CurrentHealth NetPolicy CP.PHAR.192

Epoprostenol (Flolan, Veletri)

Coverage policy and medical necessity criteria for epoprostenol (Flolan, Veletri) for treatment of pulmonary arterial hypertension (PAH) and guidance for other/ off-label indications, including initial and continuation approval criteria, documentation and approval durations across Commercial, HIM, and Medicaid lines of business.

Policy Summary

PayerHealth Net

PolicyEpoprostenol (Flolan, Veletri)

Policy CodePolicy CP.PHAR.192

Change TypeAnnual review updates (revised approval durations; clarifications)

Effective Date03.16

Next Review Date

Key ActionProvider must submit documentation supporting that member has met all approval criteria and a treatment plan detailing pump rate, dose, and quantity (in mL).

SourceLink

POLICY UPDATE CHANGES

1Q 2026 annual review: extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated.

1Q 2025 annual review: clarified criteria also applies to brand Flolan and Veletri; in Appendix B removed commercially unavailable branded products and updated dosing regimens.

Revised approval duration for Commercial line of business from length of benefit to 12 months or duration of request, whichever is less.

1Q 2022 annual review: revised medical justification language to 'must use' language for generic redirection; added generic redirection to continued therapy.

1FDA Approved Indication (WHO Group 1 PAH)

12mApproval duration (Medicaid/HIM)

12m

Coverage Summary

Scope: This policy defines coverage and medical necessity criteria for epoprostenol (Flolan, Veletri) for treatment of pulmonary arterial hypertension (PAH, WHO Group 1) and provides guidance for other/off‑label indications, initial and continued therapy, documentation, and approval durations across Commercial, HIM, and Medicaid lines of business.

Coverage stance: Covered with criteria when the policy's medical necessity requirements are met, including diagnosis of PAH, prescriber specialty, failure/intolerance to calcium channel blockers or inadequate response to acute vasodilator testing, generic redirection requirements for Flolan/Veletri, and submission of a treatment plan.

Policy subject: Epoprostenol (Flolan, Veletri) (HCPCS primary code J1325).

Approved indication (high level): Epoprostenol is indicated for treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity.

Approval durations: Medicaid/HIM – 12 months; Commercial – 12 months or duration of request, whichever is less.

Glossary (definitions from policy): PAH = Pulmonary arterial hypertension (WHO Group 1); NYHA = New York Heart Association functional class.

Initial Therapy Criteria — Pulmonary Arterial Hypertension

I. Initial Approval Criteria - A. Pulmonary Arterial Hypertension

Must meet all:

ALL of the following

Diagnosis of PAH
Prescribed by or in consultation with a cardiologist or pulmonologist
Failure of a calcium channel blocker (see Appendix B), unless member meets one of the following (a or b)
- ONE of
  - Inadequate response or contraindication to acute vasodilator testing
  - Contraindication or clinically significant adverse effects to calcium channel blockers are experienced
If request is for brand Flolan or brand Veletri, member must use generic epoprostenol sodium, unless contraindicated or clinically significant adverse effects are experienced

Initial Therapy — Other Diagnoses / Indications

Continuation Therapy Criteria — Pulmonary Arterial Hypertension (Maintenance)

Continuation Therapy — Other Diagnoses / Indications

Unapproved Indications / Exclusions

III. Diagnoses/Indications NOT authorized

Coverage is not authorized for:

Non-FDA approved indications which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to off-label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53) or evidence of coverage documents

Applicable Codes

HCPCS - relevant drug J-codeHCPCS

J1325

Injection, epoprostenol, 0.5 mg

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization criteria

Requests must meet the policy's medical necessity criteria for PAH: diagnosis of pulmonary arterial hypertension, prescribed by or in consultation with a cardiologist or pulmonologist, and failure/intolerance to a calcium channel blocker or inadequate response to acute vasodilator testing. If requesting brand Flolan or Veletri, member must use generic epoprostenol sodium unless contraindicated or clinically significant adverse effects are experienced.

Affected code: J1325

Documentation Required

Submit supporting documentation

Providers must submit office chart notes, lab results, or other clinical information supporting that the member has met all approval criteria.

Clinical Evidence & Guidelines

Key guideline citations: ACCF/AHA 2009; CHEST 2019; ESC/ERS 2015 & 2022; AHA/ATS pediatric pulmonary hypertension 2015.

Background/evidence summary: Epoprostenol (Flolan, Veletri) is a prostacyclin with an FDA‑approved indication for PAH to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies such as idiopathic or heritable PAH or PAH associated with connective tissue diseases.

Note: Guideline and prescribing information references are cited in the policy's reference list supporting these recommendations and clinical context.

Background

Background: Epoprostenol (Flolan, Veletri) is a prostacyclin indicated for the treatment of pulmonary arterial hypertension (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with New York Heart Association (NYHA) Functional Class III–IV symptoms.

Clinical note: Epoprostenol dosing and administration recommendations are provided in the policy (e.g., starting IV infusion 2 ng/kg/min for Flolan and Veletri with titration per clinical response) and prescribing information.

Definitions (inline): PAH = pulmonary arterial hypertension (WHO Group 1); NYHA = New York Heart Association functional class (grading of functional limitation from I–IV, with III–IV indicating marked to severe limitation).

Revision History

11.19.25 / P&T 02.26annual reviewLatest

1Q 2026 annual review: extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition; references reviewed and updated. (material change)

11.07.24 / P&T 02.25annual review

1Q 2025 annual review: clarified criteria also applies to brand Flolan and Veletri; Appendix B edits removed commercially unavailable branded products and updated dosing regimens; references reviewed and updated.

06.23.22 / P&T 11.22revision

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