CurrentCareSourcePolicy N/A

Leqembi (lecanemab) coverage for early Alzheimer's disease

Defines medical benefit coverage and prior authorization requirements for Leqembi (lecanemab) for members with early Alzheimer's disease (mild cognitive impairment or mild dementia), including initial and reauthorization criteria and monitoring requirements.

Policy Summary

PayerCareSource

PolicyLeqembi (lecanemab) coverage for early Alzheimer's disease

Policy CodePolicy N/A

Change TypeAdded requirement; Dosing clarified; Removed measure

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document ApoE ε4 status (results or pending test), required cognitive scores, and MRI within 12 months before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

Added requirement for ApoE ε4 testing per updated prescribing information following conversion of accelerated approval to traditional approval status.

Specified dosing: 10 mg/kg IV infusion every 2 weeks, with option after 18 months to consider every 4 weeks.

Removed Wechsler memory score as a required measure.

6 monthsinitial approval duration

6 monthsreauthorization duration

10 mg/kg q2wstandard dosing

ApoE ε4 requiredgenotype testing

MRI within 12 mopre-treatment MRI

Coverage Criteria for Leqembi (lecanemab)

inv-01: Initial Therapy

Covered when ALL of the following are met for initial authorization

Initial Authorization: Member is ≥50 years of age; AND diagnosis of early Alzheimer's disease (mild cognitive impairment due to Alzheimer's disease OR mild Alzheimer's disease–related dementia per NIA‑AA); AND medication prescribed by or in consultation with a neurologist or geriatrician; AND presence of amyloid beta pathology confirmed by PET scan OR cerebrospinal fluid (CSF) lumbar puncture; AND documentation of CDR global score 0.5 or 1.0 AND CDR Memory Box score ≥0.5; AND MMSE score 22 to 30; AND brain MRI within the prior 12 months to evaluate for pre‑existing amyloid‑related imaging abnormalities (ARIA); AND ApoE ε4 status has been or will be determined prior to starting treatment (documentation of results or pending order); AND member does NOT have recent transient ischemic attack (TIA), stroke, or seizures within the last 12 months; AND no contraindication to MRI; AND not taking an anticoagulant.

If all met, approve for 6 months

inv-02: Continuation Therapy / Reauthorization

Covered when ALL of the following are met for reauthorization

Reauthorization:

Policy Summary

PayerCareSource

PolicyLeqembi (lecanemab) coverage for early Alzheimer's disease

Policy CodePolicy N/A

Change TypeAdded requirement; Dosing clarified; Removed measure

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document ApoE ε4 status (results or pending test), required cognitive scores, and MRI within 12 months before initiating therapy.

SourceLink

On This Page

Provider Requirements and Documentation

Prior Authorization

Prior authorization required

Leqembi (lecanemab) is a medical benefit that requires prior authorization. When all initial authorization criteria are met, approval will be granted for 6 months.

Step Therapy

No step therapy agents specified

No step therapy agents are specified in this policy for Leqembi; there are no required prior failed agents listed.

Documentation Required

Required clinical documentation

Provide clinical documentation showing the member meets all initial criteria: diagnosis of early Alzheimer’s disease per NIA‑AA (MCI due to AD or mild AD‑related dementia); age ≥50; medication prescribed by or in consultation with a neurologist or geriatrician; confirmation of amyloid pathology by PET or CSF; CDR global 0.5 or 1.0 and CDR Memory Box ≥0.5; MMSE 22–30; brain MRI within the prior 12 months to evaluate for pre‑existing ARIA; and ApoE ε4 status results or a pending order for testing.

Denial Risk

Missing diagnostic or monitoring documentation may trigger denial

If the chart does not document the required diagnostic or monitoring items, the request may be denied. Missing items that commonly trigger denial include lack of documented early Alzheimer’s diagnosis per NIA‑AA, absent qualifying cognitive scores (CDR global, CDR Memory Box, or MMSE), no MRI within 12 months, or missing ApoE ε4 results or a pending test order.

Key Definitions

Amyloid‑related imaging abnormalities (ARIA)

DefinitionRadiographic findings associated with anti‑amyloid therapies, including edema (ARIA‑E) and hemosiderin deposition/microhemorrhages (ARIA‑H)

Monitoring requirementBrain MRI within prior 12 months required to evaluate for pre‑existing ARIA before initiation

Risk noteHigher incidence in ApoE ε4 homozygotes; monitoring during treatment per prescribing information

Early Alzheimer's disease

DefinitionMild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease–related dementia as per NIA‑AA criteria (population studied)

Indication contextLeqembi treatment is intended for patients in this early AD population (stage 3 or 4 trial population)

DocumentationDiagnosis per NIA‑AA criteria must be included in prior authorization request

Background on Leqembi

Leqembi (lecanemab) is an anti-amyloid beta monoclonal antibody that was initially granted accelerated FDA approval and subsequently converted to traditional approval after confirmatory data. Serious adverse events related to anti-amyloid therapies, described as amyloid-related imaging abnormalities (ARIA) including ARIA-E (edema) and ARIA-H (hemosiderin deposition/microhemorrhages), are recognized risks and require ongoing radiographic surveillance. Policy updates include an operational requirement that ApoE ε4 testing be performed (results documented or a pending test order) prior to initiation, and MRI monitoring per the prescribing information must be documented during reauthorization.

OpenPayer

Leqembi (lecanemab) coverage for early Alzheimer's disease

Coverage Criteria for Leqembi (lecanemab)

Initial Therapy — Dosing and Eligibility

Continuation / Reauthorization Requirements

Clinical Score Thresholds and Coding Key Values

Provider Requirements and Documentation

Key Definitions

Background on Leqembi

Dose and Quantity Limits

Site of Care and Infusion Setting