CurrentCignaPolicy IP0616

Orenitram (treprostinil ER tablets) for pulmonary arterial hypertension

Defines medical necessity criteria and coverage stance for Orenitram for treatment of WHO Group 1 pulmonary arterial hypertension for Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOrenitram (treprostinil ER tablets) for pulmonary arterial hypertension

Policy CodePolicy IP0616

Change TypeNew standalone policymaterial clinical criteria revisions

Effective DateJan 15, 2025

Next Review Date

Key ActionObtain prior authorization documenting WHO Group 1 PAH confirmed by right heart catheterization and required prior therapy trials or prior/current prostacyclin use.

SourceLink

POLICY UPDATE CHANGES

New stand-alone policy created; criteria previously housed in Pulmonary Hypertension Therapy (6121) class policy.

Updated confirmation of PAH diagnosis to remove echocardiogram as an option and added specific prior therapy requirements (trial of two oral therapies from specified classes each ≥ 60 days OR prior/current prostacyclin/prostacyclin receptor agonist).

Conditions Not Covered: concurrent use with Uptravi, inhaled prostacyclin products, or parenteral prostacyclin agents is considered experimental/investigational/unproven.

For patients currently receiving Orenitram, the requirement for a right heart catheterization refers to an RHC prior to starting therapy for WHO Group 1 PAH.

1 yearinitial and renewal approval duration

≥60 daysminimum trial duration for each prior oral PAH therapy

WHO Group 1

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Coverage Criteria for Orenitram (treprostinil ER tablets)

Currently Receiving Orenitram

Covered when ALL of the following are met for patients currently receiving Orenitram:

Prior RHC confirmation: Patient has had a right heart catheterization (performed prior to starting therapy for WHO Group 1 PAH); results of that catheterization confirmed the diagnosis of WHO Group 1 PAH.
Prescriber specialty: Medication is prescribed by, or in consultation with, a cardiologist or a pulmonologist.

Concurrent use of Orenitram with Uptravi (selexipag tablets and intravenous infusion), inhaled prostacyclin products, or parenteral prostacyclin agents used for pulmonary hypertension is considered experimental, investigational, or unproven and is not covered. Examples include Tyvaso, Tyvaso DPI, Ventavis, epoprostenol infusion, and treprostinil subcutaneous or intravenous infusion (Remodulin).

Any use of Orenitram that does not meet the policy’s specified coverage criteria is considered experimental, investigational, or unproven and will not be covered.

Policy Identifier and Coding Notes

Policy identifiermixed

IP0616

Coverage Policy Number — Orenitram

Prior oral therapy duration — minimum trial duration for each prior oral PAH therapy

Minimum trial duration per prior oral PAH therapyEach prior oral therapy (PDE5 inhibitor, ERA, or riociguat) must be taken for ≥ 60 days.

Acceptable oral therapy classesPhosphodiesterase type 5 (PDE5) inhibitors (e.g., sildenafil, tadalafil); Endothelin receptor antagonists (ERAs) (e.g., bosentan, ambrisentan, macitentan); riociguat (Adempas).

Combination or separate trialsTherapies may be from different classes either alone or in combination, but two oral therapies must represent two of the three specified categories.

ExceptionRequirement waived if patient is receiving or has previously received a PAH prostacyclin therapy or a prostacyclin receptor agonist.

Provider Requirements, Prior Authorization, and Exclusions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are for up to 1 year when criteria are met. Prior authorization must document diagnosis of WHO Group 1 pulmonary arterial hypertension (PAH) confirmed by right heart catheterization and meet either Initial Therapy or Continuation (currently receiving Orenitram) criteria. Receipt of sample product does not satisfy prior authorization requirements.

Approval duration: up to 1 year
Prior authorization must include RHC documentation confirming WHO Group 1 PAH
Prescriber must be a cardiologist or pulmonologist, or be in consultation with one

Documentation Required

Right Heart Catheterization (RHC) Documentation Required

Documentation of a right heart catheterization (RHC) with results confirming WHO Group 1 PAH is required. For initial therapy, the RHC must have been performed prior to initiating therapy for WHO Group 1 PAH. For patients currently receiving Orenitram, documentation of a prior RHC confirming WHO Group 1 PAH is required (the RHC refers to testing performed prior to starting therapy for WHO Group 1 PAH).

Background

Pulmonary arterial hypertension (PAH; WHO Group 1) is a progressive condition characterized by elevated pulmonary arterial pressures and increased pulmonary vascular resistance that impair exercise capacity and carry a poor prognosis. Orenitram (treprostinil extended‑release tablets) is an oral prostacyclin mimetic indicated to delay disease progression and improve exercise capacity in patients with WHO Group 1 PAH. Diagnosis is based on hemodynamic confirmation by cardiac catheterization (right heart catheterization) consistent with PAH.

Definitions and Clinical Criteria

Pulmonary arterial hypertension (PAH) hemodynamic definition

Mean pulmonary artery pressure (mPAP)> 20 mmHg at rest.

Pulmonary arterial wedge pressure (PAWP)≤ 15 mmHg.

Pulmonary vascular resistance (PVR)> 2 Wood units measured by cardiac catheterization.

Functional Class III — when oral prostanoids may be considered

Functional Class III oral prostanoid considerationOral prostanoids may be considered in patients with PAH who are WHO Functional Class III with evidence of rapid disease progression or poor prognosis and who are not willing or able to manage parenteral prostanoids.

Guideline sourcesCHEST guideline and Expert Panel Report; European Society of Cardiology/European Respiratory Society guidance recognize oral prostanoids in select patients.