CurrentMass General Brigham Health PlanPolicy N/A

Leqembi_Alzheimers_Criteria

Policy Summary

PayerMass General Brigham Health Plan

PolicyLeqembi_Alzheimers_Criteria

Policy CodePolicy N/A

Change TypeRevised (05/15/25); Added (09/13/23)

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization is required for Leqembi; contact the provided Medical or Pharmacy phone/fax and submit required documentation when all clinical criteria are met.

SourceLink

POLICY UPDATE CHANGES

05/15/25 Reviewed and updated for P&T; formatting and references updated; Aduhelm removed due to removal from the market; Adlarity removed from document and guidance to pharmacy benefit provided; reauthorization criteria split based on first and subsequent requests.

Leqembi included in criteria (09/13/2023) with provider specialty clarification, SLUMS added, MRI timeline changed from 3 to 12 months, and Leqembi preferred trial.

2Eligible diagnoses (MCI, mild AD dementia)

3Accepted cognitive assessments

12 monthsRequired MRI within

Initial approval duration

12 monthsReauthorization duration

Coverage Summary

Defines prior authorization, clinical eligibility, dosing/monitoring and reauthorization criteria for Leqembi (lecanemab-irmb) under the pharmacy and medical benefits for Mass General Brigham Health Plan / MassHealth UPPL members, effective 2025-06-01. Coverage stance: covered_with_criteria. Prior authorization is required and will be granted only when the specified clinical criteria (diagnosis of MCI or mild dementia due to AD; objective amyloid biomarker evidence; specialist prescriber; recent brain MRI; baseline cognitive testing; appropriate dosing) and monitoring/reauthorization requirements are met.

Quick facts and thresholds

Eligible diagnosesMild cognitive impairment (MCI) OR mild dementia due to Alzheimer’s disease

Accepted cognitive assessmentsMMSE, MoCA, SLUMS

MMSE threshold>= 22

MoCA threshold> 15

Brain MRI recencyWithin the last 12 months

Baseline cognitive test recencyWithin the last 3 months prior to initiation

Initial approval duration6 months

Reauthorization duration12 months

Initial Authorization / New Member Continuation

Authorization may be granted for members when ALL of the following criteria are met:

ALL of the following

Diagnosis
- Mild cognitive impairment (MCI)
- Mild dementia associated with Alzheimer's disease (AD)
Test results indicating clinically significant AD neuropathology based on ONE of the following
- Amyloid PET

First Reauthorization (initial continuation)

Authorization for first reauthorization requires ALL of the following:

ALL of the following

Dosing: Appropriate dosing
Current cognitive function test within the past three months based on ONE of the following objective assessments
- MMSE: Mini Mental State Exam (MMSE)
- MoCA: Montreal Cognitive Assessment (MoCA)

Subsequent Reauthorization (after completion of 18 months)

Subsequent Reauthorization (after completion of 18 months of treatment)

Authorization for subsequent reauthorization requires ALL of the following:

ALL of the following

MRI attestation: Attestation that all MRI monitoring has been completed in accordance with the FDA approved label
Current cognitive function test within the past three months based on ONE of the following objective assessments
- MMSE: Mini Mental State Exam (MMSE)
- MoCA: Montreal Cognitive Assessment (MoCA)

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for Leqembi; contact phone/fax numbers provided for Medical and Pharmacy benefits. Authorization may be granted when all clinical criteria are met.

Documentation Required

Specialist prescriber requirement

Prescriber must be a specialist in dementia/Alzheimer's disease (e.g., neurologist, geriatric psychiatrist, geriatrician who specializes in treating dementia).

Applicable Codes

Plan identifiers / programmixed

MassHealth UPPL

Program/plan identifier

Background & Safety

Leqembi (lecanemab-irmb) received initial accelerated FDA approval and subsequently traditional approval after clinical benefit was established, and is indicated for treatment initiated in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease. There is a boxed warning for amyloid-related imaging abnormalities (ARIA), with higher risk noted in apolipoprotein E (ApoE) ε4 homozygotes. Definitions: ARIA = amyloid-related imaging abnormalities associated with anti-amyloid therapies; MCI = mild cognitive impairment.

Revision History

05/15/25revisedLatest

Reviewed and updated for P&T; Leqembi criteria retained; removed requirement for medical records and noted prior authorization information acceptable; formatting and references updated; Aduhelm removed due to market removal and Adlarity removed from document (guidance to pharmacy benefit provided); reauthorization criteria split into first and subsequent requests; effective 06/01/2025. (is_material: false)

09/13/2023added

Leqembi added to criteria; clarified provider specialty for prescribers, added SLUMS as an assessment option, changed MRI timeline from 3 months to 12 months, and noted Leqembi as a preferred trial; effective 10/02/2023.

Policy Summary

PayerMass General Brigham Health Plan

PolicyLeqembi_Alzheimers_Criteria

Policy CodePolicy N/A

Change TypeRevised (05/15/25); Added (09/13/23)

Effective DateJun 1, 2025

Next Review Date

Key ActionPrior authorization is required for Leqembi; contact the provided Medical or Pharmacy phone/fax and submit required documentation when all clinical criteria are met.

SourceLink

On This Page

Cerebrospinal fluid (CSF) biomarkers

Prescriber is a specialist in the treatment of dementia or Alzheimer's disease (e.g., neurologist, geriatric psychiatrist, geriatrician who specializes in treating dementia)

MRI: Member has had a brain magnetic resonance imaging (MRI) within the last 12 monthswithin the last 12 months

MRI monitoring per FDA label required

Baseline cognitive function test within the last three months based on ONE of the following objective assessments

MMSE: Mini Mental State Exam (MMSE) score >= 22>= 22
MoCA: Montreal Cognitive Assessment (MoCA) score > 15> 15

Dosing: Appropriate dosing

Must follow dosing consistent with prescribing information

SLUMS: Saint Louis University Mental Status Examination (SLUMS)

MRI attestation: Attestation that all MRI monitoring has been completed in accordance with the FDA approved label

SLUMS: Saint Louis University Mental Status Examination (SLUMS)

Continuation dosing rationale

Reduced frequency: Dosing frequency reduced to every four weeks
Rationale for biweekly: Clinical rationale for continuing biweekly dosing

Documentation Required

Evidence of AD neuropathology

Provide amyloid PET OR cerebrospinal fluid (CSF) biomarkers demonstrating clinically significant AD neuropathology.

Documentation Required

MRI monitoring attestation

Attestation must be provided that MRI monitoring has been completed in accordance with the FDA approved label for reauthorizations (first and subsequent).

Documentation Required

Cognitive testing documentation

Provide results of baseline and current cognitive function tests within the specified timeframes. Baseline testing: within 3 months prior to initiation. Current testing for reauthorization: within 3 months. Accepted tests include Mini Mental State Exam (MMSE), Montreal Cognitive Assessment (MoCA), or Saint Louis University Mental Status Examination (SLUMS).

Billing Rule

Approval durations

Initial approvals will be granted for 6 months. Reauthorizations will be granted for 12 months.