Anthem Prostacyclin Coverage Update

Agent-specific Coverage Criteria

Epoprostenol (Flolan, Veletri)

Initial requests for continuous intravenous epoprostenol may be approved when ALL of the following are met:

Epoprostenol Initial Criteria

Hemodynamic criteria: A. Mean pulmonary artery pressure (mPAP) >= 25 mm Hg at rest; B. Pulmonary capillary wedge pressure (PCWP)/PAWP/left atrial pressure/LVEDP <= 15 mm Hg; C. Pulmonary vascular resistance (PVR) > 3 Wood units.mPAP >= 25 mm Hg; PCWP/PAWP/LVEDP <= 15 mm Hg; PVR > 3 WU
Documented by right-heart catheterization
WHO group: II. Individual has World Health Organization (WHO) Group I PAH (all Group 1 subtypes).
Functional class: III. New York Heart Association (NYHA) Functional Class III or IV symptoms.

Epoprostenol Continuation: There is clinically significant improvement or stabilization in clinical signs and symptoms of disease (including but not limited to improvement in walk distance, dyspnea and/or functional class).clinical assessment

Applies to continuation/renewal requests for continuous intravenous epoprostenol.

Epoprostenol Not Approved: I. WHO Group II-V pulmonary hypertension; OR II. Heart failure due to severe left ventricular systolic dysfunction; OR III. Use in combination with other prostacyclin analogs (including treprostinil formulations, iloprost) or prostacyclin receptor agonists (including selexipag); OR IV. When the above criteria are not met or for other indications.N/A

Remodulin (treprostinil)

Initial requests for continuous subcutaneous infusion of Remodulin may be approved when ALL of the following are met:

Remodulin Subcutaneous Initial

Hemodynamic criteria: A. Mean pulmonary artery pressure (mPAP) >= 25 mm Hg at rest; B. Pulmonary capillary wedge pressure (PCWP)/PAWP/left atrial pressure/LVEDP <= 15 mm Hg; C. Pulmonary vascular resistance (PVR) > 3 Wood units.mPAP >= 25 mm Hg; PCWP/PAWP/LVEDP <= 15 mm Hg; PVR > 3 WU
Documented by right-heart catheterization
WHO group: II. Individual has World Health Organization (WHO) Group I PAH (all Group 1 subtypes).
Functional class: III. New York Heart Association (NYHA) Functional Class II, III or IV symptoms.

Tyvaso (treprostinil)

Initial requests for inhaled Tyvaso may be approved when ALL of the following are met for PAH, or when the PH-ILD pathway is met:

Tyvaso PAH Initial

Hemodynamic criteria: A. Mean pulmonary artery pressure (mPAP) >= 25 mm Hg at rest; B. Pulmonary capillary wedge pressure (PCWP)/PAWP/left atrial pressure/LVEDP <= 15 mm Hg; C. Pulmonary vascular resistance (PVR) > 3 Wood units.mPAP >= 25 mm Hg; PCWP/PAWP/LVEDP <= 15 mm Hg; PVR > 3 WU
Documented by right-heart catheterization
WHO group: II. Individual has World Health Organization (WHO) Group I PAH (all Group 1 subtypes).
Functional class: III. New York Heart Association (NYHA) Functional Class III or IV symptoms.

Tyvaso PH-ILD Initial

Yutrepia (treprostinil)

Initial requests for inhaled Yutrepia may be approved when ALL of the following are met:

Yutrepia Initial

Hemodynamic criteria: A. Mean pulmonary arterial pressure (mPAP) >= 25 mm Hg at rest; B. Pulmonary capillary wedge pressure (PCWP)/PAWP/left atrial pressure/LVEDP <= 15 mm Hg; C. Pulmonary vascular resistance (PVR) > 3 Wood units.mPAP >= 25 mm Hg; PCWP/PAWP/LVEDP <= 15 mm Hg; PVR > 3 WU
Documented by right-heart catheterization

Tyvaso Initial Therapy

Initial requests for inhalation therapy with Tyvaso (treprostinil) may be approved when ALL of the following are met:

Tyvaso Initial

Hemodynamics: Right-heart catheterization showing mPAP >= 25 mm Hg; PCWP/PAWP/LVEDP <= 15 mm Hg; PVR > 3 Wood units.mPAP >= 25 mm Hg; PCWP <= 15 mm Hg; PVR > 3 WU
WHO/functional class: WHO Group I PAH and NYHA/WHO functional class III or IV (for PAH indication).
PH-ILD path: Alternatively, PH-ILD (WHO Group 3) with right-heart catheterization meeting hemodynamic thresholds AND chest HRCT showing diffuse parenchymal lung disease.

Continuation Therapy

Continuation requests may be approved when ALL of the following are met:

Continuation: There is clinically significant improvement or stabilization in clinical signs and symptoms of disease, including but not limited to improvement in walk distance, dyspnea, and/or functional class.clinical improvement or stabilization

Applies to Tyvaso, Yutrepia, Ventavis (and other agents where specified).

Yutrepia Initial Therapy

Initial requests for inhalation therapy with Yutrepia (treprostinil) may be approved when ALL of the following are met:

Yutrepia Initial: Diagnosis of PAH with right-heart catheterization meeting hemodynamic thresholds (mPAP >= 25 mm Hg; PCWP/PAWP/LVEDP <= 15 mm Hg; PVR > 3 Wood units) OR diagnosis of PH-ILD (WHO Group 3) with right-heart catheterization meeting hemodynamic thresholds AND chest HRCT showing diffuse parenchymal lung disease; plus WHO Group I PAH with NYHA/WHO functional class III or IV for PAH indication.see nodes

Yutrepia criteria mirror treprostinil inhalation hemodynamic and imaging requirements.

Ventavis Initial Therapy

Initial requests for inhalation therapy with Ventavis (iloprost) may be approved when ALL of the following are met:

Ventavis Initial: I. Diagnosis of pulmonary arterial hypertension (PAH) with right-heart catheterization demonstrating all of the following: A. mPAP >= 25 mm Hg at rest; B. PCWP/PAWP/left atrial pressure/LVEDP <= 15 mm Hg; C. PVR > 3 Wood units; II. WHO Group I PAH; III. NYHA/WHO functional class III or IV symptoms.see nodes

Not Approved / Exclusions

May Not Approve / Exclusions: Use is not approved for individuals with specified WHO groups (Tyvaso/Yutrepia: Group II, IV or V; Ventavis: Group II-V; Epoprostenol/Remodulin: Group II-V), OR when used in combination with other prostacyclin analogs or prostacyclin receptor agonists (including but not limited to epoprostenol, treprostinil formulations, iloprost, selexipag), OR when the stated diagnostic, hemodynamic, imaging, functional class, or continuation criteria are not met.

Lists of excluded combination agents include epoprostenol, treprostinil (all formulations), iloprost, and selexipag; limited exceptions allowed for specified transitions.

Use of prostacyclin therapies is restricted when the individual has pulmonary hypertension outside of WHO Group I. Specifically, continuous intravenous and subcutaneous prostacyclin agents are not approved for individuals with WHO Group II–V pulmonary hypertension. Requests also may be denied when prostacyclin therapy is requested in combination with other prostacyclin analogs or prostacyclin receptor agonists (except limited transitions or route‑change exceptions described in the policy).

Providers should document that the member meets the WHO Group I PAH designation and the agent‑specific indications prior to authorization; absence of the required WHO group classification or documentation of a non‑approved WHO group is a basis for denial.

For the inhaled treprostinil products and iloprost, the policy defines more specific WHO group exclusions. Tyvaso and Yutrepia are not approved for individuals with WHO Group II, IV, or V pulmonary hypertension. Ventavis is not approved for individuals with WHO Group II–V pulmonary hypertension. In addition, inhaled agents may not be authorized when proposed in combination with other prostacyclin analogs (for example, epoprostenol, other treprostinil formulations, iloprost) or with prostacyclin receptor agonists (for example, selexipag).

These combination‑use exclusions apply unless the request documents an allowed transition between formulations as described in the policy; absent such documentation, combination therapy is a reason for non‑approval.

Therapy will not be authorized when the stated diagnostic, WHO group, or functional class criteria are not met. For PAH indications the policy requires right‑heart catheterization demonstrating the hemodynamic thresholds defined in the policy and assignment to WHO Group I when applicable. If the required diagnostic testing or WHO/functional class documentation is missing or does not meet the policy thresholds, the request is considered not medically necessary.

When specific criteria required for approval are not satisfied (for example, missing right‑heart catheterization hemodynamics, absent HRCT for PH‑ILD pathways, or lack of required NYHA/WHO functional class), the request will be denied. The policy explicitly states that inhaled agents may not be approved when the above criteria are not met and for all other indications outside those specified.

Providers should ensure submission of the documented hemodynamic measurements, imaging when required, and functional class assessment to avoid a fallback denial based on incomplete or non‑conforming evidence.

Billing and Diagnosis Codes

HCPCS (Tyvaso, Ventavis, epoprostenol, Remodulin)HCPCS

J1325	Injection, epoprostenol; 0.5 mg [Flolan, Veletri].
J3285	Injection, treprostinil, 1 mg [Remodulin].
J7686	Treprostinil, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, 1.74 mg [TYVASO]
K0455	Infusion pump used for uninterrupted parenteral administration of medication (e.g., epoprostenol or treprostinil).
Q4074	Iloprost, inhalation solution, FDA-approved final product, non-compounded, administered through DME, unit dose form, up to 20 micrograms [Ventavis].
S0155	Sterile dilutant for epoprostenol, 50 ml [dilutant for Flolan].
S9347	Home infusion therapy, uninterrupted, long-term, controlled rate intravenous or subcutaneous infusion therapy (e.g., epoprostenol).

HCPCS / Other (Yutrepia)HCPCS

J7686	Treprostinil, inhalation solution, FDA-approved final product, noncompounded, administered through DME, unit dose form, 1.74 mg [Tyvaso]
J8499	Prescription drug, oral, non-chemotherapeutic, NOS [when specified as Yutrepia (treprostinil inhalation powder)].

ICD-10 Diagnosis codes referencedICD-10

I27.0	Primary pulmonary hypertension.
I27.20	Pulmonary hypertension, unspecified.
I27.21	Secondary pulmonary arterial hypertension.
I27.23	Pulmonary hypertension due to lung diseases and hypoxia.
I27.83	Eisenmenger's syndrome.
I27.89	Other specified pulmonary heart diseases.
I27.9	Pulmonary heart disease, unspecified.
M34.0	Progressive systemic sclerosis.
M34.81	Systemic sclerosis with lung involvement.
M34.9	Systemic sclerosis, unspecified.

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inv-17: Mean pulmonary artery pressure (mPAP) — hemodynamic threshold value

Mean pulmonary artery pressure (mPAP)>= 25 mm Hg at rest

ContextUsed as part of right‑heart catheterization diagnostic criteria for PAH per referenced specialty guidelines (Hoeper 2013; Ivy 2013; Abman 2015)

Applies toAll agent-specific PAH criteria (epoprostenol, treprostinil formulations, iloprost, Yutrepia/Tyvaso) requiring RHC confirmation

inv-18: Pulmonary capillary wedge pressure (PCWP/PAWP) or LVEDP — hemodynamic threshold value

Pulmonary capillary wedge pressure (PCWP/PAWP) or LVEDP<= 15 mm Hg

Synonyms included in policy

Prior Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization and Quantity Limits

Prior authorization is required for prostacyclin agents and inhalation/infusion products. Providers must submit documentation to support medical necessity and adhere to existing quantity limits for inhaled products (Tyvaso, Yutrepia, Ventavis) including starter/refill kit limits and per‑day ampule limits as applicable. Quantity limits: Tyvaso starter kit = 1 kit one‑time fill; Tyvaso refill kit = 1 kit per 28 days; Tyvaso 1.74 mg/2.9 mL ampule = 1 ampule per day; Tyvaso DPI titration/maintenance kits limited as specified in the policy. Additional quantity limits for other inhalation products should follow the policy's drug‑specific sections.

Prior authorization required for covered prostacyclin agents and inhalation systems
Follow stated kit and ampule limits for Tyvaso; apply similar program limits for Yutrepia/Ventavis per drug sections

Documentation Required

Provider Must Document Diagnosis of PAH

Providers must document a diagnosis of pulmonary arterial hypertension (PAH) with objective hemodynamic data from right‑heart catheterization (RHC). The submission should demonstrate that the individual meets PAH (WHO Group 1) criteria when applicable and include clinical information supporting NYHA/WHO functional class when required for the specific agent.

Clinical Background

Pulmonary arterial hypertension (PAH) is a progressive, life‑threatening disorder characterized by elevated pulmonary artery pressures, normal left‑sided filling pressures, and increased pulmonary vascular resistance. Right‑heart catheterization is required to confirm the diagnosis and to document hemodynamic criteria used for coverage decisions. FDA‑approved prostacyclin analogs (intravenous, subcutaneous, and inhaled) have demonstrated improvements in hemodynamics, exercise tolerance, and symptoms in individuals with WHO Group I PAH; agent selection and coverage depend on the specific route, approved functional class indications, and documented hemodynamics or imaging (for PH‑ILD).

Key Definitions and Functional Class

inv-30: Pulmonary arterial hypertension (PAH) — definition key hemodynamic thresholds

PAH hemodynamic definitionmPAP >= 25 mm Hg; PCWP/PAWP/LVEDP <= 15 mm Hg; PVR > 3 Wood units

Clinical implicationDefines WHO Group I pulmonary arterial hypertension requiring RHC confirmation prior to initiating covered prostacyclin therapy

Source2009 ACCF/AHA consensus and updated specialty society guidelines cited in policy (Hoeper 2013; Ivy 2013; Abman 2015)

inv-31: NYHA Functional Classification — Class I-IV definitions

Class INo limitation with ordinary physical activity

Class IISlight limitation with fatigue, dyspnea, palpitations, or angina during ordinary physical activity

Document Revision History

2026-02-20Last reviewLatest

Policy last reviewed on 2026-02-20 (administrative record of last review date).

2024-02-23Annual review — material update

Added quantity limit (operational) for prostacyclin products per document history and updated quantity-limit details for Tyvaso DPI kit configurations.

2022-06-13Select review — material change

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Prostacyclin Infusion and Inhalation Therapy