CurrentCareSourcePolicy N/A

UTILIZATION MANAGEMENT MEDICAL POLICY

Defines prior authorization and medical necessity criteria, dosing, approvals, and exclusions for epoprostenol intravenous infusion products (Veletri, Flolan, generics) for PAH (WHO Group 1) and select use in CTEPH under a medical benefit.

Policy Summary

PayerCareSource

PolicyUTILIZATION MANAGEMENT MEDICAL POLICY

Policy CodePolicy N/A

Change TypeClarified

Effective Date

Next Review Date

Key ActionPrior authorization is recommended; obtain and submit right heart catheterization documentation and ensure prescribing by or consultation with a cardiologist or pulmonologist.

SourceLink

POLICY UPDATE CHANGES

Annual revision notes indicate no criteria changes for the 10/04/2023 review; 10/09/2024 review performed.

2Covered Indications

3Not Recommended Situations

45Max Dose (ng/kg/min)

Coverage Summary

Epoprostenol intravenous infusion products (examples: Veletri, Flolan, generics) are covered with criteria for the treatment of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) and are supported for select use in chronic thromboembolic pulmonary hypertension (CTEPH) when prescribed by or in consultation with an appropriate specialist. Prior authorization is required for medical benefit coverage; approvals are generally provided for 1 year when criteria are met, with short-term approvals (up to 14 days) allowed for current users with insufficient information. Dosing is limited to a maximum of 45 ng/kg/min intravenously unless reviewed case-by-case.

Provider Actions & Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for medical benefit coverage of epoprostenol injection. Approvals are provided for 1 year when criteria are met. Short-term approvals up to 14 days are allowed when criteria are not met or information is insufficient; these short-term requests are reviewed by a nurse or pharmacist.

Approvals provided for 1 year when criteria are met
Short-term approvals up to 14 days allowed for insufficient information or unmet criteria (nurse/pharmacist review)

Documentation Required

Right heart catheterization documentation

Documentation of right heart catheterization (RHC) is required for initiation and confirmation of WHO Group 1 PAH diagnosis. If RHC documentation was previously provided for a prior authorization of another WHO Group 1 PAH medication, that prior RHC documentation is accepted as meeting this requirement.

Documentation Required

Specialist prescribing requirement

Epoprostenol must be prescribed by or in consultation with a physician who specializes in the condition treated (cardiologist or pulmonologist).

Billing Rule

Approval duration

All approvals are provided for 1 year in duration unless otherwise noted. For patients currently receiving epoprostenol with insufficient information or unmet criteria, a short-term approval of up to 14 days may be granted; these short-term approvals are reviewed by a nurse or pharmacist.

Standard approval duration: 1 year
Short-term approval: up to 14 days for current users with insufficient information (nurse or pharmacist review)

Denial Risk

Exclusion for non-PAH COPD

Coverage is not recommended for patients with COPD who do not have WHO Group 1 PAH. Claims for epoprostenol use in COPD without PAH (Group 3 pulmonary hypertension) risk denial.

Denial Risk

Concurrent prostacyclin products

Coverage is not recommended for concurrent use with other prostacyclin products. Requests for concurrent use with parenteral treprostinil products, oral prostacyclin products, or inhaled prostacyclin agents used for pulmonary hypertension risk denial.

Parenteral treprostinil products (e.g., treprostinil injection)
Oral prostacyclin products (e.g., treprostinil extended‑release tablets, selexipag)
Inhaled prostacyclin agents (e.g., treprostinil inhalation solution, iloprost inhalation solution)

Background & Evidence

Epoprostenol is an intravenous prostacyclin vasodilator indicated for pulmonary arterial hypertension (PAH) [WHO Group 1] to improve exercise capacity and has been used with varying results in patients with CTEPH, sometimes as a bridge to surgery. PAH is defined hemodynamically by right heart catheterization as a mean pulmonary artery pressure (mPAP > 20 mmHg) with pulmonary arterial wedge pressure (PAWP < 15 mmHg) and pulmonary vascular resistance (PVR) ≥ 2 Wood units. Documentation of a right heart catheterization is required to confirm WHO Group 1 PAH when initiating therapy.

Source	Details
Guideline references	CHEST (2019) and ESC/ERS (2022) cite intravenous epoprostenol for later-stage PAH; ESC/ERS (2022) also recommend considering parenteral prostacyclin for inoperable CTEPH.
Prescribing information	Flolan PI Oct 2023; Veletri PI Jul 2022; generic (epoprostenol) PI Jan 2021.

Definitions

PAHPulmonary arterial hypertension, WHO Group 1 (defined hemodynamically by RHC)

CTEPHChronic Thromboembolic Pulmonary Hypertension (Group 4 pulmonary hypertension) — persistent obstruction of pulmonary arteries, often after pulmonary embolism

RHCRight heart catheterization — required diagnostic procedure with documentation; refers to RHC prior to starting therapy for WHO Group 1 PAH

OpenPayer

UTILIZATION MANAGEMENT MEDICAL POLICY

Coverage Summary

Recommended Authorization Criteria

Code Groups

Provider Actions & Requirements

Background & Evidence

Revision History

Veletri	epoprostenol intravenous infusion (Actelion)
Flolan	epoprostenol intravenous infusion (GlaxoSmithKline, generic)
generic	epoprostenol intravenous infusion (other manufacturers)