Tyvaso Inhaled denied as non-formulary by Cigna?

Cigna's specific coverage criteria for tyvaso inhaled 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 Tyvaso (Inhaled Treprostinil) as Non-Formulary

A non-formulary denial means Cigna's drug formulary for your specific plan does not include Tyvaso (inhaled treprostinil) at a covered tier, or the drug requires additional review before it can be covered. Formulary decisions are plan-specific — what is covered on one Cigna plan may not be covered on another — so confirming the exact formulary status for your plan year is the first step.

Because Tyvaso is FDA-approved for a serious, progressive condition (pulmonary arterial hypertension or pulmonary hypertension associated with interstitial lung disease), a non-formulary denial is often challengeable through formulary exception and the standard appeal process.

## Your Federal Appeal Rights

• Formulary exception request: Before or alongside a formal appeal, ask Cigna for a formulary exception. Most plans are required to grant exceptions when a covered alternative would be medically inappropriate or ineffective for the patient's condition. Your prescriber must document why no formulary alternative is clinically suitable.
• Internal appeal (ACA §2719 / ERISA §503): File a formal internal appeal within the timeframe on the denial notice (commonly 180 days). Include the formulary exception request if not already submitted.
• External review: If the internal appeal is denied, you have approximately four months to request independent external review by an accredited IRO, whose decision binds the insurer.
• Expedited track: Available when clinical urgency makes the standard timeline unreasonable.

## Documentation to Gather

1. Diagnosis records: Documentation confirming PAH or PH-ILD from the treating specialist. 2. Formulary alternatives tried (or contraindicated): For each formulary drug in the same class, document either that it was tried and failed (with dates and outcomes) or that it is clinically unsuitable for this patient, with the prescriber's reasoning. 3. Prescriber letter of medical necessity: The specialist should address each formulary alternative by name and explain why Tyvaso is the medically necessary choice, referencing the FDA label and applicable clinical guideline organizations. 4. Clinical severity notes: Chart entries establishing disease burden and urgency.

## Criteria-Mapping Strategy

Download the current-year Cigna formulary for the patient's plan (available on Cigna's member portal or by calling member services). Identify all drugs listed in the same therapeutic class. Then document — point by point — why each formulary alternative is not appropriate for this patient. Pair this with the FDA-approved prescribing information for Tyvaso confirming the patient meets the labeled indication. This side-by-side structure is the strongest foundation for a formulary exception or non-formulary appeal reversal.