Haegarda denied for failing step therapy 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 Applies Step Therapy to Haegarda — and How to Appeal

Cigna's step-therapy requirement for Haegarda (C1 esterase inhibitor subcutaneous) means Cigna's coverage policy requires documentation that you have first tried one or more alternative HAE prophylactic treatments before Haegarda will be authorized. Step-therapy protocols are cost-management tools and are not tailored to the clinical circumstances of any individual patient.

For hereditary angioedema, a rare and potentially life-threatening condition, step-therapy requirements can be particularly harmful when safer or more effective therapy is being delayed. Many states have enacted step-therapy override laws, and federal protections apply under ERISA for self-funded plans. Most step-therapy denials are overturned when the prescriber demonstrates that alternatives have already been tried, are contraindicated, or are clinically inappropriate for this patient.

## Your Federal Appeal Rights

• Step-therapy exception / internal appeal: File under ERISA §503 or applicable state law. Your state may also have a specific step-therapy exception statute requiring Cigna to grant an override when defined clinical criteria are met. Check your state's insurance department for applicable protections.
• External review: After exhausting internal remedies, ACA §2719 independent external review is available. File within approximately four months of final internal denial. Expedited review applies when delay risks serious harm.

## Concrete Appeal Steps

1. Obtain Cigna's step-therapy criteria for Haegarda — identify exactly which agents must be tried first and for how long. 2. Review your treatment history with your prescriber to determine whether the required steps have already been completed. 3. If steps have been completed, compile dated records of each required agent tried, the duration, and the outcome. 4. If steps have not been completed because an alternative is clinically inappropriate, have your prescriber write a detailed exception letter explaining the clinical basis. 5. File the step-therapy exception or internal appeal with the full documentation package.

## Documentation to Gather

• Chronological HAE prophylactic treatment history: agent, start/stop dates, dose (per label), clinical response, and reason for discontinuation
• Prescriber letter addressing each required step in Cigna's policy and explaining why Haegarda is now the appropriate treatment
• HAE diagnosis confirmation (specialist notes, lab records)
• Attack frequency and severity records (emergency visits, hospitalizations, airway events)
• If your state has a step-therapy override law, cite the applicable statute in your appeal

## Criteria-Mapping Structure

For each required step in Cigna's protocol, create a dedicated section in the appeal: reproduce Cigna's requirement, then immediately cite the chart evidence showing it has been met, or the prescriber's clinical explanation for why it cannot safely be met. Requests that map each required step to a documented patient outcome are the most likely to succeed.