Trelegy denied as non-formulary 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 Denies Trelegy Ellipta as Non-Formulary

Cigna places Trelegy Ellipta on a non-preferred or non-covered tier on some of its formularies, typically because it has negotiated preferred-tier status for one or more competing single-inhaler or dual-inhaler products. When your prescriber writes specifically for Trelegy and no prior authorization or formulary exception is on file, the claim is denied as non-formulary. This is a plan-design decision driven by rebate contracts, not a judgment about Trelegy's clinical effectiveness.

## Why This Denial Is Appealable

Cigna must allow you to request a formulary exception (medical exception) if the formulary alternatives are clinically inappropriate for you. Grounds for exception include a documented intolerance or adverse reaction to a formulary alternative, a prior failure of a preferred agent, or a clinical reason why Trelegy specifically is the appropriate choice for your condition. Under ACA §2719 and ERISA §503, you also have internal-appeal and external independent-review rights.

## Federal Appeal Framework

• Formulary exception request: File through the prescriber's office, typically at the same time as or before the formal appeal; Cigna must respond within its utilization-management timeline.
• Internal appeal: File within 180 days of the denial notice if the exception request is denied.
• External review: Available after internal exhaustion; the IRO independently evaluates whether the non-formulary denial was appropriate.
• Expedited option: Available if delay would seriously jeopardize respiratory health; Cigna must respond within 72 hours.

## Documentation to Gather

1. Formulary alternative trial records — pharmacy records and chart notes showing that you tried the formulary-preferred inhaler(s) and experienced inadequate symptom control, increased exacerbations, or an adverse effect; document dates and clinical outcomes clearly. 2. Contraindication or intolerance documentation — if a formulary alternative cannot be used, a prescriber note explaining the specific clinical reason (not just preference). 3. Clinical differentiation rationale — if Trelegy has a characteristic (such as a specific device type, inhalation technique, or combination of three agents in a single device improving adherence) that is clinically meaningful for this patient, document that reasoning. 4. Diagnosis and severity documentation — pulmonology or primary care notes confirming COPD or asthma diagnosis, severity classification, and the rationale for triple therapy. 5. Prescriber exception letter — a letter from the treating physician explicitly addressing why the preferred formulary alternative(s) are not appropriate and why Trelegy is medically necessary.

## Criteria-Mapping Structure

Obtain Cigna's current formulary exception criteria and map each to the clinical record:

| Exception Criterion (from Cigna policy) | Supporting Documentation | |---|---| | Formulary alternative tried and failed | Pharmacy records with dates + chart outcome notes | | Formulary alternative contraindicated or not tolerated | Prescriber attestation with clinical basis | | Trelegy is medically necessary for this patient | Prescriber letter + diagnosis/severity documentation |

Review the FDA-approved prescribing information for Trelegy and Cigna's current formulary and exception policy for your specific plan and benefit year — the exact preferred alternatives and exception criteria must come from those primary sources.