial therapy - safety, concomitant therapy, dosing, prescriber: Not used in combination with other Aβ monoclonal antibodies for Alzheimer's disease (e.g., Kisunla); patient has no history of intracerebral hemorrhage within the previous year; counseling provided on ARIA risks and offer of ApoE ε4 testing with shared decision-making documented; Leqembi dosing in accordance with FDA-approved labeling; prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in dementia.

Dosing and prescriber specialty required for coverage

Anticoagulant status: Either patient is not currently taking an anticoagulant (e.g., warfarin, dabigatran) OR patient is taking an anticoagulant and counseling provided that combined use may increase risk of cerebral macrohemorrhage with prescriber attestation that shared decision-making occurred.

If anticoagulant in use, documentation of counseling and prescriber attestation required

Authorization period: Initial authorization limited to no more than 12 months.no more than 12 months

Per policy revision, initial authorization duration is 12 months maximum

Continuation Therapy

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

Continuation - diagnosis, dosing, and prescriber: Diagnosis of Alzheimer's disease; Leqembi dosing in accordance with FDA-approved labeling; prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in dementia; not used in combination with other Aβ monoclonal antibodies for Alzheimer's disease (e.g., Kisunla).

Prescriber specialty, dosing, and no concomitant Aβ mAbs required

Continuation - imaging and ARIA management: Submission of medical records confirming follow-up brain MRI completed after initiation of therapy; if ARIA has not been observed on MRI, continuation permitted; if ARIA has been observed on MRI, prescriber must attest that 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 the radiographic severity of ARIA.

Documentation of follow-up MRI and prescriber attestation when ARIA observed required

Reauthorization period: Reauthorization limited to no more than 12 months.

Not Medically Necessary / Unproven Indications

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

Coverage limited to approved AD indications with biomarker confirmation

Initial coverage (trial-based)

Covered when ALL of the following are met

Indication and disease stage: Treatment should be initiated in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease, the population studied in clinical trials.

Consistent with FDA labeling and trial inclusion

Dosing: Use intravenous lecanemab 10 mg/kg every 2 weeks as used in pivotal trials (Study 201, CLARITY AD).10 mg/kg every 2 weeks

Dose evaluated in pivotal trials

Biomarker confirmation: Patients should have evidence of amyloid pathology on PET imaging or by cerebrospinal fluid testing prior to initiation.amyloid PET positive or CSF consistent with AD

Biomarker-confirmed early AD was required for trial enrollment

Continuation Therapy (summary)

Continuation of therapy — policy revision note

Continuation authorization: Coverage criteria for continuation of therapy were revised; the prior requirement that continuation be limited to patients with MCI due to AD, mild dementia due to AD, or patients progressed to moderate/severe dementia with prescriber attestation of shared decision-making was removed.

See policy history for change effective 02/01/2026

Leqembi must not be administered in combination with other amyloid‑beta (Aβ) monoclonal antibodies. The policy explicitly excludes concurrent use with other Aβ mAbs (for example, Kisunla) for both initiation and continuation of therapy; requests for combined therapy do not meet coverage criteria.

Coverage decisions are governed by the member's benefit plan. If a member-specific Certificate of Coverage excludes experimental, investigational, or unproven treatments for the diagnosis or circumstances, Leqembi may be excluded despite the policy language here. Providers must consult the member-specific benefit document (and applicable state or federal mandates) when determining coverage.

Leqembi (lecanemab‑irmb) is considered unproven and not medically necessary for any indication other than Alzheimer's disease.

Clinical trial experience with other anti‑Aβ agents underscores the importance of biomarker confirmation and demonstrated efficacy/safety. Prior investigational anti‑Aβ antibodies often failed due to factors such as enrollment of patients without evidence of Aβ pathology, inadequate target engagement or dosing, and treatment of patients at later stages of disease. Therapies lacking demonstrated efficacy, safety, or biomarker confirmation are not supported by the evidence and therefore are considered unproven outside of appropriate clinical trial contexts.

Coding and Billing Codes

Applicable HCPCS/Product CodeHCPCS

J0174

Injection, lecanemab-irmb, 1mg.

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

Provider Actions, Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for intravenous Leqembi (lecanemab-irmb) under the medical benefit. Initial prior authorization will be for no more than 12 months; reauthorizations (continuation) are also limited to no more than 12 months.

Initial and reauthorization periods: <= 12 months
Prior authorization required for IV Leqembi under the medical benefit

Documentation Required

Required Documentation

Requests must include supporting documentation demonstrating the applicable diagnostic and biomarker criteria, baseline and follow-up imaging/testing, clinician specialty, dosing consistent with FDA labeling, and risk counseling when relevant.

Documentation: medical records/chart notes, baseline cognitive testing (MMSE, MoCA, or SLUMS) with scores

Background and Clinical Context

Alzheimer's disease (AD) is characterized pathologically by accumulation of amyloid‑beta (Aβ) plaques and neurofibrillary tau tangles, with Aβ deposition beginning decades before clinical symptoms. Leqembi is a humanized IgG1 monoclonal antibody directed against aggregated soluble and insoluble forms of Aβ and is intended to treat early symptomatic AD (mild cognitive impairment or mild dementia due to AD). Clinical development and approval efforts have focused on treating biomarker‑confirmed, early‑stage patients because prior anti‑Aβ trials frequently enrolled patients without confirmed amyloid pathology or at later disease stages, which likely contributed to negative results.

Definitions and Key Terms

Eligible diagnostic categories

Eligible diagnostic categoriesMild cognitive impairment (MCI) due to Alzheimer’s disease; mild dementia due to Alzheimer’s disease — diagnosis per National Institute on Aging and the Alzheimer’s Association (NIA-AA) criteria.

Diagnostic basisDiagnosis must follow NIA-AA criteria as specified in policy for early symptomatic AD population.

Population intentApplies to patients with early symptomatic AD (MCI or mild dementia) — the population studied in clinical trials and eligible for Leqembi under this policy.

ApoE ε4 testing

Purpose of testingApolipoprotein E (ApoE) ε4 testing informs risk of amyloid-related imaging abnormalities (ARIA).

Offer and counseling

Policy Revision History and Changes

2026-02-01revisionLatest

Changed initial authorization duration from 'no more than 6 months' to 'no more than 12 months'.

2026-02-01revision

Revised continuation coverage criteria by removing the requirement that continuation be limited to patients with MCI due to AD, mild dementia due to AD, or patients who progressed to moderate/severe dementia with prescriber attestation of shared decision-making.

2026-02-01administrative

Archived previous policy version 2025D0125C.

Policy Summary

PayerUnitedHealthcare

PolicyLeqembi (lecanemab-irmb) — Medical Benefit Drug Policy

Policy CodePolicy 2026D0125D

Change TypeMaterial revisions to authorization duration and continuation criteria

Effective DateFeb 1, 2026

Next Review DateN/A

SourceLink

On This Page

no more than 12 months

Reauthorization duration per policy

Documentation: evidence of amyloid beta pathology (positive amyloid PET or CSF biomarkers)

Baseline brain MRI within 12 months prior to treatment initiation and follow-up MRI after initiation

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

Dosing must follow FDA-approved labeling

If patient on anticoagulant, provide counseling documentation and prescriber attestation of shared decision-making

Note

Member Benefit Document Governs; Use of Utilization Management Tools

Coverage decisions should be made in reference to the member-specific benefit plan document and any applicable federal or state mandates; the member plan governs in case of conflict. UnitedHealthcare may use third‑party tools (e.g., InterQual) to assist in administering benefits.

Member-specific benefit plan document governs coverage determinations
Check for federal/state mandates that may supersede policy
UnitedHealthcare may use third-party criteria (e.g., InterQual) to assist in administration

Step Therapy

No step therapy requirements are specified in this policy for Leqembi.

Denial Risk

Denial Triggers / Risk Areas

Requests that do not meet the specified diagnostic, biomarker, imaging, dosing, or provider-type criteria may be denied as not meeting medical necessity (for example: diagnosis other than MCI due to AD or mild AD dementia, absent amyloid confirmation, missing baseline MRI, inappropriate prescriber specialty, concurrent use with other Aβ mAbs, or dosing not per FDA label).

Potential denial triggers: no confirmed amyloid pathology
Potential denial triggers: missing baseline brain MRI within 12 months prior to initiation
Potential denial triggers: prescribed by clinician not specialized in dementia care
Potential denial triggers: concurrent use with other Aβ monoclonal antibodies
Potential denial triggers: dosing inconsistent with FDA labeling

Testing for ApoE ε4 status must be offered to the patient and counseling provided on how results inform ARIA risk prior to initiating Leqembi.

Shared decision-makingPrescriber must attest that the patient has participated in shared decision-making about initiating Leqembi after being offered ApoE ε4 testing.

Alzheimer's disease clinical stages (0-6)

Stage 0Asymptomatic; biomarkers normal; no evidence of clinical change.

Stage 2-3 (early symptomatic)Stage 2: transitional decline with mild detectable change but minimal impact on daily function; Stage 3: cognitive impairment with early functional impact but independence in ADLs — these correspond to early symptomatic stages relevant to treatment consideration.

Stages 4-6Stage 4: dementia with mild functional impairment; Stage 5: moderate impairment requiring assistance; Stage 6: severe impairment with complete dependence for basic ADLs.

Leqembi (lecanemab-irmb)

Drug name and genericLeqembi (lecanemab-irmb).

ClassHumanized IgG1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta.

Pathophysiologic targetBinds aggregated amyloid-beta plaques; intended to reduce amyloid deposition characteristic of Alzheimer’s disease.