Leqembi (lecanemab-irmb) coverage policy — initial and continuation criteria for early Alzheimer's disease
Coverage policy for Leqembi (lecanemab-irmb) addressing initial and continuation authorization criteria for patients with early Alzheimer's disease (MCI due to AD or mild AD dementia) including required diagnostics, monitoring, provider type, and dosing alignment with FDA labeling.
Policy Summary
PayerUnitedHealthcare
PolicyLeqembi (lecanemab-irmb) coverage policy
Policy CodePolicy IEXD00125.02
Change TypeCriteria revisedauthorization periods updated
Effective DateNov 1, 2024
Next Review DateN/A
Key ActionSubmit prior authorization with documentation of diagnosis, qualifying cognitive scores, amyloid confirmation (PET or CSF), baseline MRI, and prescriber attestation.
Leqembi (lecanemab-irmb) may be covered for treatment of Alzheimer's disease for patients meeting specified initial and continuation criteria.
Removed requirement attesting lack of access to amyloid PET and site registration with ALZ-NET; revised diagnostic and MMSE thresholds and CSF biomarker phrasing for initial therapy.
Revised continuation therapy criteria including diagnostic language, MMSE threshold, MRI follow-up requirement, and reauthorization duration increased to 12 months.
Added Kisunla to the list of other Aβ monoclonal antibodies that must not be given in combination with Leqembi and removed TIA and stroke from examples of intracerebral hemorrhage.
Updated Background and References sections to reflect current information and archived previous policy version IEXD00125.01.
12.6%ARIA-E incidence
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.
1795
CLARITY AD participants
-0.45CDR‑SB diff at 18 mo
Init ≤6m; Reauth ≤12mAuth duration
Coverage Criteria for Leqembi (lecanemab-irmb)
Initial Therapy Criteria
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.
Biomarker evidence: Submission of medical records documenting presence of beta‑amyloid protein deposition evidenced by a positive amyloid PET brain scan OR CSF biomarker abnormalities suggestive of beta‑amyloid accumulation (examples: Aβ42:Aβ40 ratio, p‑tau181/Aβ42, CSF t‑tau/Aβ42).
Cognitive and functional scores: Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0 AND CDR Memory Box score ≥ 0.5 AND one of: MMSE ≥ 20 OR MoCA ≥ 12 OR SLUMS ≥ 17.
Safety and monitoring preconditions: Baseline brain MRI completed within 12 months prior to initiating treatment; no history of intracerebral hemorrhage within the previous year; counseling provided on ARIA risks and monitoring for symptoms; counseling provided on how ApoE ε4 testing informs ARIA risk and ApoE ε4 testing offered with prescriber attestation of shared decision‑making.
Concomitant therapy and provider: Not used in combination with other Aβ monoclonal antibodies for Alzheimer's disease (examples: Aduhelm, Kisunla); prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia; dosing per FDA labeling; initial authorization for no more than 6 months.
Continuation Therapy Criteria
Covered when ALL of the following are met for continuation of therapy:
Ongoing diagnosis: Patient continues to have mild cognitive impairment due to Alzheimer's disease OR mild dementia due to Alzheimer's disease based on NIA‑AA criteria.
Updated assessments: Submission of current medical records (measured no earlier than 4 weeks prior to the continuation request) documenting Global CDR score 0.5 or 1.0, CDR Memory Box score ≥ 0.5, and one of: MMSE ≥ 20 OR MoCA ≥ 12 OR SLUMS ≥ 17.
Post‑initiation MRI and ARIA management: Submission of follow‑up brain MRI after initiation of therapy AND either ARIA not observed on MRI OR (if ARIA observed) prescriber attests continuation is appropriate based on clinical symptoms and radiographic severity, and either follow‑up MRI demonstrates radiographic resolution/stabilization OR prescriber attests continuation appropriate based on radiographic severity.
Concomitant therapy and provider:
Not Medically Necessary / Unproven Indications
Other indications: Leqembi (lecanemab‑irmb) is unproven and not medically necessary for any indication other than mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia.
Coverage Criteria (Policy History Summary)
Coverage is provided when patients meet the revised Initial Therapy or Continuation of Therapy criteria as stated in the policy history.
Initial Therapy (revised): Patient has mild cognitive impairment or mild dementia due to Alzheimer's disease; MMSE documented ≥ 20; evidence of beta‑amyloid deposition by positive amyloid PET brain scan or CSF biomarker abnormalities (examples: Aβ42:Aβ40 ratio, p‑tau181/Aβ42, CSF t‑tau/Aβ42); not receiving other Aβ monoclonal antibodies (examples updated to include Kisunla); removed prior attestation requirements (e.g., access to amyloid PET, ALZ‑NET registration).MMSE >= 20
Derived from Policy History/Revision Information
Continuation of Therapy (revised): Diagnosis remains mild cognitive impairment or mild dementia due to Alzheimer's disease; MMSE documented ≥ 20; follow‑up brain MRI completed after initiation of therapy (timing requirement revised to completion after initiation rather than specific infusion timing); reauthorization allowed for up to 12 months; patient not receiving other Aβ monoclonal antibodies (Kisunla added).Reauthorization <= 12 months
Derived from Policy History/Revision Information
Use of Leqembi in combination with other amyloid-beta (Aβ) monoclonal antibodies for Alzheimer's disease is not permitted. Examples of other Aβ monoclonal antibodies include Aduhelm and Kisunla; patients receiving another Aβ mAb in combination with Leqembi are not eligible for coverage under this policy.
Concurrent administration of other specified Aβ monoclonal antibodies is prohibited. The policy language has been updated to explicitly add Kisunla to the list of Aβ mAbs that must not be given in combination with Leqembi; documentation that the patient is not receiving these agents is required for both initial and continuation authorization.
Leqembi (lecanemab-irmb) is considered unproven and not medically necessary for any indication other than mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia. Use of Leqembi outside these specified populations is not covered by this policy.
Dosing and Scoring References
Dosing regimen referencedmixed
10 mg/kg every 2 weeks
Lecanemab dosing regimen used in CLARITY AD and specified as effective dose
Cognitive and functional score thresholds (CDR, CDR Memory Box, MMSE/MoCA/SLUMS)
Global CDRGlobal Clinical Dementia Rating (CDR) score of 0.5 or 1.0
CDR Memory BoxCDR Memory Box score of 0.5 or greater
MMSE thresholdMini‑Mental State Examination (MMSE) score of 20 or greater
MoCA thresholdMontreal Cognitive Assessment (MoCA) score of 12 or greater
SLUMS thresholdSaint Louis University Mental Status (SLUMS) score of 17 or greater
Prior Authorization, Documentation, and Provider Responsibilities
Prior Authorization
Prior Authorization Required
Prior authorization is required for both initial and continuation therapy with Leqembi (lecanemab-irmb). Initial authorization will be for no more than 6 months; reauthorization (continuation) will be for no more than 12 months. Submit a prior authorization request with complete supporting medical records as outlined below. Failure to obtain prior authorization may result in claim denial or delay.
Initial authorization: up to 6 months
Reauthorization (continuation): up to 12 months
Documentation Required
Required Baseline Documentation
Submit baseline documentation with the initial prior authorization request. Incomplete documentation may lead to denial or delay. Required baseline records include objective diagnostic and risk information supporting the NIA-AA diagnosis of MCI due to AD or mild dementia due to AD.
Medical records documenting a NIA-AA diagnosis of one of the following: mild cognitive impairment (MCI) due to Alzheimer's disease or mild dementia due to Alzheimer's disease
Background and Rationale
Alzheimer's disease is a progressive neurodegenerative disorder characterized pathologically by deposition of amyloid-beta plaques and neurofibrillary tangles composed of tau protein. Amyloid accumulation begins years to decades before clinical symptoms, and biomarker confirmation of beta-amyloid deposition (via amyloid PET or CSF biomarkers) was required in the trials informing this policy. Clinical progression is measured with tools such as the Clinical Dementia Rating (CDR) and cognitive tests; the trials of lecanemab demonstrated reduction in amyloid burden and modest slowing of clinical decline but carry risks including amyloid-related imaging abnormalities (ARIA), which the policy addresses through baseline and follow-up MRI monitoring and counseling requirements.
Key Definitions
Definition — MCI due to Alzheimer's disease
DefinitionMild cognitive impairment (MCI) due to Alzheimer's disease: symptomatic cognitive decline not meeting criteria for dementia but with objective impairment and biomarker evidence of AD pathology
Diagnostic frameworkDiagnosis per National Institute on Aging and Alzheimer's Association (NIA‑AA) criteria
Biomarker requirementCoverage requires documentation of beta‑amyloid deposition by positive amyloid PET or CSF biomarker abnormalities
Definition — CDR / CDR-SB scoring and staging
CDR stagingGlobal CDR (CDR‑G) scores: 0.5–1.0 correspond to early symptomatic disease (mild cognitive impairment to mild dementia)
CDR‑SB purpose
Policy Summary
PayerUnitedHealthcare
PolicyLeqembi (lecanemab-irmb) coverage policy
Policy CodePolicy IEXD00125.02
Change TypeCriteria revisedauthorization periods updated
Effective DateNov 1, 2024
Next Review DateN/A
Key ActionSubmit prior authorization with documentation of diagnosis, qualifying cognitive scores, amyloid confirmation (PET or CSF), baseline MRI, and prescriber attestation.
Not used in combination with other Aβ monoclonal antibodies for Alzheimer's disease (examples: Aduhelm, Kisunla); prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia; dosing per FDA labeling; reauthorization for no more than 12 months.
Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0
CDR Memory Box score ≥ 0.5
Cognitive testing: one of the following — MMSE ≥ 20, MoCA ≥ 12, or SLUMS ≥ 17
Biomarker evidence of beta-amyloid accumulation when applicable (positive amyloid PET scan or CSF biomarker abnormalities such as Aβ42:40 ratio, p-tau181/Aβ42, or t-tau/Aβ42)
Baseline brain MRI completed within 12 months prior to initiating treatment
Documentation that the patient has no history of intracerebral hemorrhage within the previous year prior to initiating treatment
Documentation that counseling was provided on ARIA risks and ApoE ε4 testing and shared decision-making regarding initiation of therapy
Prescriber specialty documented (neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia)
Leqembi dosing consistent with FDA-approved labeling
Documentation Required
Continuation Documentation Requirements
For continuation (reauthorization) requests, submit current medical records documenting the patient continues to meet diagnostic and clinical thresholds. Updated assessments must be measured no earlier than 4 weeks prior to the continuation request. Also submit evidence of follow-up MRI after treatment initiation and documentation addressing any ARIA findings.
Current medical records confirming continued NIA-AA diagnosis of MCI due to AD or mild dementia due to AD
Updated Global CDR score of 0.5 or 1.0 and CDR Memory Box score ≥ 0.5 (assessments no earlier than 4 weeks prior to request)
Updated cognitive testing: MMSE ≥ 20 or MoCA ≥ 12 or SLUMS ≥ 17 (measured no earlier than 4 weeks prior to request)
Submission of medical records confirming follow-up brain MRI has been completed after initiation of therapy
If ARIA is not observed on MRI — document absence of ARIA; if ARIA is observed — prescriber must attest continuation is appropriate based on clinical severity and provide evidence of radiographic resolution/stabilization or rationale for continuing despite persistent ARIA
Denial Risk
Documentation and Criteria Gaps — Denial Risk
Failure to document the required diagnosis, cognitive scores, biomarker evidence, MRI follow-up, ARIA assessment, or attestations (e.g., ApoE ε4 counseling, specialist prescriber, dosing per FDA labeling) may result in denial of the request. Concurrent use of other anti–beta-amyloid monoclonal antibodies will also prevent coverage.
Denial triggers include: missing or insufficient documentation of diagnosis, cognitive testing, or biomarker confirmation; absence of required baseline or follow-up MRI; failure to attest to ApoE ε4 counseling or shared decision-making; concurrent therapy with other Aβ mAbs (examples include Aduhelm, Kisunla)
Prescriber must attest to appropriate management if ARIA is observed and provide follow-up imaging documentation
Note
Background — Standard Symptomatic Therapies
Background: Approved symptomatic therapies for Alzheimer's disease include guideline-recommended cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and the NMDA antagonist memantine. These agents provide modest symptomatic benefit; most patients with newly diagnosed AD should be offered a trial of a cholinesterase inhibitor, and continued only if clinical benefit is observed. Leqembi targets the underlying amyloid pathology and has distinct documentation and monitoring requirements compared with standard symptomatic therapy.
Leqembi is intended to target amyloid pathology and requires biomarker confirmation and specific monitoring (MRI/ARIA) in addition to standard symptomatic care
CDR‑Sum of Boxes (CDR‑SB) integrates cognitive and functional domains; scores range 0–18 with higher scores indicating greater severity