CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Ventavis (iloprost) inhalation — Coverage Criteria for Pulmonary Arterial Hypertension

Coverage and authorization criteria for Ventavis (iloprost inhalation solution) for treatment of pulmonary arterial hypertension (WHO Group 1) for members of Neighborhood Health Plan of Rhode Island when prescriber and clinical criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVentavis (iloprost) inhalation — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of PAH diagnosis (right heart catheterization hemodynamics or echocardiogram for infants <1 year) and prescriber specialty (pulmonologist or cardiologist) to qualify for a 12‑month authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

WHO Group 1disease group required

mPAP > 20 mmHg; PCWP ≤ 15; PVR ≥ 3diagnostic thresholds

Pulmonologist or cardiologistprescriber requirement

Coverage Criteria for Ventavis (iloprost)

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial therapy (PAH)

Covered when ALL of the following are met

PAH indication and prescriber

Indication aligns with FDA‑approved uses for Ventavis (to improve exercise tolerance, symptoms/NYHA class, and prevent lack of deterioration).
Studies predominately in NYHA class III–IV and idiopathic/heritable/CTD-associated PAH
Prescriber: Must be prescribed by or in consultation with a pulmonologist or cardiologist.
Prescriber specialty requirement per policy

Diagnostic confirmation: PAH confirmed by either (1) pretreatment right heart catheterization meeting specified hemodynamic thresholds OR (2) for infants <1 year, Doppler echocardiogram when catheterization cannot be performed.

Right heart catheterization results must include: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units (adult) or PVRI ≥ 3 Wood units·m2 (pediatric)

Continuation therapy

Continuation therapy covered when ALL of the following are met

Current therapy and benefit: Member is currently receiving Ventavis through a paid pharmacy or medical benefit and is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Authorization of 12 months may be granted for continuation

All indications for Ventavis (iloprost inhalation solution) outside the FDA‑approved indication for pulmonary arterial hypertension (PAH, WHO Group 1) are considered experimental/investigational and not medically necessary. Coverage is limited to uses that align with the labeled indication to improve exercise tolerance, symptoms, and prevent deterioration in PAH.

Use of Ventavis for any indication other than the FDA‑approved treatment of pulmonary arterial hypertension (PAH, WHO Group 1) is considered not medically necessary (experimental/investigational) and will not be covered.

Diagnostic Hemodynamics and Definitions

Hemodynamic thresholds from right heart catheterization

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR) — adults≥ 3 Wood units

Pulmonary vascular resistance index (PVRI) — pediatrics≥ 3 Wood units·m2

PAH diagnostic hemodynamics

Diagnostic testRight heart catheterization demonstrating specified hemodynamics

Required mPAP> 20 mmHg

Required PCWP≤ 15 mmHg

Required PVR/PVRIPVR ≥ 3 Wood units (adults) or PVRI ≥ 3 Wood units·m2 (pediatrics)

WHO Group 1

DefinitionWorld Health Organization classification for pulmonary arterial hypertension (WHO Group 1)

Coverage requirementMember must have PAH defined as WHO Group 1 for authorization of Ventavis

Indication contextVentavis is indicated for PAH (WHO Group 1) to improve exercise tolerance, symptoms, and lack of deterioration

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Authorization duration and general requirement — Prior authorization may be granted for 12 months when all listed criteria for PAH diagnosis and prescriber specialty are met; continuation requests require evidence of ongoing benefit (disease stability or improvement).

Authorization duration: 12 months
Prescriber requirement: must be prescribed by or in consultation with a pulmonologist or cardiologist

Step Therapy

Step therapy — No step therapy requirements specified in the document.

Documentation Required

Required documentation — Documentation must show the prescriber is a pulmonologist or cardiologist (or there is a documented consultation) and hemodynamic confirmation of PAH by right heart catheterization per criteria below; for infants <1 year, Doppler echocardiogram may be acceptable if catheterization cannot be performed.

Right heart catheterization results: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units (adults) or PVRI ≥ 3 Wood units·m2 (pediatrics)
For infants <1 year: Doppler echocardiogram if right heart catheterization cannot be performed

Denial Risk

Non‑FDA Indications

Non‑FDA indications denied — Requests for indications other than the FDA‑approved indication for pulmonary arterial hypertension (WHO Group 1) are considered experimental/investigational and are not medically necessary.

Denial Risk

Diagnostic Confirmation Required

Insufficient diagnostic confirmation — Requests that lack hemodynamic confirmation by right heart catheterization (or Doppler echocardiogram for infants <1 year when catheterization cannot be done) may be denied for insufficient diagnostic evidence.

Background

Pulmonary arterial hypertension (PAH, WHO Group 1) is a progressive condition for which Ventavis is FDA‑approved to improve a composite of exercise tolerance, symptoms (NYHA functional class), and to prevent clinical deterioration. Clinical trials supporting the indication primarily enrolled patients with NYHA Class III–IV symptoms and etiologies including idiopathic, heritable, or connective tissue disease–associated PAH.