Haegarda denied as not FDA-approved for this use by Cigna?

Cigna's specific coverage criteria for haegarda 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 Cigna Denies Haegarda as Not FDA-Approved — and Why You Can Appeal

This denial reason, when applied to Haegarda, is almost always an administrative error or a policy mismatch. Haegarda (C1 esterase inhibitor [recombinant], subcutaneous) has received FDA approval for use in the United States for the prophylactic treatment of hereditary angioedema (HAE). A "not FDA-approved" denial may be issued because:

• The claim was coded in a way that doesn't match the approved indication.
• The prescribing information on file reflects an off-label use that falls outside the approved labeling.
• Cigna's internal system cross-referenced an outdated policy version.
• There was a data-entry error on the prior-authorization or pharmacy claim.

If Haegarda is being prescribed in accordance with its FDA-approved indication, the factual basis for this denial does not exist and should be corrected.

## Your Federal Appeal Rights

• Internal appeal: File under ERISA §503 (employer-sponsored plans) or applicable state insurance law within the period shown on your denial letter — typically 180 days.
• External review: ACA §2719 entitles you to independent external review after exhausting internal options. File within approximately four months of final internal denial. Expedited review applies when your health is at serious risk.

## Concrete Appeal Steps

1. Call Cigna's member services immediately to determine the exact claim code and NDC number that triggered the denial — confirm whether there is a coding mismatch. 2. Obtain the current FDA-approved prescribing information (package insert) for Haegarda directly from the FDA or manufacturer. 3. Ask your prescriber to confirm in writing that the prescribed use matches the FDA-approved indication exactly. 4. If the denial is due to off-label use, have your prescriber provide a full medical-necessity letter with clinical rationale; many plans cover off-label use supported by recognized compendia or specialty guidelines. 5. File the internal appeal with the FDA label, the prescriber letter, and any compendia citations attached.

## Documentation to Gather

• Current FDA prescribing label for Haegarda (confirm indication, population, route)
• Prescriber letter confirming on-label use and HAE diagnosis
• HAE diagnostic records (specialist evaluation, confirmatory labs)
• Claim and prior-authorization paperwork to identify any coding discrepancy
• Any specialty-society guidance supporting use (cited generically)

## Criteria-Mapping Structure

Address each basis for Cigna's denial directly: (1) confirm FDA approval status with label evidence, (2) confirm the prescribed indication matches the label, and (3) if off-label, map each compendia or guideline recommendation to the specific patient diagnosis and clinical circumstances documented in the chart.