Orladeyo denied due to quantity / dose limits by Aetna?

Aetna's specific coverage criteria for orladeyo 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 Applied a Quantity Limit to Orladeyo

Aetna's quantity-limit denials for Orladeyo (berotralstat) typically arise when the amount prescribed — either the number of capsules per fill or the days' supply — exceeds the quantity that Aetna's policy permits per dispensing period. For a daily oral prophylactic like Orladeyo, this often reflects a plan-level utilization management rule rather than a clinical judgment about whether you should receive the drug at all. The correct dose and supply for your situation is determined by the FDA-approved prescribing information and your prescriber's clinical judgment, not by the quantity limit alone.

## Why This Denial Is Appealable

Quantity limits are a plan design tool, but they cannot override medical necessity. If your prescriber has documented a clinical reason why the standard quantity limit is insufficient for your care — or if the limit prevents you from filling a full month's supply as prescribed — that is grounds for a quantity-limit exception or appeal. Under ERISA §503 and ACA §2719, quantity-limit denials are reviewable adverse benefit determinations.

## Federal Appeal Framework

• Exception request: Many plans allow a quantity-limit exception request prior to formal appeal. Submit with prescriber documentation explaining the clinical need for the prescribed quantity.
• Internal appeal: File within 180 days of the denial. Aetna must respond within 30 days for pre-service denials or within the applicable urgent timeline.
• External review (ACA §2719): Available after exhausting internal appeals. The window is generally 4 months from the final internal adverse determination. The external reviewer's decision is binding.
• Expedited review: If the quantity limit is preventing access to medication during an active or imminent HAE episode, request expedited review.

## Documentation to Gather

1. Prescribing information reference — your prescriber should reference the FDA-approved label to confirm the prescribed quantity is within the labeled dosing regimen. 2. Prescriber letter — explaining the clinical basis for the prescribed quantity and why the plan's quantity limit is insufficient for continuous prophylaxis. 3. Diagnosis and severity documentation — chart notes confirming HAE diagnosis, attack frequency, and the importance of uninterrupted prophylaxis. 4. Pharmacy records — showing the fill history and demonstrating the pattern of use consistent with the prescribed regimen. 5. Applicable guideline reference — cite the relevant HAE professional society's recommendations regarding continuous prophylactic dosing to support the prescriber's clinical rationale.

## Criteria-Mapping Structure

Obtain Aetna's published quantity-limit policy for Orladeyo. Identify the specific limit that was applied and compare it to the FDA-approved labeled dosing. If the prescribed quantity aligns with the label and the label's quantity is higher than Aetna's limit, that discrepancy is the core of your appeal. Map each exception criterion from Aetna's policy to the corresponding prescriber attestation and chart documentation. Your prescriber's letter should explicitly state the medical necessity of the quantity as prescribed and confirm it is consistent with the FDA label.