Leqembi (lecanemab-irmb) – Medical Benefit Coverage Criteria
Customize your policy alerts
Sign up for sierra health and life Policy 2026D0125D alerts
Get alerted when Policy 2026D0125D changes without checking for updates manually.
Monitor payer policy activity
Covers medical-benefit administration of intravenous Leqembi for members when criteria for treatment of early Alzheimer's disease are met; distinguishes formulation obtained under pharmacy benefit. Affects prescribers and prior authorization reviewers.
Changed initial authorization duration from 'no more than 6 months' to 'no more than 12 months'.
Revised coverage criteria for continuation of therapy; removed requirement that the patient must have MCI due to AD, mild dementia due to AD, or progressed to moderate/severe dementia with prescriber attestation.
Archived previous policy version 2025D0125C.
Coverage Criteria for Leqembi (lecanemab-irmb)
Initial Therapy Criteria
Leqembi is covered when ALL of the following are met for initial therapy:
Based on NIA-AA criteria as stated in policy.
Documented by imaging or CSF per policy requirements.
Policy requires baseline MRI within 12 months before start of therapy.
Acceptable test score ranges required for initiation.
Policy specifies counseling and attestation when anticoagulants are used.
Policy excludes recent intracerebral hemorrhage.
Counseling and offer of ApoE ε4 testing required per policy.
Policy requires specialist prescriber and FDA-consistent dosing.
Policy revision sets maximum initial authorization to 12 months.
Continuation of Therapy Criteria
For continuation (reauthorization) of therapy, ALL of the following must be met:
Continuation requires ongoing AD diagnosis per policy.
Follow-up MRI is required for continuation requests.
Continuation decisions consider presence and severity/resolution of ARIA.
Concurrent use with other Aβ mAbs is excluded and specialist prescriber/dosing required.
Policy limits each reauthorization to 12 months.
Not Medically Necessary / Unproven Indications
Policy explicitly states noncoverage for other indications.
Initial Coverage (Inferred from Trials)
Covered when ALL of the following are met (as inferred from trial populations and indication):
CLARITY AD and Study 201 enrolled patients with early AD (MCI or mild dementia); FDA indicates initiation in this population.
Trials required amyloid evidence by PET or CSF.
Dose used in CLARITY AD and Study 201.
Policy revision updated initial authorization maximum to 12 months.
Use of Leqembi in combination with other amyloid-beta monoclonal antibodies is explicitly excluded. Treatment administered concurrently with another Aβ monoclonal antibody (for example, Kisunla) will not meet coverage criteria and may trigger non-coverage or denial.
Coverage of Leqembi is subject to the member-specific benefit plan terms and any applicable state or federal mandates. Review the member’s certificate of coverage and applicable mandates prior to authorization; where a mandate or the member’s benefit document conflicts with this policy, the mandate or the member specific benefit plan governs and may result in exclusion of treatment under this policy.
Leqembi is considered unproven and not medically necessary for any indication other than Alzheimer's disease. Requests for use outside the diagnosis of Alzheimer’s disease do not meet the policy’s coverage criteria.
Use of Leqembi in patient populations without evidence of amyloid pathology or in later-stage disease lacking trial support is not supported. Clinical trial experience and prior anti-Aβ development failures identify lack of demonstrated efficacy when patients without confirmed Aβ pathology were enrolled or when treatment was started at later stages with significant irreversible neurodegeneration; such uses are therefore considered unproven.
Coding — HCPCS and Diagnosis Codes
| J0174 | Injection, lecanemab-irmb, 1mg. |
| 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 |
Provider Actions, Documentation, and Authorization
Prior Authorization Required
Prior authorization is required for IV Leqembi (billing code J0174). Initial authorization will be for no more than 12 months when all coverage criteria are met. Reauthorization (continuation) requests also require documentation and will be for no more than 12 months.
- Affected code: J0174 (Injection, lecanemab-irmb, 1 mg)
- Initial and reauthorization durations: ≤ 12 months
Check Member Benefit and Plan Conflicts
Before initiating therapy, verify the member-specific benefit plan document to confirm that this medical benefit is covered for the member. Some plans or state mandates may alter coverage or require different handling of experimental/unproven therapies. Coverage decisions must follow the member specific benefit plan and any applicable federal or state mandates.
- Confirm member benefit and any state or plan mandates before submitting authorization
- Where plan language conflicts with mandates, mandates supersede
Documentation Required: Baseline Cognitive/Biomarker and Follow-up MRI/Counseling
Submission of baseline cognitive testing and evidence of amyloid pathology is required with the initial authorization request. For continuation requests, submit follow-up MRI results and documentation of ARIA counseling or clinical rationale as applicable.
- Baseline cognitive test score documented: MMSE 20–30, MoCA 17–30, or SLUMS 17–30
- Evidence of amyloid pathology: positive amyloid PET or CSF biomarker abnormalities (e.g., Aβ42/40 ratio, p-tau181/Aβ42)
- Baseline brain MRI completed within 12 months prior to initiating treatment
- For continuation: submission of follow-up brain MRI performed after treatment initiation
- For continuation when ARIA observed: prescriber attestation that continuation is appropriate based on clinical severity and either radiographic resolution/stabilization or documented rationale for continued treatment
Concomitant Aβ mAb Use — Denial Risk
Leqembi must not be used concomitantly with other amyloid‑beta monoclonal antibodies. Requests indicating combined use with another Aβ mAb (for example, Kisunla) will be denied/not covered.
- Concomitant use with other Aβ mAbs (e.g., Kisunla) is a denial condition
- Ensure medication history and current therapies are documented to show no concurrent Aβ mAb use
Prescriber, Dosing, and Utilization Tools
Prescriptions should be written by an appropriate specialist and dosing must follow FDA labeling. Use of utilization management tools and plan-specific benefit rules may affect coverage decisions.
- Prescriber requirement: neurologist, geriatric psychiatrist, or geriatrician who specializes in dementia
- Leqembi dosing must follow FDA‑approved labeling
- UnitedHealthcare and delegated plans may use third-party tools (e.g., InterQual) to assist in administration
- Member benefits, state mandates, and other utilization management tools may alter coverage — always check member-specific documents
Definitions and Clinical Measures
Background
Alzheimer’s disease is characterized by progressive cognitive decline associated with accumulation of amyloid-beta plaques and tau neurofibrillary tangles; amyloid accumulation begins years to decades before clinical symptoms. Leqembi (lecanemab-irmb) is a humanized IgG1 monoclonal antibody that targets aggregated soluble and insoluble forms of amyloid-beta to reduce plaque burden. Clinical trial data informed the policy focus on treating patients with mild cognitive impairment or mild dementia due to Alzheimer's disease and require documentation of amyloid pathology and baseline imaging prior to initiation.
Revision History and Policy Changes
Changed initial authorization duration from 'no more than 6 months' to 'no more than 12 months' and revised continuation criteria by removing the requirement that the patient be specifically attested as MCI due to AD, mild dementia due to AD, or progressed to moderate/severe dementia with prescriber attestation.
Archived previous policy version 2025D0125C.
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.