CurrentNorth Carolina MedicaidPolicy N/A

Leqembi Injection Prior Approval Criteria

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This policy governs North Carolina Medicaid prior approval for Leqembi Injection, an amyloid-directed monoclonal antibody, in beneficiaries with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia. It specifies initial approval, renewal, safety, diagnostic, monitoring, and specialist-prescribing requirements.

Policy Summary

PayerNorth Carolina Medicaid

PolicyLeqembi Injection Prior Approval Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior approval for Leqembi Injection and document that all applicable clinical, diagnostic, safety, monitoring, age, and specialist criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum beneficiary age

18–25MoCA range

Within 1 yearPre-treatment MRI

Infusions 5, 7, 14Renewal MRI monitoring

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CurrentNorth Carolina MedicaidPolicy N/A

Leqembi Injection Prior Approval Criteria

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Policy Summary

PayerNorth Carolina Medicaid

PolicyLeqembi Injection Prior Approval Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior approval for Leqembi Injection and document that all applicable clinical, diagnostic, safety, monitoring, age, and specialist criteria are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

18+Minimum beneficiary age

18–25MoCA range

Within 1 yearPre-treatment MRI

Infusions 5, 7, 14Renewal MRI monitoring

6 monthsMaximum approval period

Coverage Criteria

Initial Therapy

Covered for initial therapy when ALL of the following are met:

ALL of the following

Diagnosis of MCI due to AD or mild Alzheimer's dementia, evidenced by ALL of the following
- Clinical Dementia Rating (CDR)-Global score of 0.5 to 1
- Memory Box score ≥ 0.5
- ONE of the following
  - Montreal Cognitive Assessment (MoCA) score 18 to 25, inclusive
    The range of scores may be adjusted based on the patient's educational status.
  - Equivalent tool indicating MCI or mild dementia
- Objective evidence of cognitive impairment at screening
- Positive amyloid beta plaque evidence on positron emission tomography (PET) scan or cerebrospinal fluid (CSF) assessment of amyloid beta (1-42)
Beneficiary is age 18 or older
Prescriber attests that other conditions causing similar symptoms have been ruled out, including vascular dementia, dementia with Lewy bodies, frontotemporal dementia, and normal pressure hydrocephalus
Beneficiary does not have risk factors for intracerebral hemorrhage
Beneficiary has not had a stroke, transient ischemia attack (TIA), or seizure in the last 12 months
Beneficiary has not demonstrated clinically significant and unstable psychiatric illness in the last 6 months
Beneficiary is not currently receiving anti-platelet agents, except prophylactic aspirin or clopidogrel, anticoagulants such as Factor Xa inhibitors, or anti-thrombins such as heparin
Beneficiary has had a recent brain magnetic resonance imaging (MRI) within one year prior to initiating treatment
Baseline disease severity has been assessed using an objective measure or tool, such as MoCA, Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-13), Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment version (ADCS-ADL-MCI), or Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Leqembi is prescribed by or in consultation with a neurologist, geriatrician, or geriatric psychiatrist

Continuation or Renewal Therapy

Covered for continuation or renewal therapy when ALL of the following are met:

ALL of the following

Beneficiary continues to meet the initial-therapy criteria
Scoring on an objective measure or tool, such as ADAS-Cog 13, ADCS-ADL-MCI, MMSE, or CDR-SB, demonstrates improvement, stability, or slowing of decline in cognitive and/or functional impairment
Beneficiary has not progressed to moderate or severe Alzheimer's disease
Beneficiary has not experienced any treatment-restricting adverse effects, such as severe hypersensitivity reactions
Beneficiary has undergone MRI prior to the 5th, 7th, and 14th infusions to monitor for ARIA with edema (ARIA-E) or ARIA with hemosiderin deposition (ARIA-H)

Treatment Suspension

Leqembi administration must be suspended and not resumed until MRI demonstrates radiographic resolution and stabilization of symptoms when the following circumstance occurs:

ALL of the following

ARIA-E is asymptomatic or mildly symptomatic with moderate to severe radiographic severity
Leqembi administration is suspended until MRI demonstrates radiographic resolution and symptoms have stabilized

ARIA-Based Treatment Suspension and Resumption

Leqembi administration must be suspended and not resumed until MRI demonstrates radiographic resolution and stabilization of symptoms in the event of ANY of the following ARIA conditions:

ANY of the following

ARIA-E that is asymptomatic or mildly symptomatic with moderate to severe radiographic severity
ARIA-E with moderate to severe symptoms and any degree of radiographic severity
ARIA-H that is asymptomatic with moderate radiographic severity
ARIA-H with moderate to severe symptoms and any degree of radiographic severity
ARIA-H with severe radiographic severity

Beneficiary does not have risk factors for intracerebral hemorrhage, including prior cerebral hemorrhage greater than 1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, evidence of vasogenic edema, cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts or stroke involving a major vascular territory, or severe small vessel or white matter disease.

Beneficiary has not had a stroke, transient ischemia attack (TIA), or seizure in the last 12 months.

Beneficiary is not currently receiving anti-platelet agents, except prophylactic aspirin or clopidogrel, anticoagulants such as Factor Xa inhibitors, or anti-thrombins such as heparin.

Beneficiary has not progressed to moderate or severe Alzheimer's disease and has not experienced any treatment-restricting adverse effects, such as severe hypersensitivity reactions.

Initial Therapy Criteria

Initial Approval

Initial approval requires all of the following diagnosis, safety, age, MRI, baseline assessment, and specialist requirements.

Initial approval requirements

Diagnosis and amyloid confirmation: The patient has mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia, evidenced by a Clinical Dementia Rating-Global score of 0.5 to 1, Memory Box score of at least 0.5, Montreal Cognitive Assessment score of 18 to 25 inclusive or an equivalent tool indicating MCI or mild dementia with possible adjustment based on educational status, objective evidence of cognitive impairment at screening, and a positive PET scan or CSF assessment for amyloid beta (1-42) plaque.CDR-Global 0.5-1; Memory Box ≥ 0.5; MoCA 18-25 or equivalent
Age: The beneficiary is age 18 or older.≥18 years

Continuation and Renewal Criteria

Renewal Criteria

Renewal requires continued satisfaction of the initial criteria and all of the following additional requirements.

Renewal requirements: The beneficiary continues to meet the initial approval criteria; scoring on an objective measure or tool demonstrates improvement, stability, or slowing of decline in cognitive and/or functional impairment; the beneficiary has not progressed to moderate or severe Alzheimer's disease; the beneficiary has not experienced treatment-restricting adverse effects such as severe hypersensitivity reactions; and MRI has been performed before the 5th, 7th, and 14th infusions to monitor for ARIA-E or ARIA-H.MRI before infusions 5, 7, and 14

All renewal requirements are required.

Continuation After ARIA

During ongoing therapy, suspend Leqembi administration if ANY of the following ARIA-E or ARIA-H conditions occurs.

ARIA-based continuation requirement

Clinical Thresholds and Monitoring Parameters

Clinical Dementia Rating-Global

AssessmentClinical Dementia Rating (CDR)-Global

Required score0.5 to 1

UseRequired as evidence of mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia

Memory Box Score

AssessmentMemory Box score

Required minimum≥ 0.5

UseRequired as part of the diagnosis criteria for mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Approval Required

Prior approval remains required when Leqembi is covered under this policy. Beneficiaries under age 21 are not exempt from prior approval; consult the NCTracks Provider Claims and Billing Assistance Guide and the EPSDT provider page for additional EPSDT requirements.

NCTracks Provider Claims and Billing Assistance Guide: https://www.nctracks.nc.gov/content/public/providers/provider-manuals.html
EPSDT provider page: https://medicaid.ncdhhs.gov/medicaid/get-started/find-programs-and-services-right-you/medicaid-benefit-children-and-adolescents

Prior Authorization

Initial Authorization Requirements

For initial authorization, document that the beneficiary meets all clinical, diagnostic, safety, monitoring, age, and specialist-prescriber requirements. The required diagnostic and safety records are detailed separately below.

Mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia, with the required objective severity and cognitive findings.

Policy Background

North Carolina Medicaid reviews Leqembi Injection for beneficiaries with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia with confirmed amyloid beta plaque. Coverage is subject to prior approval and requires objective cognitive and functional assessment, exclusion of alternative diagnoses and hemorrhage risks, specialist involvement, and MRI monitoring for amyloid-related imaging abnormalities. Continued treatment depends on remaining in the permitted disease stage, demonstrating clinical stability or slowed decline, tolerating treatment, and completing required surveillance.

ARIA Definitions

ARIA-E

DefinitionAmyloid-related imaging abnormality involving edema or effusion

Asymptomatic or mildly symptomaticModerate to severe radiographic severity

Moderate to severe symptomsAny degree of radiographic severity

ARIA-H

DefinitionAmyloid-related imaging abnormality involving hemorrhagic findings

AsymptomaticModerate radiographic severity

Moderate to severe symptomsAny degree of radiographic severity

Policy Summary

PayerNorth Carolina Medicaid

PolicyLeqembi Injection Prior Approval Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionSubmit prior approval for Leqembi Injection and document that all applicable clinical, diagnostic, safety, monitoring, age, and specialist criteria are met.

SourceLink

On This Page

Alternative causes excluded: The prescriber attests that other conditions causing similar symptoms have been ruled out, including vascular dementia, dementia with Lewy bodies, frontotemporal dementia, and normal pressure hydrocephalus.

Intracerebral hemorrhage risk excluded: The beneficiary does not have risk factors for intracerebral hemorrhage, including prior cerebral hemorrhage greater than 1 cm, more than 4 microhemorrhages, superficial siderosis, vasogenic edema, cerebral contusion, aneurysm, vascular malformation, infective lesions, multiple lacunar infarcts or stroke involving a major vascular territory, or severe small vessel or white matter disease.

Recent neurologic events excluded: The beneficiary has not had a stroke, transient ischemic attack, or seizure in the last 12 months.No stroke, TIA, or seizure within 12 months

Psychiatric stability: The beneficiary has not demonstrated clinically significant and unstable psychiatric illness in the last 6 months.

Concomitant medication restrictions: The beneficiary is not currently receiving antiplatelet agents, except prophylactic aspirin or clopidogrel, anticoagulants such as Factor Xa inhibitors, or antithrombins such as heparin.

Pre-treatment MRI: The beneficiary has had a recent brain MRI before initiating treatment.Within 1 year before initiation

Baseline severity assessment: Baseline disease severity has been assessed using an objective measure or tool, such as MoCA, ADAS-Cog-13, ADCS-ADL-MCI, or CDR-SB.

Specialist involvement: Leqembi is prescribed by or in consultation with a neurologist, geriatrician, or geriatric psychiatrist.

ARIA-E with moderate to severe radiographic severity: ARIA-E is asymptomatic or mildly symptomatic with moderate to severe radiographic severity.Moderate to severe radiographic severity

ARIA-E with moderate to severe symptoms: ARIA-E has moderate to severe symptoms with any degree of radiographic severity.Moderate to severe symptoms; any radiographic severity

ARIA-H with moderate radiographic severity: ARIA-H is asymptomatic with moderate radiographic severity.Moderate radiographic severity

ARIA-H with moderate to severe symptoms: ARIA-H has moderate to severe symptoms with any degree of radiographic severity.Moderate to severe symptoms; any radiographic severity

ARIA-H with severe radiographic severity: ARIA-H has severe radiographic severity.Severe radiographic severity

Montreal Cognitive Assessment

AssessmentMontreal Cognitive Assessment (MoCA) or equivalent tool

Required score18 to 25, inclusive

Educational adjustmentThe score range may be adjusted based on the patient’s educational status

Beneficiary Age

PopulationBeneficiary

Minimum age18 years

Approval requirementBeneficiary must be age 18 or older for initial approval

Recent Brain MRI

ImagingBrain magnetic resonance imaging (MRI)

Required timeframeWithin 1 year before initiating treatment

Approval requirementA recent brain MRI is required before treatment initiation

MRI Monitoring

Monitoring testMRI

First monitoring pointBefore the 5th infusion

Second monitoring pointBefore the 7th infusion

Third monitoring pointBefore the 14th infusion

PurposeMonitor for ARIA-E or ARIA-H

Age 18 or older; alternative causes of similar symptoms ruled out; no specified intracerebral-hemorrhage risk factors; and no stroke, TIA, or seizure in the prior 12 months.

No clinically significant and unstable psychiatric illness in the prior 6 months and no prohibited concurrent antiplatelet, anticoagulant, or antithrombin therapy.

Recent brain MRI, objective baseline disease-severity assessment, and prescribing by or consultation with a neurologist, geriatrician, or geriatric psychiatrist.

Unsupported block type: prior_auth

Billing Rule

Approval Period

Initial and renewal approvals may be authorized for a maximum of 6 months.

Apply the 6-month maximum authorization period to both initial and renewal approvals.

Documentation Required

Initial Diagnostic and Safety Documentation

Initial authorization documentation must establish the diagnosis, objective cognitive impairment, amyloid pathology, and treatment safety before therapy begins.

Clinical Dementia Rating-Global score 0.5 to 1.
Memory Box score ≥ 0.5.
Montreal Cognitive Assessment score 18 to 25 inclusive, or an equivalent tool indicating MCI or mild dementia; the range may be adjusted for educational status.
Objective cognitive impairment at screening.
Positive amyloid-beta plaque confirmation by PET scan or CSF amyloid beta (1-42) assessment.
Prescriber attestation that alternative causes of similar symptoms have been ruled out.
No specified intracerebral-hemorrhage risk factors; no stroke, TIA, or seizure in the prior 12 months; and no clinically significant unstable psychiatric illness in the prior 6 months.
No current prohibited antiplatelet, anticoagulant, or antithrombin therapy, and a brain MRI performed within 1 year before treatment initiation.

Documentation Required

Baseline Severity and Specialist Documentation

Document an objective baseline assessment of disease severity and identify the qualified prescriber or consultant before initial treatment is authorized.

Use an objective measure such as MoCA, ADAS-Cog-13, ADCS-ADL-MCI, or CDR-SB.
Leqembi must be prescribed by or provided in consultation with a neurologist, geriatrician, or geriatric psychiatrist.

Documentation Required

Renewal Documentation

Renewal documentation must demonstrate continued eligibility and an objective treatment benefit or lack of clinically meaningful decline.

Beneficiary continues to meet the initial approval criteria.
An objective measure such as ADAS-Cog-13, ADCS-ADL-MCI, MMSE, or CDR-SB demonstrates improvement, stability, or slowing of cognitive and/or functional decline.
Beneficiary has not progressed to moderate or severe Alzheimer's disease.
No treatment-restricting adverse effects have occurred.
MRI monitoring has been completed before the 5th, 7th, and 14th infusions.

Documentation Required

MRI and Symptom Stabilization Documentation

If treatment is suspended for specified ARIA, Leqembi must not be resumed until MRI demonstrates radiographic resolution and symptoms have stabilized.

Document the follow-up MRI findings and clinical symptom stabilization before resuming administration.

Denial Risk

Failure to Meet Initial Approval Criteria

Initial approval may be denied when the required diagnosis, objective severity, amyloid confirmation, age, safety screening, MRI, baseline assessment, or qualified specialist-prescriber requirements are not documented or are not met.

Denial risk includes cognitive or functional findings outside the required MCI or mild-dementia range, absent objective impairment, or negative or undocumented amyloid confirmation.
Denial risk includes age under 18, an alternative unresolved diagnosis, intracerebral-hemorrhage risk factors, recent stroke/TIA/seizure, unstable psychiatric illness, prohibited concurrent therapy, or missing recent MRI.
Denial risk includes missing objective baseline severity assessment or lack of prescribing by or consultation with a neurologist, geriatrician, or geriatric psychiatrist.

Denial Risk

Failure to Meet Renewal Criteria

Renewal may be denied when the beneficiary no longer meets the initial criteria, lacks objective evidence of benefit or slowed decline, progresses to moderate or severe Alzheimer's disease, experiences treatment-restricting adverse effects, or does not complete required MRI monitoring.

Objective cognitive or functional decline without improvement, stability, or slowing of decline does not support renewal.
Progression to moderate or severe Alzheimer's disease or a treatment-restricting adverse effect does not support renewal.
Missing or inadequate continuation of the initial approval criteria supports denial.

Denial Risk

ARIA-Related Treatment Suspension

Suspend Leqembi administration when a specified ARIA event occurs. Do not resume treatment until MRI demonstrates radiographic resolution and symptoms have stabilized.

Apply the suspension and MRI-based resumption requirement to the ARIA circumstances listed in this section.

Denial Risk

ARIA Requiring Treatment Suspension

Treatment must be suspended and not resumed until MRI demonstrates radiographic resolution and symptoms have stabilized for any of the following ARIA conditions.

ARIA-E that is asymptomatic or mildly symptomatic with moderate to severe radiographic severity.
ARIA-E with moderate to severe symptoms and any degree of radiographic severity.
ARIA-H that is asymptomatic with moderate radiographic severity.
ARIA-H with moderate to severe symptoms and any degree of radiographic severity.
ARIA-H with severe radiographic severity.

Severe radiographic findingSevere radiographic severity