Orladeyo denied for missing prior authorization 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 Requires Prior Authorization for Orladeyo

Aetna requires prior authorization (PA) for Orladeyo (berotralstat) because it is classified as a specialty drug in the management of hereditary angioedema (HAE) — a rare, potentially life-threatening condition. The PA process is Aetna's mechanism for verifying that specific clinical criteria are met before covering the medication. A claim denial for "prior authorization required" usually means a prescription was dispensed or submitted without an approved PA on file, or that the PA request was submitted but not yet approved.

## Why This Denial Is Appealable

If the PA was denied on clinical grounds, that determination is an adverse benefit decision subject to full appeal rights. If the denial was issued because no PA was on file (administrative), you may be able to obtain retroactive authorization or resubmit. Under ERISA §503 and ACA §2719, you have the right to a full and fair review of any adverse benefit determination, including a PA denial, with access to the specific clinical criteria used.

## Federal Appeal Framework

• Internal appeal: File within 180 days of the PA denial. For pre-service (prospective) PA denials, Aetna must decide within 15 days (standard) or 72 hours (expedited).
• Concurrent/urgent requests: If you are actively being treated or the denial creates an urgent health risk, request expedited review — Aetna must respond within 72 hours.
• External review (ACA §2719): After a final internal denial, you may request independent external review. The window is generally 4 months from the final adverse determination. The external reviewer's decision binds the plan.
• State insurance department: If Aetna misses its decision deadlines, file a complaint with your state's insurance commissioner in parallel.

## Documentation to Gather

1. Diagnosis confirmation — specialist notes, and where applicable genetic or laboratory confirmation, establishing the HAE diagnosis and type. 2. Attack frequency and severity documentation — dated chart entries, emergency visit records, and hospitalization records documenting the burden of disease. 3. Prior-treatment history — complete documentation of all prior prophylactic and acute HAE therapies, with dates, outcomes, and reasons for inadequacy or discontinuation. 4. Prescriber PA letter — a narrative letter from your HAE specialist stating the medical necessity of Orladeyo, documenting how your case meets each of Aetna's stated PA criteria. 5. Current Aetna PA criteria — obtain the exact criteria from Aetna's published clinical policy for Orladeyo and verify each criterion is directly addressed in the submission.

## Criteria-Mapping Structure

Obtain Aetna's current PA criteria for Orladeyo (available in their clinical policy bulletins). Create a table with each criterion in the left column and the corresponding chart documentation in the right column. Your prescriber's PA letter should follow this same structure, addressing each criterion by name. This approach eliminates ambiguity and makes it straightforward for the reviewing clinician to approve. Ensure the diagnosis codes on the PA request exactly match the ICD codes listed in Aetna's coverage policy.