CurrentConnectiCarePolicy C25201-A

Leqembi (lecanemab-irmb) Coverage Criteria

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This policy governs prior authorization and coverage criteria for lecanemab-irmb products used to treat Alzheimer's disease in ConnectiCare commercial members, including eligibility, documentation, continuation requirements, dosing, prescriber qualifications, and administration settings.

Policy Summary

PayerConnectiCare

PolicyLeqembi (lecanemab-irmb) Coverage Criteria

Policy CodePolicy C25201-A

Change TypeAnnual review — no material changes

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionObtain prior authorization before treatment; initial authorization is issued for 3 months and continuation authorization for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsInitial authorization

6 monthsContinuation authorization

10 mg/kg q2wInitial IV dosing

18 monthsInfusion period

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CurrentConnectiCarePolicy C25201-A

Leqembi (lecanemab-irmb) Coverage Criteria

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Policy Summary

PayerConnectiCare

PolicyLeqembi (lecanemab-irmb) Coverage Criteria

Policy CodePolicy C25201-A

Change TypeAnnual review — no material changes

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionObtain prior authorization before treatment; initial authorization is issued for 3 months and continuation authorization for 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3 monthsInitial authorization

6 monthsContinuation authorization

10 mg/kg q2wInitial IV dosing

18 monthsInfusion period

CDR 0.5 / MMSE 21-30 / MoCA ≥16Cognitive thresholds

No changesReview outcome

Coverage Criteria

Initial Therapy

Initial therapy is covered when ALL of the following requirements are met:

ALL of the following

ONE of the following diagnostic pathways
- Documentation of a diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease based on NIA-AA diagnostic criteria: a concern regarding cognition reported by the patient or informant or observed by the clinician; objective evidence of impairment in one or more cognitive domains not explained by age or education; preservation of independence in functional abilities; and no dementia.
- Diagnosis of Alzheimer disease dementia based on NIA-AA criteria for probable Alzheimer disease dementia (see Appendix).
ONE of the following cognitive assessments
- Clinical Dementia Rating Scale (CDR) Global Score of 0.5.
- Mini-Mental State Examination (MMSE) score between 21 and 30.
- Montreal Cognitive Assessment (MoCA) score of at least 16.
Confirmation of underlying amyloid beta pathology through a PET scan or lumbar puncture (LP) for cerebrospinal fluid (CSF).
Documentation in the medical record that the member does not have any medical or neurological condition, other than Alzheimer's disease, that might be a contributing cause of the member's cognitive impairment.

Continuation Therapy

Continuation therapy is covered when ALL of the following requirements are met:

ALL of the following

Adherence requirement
- Adherence to therapy at least 85% of the time, as verified by the prescriber or the member's medication fill history.
- Adherence less than 85% of the time due to the need for surgery or treatment of an infection causing temporary discontinuation.
The prescriber attests to, or a clinical reviewer has found, no evidence of intolerable adverse effects or drug toxicity, such as amyloid-related imaging abnormalities (ARIA).
Documentation of positive clinical response, demonstrated by improvement or stabilization in baseline cognitive scoring using the same testing method provided during the initial authorization request.

FDA-Approved Use

Coverage is limited to the following FDA-approved use:

Treatment of Alzheimer's disease. Treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

All-Cause Dementia Diagnostic Criteria

All-cause dementia is diagnosed when cognitive or behavioral (neuropsychiatric) symptoms meet ALL of the following core clinical criteria:

ALL of the following

The symptoms interfere with the ability to function at work or at usual activities.
The symptoms represent a decline from previous levels of functioning and performing.
The symptoms are not explained by delirium or a major psychiatric disorder.
Cognitive impairment is detected and diagnosed through both history-taking from the patient and a knowledgeable informant and an objective cognitive assessment, either a bedside mental status examination or neuropsychological testing. Neuropsychological testing should be performed when routine history and bedside mental status examination cannot provide a confident diagnosis.
At least 2 of the following cognitive or behavioral domains are impaired

Probable Alzheimer Disease Dementia

Probable Alzheimer disease dementia requires ALL of the following:

ALL of the following

The patient meets the core criteria for dementia described above.
Insidious onset, with symptoms developing gradually over months to years rather than suddenly over hours or days.
A clear-cut history of worsening cognition by report or observation.
The initial and most prominent cognitive deficits are evident on history and examination in one of the following presentations: amnestic presentation, with impairment in learning and recall of recently learned information plus cognitive dysfunction in at least one other cognitive domain; language presentation, with prominent word-finding deficits plus deficits in other cognitive domains; visuospatial presentation, with prominent deficits in spatial cognition, including object agnosia, impaired face recognition, simultanagnosia, or alexia, plus deficits in other cognitive domains; or executive dysfunction, with prominent impairment in reasoning, judgment, and problem solving plus deficits in other cognitive domains.

Continuation therapy is not supported when the member has intolerable adverse effects or drug toxicity, including amyloid-related imaging abnormalities (ARIA).

Leqembi is contraindicated in patients with serious hypersensitivity to lecanemab-irmb or any of the product's excipients.

Leqembi must not be used concurrently with Kisunla (donanemab).

Uses of Leqembi outside the covered FDA-approved indication for Alzheimer's disease are considered experimental or investigational and follow the applicable off-label policy.

Billing and Clinical Coding

Leqembi billing codeHCPCS

J0174

Injection, lecanemab-irmb, 1 mg

Billing CodeHCPCS

J0174

Injection, lecanemab-irmb, 1 mg

Clinical Dementia Rating Scale

AssessmentClinical Dementia Rating Scale (CDR) Global Score

Qualifying threshold0.5

UseOne accepted cognitive assessment threshold for initial coverage

Mini-Mental State Examination

AssessmentMini-Mental State Examination (MMSE)

Qualifying rangeScore between 21 and 30

Use

Provider Requirements and Actions

Prior Authorization

Authorization Duration

Prior authorization is required. Initial authorization is approved for 3 months; continuation-of-therapy authorization is approved for 6 months.

Initial authorization: 3 months
Continuation of therapy: 6 months

Documentation Required

Qualified Prescriber

The medication must be prescribed by, or prescribed in consultation with, a qualified specialist.

Eligible prescribers or consultants: neurologist, geriatrician, geropsychiatric specialist, or Alzheimer's disease specialist

Clinical Background

Leqembi (lecanemab-irmb) is an anti-amyloid antibody indicated for the treatment of Alzheimer’s disease. Treatment is intended to begin during the mild cognitive impairment or mild dementia stage, consistent with the population studied in clinical trials. Coverage requires confirmation of underlying amyloid beta pathology and monitoring for amyloid-related imaging abnormalities (ARIA).

Key Definitions

NIA-AA Diagnostic Criteria

FrameworkNational Institute on Aging–Alzheimer’s Association (NIA-AA) diagnostic criteria

Mild cognitive impairment due to Alzheimer’s diseaseRequires a reported or observed concern regarding cognition, objective impairment in one or more cognitive domains not explained by age or education, preserved independence in functional abilities, and no dementia

Related diagnosisAlzheimer’s disease dementia may be established using NIA-AA criteria for probable Alzheimer’s disease dementia

Amyloid-Related Imaging Abnormalities

MeaningAmyloid-related imaging abnormalities associated with anti-amyloid treatment

ARIA-H findingsRadiographic microhemorrhages and superficial siderosis

Initial Therapy Criteria

Initial therapy requires a qualifying diagnosis, cognitive assessment, amyloid beta confirmation, and exclusion of other contributors.

Initial therapy

Qualifying diagnosis: The member has mild cognitive impairment due to Alzheimer’s disease based on NIA-AA criteria, or Alzheimer’s disease dementia based on NIA-AA criteria for probable Alzheimer’s disease dementia.
For mild cognitive impairment, documentation must include a cognition concern reported by the patient or informant or observed by the clinician, objective impairment in one or more cognitive domains not explained by age or education, preserved independence in functional abilities, and no dementia.
Cognitive assessment: The member has a Clinical Dementia Rating Scale Global Score of 0.5, a Mini-Mental State Examination score between 21 and 30, or a Montreal Cognitive Assessment score of at least 16.CDR 0.5 OR MMSE 21-30 OR MoCA >=16

Continuation Therapy Criteria

Continuation therapy requires all of the following.

Continuation therapy

Adherence is at least 85% as verified by the prescriber or medication fill history, or adherence is below 85% because surgery or treatment of an infection caused a temporary discontinuation.>=85% unless temporary surgery or infection-related interruption
Tolerability and safety: The prescriber attests to, or clinical review finds, no evidence of intolerable adverse effects or drug toxicity such as amyloid-related imaging abnormalities.
Clinical benefit or stabilization: A positive clinical response is documented, demonstrated by improvement or stabilization in baseline cognitive scoring using the same testing method used in the initial authorization request.

Dosing and Quantity Limits

Initial Leqembi IV Schedule

Dose10 mg/kg

RouteIntravenous (IV) infusion

ScheduleOnce every 2 weeks for 18 months

Post-18-Month Treatment Schedule

After 18 monthsContinue IV treatment once every 2 weeks or transition to a maintenance dosage

IV maintenance option10 mg/kg once every 4 weeks

Subcutaneous maintenance option360 mg once weekly using the Leqembi IQLIK autoinjector

Administration Site and Benefit Coverage

Billing Rule

Use an appropriate infusion-center setting

Administer infused medication under pharmacy or medical benefit coverage in a non-inpatient hospital facility-based location.

Billing Rule

Bill home injectable therapy under the pharmacy benefit

Injectable medication is covered under the pharmacy benefit and is patient self-administered at home.

Policy Summary

PayerConnectiCare

PolicyLeqembi (lecanemab-irmb) Coverage Criteria

Policy CodePolicy C25201-A

Change TypeAnnual review — no material changes

Effective DateJune 11, 2026

Next Review DateApril 1, 2027

Key ActionObtain prior authorization before treatment; initial authorization is issued for 3 months and continuation authorization for 6 months.

SourceLink

On This Page

Documentation of a new MRI before the 5th, 7th, and 14th infusions, if applicable, showing radiographic stability. If 10 or more new incident microhemorrhages or more than 2 focal areas of superficial siderosis (radiographic severe ARIA-H) are observed, treatment may be continued with caution only after clinical evaluation and a follow-up MRI demonstrates radiographic stabilization, meaning no increase in the size or number of ARIA-H findings.

For Leqembi IQLIK, the member has received 18 months or more of Leqembi infusions.

Impaired ability to acquire and remember new information, including repetitive questions or conversations, misplacing personal belongings, forgetting events or appointments, or getting lost on a familiar route.

Impaired reasoning and handling of complex tasks or poor judgment, including poor understanding of safety risks, inability to manage finances, poor decision-making ability, or inability to plan complex or sequential activities.

Impaired visuospatial abilities, including inability to recognize faces or common objects or to find objects in direct view despite good acuity, inability to operate simple implements, or inability to orient clothing to the body.

Impaired language functions, including speaking, reading, or writing difficulties such as difficulty thinking of common words while speaking, hesitations, or speech, spelling, and writing errors.

Changes in personality, behavior, or comportment, including uncharacteristic mood fluctuations such as agitation, impaired motivation, initiative, apathy, loss of drive, social withdrawal, decreased interest in previous activities, loss of empathy, compulsive or obsessive behaviors, or socially unacceptable behaviors.

The diagnosis is not applied when there is evidence of substantial concomitant cerebrovascular disease, including a history of stroke temporally related to onset or worsening of cognitive impairment, multiple or extensive infarcts, or severe white matter hyperintensity burden; core features of dementia with Lewy bodies other than dementia itself; prominent features of behavioral variant frontotemporal dementia; prominent features of semantic variant primary progressive aphasia or nonfluent/agrammatic variant primary progressive aphasia; or another concurrent active neurological disease, non-neurological medical comorbidity, or medication use that could substantially affect cognition.

One accepted cognitive assessment threshold for initial coverage

Montreal Cognitive Assessment

AssessmentMontreal Cognitive Assessment (MoCA)

Qualifying thresholdScore of at least 16

UseOne accepted cognitive assessment threshold for initial coverage

Adherence

Required adherenceAt least 85% of the time, verified by the prescriber or medication fill history

Allowed interruptionAdherence below 85% may qualify when surgery or treatment of an infection caused temporary discontinuation

Continuation requirementThe temporary interruption must be related to surgery or infection treatment

Severe ARIA-H Monitoring

Microhemorrhages10 or more new incident microhemorrhages

Superficial siderosisMore than 2 focal areas

Required responseTreatment may continue with caution only after clinical evaluation and follow-up MRI demonstrate radiographic stabilization with no increase in size or number of ARIA-H findings

Note

Label and Case-by-Case Review

Coverage is reviewed under current medical-practice standards, applicable state and federal requirements, the administered benefit, and formulary preferencing. If the FDA label was updated within the prior 180 days, medical necessity is evaluated using the updated label; coverage may be determined case by case until the policy is updated.

The requested use must be FDA-approved and provide benefit under the member's coverage.
Medical necessity is reviewed case by case when required by a recent FDA-label change or when additional information is needed.

Note

Early-Stage Alzheimer's Disease

Leqembi should be initiated only for the early-stage Alzheimer's disease population studied in clinical trials.

Mild cognitive impairment due to Alzheimer's disease or mild dementia stage of disease

Documentation Required

Medical Records and Dosing Information

Submit complete medical records and any additional information needed for coverage determination, quality improvement, or fraud, waste, and abuse review. Include patient records, test results, provider credentials when requested, and the dosing information used to establish medical necessity.

When dosing is based on weight, body surface area, or another member-specific measurement, submit that measurement.
Documentation must support medical necessity, non-investigational use, benefit coverage, and appropriate billing.

Documentation Required

Initial Clinical Documentation

For the initial request, document the qualifying diagnosis, objective cognitive impairment, amyloid pathology, and absence of another medical or neurologic cause of the impairment.

Diagnosis of mild cognitive impairment due to Alzheimer's disease or probable Alzheimer's disease dementia under applicable criteria
Clinical Dementia Rating (CDR) Global Score of 0.5, or MMSE score 21–30, or MoCA score of at least 16
Confirmation of underlying amyloid beta pathology by PET scan or lumbar puncture with CSF analysis
Medical-record documentation that no other medical or neurologic condition is contributing to the cognitive impairment

Documentation Required

Continuation Documentation

For reauthorization, document that the member continues to meet continuation criteria and that treatment remains clinically appropriate.

Adherence of at least 85%, verified by the prescriber or medication fill history; lower adherence is acceptable when temporary discontinuation was required for surgery or infection treatment
No intolerable adverse effects or drug toxicity, including ARIA, based on prescriber attestation or clinical review
Positive clinical response shown by improvement or stabilization in baseline cognitive scoring using the same testing method used for initial authorization
New MRI before the 5th, 7th, and 14th infusions, when applicable, showing radiographic stability
If severe ARIA-H is observed, continuation requires clinical evaluation and follow-up MRI demonstrating radiographic stabilization
For Leqembi IQLIK, documentation that the member has received at least 18 months of Leqembi infusions

Documentation Required

Consultation Notes

When Leqembi is prescribed in consultation with a qualified specialist, submit the consultation notes with both the initial request and each reauthorization request.

Consultation must be with a neurologist, geriatrician, geropsychiatric specialist, or Alzheimer's disease specialist

Documentation Required

ApoE ε4 Testing and Counseling

Before treatment begins, perform ApoE ε4 testing and counsel the patient about genotype-specific ARIA risk and the implications of genetic testing.

ApoE ε4 homozygotes have a higher incidence of symptomatic and serious ARIA than heterozygotes and noncarriers.
Discuss ARIA risk across genotypes and the implications of test results before testing.
Consider the expected Alzheimer's disease benefit against the risk of serious ARIA-related adverse events when deciding whether to initiate treatment.

Documentation Required

Alzheimer's Disease Diagnostic Documentation

Support the Alzheimer's disease diagnosis with clinical history, an objective cognitive assessment, and documentation of the required functional and cognitive features.

For dementia, document cognitive or behavioral symptoms that interfere with usual activities, represent decline from prior functioning, and are not explained by delirium or a major psychiatric disorder.
Use patient and knowledgeable-informant history plus objective bedside cognitive assessment or neuropsychological testing; neuropsychological testing is appropriate when routine evaluation is inconclusive.
Document impairment in at least two cognitive domains: learning and memory, reasoning and complex tasks, visuospatial abilities, or language.
For probable Alzheimer's disease dementia, document insidious onset, clear worsening of cognition, and an amnestic or non-amnestic presentation with deficits in another cognitive domain.
Do not apply probable Alzheimer's disease dementia criteria when substantial cerebrovascular disease, core Lewy body features, prominent frontotemporal dementia or primary progressive aphasia features, or another active neurologic or medical cause substantially affecting cognition is present.

Denial Risk

Insufficient Supporting Documentation

The plan may require additional records, test results, or provider credentials. Reimbursement may be denied or other action taken when submitted documentation does not support medical necessity, non-investigational use, benefit eligibility, or appropriate billing practices.

Documentation may be requested for coverage determination, quality improvement, or fraud, waste, and abuse prevention.
Inadequate, inappropriate, or excessive billing documentation may result in adverse action.

Denial Risk

Failure to Meet Initial Clinical Criteria

Initial coverage may be denied when the submitted records do not establish the required diagnosis, early-stage disease population, cognitive assessment, amyloid confirmation, or absence of another contributing condition.

No qualifying mild cognitive impairment or probable Alzheimer's disease dementia diagnosis
Cognitive score outside the required range or no qualifying CDR, MMSE, or MoCA documentation
No PET or CSF confirmation of amyloid beta pathology
Another medical or neurologic condition may be contributing to the cognitive impairment

Denial Risk

Failure to Meet Continuation Criteria

Continuation may be denied when adherence, tolerability, clinical response, MRI monitoring, toxicity management, or product-transition requirements are not documented or are not met.

Adherence is below 85% without an accepted temporary interruption for surgery or infection treatment
Intolerable adverse effects, drug toxicity, or unstable or severe ARIA is present without the required evaluation and follow-up MRI
No improvement or stabilization using the same cognitive assessment method as the initial request
Required MRI monitoring before the 5th, 7th, or 14th infusion is missing or does not show radiographic stability
For Leqembi IQLIK, fewer than 18 months of Leqembi infusions have been completed

Denial Risk

Non-Covered or Investigational Use

Uses of Leqembi outside the covered FDA-approved Alzheimer's disease indication are considered experimental or investigational and are subject to the applicable off-label policy.

Coverage is limited to the FDA-approved Alzheimer's disease use and qualifying early-stage population.

Denial Risk

Concurrent Kisunla Use

Do not use Leqembi concurrently with Kisunla (donanemab). Concurrent use is excluded from coverage.

Concurrent donanemab treatment is not covered.

Denial Risk

Serious Hypersensitivity

Leqembi is contraindicated for patients with serious hypersensitivity to lecanemab-irmb or any excipient in the product.

Do not initiate or continue treatment when serious hypersensitivity to lecanemab-irmb or its excipients is present.

MonitoringRequires MRI monitoring for radiographic stability

Dementia

Functional impactCognitive or behavioral symptoms interfere with work or usual activities and represent a decline from previous functioning

Alternative explanationsSymptoms are not explained by delirium or a major psychiatric disorder

Cognitive domainsImpairment involves at least two cognitive domains and is established through history plus objective cognitive assessment

Probable Alzheimer’s Disease Dementia

Required foundationThe patient meets criteria for dementia

CourseInsidious onset over months to years with clear worsening of cognition

Cognitive presentationProminent amnestic or non-amnestic deficits with impairment in other cognitive domains

ARIA Types

ARIA-EAmyloid-related imaging abnormalities with edema

ARIA-HAmyloid-related imaging abnormalities with hemosiderin deposition

Clinical significanceARIA is usually asymptomatic, but serious and potentially life-threatening events can rarely occur

Amyloid beta pathology: Underlying amyloid beta pathology is confirmed through a PET scan or lumbar puncture for cerebrospinal fluid.PET or CSF lumbar puncture

Alternative causes excluded: The medical record documents that no medical or neurological condition other than Alzheimer’s disease contributes to the member’s cognitive impairment.

FDA-Approved Alzheimer’s Disease Treatment Population

Initial treatment is intended for the FDA-approved Alzheimer’s disease population.

Initial Alzheimer’s disease treatment population: The patient has Alzheimer’s disease and treatment is initiated during the mild cognitive impairment or mild dementia stage of disease.Mild cognitive impairment or mild dementia stage

This reflects the population in which treatment was initiated in clinical trials.

Improvement or stabilization

MRI monitoring: A new MRI is documented before the 5th, 7th, and 14th infusions, if applicable, showing radiographic stability.MRI before infusions 5, 7, and 14

If 10 or more new incident microhemorrhages or more than 2 focal areas of superficial siderosis are observed, treatment may continue with caution only after clinical evaluation and a follow-up MRI demonstrates radiographic stabilization with no increase in size or number of ARIA-H findings.

Leqembi Iqlik transition requirement: For Leqembi Iqlik, the member has received 18 months or more of Leqembi infusions before transition.>=18 months of Leqembi infusions

Applies only to Leqembi Iqlik.

Leqembi IQLIK Dosing

ProductLeqembi IQLIK

Dose360 mg

Frequency and deviceOnce weekly using the autoinjector

Leqembi IV Maintenance Dosing

ProductLeqembi

Dose and route10 mg/kg by IV infusion

Maintenance frequencyOnce every 4 weeks