ModifiedCentenePolicy CP.PHAR.192

Epoprostenol (Flolan, Veletri)

This policy governs prior authorization, coverage criteria, and administration details for epoprostenol (Flolan, Veletri) for members of Centene-affiliated health plans (Commercial, HIM, Medicaid). It affects prescribing cardiologists/pulmonologists and their support staff seeking authorization for initiation or continuation of therapy.

Policy Summary

PayerCentene

PolicyEpoprostenol (Flolan, Veletri)

Policy CodePolicy CP.PHAR.192

Change TypeApproval duration and generic redirection clarifications

Effective DateMar 16, 2023

Next Review DateN/A

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) and a treatment plan detailing pump rate, dose, and quantity (mL).

SourceLink

POLICY UPDATE CHANGES

In Policy/Criteria, clarified criteria also applies to brand Flolan and Veletri.

Extended Medicaid and HIM initial approval duration from 6 months to 12 months for this maintenance medication for a chronic condition.

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

Removed commercially unavailable branded products from Appendix B.

12 monthsMedicaid/HIM initial approval

12 monthsCommercial approval

2 ng/kg/minStarting IV dose

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0.5 mg, 1.5 mgVial strengths

Coverage Criteria for Epoprostenol (Flolan, Veletri)

Initial Therapy (Pulmonary Arterial Hypertension)

Covered when ALL of the following are met:

Initial PAH criteria: 1. Diagnosis of pulmonary arterial hypertension (PAH).

Initial PAH criteria: 2. Prescribed by or in consultation with a cardiologist or pulmonologist.

Initial PAH criteria

3a or 3b: a. Inadequate response or contraindication to acute vasodilator testing.
3a or 3b: b. Contraindication to calcium channel blockers or clinically significant adverse effects experienced.

Initial PAH criteria: 4. If the request is for brand Flolan or brand Veletri, the member must use generic epoprostenol sodium unless contraindicated or clinically significant adverse effects are experienced.

Initial PAH criteria: 5. Provider must submit a treatment plan detailing pump rate, dose, and quantity (in mL).

Continuation Therapy (Pulmonary Arterial Hypertension)

Covered when ALL of the following are met:

Continuation PAH criteria

1a: a. Currently receiving medication via the Centene benefit or previously met initial approval criteria.
1b: b. Currently receiving medication and enrolled in a state/product with continuity of care regulations.

Continuation PAH criteria: 2. Member is responding positively to therapy.

Continuation PAH criteria: 3. If the request is for brand Flolan or brand Veletri, the member must use generic epoprostenol sodium unless contraindicated or clinically significant adverse effects are experienced.

Other Diagnoses/Indications

Requests for other indications:

Other indications: 1. If the drug has had a label change within the last 6 months that is not yet reflected in this policy, follow the applicable no-coverage or non‑formulary policy for the relevant line of business (see enumerated policies).

Other indications: 2. If the requested use (diagnosis, age, dosing regimen) is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) and criterion 1 does not apply, refer to the off‑label use policy for the relevant line of business (see enumerated policies).

Requests for uses of epoprostenol that are not FDA‑approved and are not specifically addressed in this policy are generally not authorized unless the provider submits sufficient documentation demonstrating efficacy and safety. Such documentation must align with the applicable off‑label use policies referenced by line of business (for example, CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or the member’s evidence of coverage documents.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage requirements or limitations that supersede this policy.

Use of epoprostenol for non‑FDA approved (off‑label) indications is not authorized unless there is adequate supporting evidence as required by the off‑label use policies referenced for the member’s line of business. Requests for off‑label use must follow the documentation and supporting evidence expectations set forth in those off‑label policies.

Coding and Dosing Information

Covered/Referenced Codesmixed

NDC/HCPCS not listed

No specific billing codes (CPT/HCPCS/NDC) are provided in this portion of the document.

HCPCS Codes referencedHCPCS

J1325

Injection, epoprostenol, 0.5 mg

inv-09: Starting infusion rate

Typical starting IV dose2 ng/kg/min IV

Titration instruction (Flolan)Increase by 1-2 ng/kg/min at intervals of at least 15 minutes

Titration instruction (Veletri)Increase by 2 ng/kg/min every 15 minutes or longer

inv-10: Initial approval duration

Standard initial approval duration (Medicaid/HIM)12 months

Standard initial approval duration (Commercial)12 months or duration of request, whichever is less

Provider Actions, Prior Authorization, and Operational Notes

Prior Authorization

Prior Authorization Required and Approval Duration

Prior authorization is required for epoprostenol (including Flolan and Veletri). Approval durations: Medicaid/HIM — 12 months; Commercial — 12 months or duration of request, whichever is less. Providers should note that prior authorization approvals are contingent on submission of required documentation and continued compliance with policy criteria; lack of required documentation may result in denial or delay of the request.

PA approvals are for the durations above and apply to both initial and continuation requests as specified in the policy.
If a request exceeds the stated Commercial duration, authorization may be limited to 12 months or the requested duration, whichever is less.

Documentation Required

Documentation Required to Support Requests

Providers must submit documentation (e.g., office chart notes, pump treatment plan, dosing/pump rate, lab results, prior records showing response to therapy) to support that members meet all approval criteria. For continuation requests, documentation must demonstrate ongoing positive clinical response and adherence to the treatment plan.

Definitions and Key Terms

inv-20: PAH (Pulmonary arterial hypertension)

DefinitionPulmonary arterial hypertension (PAH) = WHO Group 1 pulmonary hypertension characterized by elevated pulmonary arterial pressure and vascular resistance

FDA indication for epoprostenolFlolan and Veletri are indicated for treatment of PAH (WHO Group 1) to improve exercise capacity

Clinical contextEfficacy studies predominantly included patients with NYHA Functional Class III-IV and etiologies such as idiopathic, heritable, or connective tissue disease-associated PAH

inv-21: J1325 — HCPCS descriptor

HCPCS codeJ1325

DescriptorInjection, epoprostenol, 0.5 mg

Background

Epoprostenol is a prostacyclin indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to improve exercise capacity. Clinical efficacy data predominantly include patients with more advanced symptoms (NYHA/WHO Functional Class III–IV) and etiologies such as idiopathic, heritable, or connective tissue disease‑associated PAH. Management of epoprostenol therapy typically requires specialist involvement (cardiologist or pulmonologist) and documentation of dosing and pump parameters when seeking prior authorization.

Policy Summary

PayerCentene

PolicyEpoprostenol (Flolan, Veletri)

Policy CodePolicy CP.PHAR.192

Change TypeApproval duration and generic redirection clarifications

Effective DateMar 16, 2023

Next Review DateN/A

Key ActionProvider must submit documentation (office chart notes, lab results or other clinical information) and a treatment plan detailing pump rate, dose, and quantity (mL).

SourceLink

On This Page

Continuation PAH criteria: 4. Provider must submit a treatment plan detailing pump rate, dose, and quantity (in mL).

Initial/continued approvals require prior authorization and documentation per criteria

Include treatment plan detailing pump rate, dose, and quantity (mL).
Submit clinical records demonstrating diagnosis, specialist involvement (cardiologist or pulmonologist), prior acute vasodilator testing or reasons for calcium channel blocker failure/contraindication when applicable.

Prior Authorization

Generic Redirection Requirement for Flolan and Veletri

If the provider requests branded Flolan or branded Veletri, the member must use generic epoprostenol sodium unless there is a documented contraindication or clinically significant adverse reaction to the generic. This 'must use' generic redirection requirement also applies to continued therapy.

Exception allowed only when provider documents contraindication or clinically significant adverse effects to generic epoprostenol.
When requesting brand product, include documentation justifying medical necessity for brand over the generic.

Billing Rule

Coding May Affect Coverage and Billing

Coding information in this policy is informational only. Inclusion or omission of codes does not guarantee coverage. Providers must verify current coding guidance before claim submission to ensure appropriate billing and reimbursement.

Referenced HCPCS: J1325 — Injection, epoprostenol, 0.5 mg (informational).
Providers should confirm code applicability and modifiers with the latest professional coding resources prior to claims submission.

Denial Risk

Coverage Governance and Consequences of Incomplete Requests

Coverage is governed by the member's benefit documents and applicable state and federal requirements. Failure to submit required documentation, or requests for non‑FDA indications without appropriate off‑label evidence and corresponding policies, may result in denial. Providers should follow off‑label coverage policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) when applicable.

Coverage subject to Evidence of Coverage, contracts, state/federal requirements, and Health Plan administrative policies.
Requests for non‑FDA indications require sufficient evidence per off‑label policies; absence of such evidence may lead to denial.

Coding noteCodes referenced are informational; inclusion or exclusion does not guarantee coverage