CurrentHealth NetPolicy CP.PHAR.192

Epoprostenol (Flolan, Veletri)

Coverage and medical necessity criteria for epoprostenol products (Flolan, Veletri, and generic epoprostenol sodium) for treatment of pulmonary arterial hypertension (WHO Group 1) for members under Health Net/Centene-affiliated plans.

Policy Summary

PayerHealth Net

PolicyEpoprostenol (Flolan, Veletri)

Policy CodePolicy CP.PHAR.192

Change TypeAnnual review — no material changes noted

Effective DateMar 16, 2023

Next Review DateN/A

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

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsstandard approval duration

WHO Group 1FDA indicated population

NYHA III-IVtrial population severity

brand restrictionsformulary preference

J1325HCPCS referenced

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Coverage and Medical Necessity Criteria

Initial Therapy (PAH)

Covered when ALL of the following are met:

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

Specialist involvement: 2. Prescribed by or in consultation with a cardiologist or pulmonologist.

CCB failure or exception: 3. Failure of a calcium channel blocker (see Appendix B), unless the member has either: a) inadequate response or contraindication to acute vasodilator testing; OR b) a contraindication to calcium channel blockers or clinically significant adverse effects to CCBs.

See Appendix B for therapeutic alternatives.

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

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

Continuation Therapy (PAH)

Covered when ALL of the following are met:

Continuation eligibility: 1. Member is currently receiving medication via the Centene benefit or previously met initial approval criteria; OR member is currently receiving medication and is enrolled in a state/product with continuity of care regulations.

Refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B where applicable.

Clinical response: 2. Member is responding positively to therapy.

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

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

Other Indications / Off-label pathway

For other uses:

Recent label change: 1. If the drug has had a label change within the last 6 months (e.g., newly approved indication, age expansion, new dosing) that is not yet reflected in this policy, follow the appropriate policy for the line of business: a) for drugs on the formulary/PDL use the no coverage criteria policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, CP.PMN.255 for Medicaid); OR b) for drugs NOT on the formulary/PDL use the non-formulary policy for the relevant line of business (CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, CP.PMN.16 for Medicaid).

Lists referenced policies by line of business.

Off-label requests: 2. If the requested use is not listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.

See related off-label use policies.

Non–FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety consistent with applicable off‑label use policies. See the referenced off‑label policies for the applicable line of business (Commercial: CP.CPA.09; Health Insurance Marketplace: HIM.PA.154; Medicaid: CP.PMN.53) or other evidence of coverage documents when requesting coverage for an unlisted indication.

When state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Providers should refer to the applicable state Medicaid manual for any coverage provisions that apply to Medicaid members.

Coding, Dosing, and Approval Durations

HCPCS Codes referencedHCPCS

J1325

Injection, epoprostenol, 0.5 mg

inv-07: Initial infusion starting dose — key/value

Starting dose2 ng/kg/min IV for both Flolan and Veletri

Titration (Flolan)Increase by 1–2 ng/kg/min at intervals of at least 15 minutes as clinically indicated

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

inv-08: Initial approval duration (Medicaid/HIM) — key/value

Initial approval duration (Medicaid/HIM)12 months

Commercial approval guidanceCommercial: 12 months or duration of request, whichever is less (policy references)

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must submit documentation (such as office chart notes, lab results, and other clinical information) demonstrating that the member meets all applicable approval criteria. Requests for brand Flolan or Veletri must show why generic epoprostenol sodium cannot be used (contraindication or clinically significant adverse effects) when applicable. Prescriptions for pulmonary arterial hypertension must be written by or in consultation with a cardiologist or pulmonologist. Step-therapy requirements include failure of a calcium channel blocker per Appendix B unless the member has an inadequate response to acute vasoreactivity testing or has a contraindication/clinically significant adverse effects to calcium channel blockers. Providers must submit a treatment plan detailing pump rate, dose, and quantity (in mL).

Prior authorization required for initial and continued therapy per policy criteria
Specialist prescriber or documented specialist consultation required (cardiologist or pulmonologist)
Step therapy: documented failure of a calcium channel blocker required unless criteria for exemption met (see Appendix B and acute vasoreactivity testing exceptions)
Brand requests must document use or intolerance of generic epoprostenol sodium

Definitions, Contraindications, and Product Info

inv-18: PAH (Pulmonary Arterial Hypertension) — key/value

DefinitionPulmonary arterial hypertension (PAH, WHO Group 1) — elevated pulmonary arterial pressure; Flolan and Veletri are indicated to improve exercise capacity in WHO Group 1 PAH

Typical severity in trialsEffectiveness trials included predominantly NYHA/WHO functional class III–IV patients

Relation to productsFlolan and Veletri (epoprostenol formulations) are FDA‑approved prostacyclin pathway agents for WHO Group 1 PAH

inv-19: Contraindications (selected) — key/value

Severe left ventricular systolic dysfunctionCongestive heart failure due to severe left ventricular systolic dysfunction is listed as a contraindication

Pulmonary edema (Veletri only)

Clinical Context

Epoprostenol is a prostacyclin pathway agonist that produces pulmonary vasodilation and is indicated to improve exercise capacity in patients with pulmonary arterial hypertension (WHO Group 1). Clinical trials establishing effectiveness primarily enrolled patients with more advanced disease (predominantly NYHA/WHO functional class III–IV) and included idiopathic/heritable and connective tissue disease–associated PAH populations.

Prescribing information for Flolan and Veletri and referenced clinical literature describe epoprostenol’s mechanism as vasodilatory via prostacyclin activity and support its use in improving exercise capacity in these WHO Group 1 PAH patients. Treatment initiation and continuation decisions should reflect the populations and severity of disease studied in the clinical trials.

Policy Revision History

2025-11-07policy_edit

Policy/Criteria clarified to explicitly apply to brand Flolan and Veletri; Appendix B updated to remove commercially unavailable branded products and update dosing regimens; references reviewed and updated; P&T approval 02.25.

2025-11-19approval_duration_changeLatest

Initial approval duration for Medicaid and Health Insurance Marketplace (HIM) extended from 6 months to 12 months for maintenance therapy of this chronic medication; references reviewed and updated; P&T approval 02.26.

Policy Summary

PayerHealth Net

PolicyEpoprostenol (Flolan, Veletri)

Policy CodePolicy CP.PHAR.192

Change TypeAnnual review — no material changes noted

Effective DateMar 16, 2023

Next Review DateN/A

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

SourceLink

On This Page

Extended from 6 to 12 months for maintenance therapy in 1Q 2026 review

Prior Authorization

Prior Authorization and Approval Duration

Approval durations: Medicaid/HIM — 12 months. Commercial — 12 months or duration of request, whichever is less. HCPCS reference: J1325 (Injection, epoprostenol, 0.5 mg). Note that approval durations were revised in recent reviews; providers should expect the stated durations and check for any future updates.

Medicaid/HIM: 12 months
Commercial: 12 months or duration of request, whichever is less
Relevant HCPCS: J1325

Denial Risk

Documentation-based Denials

Requests lacking sufficient documentation to establish medical necessity or requests for non‑FDA indications without appropriate off‑label justification may be denied. Providers should include supporting evidence per the plan's off‑label use policies when applicable.

Insufficient clinical documentation (office notes, labs, treatment plan) may result in denial
Non‑FDA indications require documentation per CP.CPA.09, HIM.PA.154, or CP.PMN.53 as applicable

Billing Rule

Coding Inclusion Does Not Guarantee Coverage

Inclusion of codes in this policy is for informational purposes only and does not guarantee coverage or payment. Providers must reference current professional coding guidance prior to claim submission.

Code example: HCPCS J1325 — Injection, epoprostenol, 0.5 mg
Inclusion/exclusion of codes does not ensure reimbursement; verify up-to-date coding guidance

Note

Medical Necessity and Documentation Context

This policy is a guide to medical necessity and expected documentation; it does not constitute a guarantee of payment. The Health Plan expects providers to exercise professional judgment when treating members. Coverage decisions remain subject to benefit documents, state and federal requirements, and plan administrative policies.

Clinical policy is guidance — not a contract or payment guarantee
Coverage decisions subject to benefit terms, exclusions, and applicable laws

Prior Authorization

Generic Redirection / Formulary Preference

Generic redirection/formulary preference: members must use generic epoprostenol sodium for initial and continued therapy unless there is documented contraindication or clinically significant adverse effects to the generic product. The policy's 'must use' language for generic redirection applies to brand requests and continued therapy.

'Must use' generic epoprostenol sodium unless contraindicated or adverse effects present
Generic redirection applies to continued therapy as well as initial requests

Pulmonary edema is a contraindication specific to Veletri

HypersensitivityHypersensitivity to the drug or structurally related compounds is a contraindication

inv-20: Flolan — prescribing information

Prescribing information sourceFlolan Prescribing Information (Flolan PI referenced in policy references)

Key dosing noteFlolan dosing: initial 2 ng/kg/min IV with increases of 1–2 ng/kg/min at intervals of ≥15 minutes; further dosing based on clinical response

Reference URL (policy)Policy references Flolan PI (GlaxoSmithKline; October 2023) as source for prescribing information

inv-21: Veletri — prescribing information

Prescribing information sourceVeletri Prescribing Information (Actelion; July 2022) as cited in policy references

Key dosing noteVeletri dosing: initial 2 ng/kg/min IV with increases of 2 ng/kg/min every 15 minutes or longer; further dosing based on clinical response

Safety notePolicy cites Veletri-specific contraindication of pulmonary edema per Appendix C and Veletri PI