Haegarda denied due to quantity / dose limits 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 Imposes Quantity Limits on Haegarda — and How to Appeal

Cigna may approve Haegarda (C1 esterase inhibitor subcutaneous) for hereditary angioedema (HAE) prophylaxis but limit the quantity dispensed per fill or per month below what your prescriber has ordered. Quantity limits are set based on standard population dosing ranges in Cigna's coverage policy and do not account for individual patient variation — some patients require a dosing regimen that differs from the population average due to body weight, disease severity, or clinical response.

A quantity-limit denial does not mean the drug is not covered; it means Cigna requires additional justification to authorize the prescribed amount.

## Your Federal Appeal Rights

• Quantity-limit exception / internal appeal: ERISA §503 and applicable state law provide the right to appeal any adverse benefit determination, including a quantity-limit restriction. File within the timeframe on your denial notice.
• External review: After exhausting internal remedies, ACA §2719 entitles you to independent external review. File within approximately four months of final internal denial. Expedited review is available when your health is at serious risk.

## Concrete Appeal Steps

1. Request Cigna's written quantity-limit policy for Haegarda — specifically the maximum quantity per period it will authorize without exception. 2. Ask your prescriber to document in the chart the clinical basis for the ordered quantity — including the dosing rationale per the FDA-approved prescribing label and any patient-specific factors (e.g., body weight, documented inadequate response at a lower dose). 3. Obtain a prescriber letter explaining why the prescribed quantity is medically necessary and not amenable to reduction. 4. File the internal appeal or quantity-limit exception request with the supporting documentation. 5. If denied internally, proceed to external review.

## Documentation to Gather

• Current FDA-approved prescribing information for Haegarda, including the dosing guidance
• Prescriber letter detailing the clinical rationale for the prescribed quantity and frequency
• Patient-specific factors relevant to dosing: body weight (if relevant per label), attack frequency on current regimen, documented outcomes
• Any chart notes reflecting that the quantity limit would result in under-dosing or inadequate prophylaxis
• Treatment history showing dose adjustments and clinical responses

## Criteria-Mapping Structure

Address Cigna's quantity limit directly: (1) cite the FDA label's dosing guidance and confirm the prescribed amount falls within or is justified relative to that guidance, (2) cite the patient-specific clinical factors that support the ordered quantity, and (3) document the clinical consequence of the reduced quantity — such as breakthrough attacks — with chart evidence. This structure gives the reviewer a clear basis for granting the exception.