Trelegy denied as not medically necessary 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 on Medical-Necessity Grounds

Cigna requires that Trelegy Ellipta — a single-inhaler triple combination therapy for COPD or asthma — be prescribed for a patient who meets specific disease-severity and prior-treatment criteria set out in Cigna's coverage policy. A medical-necessity denial typically means that the submitted records did not adequately demonstrate: (1) the confirmed diagnosis with objective severity documentation, (2) that the patient has used and had an inadequate response to or is intolerant of simpler inhaler regimens, or (3) that the treating physician's rationale for escalating to triple therapy is supported by the clinical record.

## Why This Denial Is Appealable

Medical-necessity denials for Trelegy are among the most successfully appealed when the prescriber provides a thorough clinical narrative that maps directly to Cigna's stated criteria. Cigna must comply with ACA §2719 external-review requirements and, for self-funded employer plans, ERISA §503's full-and-fair review standard. An independent IRO will review the clinical evidence against accepted specialty standards, not solely Cigna's internal policy.

## Federal Appeal Framework

• Internal appeal: File within 180 days of the denial notice; include the complete clinical package.
• External review: Available after the internal process is exhausted or if Cigna misses its decision deadline; the IRO applies accepted clinical standards.
• Expedited option: Available when your respiratory condition creates urgency; Cigna must respond within 72 hours internally and the IRO within 72 hours externally.

## Documentation to Gather

1. Diagnosis and severity confirmation — pulmonology or primary care notes with spirometry results (or other objective severity measures) confirming COPD diagnosis and severity classification, or asthma diagnosis with documented control assessment; these records must be in the chart, not just asserted in the appeal letter. 2. Prior inhaler therapy history — pharmacy records and chart notes documenting each prior inhaler regimen tried (LABA/ICS, LAMA, or LABA/LAMA), with start and end dates and the documented clinical reason for each change (inadequate symptom control, exacerbations, intolerance). 3. Exacerbation history — hospital admission records, urgent care visits, oral steroid courses, or other documentation of exacerbations that support escalation to triple therapy. 4. Prescriber medical-necessity letter — a detailed letter from the treating physician explaining the diagnosis, disease severity, prior-therapy timeline, and why single-inhaler triple therapy with Trelegy is now medically necessary. 5. Applicable guideline reference — reference to the relevant guideline organization (e.g., GOLD guidelines for COPD, GINA for asthma) supporting triple therapy at the patient's current disease stage.

## Criteria-Mapping Structure

Obtain Cigna's current medical policy for Trelegy and map each requirement to the clinical record:

| Cigna Coverage Criterion | Chart Evidence | |---|---| | Confirmed diagnosis of covered indication | Specialist note + objective test results, date ___ | | Severity meets coverage threshold | Spirometry or validated severity tool in chart, date ___ | | Required prior inhaler therapies tried | Pharmacy records + chart notes, dates ___ | | Clinical rationale for escalation | Exacerbation history + prescriber letter |

Review the FDA-approved prescribing information for Trelegy and Cigna's current published coverage policy to identify the exact criteria — do not rely on prior-year policy language, as these requirements are updated periodically.