Anti Amyloid Leqembi denied due to quantity / dose limits by Aetna?

Aetna'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 Aetna Limits Quantity for Leqembi — and Why You Can Appeal

Leqembi (lecanemab) is administered by intravenous infusion on a defined schedule set out in the FDA-approved prescribing information. Aetna's quantity-limit restriction caps how many infusions or vials it will authorize within a coverage period. This denial often arises when the requested quantity exceeds what the insurer's policy permits — even when the prescriber is following the exact dosing schedule in the FDA label.

## Why This Denial Is Appealable

Quantity limits must be clinically grounded. If Aetna's limit is inconsistent with the FDA-approved dosing schedule for your patient's weight or clinical status, that mismatch is a strong basis for appeal. Aetna is required under ACA §2719 and applicable state law to offer a full internal appeal followed by independent external review. For ERISA-governed employer plans, ERISA §503 guarantees a full-and-fair review. You generally have up to 180 days from the denial notice to file an internal appeal, and the external review window under federal rules is approximately four months from exhaustion of internal remedies. If a delay would cause serious harm, request expedited review, which typically must be decided within 72 hours.

## What to Gather

• Diagnosis confirmation: Amyloid-confirmed early Alzheimer's disease (PET or CSF documentation, clinical staging records).
• Prescriber letter: A detailed medical-necessity letter from the treating neurologist or specialist explaining the prescribed quantity, citing the FDA label's approved dosing schedule, and confirming the patient's weight and clinical parameters that drive the quantity requested.
• Quantity justification: Pull the exact dosing table from the FDA prescribing information and show how the authorized infusion count follows directly from it for this patient's characteristics.
• Prior treatment and monitoring records: Evidence of baseline and ongoing safety assessments (MRI surveillance) as required by the REMS program and label.

## Criteria-Mapping Approach

Obtain Aetna's published medical policy and quantity-limit policy for Leqembi. List every requirement the policy states. Next to each, document the specific chart fact, lab value, or imaging result that satisfies it. If the policy's limit contradicts the FDA-approved dosing schedule, call that discrepancy out explicitly in the appeal letter and request that Aetna reconcile its policy with the label. The applicable clinical practice guideline organizations — including those aligned with neurology and Alzheimer's disease care — can also be cited generically to reinforce standard-of-care framing.