CurrentmhnPolicy CP.PHAR.596

Clinical Policy: Lecanemab-irmb (Leqembi)

Defines medical necessity criteria, initial and continued therapy requirements, dosing limits, exclusions, documentation and authorization durations for lecanemab-irmb (Leqembi / Leqembi Iqlik) across Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Lecanemab-irmb (Leqembi)

Policy CodePolicy CP.PHAR.596

Change TypeMaterial updates to criteria, dosing, exclusions and testing requirements

Effective DateJan 6, 2023

Next Review Date

Key ActionProvider must submit documentation showing member meets all approval criteria including diagnosis, cognitive and functional test scores, MRI results, and beta-amyloid confirmation.

POLICY UPDATE CHANGES

Added specialist requirement and prescriber attestation re: ApoE4 ARIA risk per FDA labeling.

Removed requirement for enrollment in NIH-sponsored trial and added cognitive/functional testing and baseline MRI requirements per CMS registry requirements.

Added exclusion against concomitant use with Kisunla and clarified covered indication as 'MCI due to AD'.

Removed age limit of 50-90 years.

Added SC (Leqembi Iqlik) dosing and authorization limits and option for maintenance dosing every 4 weeks after 18 months.

Clarified timing for continued therapy neurocognitive testing (within last month) and pre-infusion MRI (within prior week).

1Covered FDA Indication (AD - MCI/mild dementia)

3Required baseline tests (amyloid PET or CSF, MRI, cognitive/functional)

10Max IV dose mg/kg q2w

360SC weekly dose (mg)

Coverage Summary

Coverage stance: covered_with_criteria for lecanemab-irmb (Leqembi / Leqembi Iqlik). Covered indication: treatment of MCI due to Alzheimer's disease or mild AD dementia per policy-aligned FDA indication. Approval requires confirmation of amyloid pathology, baseline brain MRI, and baseline cognitive and functional testing. Dosing options include IV infusion at a maximum of 10 mg/kg every 2 weeks and a subcutaneous option (Leqembi Iqlik) at 360 mg once weekly. Exclusions include current concomitant anticoagulant or antiplatelet therapy, concurrent use with Kisunla™, and recent (within 12 months) history of stroke, TIA, or seizures. Prescribing must be by or in consultation with a geriatrician or neurologist and prescriber attestation regarding ARIA risk in ApoE4 homozygotes is required.

Compact thresholds & dosing

MMSE>= 22

MoCA>= 16

FAQ<= 9

FAST3-4

CDR-SB0.5-9

Max IV dose10 mg/kg every 2 weeks

SC dose360 mg once weekly

Baseline MRI microhemorrhage limitFewer than 4 microhemorrhages (<= 10 mm)

Initial Therapy Criteria

Initial Approval Criteria - Alzheimer's Disease

Covered when ALL of the following are met:

ALL of the following

Diagnosis of MCI due to AD or mild AD dementia (see Appendix E)
Prescribed by or in consultation with a geriatrician or neurologist
Added specialist requirement per FDA labeling
Documentation of beta-amyloid plaques verified by one of
- Positron emission tomography scan
- Cerebrospinal fluid testing

Initial Therapy — Other Indications

Initial Approval Criteria - Other diagnoses/indications

If not FDA-approved indication or recent label change:

ANY of the following

If drug underwent label change within last 6 months not reflected here, follow specified formulary or non-formulary policies
Refer to CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.PMN.16
If requested use is not listed in Section III and criterion 1 above does not apply, refer to off-label use policy for the relevant line of business
Refer to CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Continuation Therapy Criteria

Continued Therapy - Alzheimer's Disease

Continued therapy authorized when ALL of the following are met:

ALL of the following

ANY of the following
- Member currently receiving medication via Centene benefit or member has previously met initial approval criteria
- Member currently receiving medication and enrolled in a state/product with continuity of care regulations
  Refer to CC.PHARM.03A and CC.PHARM.03B
Member is responding positively to therapy as evidenced by slowed decline in cognition
Recent cognitive test (within last month)

Continuation Therapy — Other Indications

Continued Therapy - Other diagnoses/indications

Refer to formulary/non-formulary or off-label policies when applicable

ANY of the following

If label changed within last 6 months not reflected, follow CP.CPA.190 or HIM.PA.33 or CP.PMN.255 or HIM.PA.103 or CP.PMN.16 as applicable
If requested use not listed in Section III and above does not apply, refer to off-label policies CP.CPA.09, HIM.PA.154, CP.PMN.53

Diagnoses / Indications Not Authorized

Diagnoses/Indications NOT authorized

Non-FDA approved indications not addressed in this policy are not authorized unless sufficient documentation per off-label use policies or evidence of coverage documents is provided

Provider Actions

Prior Authorization

Prior authorization required

Authorization is required prior to initiation. Initial approval duration: 3 months (equivalent to 6 IV doses). Continued therapy authorizations are tied to infusion counts and milestones (see continued therapy approval durations).

Initial: 3 months = 6 IV doses (approval duration)
Continued therapy: authorizations aligned to infusion counts (up to 6th, up to 13th, 12 per PA through first 18 months, then 12 months after 18 months)

Documentation Required

Submit supporting documentation

Submit office notes, laboratory results, and imaging demonstrating the member meets all approval criteria, including diagnosis, confirmation of beta-amyloid plaques, baseline and/or recent cognitive and functional test scores, and MRI results.

Applicable Codes

Drug J-code (informational)HCPCS

J0174

Lecanemab-irmb, 1 mg

Clinical Evidence

Evidence summary: Key randomized controlled evidence includes Van Dyck et al., NEJM 2023 demonstrating efficacy of lecanemab in early Alzheimer's disease. Coverage criteria are aligned with the FDA Prescribing Information for Leqembi/Leqembi Iqlik and with the CMS National Coverage Determination for anti-amyloid monoclonal antibodies (CAG-099469N). Policy elements (amyloid confirmation, baseline and follow-up MRIs, and required cognitive/functional testing) reflect FDA labeling and CMS registry requirements.

Background

Background: Lecanemab-irmb is a monoclonal antibody that targets amyloid beta and is FDA-approved for use in patients with mild cognitive impairment or mild dementia due to Alzheimer's disease. MRI safety screening and follow-up MRIs are required to manage the boxed warning and risk of amyloid-related imaging abnormalities (ARIA). The policy requires specialist prescribing (geriatrician or neurologist) and a prescriber attestation that ARIA risk in ApoE4 homozygotes has been discussed. Dosing and administration options per the Prescribing Information include IV infusions at 10 mg/kg every 2 weeks with an option to transition to every 4 weeks after 18 months, and a subcutaneous formulation (Leqembi Iqlik) available as a 360 mg weekly autoinjector.

Definitions

ARIAAmyloid-related imaging abnormalities

MCIMild cognitive impairment

MMSEMini-Mental State Examination

MoCAMontreal Cognitive Assessment

FAQ

Revision History

2023-01-06policy_effective

Policy effective date published (Clinical Policy CP.PHAR.596).

2023-01-06material_change_added

Added specialist prescribing requirement: prescriber must be a geriatrician or neurologist and attest that ARIA risk in ApoE4 homozygotes was discussed, aligned with FDA labeling.

2023-01-06material_change_revised

Initial and continued approval criteria updated per CMS registry/FDA labeling: removed NIH trial enrollment requirement; added baseline cognitive (MMSE ≥ 22 or MoCA ≥ 16) and functional testing (FAQ ≤ 9, FAST 3-4, or CDR‑SB 0.5‑9); added baseline MRI within prior year with specific hemorrhage/edema/siderosis exclusions; exclusions for recent TIA/stroke/seizures and concomitant anticoagulant/antiplatelet use.

Policy Summary

Payermhn

PolicyClinical Policy: Lecanemab-irmb (Leqembi)

Policy CodePolicy CP.PHAR.596

Change TypeMaterial updates to criteria, dosing, exclusions and testing requirements

Effective DateJan 6, 2023

Next Review Date

Key ActionProvider must submit documentation showing member meets all approval criteria including diagnosis, cognitive and functional test scores, MRI results, and beta-amyloid confirmation.

On This Page

Baseline cognitive test (one of)

Mini-Mental State Examination (MMSE) score ≥ 22MMSE ≥ 22
Montreal Cognitive Assessment (MoCA) score ≥ 16MoCA ≥ 16

Baseline functional test (one of) with resulting score

Functional Assessment Questionnaire (FAQ) score ≤ 9FAQ ≤ 9
Functional Assessment Staging Test (FAST) score of 3-4FAST = 3-4
Clinical Dementia Rating-Sum of Boxes (CDR-SB) of 0.5-9CDR-SB 0.5-9

ALL of the following

Fewer than 4 microhemorrhages (defined as ≤ 10 mm at the greatest diameter)microhemorrhages ≤ 3 (≤10 mm)
Absence of any macrohemorrhages > 10 mm at greatest diameterno macrohemorrhage > 10 mm
Absence of superficial siderosis
Absence of vasogenic edema, cerebral contusion, encephalomalacia, aneurysms, or vascular malformations

No history of transient ischemic attacks (TIA), stroke, or seizures within the past 12 months

Member is not currently taking concomitant anticoagulant or antiplatelet therapy

Prescriber attestation that prescriber discussed potentially increased risk of amyloid-related imaging abnormalities (ARIA) in ApoE4 genetic homozygotes

Leqembi is not prescribed concurrently with Kisunla™

Dose does not exceed 10 mg/kg every 2 weeksmax 10 mg/kg IV q2w

title”: “Initial Approval Criteria - Alzheimer's Disease

MMSE score ≥ 22MMSE ≥ 22

MoCA score ≥ 16MoCA ≥ 16

Recent functional test (within last month)

FAQ score ≤ 9FAQ ≤ 9
FAST score of 3-4FAST = 3-4
CDR-SB of 0.5-9CDR-SB 0.5-9

ALL of the following

Absence of any macrohemorrhage (> 10 mm at greatest diameter; symptomatic or not)no macrohemorrhage > 10 mm
Fewer than 10 cerebral microhemorrhages cumulatively (symptomatic or not)microhemorrhages < 10 cumulatively
Absence of symptomatic cerebral microhemorrhages or symptomatic superficial siderosis

Member is not currently taking concomitant anticoagulant or antiplatelet therapy

Leqembi or Leqembi Iqlik are not prescribed concurrently with Kisunla

Dose increase request must not exceed

IV infusions: 10 mg/kg once every 2 weeksmax IV 10 mg/kg q2w
SC injections: 360 mg once weeklymax SC 360 mg weekly

Office/clinic notes documenting diagnosis and prescriber attestation
Laboratory results or CSF demonstrating amyloid when applicable
Imaging reports (brain MRI) demonstrating required findings
Baseline and/or recent cognitive and functional test scores

Documentation Required

MRI timing requirements

Baseline brain MRI within the prior year is required for initiation. For continued therapy, a brain MRI obtained within the week prior to the 7th and 14th infusions is required to document absence of specified findings.

Baseline MRI: within the last year prior to initiation
Pre-7th and pre-14th infusion MRI: within the last week prior to those infusions
Exclude macrohemorrhage > 10 mm at greatest diameter
Baseline: fewer than 4 microhemorrhages (≤ 10 mm); pre-7th/14th: fewer than 10 cumulative microhemorrhages
Absence of superficial siderosis
Absence of vasogenic edema, cerebral contusion, encephalomalacia, aneurysms, or vascular malformations

Documentation Required

Cognitive/functional testing timing

Baseline cognitive and functional testing is required for initiation. For continued therapy, recent (within the last month) cognitive and functional test results are required to document ongoing eligibility.

Accepted cognitive tests and thresholds: MMSE ≥ 22; MoCA ≥ 16
Accepted functional tests and thresholds: FAQ ≤ 9; FAST = 3-4; CDR-SB = 0.5-9
Recent testing for continuation must be within the last month

Denial Risk

Concomitant anticoagulant/antiplatelet use exclusion

Claims may be denied if the member is currently taking concomitant anticoagulant or antiplatelet therapy or has recent history of TIA, stroke, or seizures per policy criteria. Concurrent prescribing with Kisunla is also excluded.

Exclusion for concomitant anticoagulant/antiplatelet use (may lead to denial)
Exclusion for recent TIA, stroke, or seizures within the past 12 months
Leqembi / Leqembi Iqlik must not be prescribed concurrently with Kisunla

Billing Rule

Dose limits enforcement

Dose requests that exceed the policy limits will not meet criteria. Maximum dosing allowed: IV 10 mg/kg every 2 weeks or SC 360 mg once weekly.

Requests exceeding 10 mg/kg IV every 2 weeks or 360 mg weekly SC will be denied
Informational HCPCS code: J0174 (lecanemab-irmb, 1 mg)

Functional Assessment Questionnaire

FASTFunctional Assessment Staging Test

CDR-SBClinical Dementia Rating - Sum of Boxes

2024-08-07material_change_added

Clarified covered indication wording as 'MCI due to AD' and added exclusion against concomitant use with Kisunla; clarified reauthorization timing to authorize up to the 13th infusion for members with <14 but ≥7 total infusions.

2024-12-24material_change_removed

Removed previous age limit (50–90 years) from the policy.

2025-03-11material_change_added

Updated maintenance dosing options to include transition after 18 months from IV 10 mg/kg every 2 weeks to maintenance IV 10 mg/kg every 4 weeks per Prescribing Information; noted SC dosing regimen (Leqembi Iqlik) as 360 mg weekly.

2025-05-01clarification

Clarified Continued Therapy section wording to remove the term 'baseline' for required cognitive and functional tests so therapy is not continued in those who have progressed beyond mild disease.

2025-09-02clarifiedLatest

Clarified reauthorization and monitoring timing: neurocognitive testing for continued therapy must be recent (within the last month) and pre-infusion MRIs required prior to the 7th and 14th infusions must be performed within the prior week; added dosing and authorization limits for FDA-approved SC Leqembi Iqlik; approval durations for initial and continued therapy specified (initial 3 months = 6 IV doses; continued therapy authorization tied to infusion counts and milestones).

2025-11-25policy_last_reviewLatest

Policy last review date recorded.