CurrentHawaii Medical Service Association (HMSA)Policy N/A

LEQEMBI (lecanemab-irmb) Coverage Criteria

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This policy governs HMSA coverage and prior authorization for Leqembi in members with Alzheimer's disease, including initial and continuation therapy requirements. It applies to HMO, PPO, and QUEST lines of business and requires clinical documentation, specialist prescribing or consultation, and monitoring for amyloid-related imaging abnormalities.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLEQEMBI (lecanemab-irmb) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFebruary 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests for Leqembi using the HMSA medical specialty drug policy website and fax form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PA required

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CurrentHawaii Medical Service Association (HMSA)Policy N/A

LEQEMBI (lecanemab-irmb) Coverage Criteria

Customize your policy alerts

Sign up for all Hawaii Medical Service Association (HMSA) policy alerts

Know when Hawaii Medical Service Association (HMSA) releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLEQEMBI (lecanemab-irmb) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFebruary 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests for Leqembi using the HMSA medical specialty drug policy website and fax form.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

PA required

Utilization management

6 monthsInitial authorization

12 monthsContinuation authorization

50 yearsStandard age threshold

Coverage Criteria and Exclusions

Covered indication

Covered when all approval criteria are met and the member has no exclusions to the prescribed therapy.

Treatment of Alzheimer's disease, initiated during the mild cognitive impairment or mild dementia stage.
The member has no exclusions to the prescribed therapy, including suspected non-Alzheimer neurodegenerative cognitive impairment, recent transient ischemic attack, stroke or seizure, inadequately controlled bleeding disorder, or concurrent use of another amyloid beta-directed antibody.

Initial therapy - Alzheimer's disease

Initial authorization for 6 months may be granted when all of the following criteria are met.

Age or early-onset disease

Member is 50 years of age or older.50 years or older
Member is younger than 50 years and has an APP, PSEN1, or PSEN2 mutation, or other clinical documentation supporting early-onset Alzheimer's disease.

Disease stage: Member has mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia.

Objective baseline cognitive impairment: Member has objective evidence of cognitive impairment at baseline, as described in Appendix A.

Appendix A includes cognitive concern or change, objective impairment in one or more cognitive domains, preserved functional independence, and no dementia.

Baseline cognitive score

Clinical Dementia Rating-Global Score (CDR-GS) is 0.5 or 1.CDR-GS 0.5 or 1
Mini-Mental Status Examination (MMSE) score is 21-30.MMSE 21-30
Montreal Cognitive Assessment (MoCA) score is greater than or equal to 16.MoCA >=16

Confirmed amyloid pathology

A positron emission tomography (PET) scan confirms the presence of amyloid pathology.
Lumbar puncture confirms at least one qualifying cerebrospinal fluid finding, as determined by the laboratory assay: elevated phosphorylated tau (P-tau) and/or total tau (T-tau) with reduced beta amyloid-42 (AB42); low AB42/AB40 ratio; elevated P-tau/AB42 ratio; or elevated T-tau/AB42 ratio.

Pretreatment MRI: Member has a recent brain MRI to evaluate for pre-existing amyloid-related imaging abnormalities (ARIA).Within 1 year before treatment initiation

ApoE epsilon 4 risk disclosure

ApoE epsilon 4 genotype testing has been performed before treatment initiation to inform the member of the risk of developing ARIA.
ApoE epsilon 4 genotype testing has not been performed, and the prescriber informed the member that it cannot be determined whether the member is ApoE epsilon 4 homozygous and may be at higher risk for ARIA.

Concurrent antithrombotic therapy: If aspirin, another antiplatelet, or an anticoagulant is being used concurrently, the member has been on a stable dose before initiation of Leqembi.Stable for at least 4 weeks before initiation

Applies when concurrent antithrombotic use is present.

Continuation therapy - first reauthorization

First reauthorization after the initial 6-month approval period may be granted for 12 months when all applicable criteria are met.

Prior initial approval: Member met all initial authorization criteria at the time of initial approval.

MRI monitoring: Member has been evaluated for evidence of amyloid-related imaging abnormalities (ARIA) on MRI before the fifth, seventh, and fourteenth doses.MRI before doses 5, 7, and 14

ARIA-E management

For mild ARIA-E with no symptoms or mild clinical symptoms, dosing may continue based on clinical judgment.
For mild ARIA-E with moderate or severe symptoms, moderate ARIA-E with any symptom status, or severe ARIA-E with any symptom status, dosing is suspended until MRI demonstrates radiographic resolution and symptoms resolve.

Continuation therapy - beyond 18 months

Reauthorizations beyond the initial 18 months of therapy may be granted for 12 months when all of the following criteria are met.

Prior initial approval: Member met all initial authorization criteria at the time of initial approval.

Positive clinical response

Clinical Dementia Rating-Global Score (CDR-GS) remains 0.5 or 1.CDR-GS 0.5 or 1
MMSE decline is 3 points or less per year.MMSE decline <=3 points per year
MoCA score remains greater than or equal to 16.MoCA >=16

Coverage is not provided when cognitive impairment is suspected to result from a neurodegenerative condition other than Alzheimer's disease, including frontotemporal lobar degeneration or possible or probable dementia with Lewy bodies.

Coverage is not provided for a transient ischemic attack, stroke, or seizure within the past 12 months.

Coverage is not provided for a bleeding disorder that is not adequately controlled, including a platelet count below 50,000 or an international normalized ratio (INR) above 1.5.

Leqembi must not be used in combination with another amyloid beta-directed antibody, including aducanumab.

Clinical Thresholds and Coding Criteria

Age eligibility

Standard age thresholdMember is 50 years of age or older.

Younger than 50Member younger than 50 must have an APP, PSEN1, or PSEN2 genetic mutation, or other clinical documentation supporting early-onset Alzheimer’s disease.

Early-onset documentationGenetic testing or clinical documentation supporting early-onset Alzheimer’s disease is required when the member is younger than 50.

CDR-GS threshold

Qualifying CDR-GSA Clinical Dementia Rating-Global Score of 0.5 or 1 qualifies at baseline.

CDR-GS 0.5A score of 0.5 represents very mild dementia.

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Leqembi (lecanemab-irmb). Submit the request through the HMSA medical specialty drug policy process.

Prior Authorization

Prior Authorization Required for Leqembi

Coverage for Leqembi requires prior authorization before treatment is initiated.

Documentation Required

Initial Request Documentation

For an initial request, submit records supporting the member's eligibility and diagnosis, including genetic or early-onset Alzheimer's documentation when applicable.

Leqembi Clinical Background

Leqembi (lecanemab-irmb) is indicated for the treatment of Alzheimer's disease. Treatment should be initiated during the mild cognitive impairment or mild dementia stage, the population studied in clinical trials. Coverage requires objective cognitive impairment and biological confirmation of amyloid pathology; continued treatment includes serial MRI surveillance for amyloid-related imaging abnormalities and assessment of clinical response.

Key Clinical Definitions

Mild cognitive impairment due to Alzheimer’s disease

Cognitive concernA reported or observed change in cognition is present, based on the patient, informant, or clinician’s report or observation.

Objective impairmentObjective impairment is present in one or more cognitive domains, typically including memory, based on formal or bedside testing.

Functional independenceIndependence in functional abilities is preserved.

Dementia statusThe individual is not demented.

Clinical Dementia Rating-Global Score (CDR-GS)

Assessment methodThe CDR is obtained through semi-structured interviews of the patient and informants.

Initial Therapy

Initial therapy - Alzheimer's disease

Authorization of 6 months may be granted for Alzheimer's disease when all of the following criteria are met.

Age or early-onset disease

Member is 50 years of age or older.50 years or older
Member is younger than 50 years and has an APP, PSEN1, or PSEN2 mutation, or other clinical documentation supporting early-onset Alzheimer's disease.

Disease stage: Member has mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia.

Objective baseline cognitive impairment:

Continuation and Reauthorization

First reauthorization

First reauthorization after the initial 6-month approval period may be granted for 12 months when all criteria are met.

Prior initial approval: Member met all initial authorization criteria at the time of initial approval.

MRI monitoring: Member has been evaluated for ARIA on MRI before the fifth, seventh, and fourteenth doses.MRI before doses 5, 7, and 14

ARIA-E management

For mild ARIA-E with no symptoms or mild clinical symptoms, dosing may continue based on clinical judgment.

Policy Summary

PayerHawaii Medical Service Association (HMSA)

PolicyLEQEMBI (lecanemab-irmb) Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateFebruary 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization requests for Leqembi using the HMSA medical specialty drug policy website and fax form.

SourceLink

On This Page

ARIA-H management

For mild ARIA-H without symptoms, dosing may continue.
For mild ARIA-H with symptoms, moderate ARIA-H with any symptom status, or severe ARIA-H with any symptom status, dosing is suspended until MRI demonstrates radiographic stabilization and symptoms resolve.

A score of 1 represents mild dementia.

MMSE threshold

Qualifying MMSE rangeA baseline Mini-Mental Status Examination score of 21–30 qualifies.

Minimum scoreThe qualifying range begins at 21.

Maximum scoreThe qualifying range extends through 30.

MoCA threshold

Qualifying MoCA thresholdA Montreal Cognitive Assessment score of greater than or equal to 16 qualifies at baseline.

Minimum qualifying scoreThe minimum qualifying MoCA score is 16.

Assessment timingThe qualifying score must be documented at baseline.

Pretreatment MRI

Required imagingA recent brain MRI is required to evaluate for pre-existing amyloid-related imaging abnormalities (ARIA).

Timing before initiationThe MRI must be obtained within one year before initiating treatment.

PurposeThe pretreatment MRI evaluates for pre-existing ARIA before Leqembi is initiated.

Stable antithrombotic therapy

Applicable therapyThe requirement applies when aspirin, another antiplatelet, or an anticoagulant is used concurrently.

Required stabilityThe member must be on a stable antithrombotic dose for at least 4 weeks before initiation.

TimingThe 4-week stable-dose period must occur before initiation of the requested medication.

Platelet count

Coverage exclusionCoverage is excluded for an inadequately controlled bleeding disorder when the platelet count is less than 50,000.

ThresholdPlatelet count below 50,000 triggers the exclusion.

Bleeding-risk contextThe platelet threshold is listed as part of the policy’s bleeding-disorder exclusion.

INR

Coverage exclusionCoverage is excluded for an inadequately controlled bleeding disorder when the INR is greater than 1.5.

ThresholdINR above 1.5 triggers the exclusion.

Bleeding-risk contextThe INR threshold is listed as part of the policy’s bleeding-disorder exclusion.

MMSE continuation response

Continuation responseA positive clinical response may be shown by an MMSE decline of 3 points or less per year.

Maximum annual declineThe maximum stated decline is 3 MMSE points per year.

Assessment consistencyThe repeat assessment tool must be the same tool submitted with the initial request.

Genetic testing results documenting an APP, PSEN1, or PSEN2 mutation, if applicable.
Clinical documentation supporting early-onset Alzheimer's disease for members younger than 50, if applicable.
Chart notes documenting mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease.
Baseline results from at least one qualifying cognitive assessment tool: CDR-GS, MMSE, or MoCA.
Evidence of amyloid pathology from a baseline PET scan or lumbar puncture.
Brain MRI performed within 1 year before treatment initiation.

Documentation Required

Continuation Request Documentation

For continuation requests, submit current clinical assessments and the required MRI monitoring records.

The most recent CDR-GS, MMSE, or MoCA assessment, performed less than 1 month before the continuation request.
MRI results obtained before the 5th, 7th, and 14th doses.

Documentation Required

Required Baseline Clinical Evidence

Document the baseline clinical evidence required for the initial 6-month authorization.

Member is age 50 or older, or, if younger than 50, has an APP, PSEN1, or PSEN2 mutation or other documentation supporting early-onset Alzheimer's disease.
Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia, with objective evidence of cognitive impairment.
At least one qualifying baseline score: CDR-GS 0.5 or 1; MMSE 21–30; or MoCA ≥16.
Amyloid pathology confirmed by PET or lumbar puncture showing qualifying CSF findings, including abnormal amyloid and/or tau biomarkers.
Brain MRI performed within 1 year before initiation to evaluate for pre-existing ARIA.
ApoE ε4 genotype testing performed before treatment, or documentation that testing was not performed and the member was informed that homozygous status and higher ARIA risk cannot be determined.
If taking aspirin, another antiplatelet, or an anticoagulant, the member must have received a stable dose for at least 4 weeks before initiation.

Prior Authorization

Prior Authorization Fax Form

Use the HMSA medical specialty drug policy fax form for prior authorization submissions.

Refer to the HMSA medical specialty drug policy website for the current fax form.

Denial Risk

Non-Alzheimer Neurodegenerative Disease

Coverage will not be provided when cognitive impairment is suspected to result from a neurodegenerative disease other than Alzheimer's disease.

Examples include frontotemporal lobar degeneration (FTLD) and Lewy body disease meeting consensus criteria for possible or probable dementia with Lewy bodies.

Denial Risk

Recent TIA, Stroke, or Seizure

Coverage will not be provided for a history of transient ischemic attack, stroke, or seizure within the preceding 12 months.

Confirm that no TIA, stroke, or seizure occurred during the 12 months before treatment.

Denial Risk

Uncontrolled Bleeding Risk

Coverage will not be provided for an inadequately controlled bleeding disorder.

Platelet count <50,000.
INR >1.5.

Denial Risk

Concurrent Amyloid Beta-Directed Antibody

Leqembi must not be used in combination with another amyloid beta-directed antibody.

Examples include aducanumab.

Denial Risk

Failure to Meet Initial Clinical Criteria

The initial request may be denied if the member does not meet all initial authorization requirements for Alzheimer's disease.

Does not meet the applicable age or early-onset Alzheimer's documentation requirement.
Does not have mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia with objective cognitive impairment.
Does not have a qualifying baseline CDR-GS, MMSE, or MoCA score.
Does not have PET- or lumbar-puncture-confirmed amyloid pathology.
Does not have a brain MRI within 1 year before initiation.
Required ApoE ε4 risk counseling/testing information is absent.
Concurrent antithrombotic therapy has not been stable for at least 4 weeks, when applicable.

Denial Risk

Failure to Meet Continuation Criteria

Reauthorization may be denied when continuation requirements are not met. The member must have satisfied the initial criteria, completed required ARIA MRI monitoring, and—after the initial 18 months—demonstrated a positive clinical response.

MRI monitoring was not completed before the 5th, 7th, and 14th doses, or ARIA findings do not support continued dosing.
For ARIA-E, dosing must be suspended when required until MRI resolution and symptoms resolve; for ARIA-H, dosing must be suspended when required until MRI stabilization and symptoms resolve.
After the initial 18 months, the member must show stabilization or slowed progression using the same assessment tool submitted initially: CDR-GS 0.5 or 1, MMSE decline of no more than 3 points per year, or MoCA ≥16.
Requests with scores outside the specified ranges or greater-than-allowed progression may be reviewed case by case.

Domains assessedCognitive functioning is rated in memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care.

ScaleThe CDR uses a 5-point scale from 0 to 3, including half-point scoring at 0.5.

Score meanings0 is normal; 0.5 is very mild dementia; 1 is mild dementia; 2 is moderate dementia; and 3 is severe dementia.

Amyloid-related imaging abnormalities (ARIA)

ARIA definitionAmyloid-related imaging abnormalities are MRI findings associated with amyloid-targeting therapy.

ARIA-EARIA-E consists of FLAIR hyperintensity reflecting edema or effusion-type changes, involving the sulcus, cortex, or subcortical white matter.

ARIA-H microhemorrhageARIA-H microhemorrhage is classified by the number of new incident microhemorrhages: 1–4, 5–9, or 10 or more.

ARIA-H superficial siderosisARIA-H superficial siderosis is classified by focal areas: 1, 2, or more than 2 areas.

Member has objective evidence of cognitive impairment at baseline, as described in Appendix A.

Baseline cognitive score

CDR-GS is 0.5 or 1.CDR-GS 0.5 or 1
MMSE is 21-30.MMSE 21-30
MoCA is greater than or equal to 16.MoCA >=16

Confirmed amyloid pathology

PET scan confirms amyloid pathology.
Lumbar puncture confirms at least one qualifying CSF finding: elevated P-tau and/or T-tau with reduced AB42, low AB42/AB40 ratio, elevated P-tau/AB42 ratio, or elevated T-tau/AB42 ratio.

Pretreatment MRI: Member has a recent brain MRI to evaluate for pre-existing ARIA.Within 1 year before treatment initiation

ApoE epsilon 4 risk disclosure

ApoE epsilon 4 genotype testing has been performed before treatment initiation to inform the member of ARIA risk.
Testing has not been performed and the prescriber informed the member that ApoE epsilon 4 homozygosity cannot be determined and may confer higher ARIA risk.

Concurrent antithrombotic therapy: If aspirin, another antiplatelet, or an anticoagulant is used concurrently, the member has been on a stable dose for at least 4 weeks before initiation.At least 4 weeks before initiation

For mild ARIA-E with moderate or severe symptoms, moderate ARIA-E with any symptom status, or severe ARIA-E with any symptom status, dosing should be suspended until MRI shows radiographic resolution and symptoms resolve.

ARIA-H management

For mild ARIA-H without symptoms, dosing may continue.
For mild ARIA-H with symptoms, moderate ARIA-H with any symptom status, or severe ARIA-H with any symptom status, dosing should be suspended until MRI shows radiographic stabilization and symptoms resolve.

Continuation beyond 18 months

Reauthorizations beyond the initial 18 months may be granted for 12 months when all criteria are met.

Prior initial approval: Member met all initial authorization criteria at the time of initial approval.

Positive clinical response

CDR-GS remains 0.5 or 1.CDR-GS 0.5 or 1
MMSE decline is 3 points or less per year.MMSE decline <=3 points per year
MoCA score remains greater than or equal to 16.MoCA >=16