Orladeyo denied as not FDA-approved for this use 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 Issued a Not-FDA-Approved Denial for Orladeyo

A "not-FDA-approved" denial for Orladeyo (berotralstat) most commonly occurs due to an administrative or coding error — either the submitted diagnosis code did not match the labeled indication, the drug was requested for an off-label use, or Aetna's system failed to recognize the current approval status. Because Orladeyo has received FDA approval for its indicated use in hereditary angioedema (HAE), a not-FDA-approved denial for an on-label HAE request is facially incorrect and should be corrected on appeal.

## Why This Denial Is Appealable

An erroneous not-FDA-approved denial is one of the strongest grounds for appeal. The FDA approval status is a matter of public record, documented in the prescribing information. If the denial arose from a coding error or an outdated policy, the appeal is essentially an administrative correction. If the denial reflects a genuine off-label use, the appeal becomes a medical-necessity and peer-reviewed evidence argument. In either case, the federal appeal framework fully applies.

## Federal Appeal Framework

• Internal appeal (ERISA §503 / ACA §2719): File within 180 days of the denial. Aetna must respond within 30 days for pre-service denials. Include the FDA approval documentation directly.
• External review: Available after exhausting internal appeals. Because this type of denial can involve a medical judgment (off-label use) or a factual error, external review by an independent specialist is available. The window is generally 4 months from the final internal denial.
• Expedited review: If the delay poses a health risk, request expedited processing at both levels.

## Documentation to Gather

1. FDA prescribing information — obtain the current FDA-approved label for Orladeyo and include it with your appeal, highlighting the approved indication that matches your diagnosis. 2. Diagnosis confirmation — specialist notes confirming the HAE diagnosis that corresponds to the labeled indication. 3. Prescription and prior-authorization submission records — review for any coding errors (ICD-10 diagnosis code, NDC, or indication mismatch) that may have triggered the denial. 4. Prescriber letter — should confirm the on-label use, cite the FDA-approved indication verbatim, and explain that this is a standard-of-care treatment for HAE. 5. Guideline support — reference to the relevant HAE professional society's treatment guidelines to further establish the indication.

## Criteria-Mapping Structure

For an on-label not-FDA-approved denial, the mapping is straightforward: (a) copy the FDA-approved indication from the prescribing label, (b) provide the chart documentation confirming your diagnosis matches that indication, and (c) request that Aetna identify the specific regulatory or clinical basis for the denial in their response. If Aetna cannot identify a factual basis, the denial should not be sustained. If the use is genuinely off-label, your prescriber must additionally provide peer-reviewed clinical evidence and guideline support for the off-label application.