CurrentMass General Brigham Health PlanPolicy N/A

Ventavis

Defines prior authorization, quantity limit, specialty pharmacy requirement, clinical criteria for initiation and continuation of Ventavis (for PAH WHO Group 1), required diagnostic confirmation, approval duration, and excluded indications.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVentavis

Policy CodePolicy N/A

Change TypeAdministrative classification change (SGM → Custom)

Effective DateJan 1, 2024

Next Review Date

Key ActionPrior authorization is required for Ventavis; ensure documentation of specialist consultation and hemodynamic confirmation is provided.

SourceLink

POLICY UPDATE CHANGES

Reviewed at Dec P&T, switched from SGM to Custom; effective 1/1/2024

1FDA-approved indication (PAH WHO Group 1)

12 monthsApproval duration

SpecialtySpecialty pharmacy requirement

Coverage Summary

Ventavis (iloprost) is FDA-approved for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve a composite endpoint of exercise tolerance, symptoms (NYHA Class), and lack of deterioration. All other indications are considered experimental/investigational and not medically necessary. Approvals will be granted for 12 months, and the drug is designated as a specialty medication that must be filled at a contracted specialty pharmacy.

Continuation of Therapy Criteria

Continuation of Therapy

Authorization may be granted for members already receiving therapy when ALL of the following are met:

ALL of the following

Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement
Document disease stability or improvement to support ongoing approval

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required (Program Type: Prior Authorization) for Ventavis. Authorization may be granted for members new to the plan who are currently receiving the medication or when all clinical criteria are met.

Documentation Required

Specialist prescribing requirement

Medication must be prescribed by or in consultation with a pulmonologist or cardiologist. Documentation of the consulting specialist must be available.

Documentation Required

Hemodynamic confirmation required

Provide pretreatment right heart catheterization results showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 3 Wood units. For infants less than one year of age, PAH may be confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.

Documentation Required

Continuation documentation

For continuation of therapy, document disease stability or disease improvement to support ongoing approval.

Billing Rule

Specialty pharmacy dispensing

This medication has been designated specialty and must be filled at a contracted specialty pharmacy under the Pharmacy Benefit.

Billing Rule

Approval duration

Approvals will be granted for 12 months.

Definitions & Background

PAH: Pulmonary arterial hypertension — WHO Group 1 pulmonary hypertension.

Right heart catheterization criteria: Hemodynamic confirmation defined as mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 3 Wood units.

Ventavis (iloprost) is FDA-approved for PAH (WHO Group 1) to improve exercise tolerance, symptoms (NYHA Class), and lack of deterioration; all other indications are investigational.

Policy Summary

PayerMass General Brigham Health Plan

PolicyVentavis

Policy CodePolicy N/A

Change TypeAdministrative classification change (SGM → Custom)

Effective DateJan 1, 2024

Next Review Date

Key ActionPrior authorization is required for Ventavis; ensure documentation of specialist consultation and hemodynamic confirmation is provided.

SourceLink

On This Page

OpenPayer

Ventavis

Coverage Summary

Initial Therapy Criteria (new to plan or new start)

Continuation of Therapy Criteria

Exclusions / Not Medically Necessary

Provider Actions & Prior Authorization

Applicable Codes

Clinical Evidence & References

Definitions & Background

Revision History