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

Cigna's specific coverage criteria for trelegy 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 May Issue a "Not FDA-Approved" Denial for Trelegy

Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) is an FDA-approved triple-combination inhaled therapy. A "not FDA-approved" denial from Cigna is almost always a coding or administrative error — the drug is fully approved, so the denial likely reflects a miscoded indication, an incorrect NDC or J-code on the claim, or a mismatch between the submitted diagnosis code and Trelegy's approved indications. Occasionally, a plan interprets an off-label use of an approved drug as "not approved," which is a distinct but equally appealable issue.

## Why This Denial Is Appealable

Because FDA approval is a matter of public record, a factual correction appeal has strong footing. If the denial rests on an off-label use argument, federal law and most state insurance codes still protect the right to appeal on medical-necessity grounds, and many plans must cover off-label uses supported by recognized compendia or clinical guidelines.

## Your Federal Appeal Rights

• Internal appeal: File within the timeframe on your Explanation of Benefits (EOB). Cigna must respond within the regulatory deadline for urgent or standard reviews.
• External review (ACA §2719): If the internal appeal is denied, you have the right to an independent external review — generally within about four months of the initial denial. An accredited Independent Review Organization (IRO) decides, and its decision is binding on the plan.
• ERISA §503: If your coverage is through an employer plan, ERISA guarantees a full-and-fair review with the right to all documents the plan relied upon.
• Expedited review: If you are in active treatment or face serious deterioration of health, request expedited review — a decision is typically required within 72 hours.

## Documentation to Gather

• FDA approval confirmation: Print the current FDA label from DailyMed or FDA.gov confirming Trelegy's approved indications.
• Diagnosis documentation: Chart notes confirming your diagnosis (COPD or asthma, as applicable) aligned with an approved indication.
• Claim and EOB: The exact codes submitted and the denial language, so you can pinpoint the specific mismatch.
• Prescriber letter: A brief letter from your physician stating the prescribed indication, confirming it falls within FDA-approved use.
• Prior authorization file: If a PA was filed, include the approval number or submission confirmation.

## Criteria-Mapping Structure

Pull the exact text of Cigna's denial reason from your EOB. Then create a side-by-side document:

| Cigna's Stated Reason | Your Counter-Evidence | |---|---| | [Exact denial language] | FDA label section confirming approval for [your diagnosis] | | [Any indication mismatch] | Treating physician's chart note + prescriber letter confirming on-label use |

Attach the printed FDA label as Exhibit A. This format gives Cigna's appeal reviewer everything needed to reverse the decision in a single document.