ModifiedAnthemPolicy CC-0228

Leqembi (lecanemab-irmb) — coverage criteria for IV and IQLIK formulations

Medical policy governing clinical criteria, monitoring, and authorization for Leqembi IV and Leqembi IQLIK SC autoinjector in adults with early Alzheimer's disease; affects prescribers and reviewers of prior authorization requests.

Policy Summary

PayerAnthem

PolicyLeqembi (lecanemab-irmb) — coverage criteria for IV and IQLIK formulations

Policy CodePolicy CC-0228

Change TypeAdded IQLIK autoinjectorclarified MRI monitoringupdated safety and dosing limits

Effective Date

Next Review DateSep 8, 2026

Key ActionObtain prior authorization with required documentation including prescriber specialty, age 50–90, objective memory testing, amyloid confirmation, baseline MRI, and documentation of ≥18 months IV Leqembi if requesting IQLIK.

SourceLink

POLICY UPDATE CHANGES

Approval of Leqembi IQLIK autoinjector for subcutaneous home administration after at least 18 months of IV use was included.

Requirement for baseline and periodic MRI monitoring (prior to specific infusion numbers) and evaluation if ARIA suspected.

Updated safety information emphasizing ARIA incidence and ApoE ɛ4–related risk; added discussion recommendations.

Added Leqembi IQLIK to clinical criteria and updated MRI frequency requirements and coding (C9399, J0174, J3590).

Added quantity limits: IV 10 mg/kg every 2 weeks; IQLIK 4 autoinjectors per 28 days.

22%ARIA incidence

40%

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Coverage Criteria for Leqembi

Initial Therapy

Initial requests may be approved when ALL of the following are met:

Eligibility and clinical staging: Prescribed by or in consultation with a neurologist, geriatrician, neuropsychiatrist, or psychiatrist; age 50–90; diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease OR mild Alzheimer’s disease dementia.

van Dyck 2022

Cognitive testing requirements: Objective impairment in episodic memory on specified memory tests (e.g., Free and Cued Selective Reminding Test, Rey Auditory Verbal Learning Test, California Verbal Learning Test, Logical Memory I/II of the Wechsler Memory Scale, or other versions); CDR-Global score 0.5–1.0; CDR Memory Box score >= 0.5; MMSE 22–30 (inclusive).CDR-Global 0.5-1.0; MMSE 22-30

NCT03887455; Perneczky 2006

Amyloid confirmation: Presence of amyloid beta documented by PET imaging OR cerebrospinal fluid (Aβ42) testing.

van Dyck 2022; Jack 2018

Baseline MRI safety: Baseline MRI within the past year that does not show: more than 4 microhemorrhages (<=10 mm), a single macrohemorrhage >10 mm, superficial siderosis, vasogenic edema, contusion/encephalomalacia/aneurysm/vascular malformation/infective lesion, multiple lacunar infarcts or major territorial stroke, severe small vessel or white matter disease, space-occupying lesions, or brain tumors (except meningiomas/arachnoid cysts <1 cm).microhemorrhages <=4; macrohemorrhage <=10 mm

Label; NCT03887455

IQLIK-specific: If request is for Leqembi IQLIK autoinjector, documentation that the individual has had at least 18 months of intravenous Leqembi use.>=18 months IV use

Label 2025

Continuation Therapy

Continuation requests may be approved when ALL of the following are met:

ARIA absence: No evidence of symptomatic moderate to severe ARIA-E; no evidence of moderate to severe ARIA-E on MRI; no evidence of symptomatic ARIA-H; and no evidence of moderate to severe ARIA-H on MRI.

Label 2023

Monitoring and clinical judgment: Prescriber will review MRI prior to the next dose if ARIA is suspected; based on provider clinical judgment, the benefits of continuation outweigh the risks.

Label 2023

IQLIK-specific continuation: If request is for Leqembi IQLIK autoinjector, documentation that the individual has had at least 18 months of intravenous Leqembi use.>=18 months IV use

Label 2025

Leqembi/Leqembi IQLIK may not be approved for individuals with conditions or findings that suggest causes of cognitive impairment other than Alzheimer’s disease. Specific exclusion conditions include: any medical or neurological condition (other than AD) that might contribute to cognitive impairment; history of TIA, stroke, or seizures within the past year; contraindications to brain MRI (e.g., non‑MRI compatible pacemaker/defibrillator or implants); MRI evidence of other clinically significant lesions indicating another cause of cognitive impairment; uncontrolled bleeding disorders (platelets <50,000 or INR >1.5); and any uncontrolled immunologic disease or immunologic disease requiring treatment with immunoglobulins, systemic monoclonal antibodies or derivatives, systemic immunosuppressants, or plasmapheresis.

Administrative wording for non‑approvable criteria has been updated to explicitly state restrictions applying to all other indications outside the specified clinical criteria. The document history records this change and notes formatting and wording updates implemented during the 2025 reviews.

Treatment with Leqembi/Leqembi IQLIK that does not meet the specified clinical criteria in this policy — or that is requested for indications not covered by these criteria — is not approved (considered not medically necessary).

The codes listed in this policy are provided for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, or device code does not imply member coverage or provider reimbursement; coverage determinations depend on the member’s contract benefits in effect at the time of service and applicable prior authorization requirements.

Coding and Dosing Limits

Informational coding sectionmixed

No codes listed

HCPCS - Unclassified NOCHCPCS

C9399

Unclassified drugs or biologicals [when specified as Leqembi IQLIK (lecanemab-irmb)]

HCPCS - Leqembi injectableHCPCS

J0174

Injection, lecanemab-irmb, 1mg [Leqembi]

HCPCS - Unclassified biologicsHCPCS

J3590

Unclassified biologics [when specified as Leqembi IQLIK (lecanemab-irmb)]

ICD-10 DiagnosisICD-10

G30.0-G30.9

Alzheimer's disease

Dosing and imaging thresholds

IV dosing limit10 mg/kg every 2 weeks (Leqembi intravenous formulation)

IQLIK dosing limit4 autoinjectors per 28 days (Leqembi IQLIK 360 mg autoinjector)

Baseline MRI timingBaseline MRI must be within the past year

Baseline MRI microhemorrhage thresholdNo more than 4 microhemorrhages (each ≤10 mm at greatest diameter)

Baseline MRI macrohemorrhage thresholdNo single macrohemorrhage >10 mm at greatest diameter

Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Leqembi/Leqembi IQLIK (lecanemab-irmb). Initial and continuation requests must meet the clinical criteria listed in the policy. Initial approvals and continuations are subject to review for safety (including ARIA) and ongoing benefit-risk assessment by the prescriber. Dosing limits apply as specified in the policy.

Prior authorization required.
Prescriber must document MRI review schedule and safety discussions with patient/caregiver.
Dosing limits: IV Leqembi 10 mg/kg every 2 weeks; IQLIK autoinjector 4 autoinjectors per 28 days.

Billing Rule

Coding included; verify coverage

Codes listed below are provided for billing and administrative reference only. Inclusion does not guarantee member coverage — coverage is determined by the member's contract and benefit plan at time of service. Verify coverage and reimbursement with the member's plan prior to ordering or billing.

Background and Scope

Background: Leqembi (lecanemab-irmb) is an amyloid beta–directed monoclonal antibody approved for treatment of adults with early Alzheimer’s disease (mild cognitive impairment due to AD or mild AD dementia). The product exists as an IV infusion formulation and, as of the 2025 update, a subcutaneous autoinjector formulation (Leqembi IQLIK) was added to the clinical criteria and quantity limits. The policy was revised to incorporate MRI monitoring requirements, safety counseling regarding ARIA and ApoE ɛ4 risks, and the IQLIK switching requirement of at least 18 months of prior IV Leqembi use before transitioning to the autoinjector.

Definitions and Key Measures

ARIA — definitions and imaging findings

ARIA definition (general)Amyloid Related Imaging Abnormalities (ARIA) = abnormalities observed on brain MRI

ARIA-EARIA with edema: findings consistent with brain edema or sulcal effusions

ARIA-HARIA with hemorrhage: findings consistent with microhemorrhage and superficial siderosis

CDR and CDR-SB — definitions and thresholds

CDR purposeClinical Dementia Rating (CDR) scale used to stage dementia severity across six domains

CDR Global thresholds for eligibilityCDR-Global score of 0.5 to 1.0 required for treatment (maps to questionable impairment to mild dementia)

Policy Summary

PayerAnthem

PolicyLeqembi (lecanemab-irmb) — coverage criteria for IV and IQLIK formulations

Policy CodePolicy CC-0228

Change TypeAdded IQLIK autoinjectorclarified MRI monitoringupdated safety and dosing limits

Effective Date

Next Review DateSep 8, 2026

SourceLink

On This Page

Note

Coding (informational)

The following codes are associated with Leqembi/Leqembi IQLIK for provider billing and administrative use.

HCPCS: C9399 (Unclassified drugs or biologicals) — when specified as Leqembi IQLIK (lecanemab-irmb)
HCPCS: J0174 (Injection, lecanemab-irmb, 1 mg) — Leqembi
HCPCS: J3590 (Unclassified biologics) — when specified as Leqembi IQLIK (lecanemab-irmb)
ICD-10: G30.0-G30.9 (Alzheimer's disease)

Documentation Required

Required documentation for prior authorization

Document the following information when submitting a prior authorization request to support review and adjudication.

Prescriber specialty (neurologist, geriatrician, neuropsychiatrist, or psychiatrist) or documentation of consultation with one of these specialists.
Patient age (must be 50–90 years).
Diagnosis: MCI due to AD or mild AD dementia (supporting clinical documentation).
Objective memory testing results (e.g., Free and Cued Selective Reminding Test, Rey AVLT, California Verbal Learning Test, Logical Memory I/II) demonstrating episodic memory impairment.
Clinical Dementia Rating (CDR) Global score (0.5–1.0) and CDR Memory Box score (≥ 0.5).
MMSE score (22–30 inclusive).
Evidence of amyloid β positivity (amyloid PET or CSF Aβ1-42).
Baseline MRI within the past year and MRI reports demonstrating absence of exclusionary findings (e.g., >4 microhemorrhages, macrohemorrhage >10 mm, superficial siderosis, vasogenic edema, significant stroke or mass lesion).
If IV therapy: documentation that MRI will be/were reviewed before the 3rd, 5th, 7th, and 14th infusions and prior to any dose when ARIA is suspected.
If request is for Leqembi IQLIK autoinjector: documentation of at least 18 months of prior IV Leqembi use.
Documentation that prescriber discussed and the patient/caregiver acknowledged safety risks including ARIA and increased ARIA risk with ApoE ε4 homozygosity.
For continuation requests: documentation of absence of symptomatic moderate to severe ARIA-E or ARIA-H and MRI evidence, and clinician assessment that benefits outweigh risks.

Denial Risk

Common denial triggers

Requests may be denied for common reasons — ensure documentation addresses these areas to avoid delay or denial.

Diagnoses or cognitive impairment attributable to causes other than Alzheimer's disease.
Recent TIA, stroke, or seizure within the past year.
Contraindications to MRI or lack of recent baseline MRI (within past year) without acceptable justification.
MRI findings that meet exclusion criteria (e.g., >4 microhemorrhages, macrohemorrhage >10 mm, superficial siderosis, mass lesions).
Insufficient documentation of amyloid positivity (PET or CSF).
Insufficient memory testing results or missing CDR/MMSE scores outside required ranges.
Lack of documentation of prior IV Leqembi use when requesting IQLIK autoinjector (minimum 18 months).

Note

Coverage contingent on member contract

Coverage of services, procedures, and drugs is contingent upon the member's contract and plan benefits in effect at the time of service. Coding lists in this policy do not by themselves determine coverage or payment.

Verify member eligibility, benefits, and prior authorization requirements before initiating therapy.
Contact the payer or use the payer's provider portal to confirm coverage and obtain any required authorizations.