Anti Amyloid Leqembi denied as not FDA-approved for this use by UnitedHealthcare?

UnitedHealthcare's specific coverage criteria for anti amyloid leqembi are defined in its own published medical/coverage policy and the FDA-approved prescribing label. A successful appeal documents that your medical records satisfy each criterion those sources list — confirmed diagnosis, any required prior treatments (with dates and outcomes), and clinical severity. If the exact criteria weren't included with your denial, request them in writing; your appeal then maps each requirement to the matching fact in your chart.

## Why UHC Denied Leqembi as Not FDA-Approved — and Why You Can Appeal

This denial type is among the most directly correctable: Leqembi (lecanemab) holds traditional FDA approval for the treatment of Alzheimer's disease with confirmed amyloid pathology. A "not FDA-approved" denial for this drug almost always reflects a stale policy, a coding error, or an internal classification that has not been updated to reflect the drug's full approval status. It is not a clinically defensible denial for an on-label use of a traditionally approved therapy.

## Why This Denial Is Appealable

Under ACA §2719 and ERISA §503, every denial must have a clinical or policy basis that can withstand independent scrutiny. A factually incorrect denial — one asserting non-approval of an approved drug — is highly likely to be reversed at internal appeal or external review. Under federal rules, you have up to 180 days from the denial notice to file an internal appeal, and the external review window is approximately four months from exhaustion of internal remedies. For urgent clinical situations, expedited review (typically resolved within 72 hours) is available.

## What to Gather

• FDA approval documentation: The FDA approval letter and the current FDA prescribing information for Leqembi, showing traditional (not accelerated) approval and the approved indication. These are publicly available on the FDA website.
• Indication match: The prescriber's confirmation that the patient's use is within the FDA-approved indication.
• Amyloid confirmation: PET or CSF results confirming amyloid positivity, matching the approved patient population.
• Denial letter with the specific basis cited: If the denial letter references a specific UHC policy provision or a policy date, note it — if the policy predates full approval, that discrepancy belongs front and center in the appeal.
• Prescriber letter: A brief cover letter from the treating specialist stating unambiguously that lecanemab is FDA-approved, that the use is on-label, and attaching the FDA documentation.

## Criteria-Mapping Approach

Request the specific UHC policy provision cited in the denial. If the policy version predates traditional FDA approval, document the timeline. The appeal letter should open with a clear, factual statement of approval status and attach supporting FDA documentation. This is a narrow, document-driven appeal — brevity and precision matter more here than clinical narrative length.