Haegarda denied as non-formulary 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 Non-Formulary — and Why You Can Appeal

When Cigna lists Haegarda (C1 esterase inhibitor subcutaneous) as non-formulary, it means the drug does not appear on your specific plan's approved drug list, or it appears at a tier that requires prior authorization or a formulary exception before coverage is granted. Insurers design formularies primarily around cost and average-population utilization; a non-formulary status does not reflect a clinical judgment about whether Haegarda is appropriate for you personally.

For a rare disease like hereditary angioedema (HAE), where alternative treatments may be limited or clinically inferior for a given patient, formulary-exception appeals succeed at a meaningful rate when medical necessity is well-documented.

## Your Federal Appeal Rights

• Formulary exception request: Most plans are required to have a formulary exception process. This is the first step and is separate from — but may run alongside — the formal appeal.
• Internal appeal: ERISA §503 or state law guarantees a full-and-fair internal review of any adverse benefit determination.
• External review: After exhausting internal remedies, ACA §2719 provides independent external review. File within approximately four months of final denial. Expedited review is available in urgent situations.

## Concrete Appeal Steps

1. Contact Cigna to confirm the exact formulary-exception request procedure for your plan and the deadline to file. 2. Simultaneously request a copy of the applicable drug coverage/formulary policy. 3. Have your prescriber submit a formulary-exception request with a supporting medical-necessity letter explaining why the formulary alternatives are clinically inappropriate or have already failed. 4. If the exception is denied, file a formal internal appeal, then escalate to external review if needed.

## Documentation to Gather

• Confirmed HAE diagnosis (specialist records, lab confirmation)
• Documented history with any formulary-listed HAE prophylactic alternatives, including dates, outcomes, and reasons those options are not adequate for this patient
• Prescriber letter stating medical necessity for Haegarda specifically and addressing why formulary alternatives are not clinically appropriate
• Records of HAE attack frequency, severity, and any emergency or acute-care utilization
• Relevant specialty-society clinical guideline references (cited generically, e.g., the USHA/WAO guidelines)

## Criteria-Mapping Structure

For the formulary exception and any subsequent appeal, structure the response so that every formulary-alternative the insurer could propose is addressed directly: name the alternative, cite the chart record showing it was tried or is medically contraindicated (per your prescriber's clinical judgment), and state the outcome or reason for unsuitability. This prevents back-and-forth step-therapy requests and positions the appeal for swift resolution.