Anti Amyloid Leqembi denied due to quantity / dose limits 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 Limits Quantity for Leqembi — and Why You Can Appeal

Leqembi (lecanemab) is administered by intravenous infusion on a schedule defined in the FDA-approved prescribing information. UHC's quantity-limit restriction caps the number of infusions or vials it will authorize within a given period. When the treating team follows the FDA-approved dosing schedule and the authorized quantity falls short of what the label requires, a quantity-limit denial is both medically inappropriate and appealable.

## Why This Denial Is Appealable

Quantity-limit policies must be consistent with the FDA-approved dosing schedule for the patient's clinical parameters. When they are not, the insurer is effectively preventing on-label use of an approved therapy. Under ACA §2719 and ERISA §503, UHC must provide a full internal appeal and access to independent external review. You have up to 180 days from the denial notice to file internally. The external review window under federal rules is approximately four months from exhaustion of internal remedies. Request expedited review if clinical urgency applies — decisions typically come within 72 hours.

## What to Gather

• FDA prescribing information: Print and attach the relevant dosing section of the FDA label, showing the approved administration schedule and the parameters that determine infusion frequency or quantity.
• Patient-specific dosing calculation: The prescriber should document how the patient's clinical characteristics determine the prescribed quantity under the FDA label.
• Prescriber medical-necessity letter: A letter confirming that the requested quantity matches the FDA-approved schedule for this patient, that reducing the quantity would mean providing sub-label dosing, and that sub-label dosing is not clinically appropriate.
• Diagnosis and eligibility records: Amyloid confirmation, staging records, and any REMS or safety monitoring documentation.

## Criteria-Mapping Approach

Obtain UHC's quantity-limit policy for Leqembi. Identify the specific limit applied and the clinical basis UHC cites for it. Map the FDA label's dosing schedule against that limit. If the label requires more infusions per period than UHC authorizes, that gap is the core of the appeal. The prescriber's letter should make the arithmetic of the discrepancy explicit and ask UHC to align its limit with the FDA-approved schedule for this patient.