Leqembi (lecanemab-irmb) — Coverage Determination
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Policy governing medical necessity and coverage determinations for Leqembi (lecanemab-irmb) for treatment of Alzheimer's disease for Wellmark Blue Cross and Blue Shield members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Determinations
Overall coverage determination
Covered when ALL of the following are met:
policy conclusion based on clinical trial inconsistency and safety (ARIA) concerns
This policy may not apply to Federal Employee Program (FEP) members. Benefit determinations are based on the applicable contract language in effect when services were rendered, and exclusions, limitations, or exceptions may apply; individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable, and benefits for FEP members are determined by the Federal Employee Program.
Leqembi (lecanemab-irmb) is considered not medically necessary for all indications, including treatment of Alzheimer’s disease, due to insufficient evidence to determine clinical efficacy, inconsistent clinical trial results, important safety concerns, and uncertainty of the risk–benefit profile.
Provider Actions, Prior Authorization, and Documentation
Prior authorization required for lecanemab claims
Claims for lecanemab (HCPCS J0174 and the listed unclassified drug/biologic codes) require prior authorization consistent with the policy determination that the therapy is not medically necessary for all indications.
No step therapy specified
No step therapy requirements are specified in this medical policy document.
Recommended clinical documentation and ARIA screening
Document clinical justification and safety screening before initiating therapy: record disease stage (MCI or mild dementia), MRI results for ARIA screening, and consider ApoE ε4 testing as noted in prescribing information.
- Evidence of patient staging consistent with trial population (mild cognitive impairment or mild dementia).
- Brain MRI obtained within one year prior to initiation and prior to the 5th, 7th, and 14th infusions for ARIA monitoring.
- Document exclusionary risk factors (history of large intracerebral hemorrhage, >4 microhemorrhages, superficial siderosis, vasogenic edema, aneurysm, vascular malformation, significant stroke or severe small vessel disease) and counsel regarding increased ARIA risk in ApoE ε4 carriers; consider documenting ApoE ε4 testing.
Coverage denial risk due to not medically necessary determination
Leqembi (lecanemab-irmb) is considered not medically necessary for all indications; claims for treatment may be denied on that basis.
- The policy conclusion that Leqembi is not medically necessary should be used to adjudicate claims; lack of medical necessity may trigger denial.
Billing and Coding
Key Definitions
Background
Leqembi (lecanemab-irmb) is an anti-amyloid beta monoclonal antibody indicated for the treatment of Alzheimer’s disease in the early disease population (mild cognitive impairment or mild dementia) and is administered intravenously every 2 weeks. The policy notes that despite regulatory approvals, the evidence is insufficient to establish clear clinical benefit and there are important safety concerns (notably amyloid-related imaging abnormalities), which factor into the policy’s noncoverage determination.
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