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

Cigna's specific coverage criteria for nucala 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 Denied Nucala as "Not FDA-Approved" — and Why This Is Almost Certainly Appealable

Nucala (mepolizumab) holds FDA approval for multiple indications, including severe eosinophilic asthma. A "not FDA-approved" denial for Nucala almost always indicates one of the following: the claim was submitted with an indication code that does not match an approved indication in Cigna's system; the coverage policy for the specific off-label use being treated requires additional documentation; or the denial was issued in error. In any of these scenarios, the denial is directly challengeable.

If the use is on-label, the appeal should open with a clear, documented statement of FDA approval status and the specific approved indication that applies.

## Your Federal Appeal Rights

• Internal appeal (ACA §2719 / ERISA §503): You have the right to a full-and-fair internal review. Submit within the timeframe on your denial notice.
• External review: Available after internal remedies are exhausted, typically within approximately four months of a final adverse determination. An IRO reviewer applies objective clinical and regulatory standards independently of Cigna.
• Expedited review: Available when asthma severity or eosinophilic disease activity makes the standard timeline medically inappropriate.

## Concrete Appeal Steps

1. Confirm the specific indication for which Nucala was prescribed — this must correspond to an FDA-approved indication. 2. Obtain the current FDA-approved prescribing label for Nucala identifying the approved indication. 3. Compare the ICD-10 code on the claim to the approved indication — correct any coding discrepancy. 4. Have the prescribing specialist write a letter citing the FDA approval and the specific patient diagnosis. 5. Submit the appeal with the prescribing label, clinical letter, and corrected claim information.

## Documentation to Gather

• Diagnosis confirmation: Specialist-confirmed diagnosis matching an FDA-approved Nucala indication, with chart documentation.
• FDA labeling: Copy of the approved prescribing information identifying the covered indication.
• Claim coding review: Confirm the ICD-10 codes submitted match the approved indication.
• Clinical severity: Chart documentation supporting the need for biologic therapy — exacerbation history, failed prior therapies, eosinophil count from the lab record.
• Prescriber letter: Directly cites FDA approval status and maps the patient's diagnosis to the approved label.

## Criteria-Mapping Structure

Side-by-side, present (1) the FDA-approved indication language from the prescribing label and (2) the documented diagnosis from the specialist's chart note. If the indication matches, the not-FDA-approved rationale fails on its face. Reference the applicable guideline organization generically (e.g., the applicable GINA or eosinophilic disease society guideline) to further establish that this use reflects the recognized standard of care.