CurrentMass General Brigham Health PlanPolicy N/A

Ventavis (iloprost) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy governing prior authorization, specialty distribution, and coverage criteria for Ventavis (iloprost) for treatment of pulmonary arterial hypertension (WHO Group 1) for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVentavis (iloprost) — Coverage Criteria for PAH (WHO Group 1)

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date01/01/2024

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation confirming PAH (WHO Group 1) with hemodynamic confirmation and prescriber specialty.

SourceLink

12 monthsapproval duration

WHO Group 1indication required

RHC requiredhemodynamic confirmation

Specialty pharmacydispensing

Coverage Criteria for Ventavis (iloprost)

Prescriber: Medication prescribed by or in consultation with a pulmonologist or cardiologist.

Indication: Member has pulmonary arterial hypertension (WHO Group 1).

Refer to WHO classification appendix for subgroups.

Hemodynamic confirmation: PAH confirmed by either (a) pretreatment right heart catheterization with all of the following: mPAP > 20 mmHg; PCWP < 15 mmHg; and PVR >= 3 Wood units, or (b) for infants <1 year, Doppler echocardiogram if right heart catheterization cannot be performed.mPAP > 20 mmHg; PCWP < 15 mmHg; PVR >= 3 Wood units

Continuation of Therapy

Covered when ALL of the following are met:

Clinical benefit: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Approvals granted for 12 months.

Use of Ventavis (iloprost inhalation solution) for indications other than pulmonary arterial hypertension (PAH, WHO Group 1) is considered experimental/investigational and not medically necessary.

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ventavis (iloprost inhalation solution). Highlight: members new to the plan who are currently receiving the medication may be eligible for authorization (excluding samples or manufacturer patient assistance program supply). Prior authorization requests must follow normal transfer-of-care rules and include the clinical documentation listed below.

Members new to the plan currently receiving therapy may be eligible for PA (exclude samples or manufacturer PAP supplies)
Requests must follow transfer-of-care/prior authorization procedures

Billing Rule

Dispensing Requirement — Specialty Pharmacy

This medication is designated as a specialty product and must be dispensed through a contracted specialty pharmacy as part of the pharmacy benefit. Operational note: contact the specialty pharmacy services below for prior authorization submission, dispensing, and benefit coordination.

Specialty pharmacy required — Medical and Specialty Medications contact: Phone: 877-519-1908; Fax: 855-540-3693
Non-specialty medications contact: Phone: 800-711-4555

Step Therapy

Benefit and Specialty Limits

Benefit and specialty limits apply. Ventavis is subject to the plan's pharmacy benefit limits and any applicable step therapy or quantity limits. Note that use for indications other than PAH (WHO Group 1) is considered experimental/investigational and is not medically necessary per policy and may be denied.

Benefit: Pharmacy Benefit; Quantity limit and step therapy may apply
Specialty limitation: Must be filled at contracted specialty pharmacy
Non‑FDA-approved indications are experimental/investigational and not medically necessary

Background on Ventavis (iloprost)

Ventavis (iloprost inhalation solution) is an inhaled prostacyclin analogue FDA‑approved for the treatment of pulmonary arterial hypertension (PAH, WHO Group 1) to improve a composite endpoint of exercise tolerance, symptoms (NYHA functional class), and prevention of clinical deterioration. Pivotal trials supporting approval primarily enrolled patients with NYHA Class III–IV symptoms and included idiopathic, heritable, and connective tissue disease–associated PAH.

Definitions and Hemodynamic Confirmation

PAH (WHO Group 1) subtypes

Idiopathic PAHIdiopathic pulmonary arterial hypertension (WHO Group 1.1)

Heritable PAHHeritable pulmonary arterial hypertension (WHO Group 1.2)

Drug- and toxin-induced PAHPAH due to drug or toxin exposure (WHO Group 1.3)

PAH associated with other conditionsPAH associated with connective tissue disease, HIV, portal hypertension, congenital heart disease, or schistosomiasis (WHO Group 1.4 subgroups)

Other Group 1 subtypesLong-term responders to calcium channel blockers; PVOD/PCH involvement; persistent pulmonary hypertension of the newborn syndrome (listed WHO Group 1 subtypes)

Hemodynamic confirmation of PAH

Right heart catheterization confirmationPretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP < 15 mmHg, and PVR ≥ 3 Wood units

Alternate for infants <1 yearDoppler echocardiogram may be used to confirm PAH if right heart catheterization cannot be performed in infants <1 year

Prescriber requirementHemodynamic confirmation must be documented when prescribed by or in consultation with a pulmonologist or cardiologist