CurrentBaylor Scott & White Health PlanPolicy 301

Lecanemab-irmb (Leqembi) Coverage Criteria

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Defines medical necessity and prior authorization requirements for lecanemab (Leqembi) for patients with MCI due to Alzheimer disease or mild AD dementia; applies to Baylor Scott & White Health Plan lines of business including Medicare and Medicaid as noted.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyLecanemab-irmb (Leqembi) Coverage Criteria

Policy CodePolicy 301

Change TypeNo material changes

Effective Date03/01/2026

Last ReviewFeb 26, 2026

Next Review Date02/26/2027

Key ActionObtain prior authorization with documentation that all initiation criteria are met, including diagnosis, specialist involvement, age 50–90, cognitive test scores, amyloid confirmation, and baseline MRI without exclusionary findings.

SourceLink

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CurrentBaylor Scott & White Health PlanPolicy 301

Lecanemab-irmb (Leqembi) Coverage Criteria

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyLecanemab-irmb (Leqembi) Coverage Criteria

Policy CodePolicy 301

Change TypeNo material changes

Effective Date03/01/2026

Last ReviewFeb 26, 2026

Next Review Date02/26/2027

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

50-90eligible member age range

MMSE 21-30cognitive thresholds

12 monthsauthorization duration

J0174HCPCS code

301policy number

Coverage and Medical Necessity Criteria

Continuation/Renewal Therapy

Renewal covered when ALL of the following are met:

Renewal eligibility: MRI conducted prior to the 5th, 7th, and 14th infusions to monitor for ARIA; member has not started new medications that increase ARIA risk without documented discussion and monitoring plan; member has not missed more than two consecutive doses or more than two doses in a 6-month period; no new medical or neurological conditions (other than AD) that could contribute to cognitive impairment; no seizures, stroke, or TIA in the past 12 months; no history of cerebrovascular abnormalities; bleeding disorder remains under adequate control (e.g., platelet count and INR as applicable); cognition scores have not worsened to moderate or advanced disease using the same cognitive test(s) used at initiation (i.e., not meeting thresholds for moderate/advanced: MMSE ≤20, CDR-GS >1, MoCA <16); and side effects are manageable or absent.see child nodes

Authorization duration 12 months

Experimental / Investigational

Not covered:

Other indications: Use of lecanemab for all indications other than those specified (MCI due to AD or mild AD dementia with amyloid confirmation) is considered experimental and investigational and is not covered.N/A

Chunk 10

Baseline neuroimaging and recent neurologic events are key exclusionary criteria. The policy requires a baseline MRI within 1 year that does not show any of the following: >4 microhemorrhages (≤10 mm), a single microhemorrhage >10 mm, superficial siderosis, vasogenic edema, cerebral contusion/encephalomalacia/aneurysm/vascular malformation/infectious lesion, multiple lacunar infarcts or major stroke, space-occupying lesions, or brain tumors (except meningiomas/arachnoid cysts <10 mm).

Clinical qualifiers that preclude initiation include seizures, stroke, or transient ischemic attack (TIA) in the past 12 months, a history of cerebrovascular abnormalities, any medical or neurological condition other than Alzheimer's disease that could explain the cognitive impairment, and bleeding disorders not under adequate control (for example, platelet count <50,000 or INR >1.5 for non‑warfarin patients).

Prior to initiating therapy the specialist must have excluded other causes of cognitive decline (e.g., Lewy body dementia, cerebrovascular disease, Parkinson's disease, vitamin B12 deficiency) and ensured stability of concomitant therapies: stable AD symptomatic therapy for 12 weeks and stable anticoagulant therapy for 4 weeks when applicable. APOE ɛ4 testing and documentation of a risk discussion about ARIA are also required before treatment.

The policy cites federal guidance and regulatory communications that inform coverage and documentation expectations, including the CMS NCA and NCD on monoclonal antibodies directed against amyloid and the FDA announcement converting an Alzheimer's therapy to traditional approval. These references may affect program-specific limits or monitoring expectations and are listed in the policy bibliography.

Providers must submit supporting documentation consistent with these references: amyloid confirmation by PET or CSF (submit imaging/assay results) and baseline/surveillance MRIs per the policy. While the policy itself defines the clinical criteria and MRI thresholds, external guidance (CMS/FDA/VA) referenced in the policy may impose additional reporting or monitoring requirements that influence authorization decisions.

Use of lecanemab for any indication other than mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia with confirmed amyloid pathology is considered experimental and investigational and therefore not covered, because effectiveness for other indications has not been established.

Within the provided excerpts there are no standalone sections labeled 'not medically necessary' that contradict the covered criteria. The policy references CMS and FDA communications and other external guidance, but the excerpts do not include explicit separate statements using the phrase 'not medically necessary' beyond classifying off‑label uses as experimental/investigational.

Billing and Diagnosis Coding

HCPCS CodesHCPCSCovered

J0174

Injection, lecanemab-irmb, 1 mg

ICD-10 Codes (may apply)ICD-10

Z00.6	Encounter for examination for normal comparison and control in clinical research program
G30.0	Alzheimer's disease with early onset
G30.1	Alzheimer's disease with late onset
G30.8	Other Alzheimer's disease
G30.9	Alzheimer's disease, unspecified
G31.84	Mild cognitive impairment, so stated

Cognitive test thresholds — initiation and renewal

Initiation — MMSEMMSE (Mini‑Mental State Exam) score 21–30

Initiation — CDR‑GSCDR‑GS (Clinical Dementia Rating‑Global Scale) score = 0.5 or 1

Initiation — MoCAMoCA (Montreal Cognitive Assessment) score ≥16

Renewal — MMSEMMSE score greater than 20 (must not be 20 or lower)

Renewal — CDR‑GSCDR‑GS score ≤1 (must not be >1)

Renewal — MoCAMoCA score ≥16 (must not be <16)

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for lecanemab (Leqembi®). Submit documentation demonstrating that ALL initiation criteria are met, including diagnosis, prescriber specialty, age, cognitive testing scores, biomarker confirmation, and specialist evaluation. For Medicare plans, refer to CMS NCD 200.3. For Medicaid, confirm Texas Medicaid procedures and HB154 applicability where relevant.

Prior authorization required prior to initiation
Include copy of imaging results or CSF diagnostic immunoassay
Provide specialist consultation notes when applicable

Documentation Required

Required imaging and biomarker documentation

Baseline and surveillance brain MRI and amyloid biomarker documentation are required. Submit a baseline MRI performed within 1 year prior to initiation and results of one of the following confirming amyloid pathology: amyloid PET scan or CSF assay showing Aβ/tau profile consistent with AD. Copies of imaging and laboratory reports must be included with the authorization request.

Key Definitions and Drug Identifier

ARIA — definition and clinical significance (ARIA‑E, ARIA‑H)

Definition — ARIAAmyloid‑related imaging abnormalities (ARIA) are radiographic findings associated with anti‑amyloid therapies, including brain edema/effusion (ARIA‑E) and microhemorrhages/hemorrhagic findings (ARIA‑H).

Clinical significance — ARIA‑EARIA‑E (vasogenic edema/brain swelling) has been observed with lecanemab and may present asymptomatically or with headache, confusion, nausea, or focal neurologic signs; monitoring with MRI is required per policy.

Clinical significance — ARIA‑HARIA‑H refers to microhemorrhages and superficial siderosis; presence of multiple microhemorrhages or superficial siderosis on baseline MRI are exclusionary findings per policy.

Lecanemab‑irmb (Leqembi) — description and references

Drug descriptionLecanemab‑irmb (Leqembi®) is a monoclonal antibody directed against aggregated amyloid‑β, indicated for initiation in patients with mild cognitive impairment due to AD or mild AD dementia; approval based on phase 2 and confirmatory Clarity AD trial data showing slowed clinical decline and reduced Aβ plaque.

Clinical Background

Alzheimer's disease is an irreversible neurodegenerative disorder characterized by progressive cognitive decline in memory, thinking, and function. Accumulation of amyloid‑beta (Aβ) plaques is a core pathological hallmark and a therapeutic target for disease‑modifying monoclonal antibodies.

Lecanemab (Leqembi®) is an anti‑Aβ monoclonal antibody developed for patients with early Alzheimer's disease (mild cognitive impairment due to AD or mild AD dementia). Clinical trial data and regulatory materials referenced in the policy demonstrate treatment effect on disease progression but also identify risks such as amyloid‑related imaging abnormalities (ARIA), which necessitate informed risk discussion and MRI monitoring.

Policy Version and Revision History

2026-03-01effective_dateLatest

Policy became effective for Lecanemab-irmb (Leqembi®) under Policy 301.

2026-02-26last_review

Policy clinical content was last reviewed on this date prior to the effective date.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyLecanemab-irmb (Leqembi) Coverage Criteria

Policy CodePolicy 301

Change TypeNo material changes

Effective Date03/01/2026

Last ReviewFeb 26, 2026

Next Review Date02/26/2027

SourceLink

On This Page

Baseline MRI (within 1 year) — required; include report and images if available
Amyloid PET OR CSF assay (Aβ42, p‑tau, t‑tau or Aβ42/ttau index) — submit results
Surveillance MRIs per FDA labeling and local protocols to monitor for ARIA

Denial Risk

Exclusionary clinical/MRI findings

Exclude members with specified clinical or MRI findings that increase risk of harm from treatment. Authorization will not be approved when exclusionary MRI or clinical conditions are present.

MRI exclusions on baseline scan: >4 microhemorrhages (≤10 mm), any single microhemorrhage >10 mm, superficial siderosis, vasogenic edema, cerebral contusion, encephalomalacia, aneurysms, vascular malformations, infection lesions, multiple lacunar infarcts or stroke in a major vascular territory, severe small vessel/white matter disease, space-occupying lesions, brain tumors (except meningiomas or arachnoid cysts <10 mm are not exclusionary)
Clinical exclusions: seizures, stroke, or TIA within past 12 months; history of cerebrovascular abnormalities; uncontrolled bleeding disorder (e.g., platelets <50,000 or INR >1.5 for patients not on warfarin); any non-AD medical or neurological condition likely contributing to cognitive impairment

Note

Policy references clinical trial reports

Policy references clinical trial reports, regulatory guidance, and technology assessments which inform documentation expectations and clinical criteria. Include relevant diagnostic evidence in the request to align with trial populations and FDA labeling.

Key references: NEJM pivotal trial (van Dyck et al.), FDA prescribing information, ICER and Hayes reports, VA criteria for use
Use referenced trials and prescribing information to support that member meets early AD (MCI or mild dementia) and biomarker-positive criteria

Documentation Required

Concomitant medication stability

Members must be on stable dosing of concomitant therapies prior to lecanemab initiation. Document stability of symptomatic AD medications and anticoagulant therapy for the specified durations.

Stable dose of AD symptomatic therapy (e.g., donepezil, rivastigmine, galantamine, memantine) for ≥12 weeks prior to initiation
Stable anticoagulant therapy (e.g., enoxaparin, warfarin, apixaban, dabigatran, rivaroxaban) for ≥4 weeks prior to initiation

Step Therapy

Step therapy

No step therapy requirements are detailed in this policy excerpt. Authorization decisions are based on meeting the listed clinical, imaging, and safety criteria rather than prior failure of alternative therapies.

Policy does not specify step therapy or prerequisite treatments for lecanemab

Regulatory/reference labelingSee FDA prescribing information: Leqembi (lecanemab‑irmb) [prescribing information], Eisai and Biogen; July 2023.

Key trials/publicationsNotable references include the Clarity AD confirmatory trial and phase 2 studies (Swanson et al., McDade et al., van Dyck et al.) documenting biomarker and cognitive effects and ARIA risk.