CurrentNeighborhood Health Plan of Rhode IslandPolicy 1643-A

Orenitram (treprostinil) extended‑release tablets — coverage criteria

Policy governing coverage and authorization criteria for Orenitram (treprostinil) extended‑release tablets for treatment of pulmonary arterial hypertension (WHO Group 1) for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOrenitram (treprostinil) extended‑release tablets — coverage criteria

Policy CodePolicy 1643-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for 12 months when all coverage criteria for PAH (WHO Group 1) are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

WHO Group 1required classification

mPAP >20; PCWP ≤15; PVR >2hemodynamic criteria

Doppler OK <1 yrinfant alternative

Coverage Criteria for Orenitram (treprostinil)

Initial therapy (PAH)

Authorization of 12 months may be granted for treatment of PAH when ALL of the following criteria are met:

PAH coverage criteria: 1) Member has pulmonary arterial hypertension (PAH) defined as WHO Group 1 pulmonary hypertension.

Hemodynamic confirmation of PAH: 2) PAH was confirmed by either: a) pretreatment right heart catheterization showing all of: mean pulmonary arterial pressure (mPAP) > 20 mmHg; pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg; and pulmonary vascular resistance (PVR) > 2 Wood units (for pediatric members, pulmonary vascular resistance index [PVRI] > 3 Wood units·m2 is also acceptable); OR b) for infants < 1 year, Doppler echocardiogram when right heart catheterization cannot be performed.mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR > 2 Wood units (PVRI > 3 Wood units·m2 for pediatrics)

Authorization period: 12 months

Continuation therapy

Continuation of Therapy

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyOrenitram (treprostinil) extended‑release tablets — coverage criteria

Policy CodePolicy 1643-A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization for 12 months when all coverage criteria for PAH (WHO Group 1) are met.

SourceLink

On This Page

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Continuation: Authorization of 12 months may be granted for members with an indication listed in the coverage criteria who are currently receiving the requested medication through a paid pharmacy or medical benefit and who are experiencing benefit from therapy as evidenced by disease stability or disease improvement.

Continuation requires demonstration of benefit

All indications other than FDA‑approved PAH (WHO Group 1) are considered experimental/investigational and not medically necessary.

Use of Orenitram for indications that are not FDA‑approved or compendial is not medically necessary.

Drug and Diagnostic Coding

Covered drugNDC | drugCovered

Orenitram / treprostinil

Extended‑release tablets (brand and generic names and all dosage forms/strengths as listed)

Hemodynamic thresholds

Mean pulmonary arterial pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units

Pediatric pulmonary vascular resistance index (PVRI)> 3 Wood units·m2 (acceptable alternative for pediatrics)

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Authorization of 12 months may be granted when all listed criteria are met; continuation of therapy may receive 12-month authorization.

Authorization period: 12 months when criteria met
Continuation: 12 months may be granted for members currently receiving therapy who demonstrate benefit (disease stability or improvement)

Denial Risk

Prescriber Specialty and Coverage Limitation

Medication must be prescribed by or in consultation with a pulmonologist or cardiologist. Use for indications other than FDA‑approved PAH (WHO Group 1) is considered experimental/investigational and not medically necessary.

Prescriber requirement: Must be prescribed by or in consultation with a pulmonologist or cardiologist
Coverage limitation: Indications other than FDA‑approved PAH (WHO Group 1) are experimental/investigational and not medically necessary

Background

Pulmonary arterial hypertension (PAH, WHO Group 1) is characterized by progressive elevation in pulmonary arterial pressure and vascular resistance that reduces exercise capacity and worsens clinical outcomes. Orenitram (treprostinil) extended‑release tablets are FDA‑approved for the treatment of PAH to delay disease progression and improve exercise capacity; pivotal trials primarily enrolled patients with WHO functional class II–III disease and etiologies such as idiopathic, heritable, or connective tissue disease‑associated PAH.

Definitions and Hemodynamic Confirmation

Hemodynamic confirmation of PAH

Required pretreatment testRight heart catheterization (RHC) demonstrating all listed hemodynamic criteria

mPAP criterionMean pulmonary arterial pressure (mPAP) > 20 mmHg

PCWP criterionPulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg

PVR/PVRI criterionPulmonary vascular resistance (PVR) > 2 Wood units; for pediatrics, PVRI > 3 Wood units·m2 is acceptable

Infants exceptionFor infants < 1 year, Doppler echocardiogram may be used if RHC cannot be performed