Orladeyo denied as not medically necessary 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 Denied Orladeyo for Medical Necessity

A medical-necessity denial means Aetna's reviewer determined that the clinical information submitted did not adequately demonstrate that Orladeyo (berotralstat) is necessary for your specific condition at this time. For hereditary angioedema (HAE) prophylaxis, this typically means the submission lacked sufficient documentation of attack frequency, severity, impact on daily functioning, or inadequate response to other options. This is almost always a documentation gap rather than a genuine clinical disagreement — and it is one of the most commonly overturned denial types on appeal.

## Why This Denial Is Appealable

Aetna's medical-necessity criteria must align with the FDA-approved indication and with accepted clinical standards for HAE management. If your chart genuinely supports the prescription, the appeal process exists precisely to surface that evidence. Under ERISA §503, Aetna must provide the specific clinical rationale for the denial and must conduct a full and fair review of any new information you submit.

## Federal Appeal Framework

• Internal appeal: Submit within 180 days of the denial notice. Aetna must decide within 30 days for pre-service denials; expedited cases are decided within 72 hours.
• External review (ACA §2719): If the internal appeal is denied or Aetna misses its deadline, you may request binding independent external review. The external reviewer is a board-certified specialist who reviews the record de novo. The window to request is generally 4 months from the final internal denial.
• Expedited pathway: If you are in the middle of an HAE attack cycle or at imminent risk, request expedited review at both the internal and external levels simultaneously.

## Documentation to Gather

1. Diagnosis confirmation — specialist diagnosis notes, and where applicable, laboratory or genetic confirmation of HAE type, establishing the underlying condition unambiguously. 2. Attack history — a dated log or chart entries documenting attack frequency, severity, anatomical location (laryngeal attacks carry higher urgency), emergency visits, and hospitalizations. 3. Prior-treatment history — complete list of prior prophylactic and acute treatments tried, with start/stop dates, outcomes, and documented reasons for inadequacy or discontinuation. 4. Clinical severity documentation — chart notes demonstrating how HAE affects your daily activities, work, and quality of life. 5. Prescriber medical-necessity letter — a narrative letter from your specialist explaining why Orladeyo is medically necessary for you specifically, referencing the applicable HAE clinical guideline organization's standards.

## Criteria-Mapping Structure

Obtain Aetna's current coverage/clinical policy for Orladeyo. Copy each listed criterion verbatim into a two-column table. In the second column, cite the exact chart entry — by date and document type — that satisfies each criterion. This structured mapping is the single most effective tool in a medical-necessity appeal: it removes ambiguity and forces the reviewer to address each criterion individually. Your prescriber's letter should reference the same table and attest that each criterion is met.