CurrentmhnPolicy CP.PHAR.596

Clinical Policy: Lecanemab-irmb (Leqembi, Leqembi Iqlik)

Defines medical necessity, dosing, product availability, coding implications, and administrative requirements for coverage of lecanemab-irmb (Leqembi / Leqembi Iqlik) for applicable members and providers.

Policy Summary

Payermhn

PolicyLecanemab-irmb (Leqembi, Leqembi Iqlik) clinical policy

Policy CodePolicy CP.PHAR.596

Key ActionObtain prior authorization and submit claims referencing HCPCS J0174 for lecanemab-irmb.

Change TypeMultiple material updates (dosing, SC formulation, exclusions, monitoring)

Effective DateJan 6, 2023

Next Review Date

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.

Removed the requirement for follow-up MRIs in the Continued Therapy section.

Added dosing and authorization limits for the subcutaneous formulation Leqembi Iqlik and noted it should not be used concomitantly with Kisunla.

Clarified Continued Therapy neurocognitive testing must be recent (within the last month) and later updated to specify 'recent (within the last month)' and then adjusted to require tests be 'recent (within the last month)' and pre-infusion MRIs within the prior week (later removed).

Removed the age limit of 50-90 years of age from the policy.

10 mg/kg IVrecommended infusion dose

q2 weeksinitial IV dosing interval

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Coverage Criteria

Covered when dosing, safety, specialist, and authorization requirements per FDA labeling and this policy are met.

Dosing: Initial regimen: 10 mg/kg IV every 2 weeks; after 18 months, may continue 10 mg/kg IV every 2 weeks or transition to maintenance 10 mg/kg IV every 4 weeks; alternative formulation: 360 mg subcutaneous weekly (Leqembi Iqlik).Maximum IV dose 10 mg/kg q2w; SC 360 mg/week

Includes option to transition to every-4-week IV maintenance after the initial 18 months per updated dosing guidance.

Safety and specialist requirements: Prescriber must be a specialist per labeling and must document discussion of ARIA risk (including increased risk in APOE4 homozygotes) and risks with anticoagulant/antithrombotic therapy; obtain baseline MRI and document history of stroke/TIA/seizures to assess elevated ARIA risk.

Concomitant anticoagulant/antiplatelet therapy is excluded; concomitant use with Kisunla is excluded (Leqembi Iqlik should not be used concomitantly with Kisunla).

Authorization durations and reauthorization: Initial and continued authorization durations follow LOB-specific rules; initial and continued approval durations have been extended for certain lines of business (e.g., Medicaid/HIM initial 6 months and continued 12 months); Commercial reauthorizations may be 6 months or aligned to renewal date.

Policy clarifies infusion counts and reauthorization timing (e.g., authorization up to the 13th infusion for members with <14 but ≥ 7 prior infusions).

Exclusions and discontinuation: Therapy is not to be continued for members who have progressed to the moderate stage of disease severity; concomitant use with anticoagulant/antiplatelet therapy or with Kisunla is excluded.

Follow policy guidance for discontinuation when disease progresses beyond mild stage.

The policy excludes concomitant use of lecanemab-irmb (Leqembi) with therapeutic anticoagulant or antiplatelet therapy. Providers must not authorize treatment when a member is receiving these agents because they increase the risk of amyloid‑related imaging abnormalities (ARIA) and are specifically listed as an exclusion in the coverage criteria.

The subcutaneous formulation Leqembi Iqlik is added as an authorized alternative formulation but the policy explicitly states that Leqembi Iqlik should not be used concomitantly with Kisunla. This concomitant‑use prohibition with Kisunla applies to all formulations and was added in recent updates to align product-specific constraints.

Failure to document required baseline assessments (including MRI and pertinent history to identify elevated ARIA risk) or to provide specialist attestation that risks were discussed may trigger denial of coverage when concomitant excluded therapies are present.

Continued therapy is not permitted for members who have progressed to the moderate stage of disease severity; coverage is limited to those who remain in the mild stage (MCI due to AD / mild AD). The policy requires documentation showing the member continues to meet mild‑stage criteria at each reauthorization.

Neurocognitive testing used to support reauthorization must be recent (within the last month) per the 4Q 2025 clarification; this ensures the member has not progressed beyond mild disease. Previously referenced timing for pre‑infusion MRIs was revised across updates and the later policy edition removed the follow‑up MRI requirement for Continued Therapy, so ongoing MRI timing is no longer required for reauthorization.

Providers must include required documentation (specialist attestation, cognitive/functional testing results, baseline MRI/history of stroke/TIA/seizures where applicable) with prior authorization and reauthorization requests to demonstrate continued eligibility and to support safe monitoring for ARIA.

Coding and Dosing

HCPCS CodesHCPCS

J0174

Lecanemab-irmb, 1 mg

Maximum IV dose — dosing summary (inv-05)

Recommended IV maintenance dosing (actionable)10 mg/kg IV every 2 weeks (may be continued after 18 months) or transition to 10 mg/kg IV every 4 weeks for maintenance

Maximum IV dose10 mg/kg every 2 weeks

Initial IV dosing interval10 mg/kg IV every 2 weeks

Alternative maintenance option10 mg/kg IV every 4 weeks (may be considered after 18 months)

Subcutaneous alternative360 mg SC every week (Leqembi Iqlik)

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for lecanemab (Leqembi) therapy. Claims must reference HCPCS code J0174 for lecanemab (lecanemab-irmb, 1 mg).

Prior authorization required for all lines of business.
Submit claims with HCPCS J0174.

Step Therapy

No specific step therapy algorithm is imposed within this policy document. Clinicians should follow the coverage criteria for initial and continued therapy as specified elsewhere in the policy when determining eligibility for treatment.

No step edits or prerequisite therapies are required by this policy section.

Definitions

ARIA — definition/term entry (inv-11)

TermAmyloid-related imaging abnormalities (ARIA)

Purpose of identificationBaseline MRI and history of stroke, TIA, and seizures required to identify patients at increased risk for ARIA

Risk considerationsPolicy notes increased ARIA risk in certain patients (e.g., APOE4 homozygotes) and requires specialist discussion of these risks

Monitoring implicationFollow-up MRI results required for Continued Therapy to identify new-onset ARIA (per prior policy iterations)

Background

Lecanemab‑irmb is an anti‑amyloid monoclonal antibody indicated for early Alzheimer’s disease (mild cognitive impairment due to AD and mild AD). The product is available as IV infusions and, more recently, as a subcutaneous autoinjector formulation (Leqembi Iqlik).

The policy covers both formulations when dosing and monitoring requirements are met: the IV regimen is 10 mg/kg every 2 weeks (with an option after 18 months to continue every 2 weeks or transition to every 4 weeks), and the SC option is 360 mg weekly for Leqembi Iqlik.

This policy defines the scope of coverage, required safety assessments (including specialist involvement and baseline MRI/history to assess ARIA risk), exclusion criteria (e.g., concomitant anticoagulant/antiplatelet therapy and prohibited concomitant use with Kisunla), and coding/authorization expectations for payers and providers.