Haegarda denied as experimental or investigational 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 Experimental — and Why You Can Appeal

Haegarda (C1 esterase inhibitor subcutaneous) received FDA approval for routine prophylaxis to prevent HAE attacks in adolescents and adults. Despite this, Cigna may issue an "experimental or investigational" denial if its internal coverage policy has not been updated to reflect current evidence, if the specific indication or patient population falls outside a narrowly written policy, or if the reviewer applied an outdated policy version.

An FDA-approved drug used in accordance with its approved labeling is, by definition, not experimental. This denial type is among the most successfully overturned on appeal when the right documentation is presented.

## Your Federal Appeal Rights

• Internal appeal: File under ERISA §503 or applicable state law within the deadline on your denial letter (commonly 180 days).
• External review: Under ACA §2719, you may escalate to an Independent Review Organization after the internal process. The external-review window is approximately four months from final denial. Expedited review (72-hour turnaround) is available for urgent medical situations.

## Concrete Appeal Steps

1. Obtain Cigna's written denial and the specific medical/coverage policy cited as the basis for the experimental determination. 2. Pull the FDA approval letter and the current FDA-approved prescribing information (label) for Haegarda, confirming the approved indication matches your prescribed use. 3. Ask your prescriber to write a letter stating that the prescribed use is consistent with the FDA-approved indication and with current specialty-society clinical guidance. 4. If Cigna cites specific studies or a technology-assessment report, obtain those documents and have your prescriber respond to each point. 5. Submit the internal appeal; if denied, proceed immediately to external review.

## Documentation to Gather

• FDA-approved prescribing information for Haegarda (current label)
• Confirmed HAE diagnosis records
• Prescriber letter affirming on-label use and medical necessity
• Any relevant USHA (US Hereditary Angioedema Association) or international guideline references cited generically
• Records of HAE attack frequency, severity, and impact on daily functioning

## Criteria-Mapping Structure

Side-by-side each of Cigna's stated experimental-determination criteria against a documented rebuttal. For every element the policy lists as lacking, provide the corresponding evidence: the FDA approval date and indication, the chart confirmation of diagnosis, and the prescriber's clinical reasoning. This structured rebuttal gives the IRO reviewer a clear path to overturn.