CurrentCignaPolicy IP0753

Inhaled Prostacyclin Products

Defines prior authorization, medical necessity criteria, documentation, approved indications, durations, and exclusions for inhaled treprostinil products (Tyvaso, Tyvaso DPI, Yutrepia) for PAH (WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (WHO Group 3). Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyInhaled Prostacyclin Products

Policy CodePolicy IP0753

Change TypeNew policyrevision removed Ventavis (11/15/202512/15/2025)

Effective DateDec 15, 2025

Next Review Date

Key ActionPrior Authorization is required; ensure right heart catheterization documentation and specialist (cardiologist or pulmonologist) prescribing/consultation are provided for approvals.

SourceLink

POLICY UPDATE CHANGES

New policy created (Summary of Changes = New policy).

Ventavis was removed from the policy.

2Covered Indications (WHO groups)

3Products listed

1 yr / 4 moTypical approval durations

Coverage Summary

Scope: This policy covers the inhaled treprostinil products Tyvaso, Tyvaso DPI, and Yutrepia for their FDA‑approved indications: pulmonary arterial hypertension (WHO Group 1 PAH) and pulmonary hypertension associated with interstitial lung disease (WHO Group 3 PH‑ILD). Prior authorization is required and approvals are provided for the durations specified in the criteria: typical approvals are 1 year for WHO Group 1 and for ongoing users, and an initial 4‑month approval period for new WHO Group 3 therapy. Uses outside these WHO Group 1 or Group 3 indications are considered not medically necessary and are excluded from coverage.

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FDA‑Approved Indication — WHO Group 3 (PH‑ILD)

FDA-Approved Indications - Pulmonary Hypertension Associated with Interstitial Lung Disease (WHO Group 3)

Approve for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy

Patient has a diagnosis of World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease
Patient with connective tissue disease is required to have a baseline forced vital capacity < 70%< 70%
Patient has evidence of diffuse parenchymal lung disease on computed tomography of the chest
The patient has had a right heart catheterization
Documentation required
Results of the right heart catheterization confirm the diagnosis of WHO Group 3 pulmonary hypertension associated with interstitial lung disease
The medication is prescribed by or in consultation with a cardiologist or a pulmonologist

B) Patient is Currently Receiving Tyvaso, Tyvaso DPI, or Yutrepia for WHO Group 3

Patient has a diagnosis of World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease
The patient has had a right heart catheterization
Refers to prior to starting therapy with a medication for WHO Group 3 PAH
Results of the right heart catheterization confirm the diagnosis of World Health Organization (WHO) Group 3 pulmonary hypertension associated with interstitial lung disease
According to the prescriber, patient has had a response to therapy
Examples: increase/maintenance in six-minute walk distance from baseline, improved exercise capacity, decreased NT-proBNP, lessened clinical worsening, reduced rate of exacerbations
The medication is prescribed by or in consultation with a cardiologist or a pulmonologist

Special baseline threshold for WHO Group 3 connective tissue disease patients: a baseline forced vital capacity (FVC) < 70% is required as part of the initial therapy criteria for pulmonary hypertension associated with interstitial lung disease.

Conditions Not Covered / Exclusions

Conditions Not Covered

Tyvaso, Tyvaso DPI, and Yutrepia for any other use is considered not medically necessary, including:

Concurrent use with oral or parenteral prostacyclin agents used for pulmonary hypertension is not recommended

Examples include Orenitram (treprostinil ER tablets), selexipag (Uptravi), epoprostenol infusion, treprostinil subcutaneous or intravenous infusion (Remodulin, generic)

Tyvaso, Tyvaso DPI, and Yutrepia for any other use is considered not medically necessary. Concurrent use with oral or parenteral prostacyclin agents for pulmonary hypertension is not recommended and claims for indications outside the listed WHO Group 1 or Group 3 criteria (including such concurrent use) will be denied.

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization is required for coverage of Tyvaso, Tyvaso DPI, and Yutrepia. Approvals are provided for the durations noted in the policy: generally 1 year for most WHO Group 1 PAH indications and for patients currently receiving therapy; initial therapy for WHO Group 3 pulmonary hypertension associated with interstitial lung disease is approved for 4 months (with ongoing users for Group 3 approved for 1 year).

Documentation Required

Right heart catheterization documentation

Documentation of right heart catheterization is required to confirm the diagnosis for both WHO Group 1 PAH and WHO Group 3 pulmonary hypertension associated with interstitial lung disease. Documentation may include chart notes or catheterization laboratory reports. If right heart catheterization documentation was previously provided for prior authorization of a different medication indicated for WHO Group 1 PAH, that prior documentation is considered to satisfy this policy's documentation requirement.

Documentation Required

Specialist prescribing requirement

The medication must be prescribed by or in consultation with a cardiologist or a pulmonologist for both WHO Group 1 and WHO Group 3 indications; this specialist prescribing/consultation requirement is part of the approval criteria.

Denial Risk

Not medically necessary for other uses

Use of Tyvaso, Tyvaso DPI, or Yutrepia for any indication outside the listed WHO Group 1 or Group 3 criteria is considered not medically necessary and will be denied. Concurrent (concomitant) use with oral or parenteral prostacyclin agents used for pulmonary hypertension is not recommended and is listed as a condition not covered.

Clinical Evidence

TRIUMPHTRIUMPH — basis for Yutrepia PAH approval

INCREASEINCREASE — basis for Yutrepia Group 3 (ILD) approval

INSPIREINSPIRE — safety/tolerability evidence for Yutrepia

Evidence summary: Key trials and regulatory bases include TRIUMPH (supporting Yutrepia approval for PAH), INCREASE (supporting Yutrepia approval for pulmonary hypertension associated with interstitial lung disease / WHO Group 3), and INSPIRE (safety/tolerability data). These trials/approvals underpin the products' indications for WHO Group 1 PAH and WHO Group 3 PH‑ILD.

Background

Background: Tyvaso, Tyvaso DPI, and Yutrepia are inhaled treprostinil (prostacyclin) therapies indicated to improve exercise ability in patients with WHO Group 1 pulmonary arterial hypertension and WHO Group 3 pulmonary hypertension associated with interstitial lung disease. These agents are generally used later in the treatment pathway and are typically prescribed by or in consultation with specialists (cardiologists or pulmonologists). Right heart catheterization hemodynamic confirmation is required to document the diagnosis prior to initiation (documentation such as catheterization reports is required for prior authorization).

Definition (WHO Group 1 PAH): Pulmonary arterial hypertension is defined hemodynamically by a mean pulmonary artery pressure (mPAP) > 20 mmHg at rest, a pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg, and a pulmonary vascular resistance (PVR) > 2 Wood units measured by cardiac catheterization.