Orladeyo denied as non-formulary 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 as Non-Formulary

A non-formulary denial means Orladeyo (berotralstat) is not included on Aetna's standard drug formulary tier at a covered cost-share level for your specific plan. Formulary decisions are made at the plan design level and may not reflect the clinical appropriateness of the medication for your situation. Non-formulary denials are not final: virtually every plan that is subject to the ACA or ERISA must have a formulary exception process, and hereditary angioedema is a condition where formulary exceptions are frequently granted.

## Why This Denial Is Appealable

If Orladeyo is the clinically appropriate treatment for your HAE and no formulary alternative is equally safe and effective for you, you are entitled to request a formulary exception. Aetna must consider exceptions when a covered formulary drug would be contraindicated, cause an adverse reaction, or be clinically less effective for you. This is a medical judgment, and your prescriber's documentation drives the outcome.

## Federal Appeal Framework

• Formulary exception request: This is typically the first step — it runs parallel to or precedes a formal internal appeal. Submit with prescriber documentation.
• Internal appeal (ERISA §503 / ACA §2719): If the exception is denied, file a formal internal appeal within 180 days of the denial notice.
• External review: After a final internal denial, you may request independent external review. The external reviewer's decision is binding. The window is generally 4 months from the final internal adverse determination.
• Expedited option: Available if the standard timeline poses a health risk; request expedited exception and appeal simultaneously.

## Documentation to Gather

1. Diagnosis confirmation — specialist notes confirming HAE diagnosis and current clinical status. 2. Formulary-alternative assessment — your prescriber should document each formulary-listed HAE prophylactic option and explain in writing why each is not appropriate for you (inadequate efficacy, prior failure, tolerability, or contraindication as determined by your clinician). 3. Prior-treatment history — dates, agents, outcomes, and reasons for discontinuation of any previously tried prophylactic therapies. 4. Prescriber medical-necessity letter — should explicitly state that Orladeyo is medically necessary and that no formulary alternative is clinically equivalent for your case. 5. Applicable guideline reference — cite the relevant HAE professional society guideline organization to support individualized treatment selection.

## Criteria-Mapping Structure

For a formulary exception, Aetna's policy will typically require documentation that: (a) the formulary alternatives are contraindicated or clinically inappropriate for the patient, (b) the patient has tried and failed formulary alternatives (if applicable), or (c) the non-formulary drug is medically necessary. Map each requirement to a specific chart entry and prescriber attestation. Confirm the exact criteria in Aetna's current formulary exception policy — criteria wording matters, and your letter should mirror it.