Leqembi (lecanemab-irmb) intravenous infusion — coverage criteria
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Medical benefit policy governing coverage and prior authorization criteria for Leqembi (lecanemab-irmb) IV infusion for the treatment of Alzheimer's disease for Sierra Health and Life / UnitedHealthcare Commercial members.
Updated list of applicable HCPCS codes and revised description for J0174.
Coverage Criteria for Leqembi (lecanemab-irmb)
Initial Therapy
Leqembi is covered when ALL of the following are met for initial therapy:
Continuation Therapy
For continuation of therapy, ALL of the following must be met:
ARIA assessment after initiation
- No ARIA observed: ARIA has not been observed on follow-up MRI.
- ARIA observed with resolution/stability or prescriber attestation: ARIA has been observed on MRI; prescriber attests continuation of therapy is appropriate based on clinical severity AND either follow-up MRI demonstrates radiographic resolution or stabilization, or prescriber attests continuation is appropriate based on radiographic severity of ARIA.
Unproven / Not Medically Necessary
Initial therapy coverage criteria
Covered when ALL of the following are met (policy references clinical trial population and FDA indication):
Use of Leqembi in combination with other amyloid‑beta (Aβ) monoclonal antibodies (for example, Kisunla) is explicitly excluded and will trigger denial of coverage. The policy requires that Leqembi not be administered concomitantly with other Aβ mAbs for both initial and continuation therapy determinations.
FDA approval for Leqembi is provided for informational purposes only. FDA approval alone is not a basis for coverage; coverage decisions are determined by the member‑specific benefit plan document and any applicable state or federal mandates, which may supersede policy language.
Leqembi is considered unproven and not medically necessary for any indication other than Alzheimer's disease. Coverage and medical necessity determinations are limited to the FDA‑indicated population (mild cognitive impairment or mild dementia due to Alzheimer's disease) and uses outside that indication are not supported by the policy.
Prior failures of investigational anti‑Aβ therapies have frequently been associated with treatment of patients who lacked biomarker confirmation of amyloid pathology or who were enrolled at later stages of disease when irreversible neurodegeneration was more advanced. As a result, the policy requires documentation of biomarker‑confirmed Aβ pathology (amyloid PET or CSF) and limits treatment to the early AD population—conditions intended to avoid repeating factors that contributed to prior negative trials.
Coding and Diagnostic Codes
| J0174 | Lecanemab-irmb, for intravenous injection, 1 mg. |
| 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 |
| J0174 | Updated description for J0174 per applicable codes list |
Provider Actions, Prior Authorization, and Documentation Requirements
Prior Authorization Required
Prior authorization is required for Leqembi (lecanemab-irmb). Initial and reauthorization approvals are limited to no more than 12 months. Treatment must align with the FDA-indicated population (patients with mild cognitive impairment or mild dementia due to Alzheimer's disease) and member-level eligibility requirements in the criteria. Providers must consult the member-specific benefit plan document to determine coverage, step therapy, or exceptions, as the benefit document governs coverage decisions and may supersede this policy where applicable.
- Initial authorization: ≤ 12 months
- Reauthorization: ≤ 12 months
- Treatment initiation population: mild cognitive impairment or mild dementia (per FDA/CLARITY AD)
- Benefit document supersedes policy where applicable
Documentation Required for Continuation of Therapy
Providers must submit documentation to support continuation (reauthorization) of therapy, including evidence of ongoing benefit and safety monitoring. Required items include follow-up brain MRI after treatment initiation and documentation that continued use is appropriate given MRI findings and clinical status. If ARIA is observed, prescriber attestation regarding appropriateness of continuation and evidence of radiographic resolution/stability or clinical justification must be provided.
- Follow-up brain MRI completed after initiation of therapy
- Documentation of continued clinical benefit and safety monitoring
- If ARIA observed: prescriber attestation that continuation is appropriate and evidence of radiographic resolution/stabilization or clinical justification
Required Documentation for Initial Therapy
Submit medical records documenting cognitive testing and confirmation of amyloid pathology as part of the initial authorization. Documentation should include standardized cognitive scores and one or more amyloid biomarker results.
- Cognitive testing: MMSE 20–30 or MoCA 17–30 or SLUMS 17–30
- Amyloid evidence: positive amyloid PET OR CSF biomarker abnormalities (e.g., Aβ42/40 ratio, ptau181/Aβ42, ttau/Aβ42)
- Differential diagnoses ruled out in documentation
Clinical Trial Evidence to Document
Clinical trial evidence should be provided or referenced to document that the member matches trial populations and expected endpoints. CLARITY AD enrolled patients with early Alzheimer's disease (MCI or mild dementia) with amyloid confirmation and used CDR‑SB, ADAS‑cog14, ADCOMS, and ADCS‑MCI‑ADL as endpoints. Safety signals (ARIA‑E, ARIA‑H, infusion reactions) observed in trials should be considered in risk counseling and documentation.
- Trial population: early AD (MCI or mild dementia), age 50–90, amyloid positive
- Key endpoints: CDR‑SB primary; ADAS‑cog14, ADCOMS, ADCS‑MCI‑ADL secondary
- Safety signals to document: ARIA‑E (≈12.5%), ARIA‑H (≈17%), infusion reactions (≈26%)
Plan-Determined Step Requirements and Benefit Routing
Benefit plans may impose step therapy, experimental/investigational exclusions, or allow investigational coverage for life‑threatening conditions. Providers must review member-specific benefit documents to determine whether step requirements apply, whether Leqembi is routed to the pharmacy or medical benefit, and whether experimental/unproven exclusions are overridden by the member's certificate of coverage or applicable state mandates.
- Leqembi IQLIK (subcutaneous) generally billed under pharmacy benefit unless member plan specifies otherwise
- IV Leqembi billed under the medical benefit
- Member-specific benefit document determines step therapy and investigational coverage; state mandates may supersede
Background
Alzheimer's disease is characterized by abnormal accumulation of amyloid‑beta (Aβ) plaques and neurofibrillary tangles of tau. Amyloid deposition typically begins decades before clinical symptoms emerge; abnormal Aβ can be detected with amyloid PET or CSF biomarkers, and CSF p‑tau and t‑tau are also used to support a diagnosis in patients with mild cognitive impairment. The policy aligns treatment with the pathophysiology and trial populations by requiring evidence of Aβ pathology prior to initiating therapy.
Definitions and Key Terms
Revision History and Policy Changes
Administrative quarterly edit to applicable HCPCS codes and revised description for J0174; previous policy version 2026D0125D archived.
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