ModifiedHealth NetPolicy CP PHAR.596

Lecanemab-irmb (Leqembi) coverage criteria

This policy governs medical necessity criteria, authorization, and continued therapy requirements for lecanemab-irmb (Leqembi) for members across Commercial, Health Insurance Marketplace, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyLecanemab-irmb (Leqembi) coverage criteria

Policy CodePolicy CP PHAR.596

Change TypeModified coverage criteria and exclusionsdosing and documentation updates

Effective Date01.06.23

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, baseline cognitive and functional testing, baseline MRI, and prescriber attestation about ARIA risk.

SourceLink

POLICY UPDATE CHANGES

Updated the maintenance dosing regimen to include the option for every 4 week dosing after the initial 18 months of therapy per the Prescribing Information.

Removed the requirement for enrollment in an NIH-sponsored trial for both Initial and Continued Therapy.

Added requirements for cognitive (MoCA or MMSE) and functional (FAQ, FAST, or CDR-SB) testing to align with CMS patient registry elements.

Added exclusions for concomitant anticoagulant/antiplatelet therapy and concomitant use with Kisunla.

Clarified reauthorization duration to authorize infusions up to the 13th total infusion for members with 14 total infusions but <= 7 total infusions at a given time.

Added attestation that prescriber has discussed potentially increased risk of ARIA in ApoE4 homozygotes and with concomitant anticoagulants/antithrombotics.

New HCPCS/J-code added for lecanemab administration (J0174 referenced).

3 monthsinitial approval (6 infusions)

10 mg/kgmaximum dose every 2 weeks

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Coverage Criteria for Lecanemab (Leqembi)

inv-01: Initial Therapy

Covered when ALL of the following are met

Initial Approval: 1. Diagnosis of mild cognitive impairment (MCI) due to Alzheimer disease (AD) or mild AD dementia (see Appendix E); 2. Prescribed by or in consultation with a geriatrician or neurologist; 3. Documentation of presence of beta-amyloid plaques verified by PET scan OR cerebrospinal fluid testing; 4. Baseline cognitive testing with MMSE >= 22 OR MoCA >= 16; 5. Baseline functional testing with one of: FAQ score < 9 OR FAST score 3-4 OR CDR-SB 0.5-9; 6. Recent (within last year) brain MRI showing all of the following: absence of macrohemorrhages > 10 mm; fewer than 4 microhemorrhages (< 10 mm); absence of superficial siderosis; absence of vasogenic edema, cerebral contusion, encephalomalacia, aneurysms, or vascular malformations; 7. Member is not currently taking concomitant anticoagulant or antiplatelet therapy; 8. No history of transient ischemic attack (TIA), stroke, or seizures within the past 12 months; 9. Prescriber attestation that the potentially increased risk of amyloid-related imaging abnormalities (ARIA) in ApoE4 homozygotes was discussed with the member; 10. Dose does not exceed 10 mg/kg every 2 weeks; 11. Leqembi is not prescribed concurrently with Kisunla.

Approval duration: 3 months (6 infusion doses)

inv-02: Continuation Therapy

Covered when ALL of the following are met for continuation

Continued Therapy: 1. Member is currently receiving medication via the Centene benefit or has previously met initial approval criteria; 2. Member is responding positively to therapy as evidenced by slowed decline in cognition; 3. Documentation of cognitive testing with MMSE >= 22 OR MoCA >= 16; 4. Documentation of functional testing with one of: FAQ score < 9 OR FAST score 3-4 OR CDR-SB 0.5-9; 5. Prior to the 7th infusion, recent (within the last month) brain MRI documenting: absence of any macrohemorrhage > 10 mm; fewer than 10 cumulative cerebral microhemorrhages; absence of symptomatic cerebral microhemorrhages or symptomatic superficial siderosis; 6. Member is not currently taking concomitant anticoagulant or antiplatelet therapy; 7. Leqembi is not prescribed concurrently with Kisunla; 8. If request is for a dose increase, the new dose does not exceed 10 mg/kg every 2 weeks.

Approval duration varies by number of prior infusions: members with <14 total infusions but >=7 total infusions: up to the 13th total infusion; members with <7 total infusions: up to the 6th total infusion; members with >=14 total infusions: 12 infusions per PA approval.

inv-03: Modified Coverage Criteria

Coverage is conditional on meeting documented clinical and safety requirements introduced with full FDA approval and CMS registry alignment.

Initial Therapy requirements: Requires baseline cognitive testing (MoCA or MMSE) AND baseline functional testing (FAQ, FAST, or CDR-SB) AND baseline brain MRI AND documentation of history of stroke/TIA/seizures AND prescriber attestation that ARIA risk (including heightened risk in ApoE4 homozygotes and with anticoagulants/antithrombotics) was discussed; enrollment in an NIH-sponsored trial is NOT required.

Added during conversion to full FDA approval; aligned to CMS patient registry elements

Continued Therapy requirements: Requires follow-up MRI to assess for new-onset ARIA AND ongoing cognitive and functional testing demonstrating the member remains in the mild stage of Alzheimer disease (removed the word 'baseline' to avoid continuing therapy in those who have progressed to moderate disease); enrollment in an NIH-sponsored trial is NOT required.

Modified during conversion to full FDA approval to align with CMS registry and safety monitoring

Requests for non–FDA approved indications are not authorized unless the provider supplies sufficient documentation of efficacy and safety per the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP PMN.53 (Medicaid).

Use of Leqembi with concomitant anticoagulant or antiplatelet therapy is excluded and may result in denial. Additionally, concomitant use with Kisunla is explicitly excluded. These exclusions were added when the policy was updated to align with FDA approval and safety requirements.

If the requested use is not listed among the Diagnoses/Indications for which coverage is NOT authorized and the drug is not on the applicable formulary or PDL, follow the relevant formulary/no‑coverage and off‑label use policies for the member's line of business (for example, CP.CPA.190, HIM.PA.33, CP PMN.255 for formulary/no‑coverage guidance; or the referenced non‑formulary and off‑label policies identified in the policy). Requests for uses not covered by those pathways require review under the off‑label use process described in those policies.

Continuation of therapy is not supported if follow‑up cognitive and functional testing indicates that the member has progressed beyond the mild stage of Alzheimer disease (i.e., into the moderate stage). The policy requires documentation of follow‑up testing to confirm the member remains in the mild stage before authorizing continued treatment.

Coding and Thresholds

HCPCS CodesHCPCS

J0174

Lecanemab-irmb mg

HCPCS / Drug J-code referencedHCPCS

J0174

Lecanemab-irmb mg

Cognitive and functional thresholds

MMSE thresholdMMSE score ≥ 22 required for baseline and continued therapy documentation

MoCA thresholdMoCA score ≥ 16 required for baseline and continued therapy documentation

FAQ thresholdFunctional Assessment Questionnaire (FAQ) score < 9 required for baseline and continued therapy documentation

CDR‑SB thresholdClinical Dementia Rating – Sum of Boxes (CDR‑SB) score 0.5–9 required as a functional measure

FAST thresholdFunctional Assessment Staging Test (FAST) score 3–4 required as a functional measure

Maximum dosing / infusion count

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — Prescriber must document diagnosis of MCI due to AD or mild AD dementia and meet all listed initial approval criteria. Provider must submit documentation (such as office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

Prescriber must be a neurologist or geriatrician or request must be in consultation with one.
Dose limit: does not exceed 10 mg/kg every 2 weeks; Approval duration: 3 months (6 infusion doses).
Leqembi is not to be prescribed concurrently with Kisunla.

Documentation Required

Required Baseline Documentation and Attestation

Required baseline documentation and attestation — Prescriber must document and submit baseline cognitive and functional testing, baseline MRI, history screening, and an attestation regarding ARIA risk discussion.

Background

Leqembi (lecanemab‑irmb) is a monoclonal antibody that targets amyloid beta and is indicated for treatment of early Alzheimer disease (mild cognitive impairment due to AD or mild AD dementia). The policy was updated after full FDA approval to add requirements for cognitive and functional testing, baseline and follow‑up MRI to monitor for amyloid‑related imaging abnormalities (ARIA), and prescriber attestation regarding ARIA risk in APOE4 homozygotes and with anticoagulant/antithrombotic use.

Definitions and Safety Notes

ARIA / Contraindication

ARIA riskARIA (amyloid‑related imaging abnormalities) is a known increased risk associated with lecanemab and is called out in Boxed Warnings

Contraindication: hypersensitivityContraindication includes serious hypersensitivity to lecanemab‑irmb or any excipients of Leqembi

Baseline MRI and history requirementPrescriber must document baseline MRI and history of stroke/TIA/seizures to identify patients at increased risk for ARIA

Prescriber attestationPrescriber must attest that the potentially increased ARIA risk in ApoE4 homozygotes and with anticoagulants/antithrombotics was discussed with the member

amyloid-related imaging abnormalities (ARIA)

DefinitionARIA: amyloid‑related imaging abnormalities associated with anti‑amyloid therapies (noted in policy as ARIA)

Policy Summary

PayerHealth Net

PolicyLecanemab-irmb (Leqembi) coverage criteria

Policy CodePolicy CP PHAR.596

Change TypeModified coverage criteria and exclusionsdosing and documentation updates

Effective Date01.06.23

Next Review DateN/A

Key ActionSubmit prior authorization with documentation of diagnosis, baseline cognitive and functional testing, baseline MRI, and prescriber attestation about ARIA risk.

SourceLink

On This Page

Documentation Required

Follow-up Documentation for Continued Therapy

Follow-up documentation for continued therapy — For authorization renewal, prescriber must submit follow-up MRI and cognitive/functional testing demonstrating continued eligibility and absence of new ARIA.

Follow-up MRI results required to identify new-onset ARIA prior to continued dosing.
Follow-up cognitive and functional testing required to confirm the member remains in the mild stage of disease (use same instruments as baseline: MMSE or MoCA; FAQ, FAST, or CDR‑SB).
Reauthorization may be denied if testing shows progression beyond mild AD or new MRI findings consistent with ARIA or other exclusion criteria.

Note

Formulary / Off‑Label Pathway

Formulary/off-label pathway — If the requested product or indication is not on the formulary or not listed in coverage sections, follow the applicable formulary, non‑formulary, or off‑label use policies for the member's line of business.

For drugs on the formulary/PDL: follow the no‑coverage criteria policy for the relevant LOB (e.g., CP.CPA.190 for commercial, HIM.PA.33 for marketplace, CP PMN.255 for Medicaid).
For drugs not on the formulary/PDL: follow the non‑formulary policy for the relevant LOB (e.g., CPCPA.190 commercial, HIM.PA.103 marketplace, CP PMN.16 Medicaid).
For uses not specifically listed in the policy, refer to the off‑label use policies (e.g., CP.CPA.09 commercial, HIM.PA.154 marketplace, CP PMN.53 Medicaid) and provide sufficient documentation of efficacy and safety.