CurrentUnitedHealthcarePolicy 2026D0125E

Leqembi (lecanemab-irmb) intravenous infusion

Defines UnitedHealthcare medical benefit coverage criteria, documentation, continuation and exclusions for Leqembi (lecanemab-irmb) administered by IV infusion for treatment of Alzheimer's disease, including applicable procedure and diagnosis codes and clinical evidence references.

Policy Summary

PayerUnitedHealthcare

PolicyLeqembi (lecanemab-irmb) intravenous infusion

Policy CodePolicy 2026D0125E

Change TypeRevised (applicable HCPCS codes; J0174 description updated)

Effective DateApr 1, 2026

Next Review Date

Key ActionSubmit medical records documenting diagnosis, amyloid confirmation, baseline and follow-up MRIs, cognitive scores, counseling/ApoE ε4 offer/attestation, anticoagulant status, and prescriber specialty to support initial authorization (≤12 months) and reauthorization.

SourceLink

POLICY UPDATE CHANGES

Applicable HCPCS codes list updated and description for J0174 revised; previous policy version 2026D0125D archived.

2Covered Cognitive Stages (MCI or mild dementia)

12 monthsInitial/Reauthorization maximum duration

J0174Primary HCPCS drug code

ARIA-E 12.5% / ARIA-H 17.0%Observed ARIA rates (CLARITY AD)

Not Medically Necessary / Unproven Uses

Not medically necessary / Unproven

Leqembi is unproven and not medically necessary when used:

Not medically necessary / Unproven: For any indication other than Alzheimer's disease

Denial Risk

Combination therapy exclusion

Claims may be denied or not considered medically necessary if Leqembi is used together with other amyloid‑beta monoclonal antibodies for Alzheimer's disease (for example, Kisunla).

Provider Actions / Prior Authorization & Documentation

Prior Authorization

Initial prior authorization requirements

Submit medical records documenting: diagnosis per NIA‑AA (MCI due to AD or mild dementia due to AD); confirmation of amyloid pathology (positive amyloid PET or abnormal CSF biomarkers); baseline brain MRI completed within 12 months prior to initiating treatment; cognitive test score (MMSE 20–30 OR MoCA 17–30 OR SLUMS 17–30); counseling and documentation that ApoE ε4 testing was offered with prescriber attestation of shared decision‑making if therapy initiated; anticoagulant status and absence of intracerebral hemorrhage within the prior year; and note that initial authorization will be for no more than 12 months.

J0174
G30.0, G30.1, G30.8, G30.9 (example diagnosis codes)

Prior Authorization

Reauthorization requirements

Submit medical records confirming follow‑up brain MRI after initiation of therapy; document ARIA status and prescriber attestations when ARIA is observed (including whether follow‑up MRI shows resolution/stabilization or prescriber attests continuation appropriate based on radiographic severity); ensure prescriber specialty (neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia) and dosing per FDA label are documented. Reauthorization is for no more than 12 months.

J0174

Documentation Required

ApoE ε4 counseling and testing offer

Document that counseling was provided on how ApoE ε4 status informs ARIA risk, that ApoE ε4 testing was offered to the patient, and include a prescriber attestation that shared decision‑making occurred if therapy is initiated.

Documentation Required

ARIA counseling and monitoring

Document counseling about the risk of amyloid‑related imaging abnormalities (ARIA‑E and ARIA‑H), instruct the patient to monitor for symptoms (headache, dizziness, visual disturbances, nausea, vomiting), and document that a follow‑up brain MRI was completed after therapy initiation.

Documentation Required

Prescriber specialty requirement

Ensure the prescription is from a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia; document prescriber specialty in the record.

Clinical Evidence

-0.45CDR-SB difference at 18 months (lecanemab vs placebo): -0.45 (95% CI -0.67 to -0.23); p<0.001

-59.12Amyloid PET change (centiloids): adjusted mean difference -59.12 (95% CI -62.64 to -55.60); p<0.001

12.5%ARIA-E incidence in CLARITY AD: 12.5% (symptomatic 2.8%)

17.0%ARIA-H incidence in CLARITY AD: 17.0% (symptomatic 0.7%)

Background evidence: Leqembi is a humanized IgG1 monoclonal antibody indicated for treatment of Alzheimer’s disease in patients with MCI or mild dementia. Clinical trials including Study 201 and CLARITY AD demonstrated amyloid plaque reduction and modest slowing of clinical decline, but treatment was associated with amyloid-related imaging abnormalities (ARIA) and infusion-related reactions.

Background & Definitions

Leqembi is a humanized IgG1 monoclonal antibody directed against aggregated soluble and insoluble amyloid beta. The FDA indication specifies treatment for Alzheimer’s disease initiated in patients with mild cognitive impairment or mild dementia. Clinical trials (Study 201 and the phase 3 CLARITY AD trial) showed reduction in brain amyloid plaques (large centiloid reductions on PET) and a modest slowing of clinical decline (e.g., difference on CDR-SB at 18 months), while safety concerns included ARIA (ARIA‑E and ARIA‑H) and infusion-related reactions.

Term	Definition
{"text":"ARIA","status":""},{"text":"Amyloid-related imaging abnormalities, including ARIA-E (edema/effusions) and ARIA-H (microhemorrhage/hemosiderin)","status":""}
{"text":"NIA-AA","status":""},{"text":"National Institute on Aging and the Alzheimer's Association","status":""}

Policy Summary

PayerUnitedHealthcare

PolicyLeqembi (lecanemab-irmb) intravenous infusion

Policy CodePolicy 2026D0125E

Change TypeRevised (applicable HCPCS codes; J0174 description updated)

Effective DateApr 1, 2026

Next Review Date

SourceLink

On This Page

OpenPayer

Leqembi (lecanemab-irmb) intravenous infusion

Coverage Summary

Initial Therapy — Medical Necessity Criteria

Continuation (Reauthorization) Criteria

Not Medically Necessary / Unproven Uses

Applicable Codes

Provider Actions / Prior Authorization & Documentation

Clinical Evidence

Background & Definitions

Revision History

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