Tyvaso Inhaled denied for failing step therapy 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 Applies Step Therapy to Tyvaso (Inhaled Treprostinil)

Cigna's coverage policy for pulmonary arterial hypertension typically requires that patients try and fail one or more lower-cost PAH therapies before Tyvaso (inhaled treprostinil) will be approved. This is called step therapy — also known as "fail first." A step-therapy denial does not mean the drug is inappropriate; it means Cigna's records do not reflect documented failure of, or contraindication to, the required prior-step agents.

Step-therapy denials are among the most winnable appeals when the prescriber's records are complete. Many states also have step-therapy override laws that apply to state-regulated plans; check whether your state has enacted such a law and whether it applies to this plan.

## Your Federal Appeal Rights

• Step-therapy override request: This is often handled as a prior-authorization exception rather than a formal appeal — but if denied, it feeds directly into the appeal process.
• Internal appeal (ACA §2719 / ERISA §503): File within the timeframe on the denial notice (commonly 180 days).
• External review: If internal appeal fails, request IRO review within approximately four months. External reviewers routinely override step-therapy requirements when clinical contraindications or prior failures are documented.
• State step-therapy law: If the plan is state-regulated (not self-funded ERISA), your state's insurance department may mandate that the insurer grant an override when the prescriber documents clinical justification.

## Documentation to Gather

1. Complete prior-therapy history: For every drug Cigna's step-therapy protocol requires, provide the drug name, dates of use, response assessment, and documented reason for discontinuation (failure, intolerance, or contraindication). Use chart notes, pharmacy records, and the prescriber's narrative. 2. Contraindication or intolerance documentation: If a required prior-step drug was not tried because it is contraindicated or clinically unsuitable for this patient, the prescriber must document the clinical basis — referencing the FDA prescribing information for that drug. 3. Specialist clinical assessment: A letter from the treating pulmonologist explaining why the clinical trajectory warrants proceeding to Tyvaso without completing (or after completing) the required steps. 4. Cigna's step-therapy criteria: Obtain the exact current step-therapy protocol from Cigna's coverage policy library so the appeal addresses every stated requirement.

## Criteria-Mapping Strategy

List each required prior-step drug from Cigna's protocol. For each one, document in the appeal letter: (a) whether it was tried — with dates and outcomes — or (b) the specific clinical reason it was not tried, citing the relevant FDA prescribing information. Append chart notes and pharmacy records as exhibits. This structured, step-by-step format directly neutralizes the step-therapy denial and gives the reviewer a clear basis for override.