CurrentCignaPolicy N/A

Pulmonary Arterial Hypertension - Orenitram Prior Authorization Policy

This prior authorization policy defines coverage criteria, documentation requirements, and restrictions for Orenitram (treprostinil extended-release tablets) for WHO Group 1 pulmonary arterial hypertension for Cigna-administered benefit plans.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Orenitram Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised prior therapy requirementadded exclusions examples

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are issued for one year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

The option requiring trial of two oral PAH medications was changed to require trial of (or current use of) one other oral PAH medication.

Conditions Not Covered now explicitly state that concurrent use with selexipag (Uptravi), inhaled prostacyclin products, or parenteral prostacyclin agents is not permitted.

Tyvaso DPI and Tadliq were added as example agents in relevant categories.

WHO Group 1indication covered

1 yearauthorization duration

≥ 60 daysminimum trial

<20,000US prevalence context

Coverage Criteria for Orenitram (treprostinil ER)

Initial Therapy

Covered when ALL of the following are met:

Initial Therapy criteria

Diagnosis and hemodynamics: Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) AND patient has had a right heart catheterization with results confirming WHO Group 1 PAH (documentation required).
Prior therapy: Either: (a) patient has tried or is currently receiving at least one oral PAH medication from a different category (one PDE5 inhibitor, one ERA, or riociguat) each for >= 60 days; OR (b) patient is receiving or has received a PAH prostacyclin therapy or a prostacyclin receptor agonist (e.g., selexipag).
Prescribing: Medication is prescribed by or in consultation with a cardiologist or a pulmonologist.

Policy Summary

PayerCigna

PolicyPulmonary Arterial Hypertension - Orenitram Prior Authorization Policy

Policy CodePolicy N/A

Change TypeRevised prior therapy requirementadded exclusions examples

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization; approvals are issued for one year when criteria are met.

SourceLink

On This Page

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Diagnosis and hemodynamics (separate node): Patient has a diagnosis of WHO Group 1 PAH; AND right heart catheterization performed with results confirming WHO Group 1 PAH (see documentation requirements).

Current Orenitram therapy

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

Continuation Therapy criteria

Diagnosis and hemodynamics: Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH) AND patient has had a right heart catheterization with results confirming WHO Group 1 PAH.
Prescribing: Medication is prescribed by or in consultation with a cardiologist or a pulmonologist.

Prescribing (separate node): Medication is prescribed by, or in consultation with, a cardiologist or a pulmonologist.

Concurrent use of Orenitram with other prostacyclin pathway agents is not permitted. Specifically, requests for concomitant therapy with selexipag (Uptravi), inhaled prostacyclin products (for example, Tyvaso, Tyvaso DPI, Ventavis), or parenteral prostacyclin agents (for example, epoprostenol or treprostinil infusion products) are considered experimental/investigational and are not covered. Such combinations may be denied when submitted for coverage.

Coding and Trial Duration

Minimum trial duration for prior oral PAH medication

Minimum trial duration>= 60 days

Applies toEach prior oral PAH medication trial (PDE5 inhibitor, ERA, or riociguat)

Counting rulesEach medication must be tried for ≥ 60 days; combination regimens count if each agent meets duration

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Orenitram (treprostinil extended‑release tablets). Approvals are issued for 1 year when criteria are met. Because of the specialized skills required for evaluation and monitoring, Orenitram must be prescribed by or in consultation with a physician who is a cardiologist or pulmonologist. Documentation of the consultation or prescribing specialist must be included with the prior authorization request (e.g., chart note, consult note, or prescription with specialist NPI).

Prior authorization approvals issued for 12 months when criteria are met
Documentation (chart notes, consult note, RHC report) must be submitted with the PA request

Step Therapy

Step Therapy / Prior Medication Requirement

For initiation of Orenitram, the patient must have tried or currently be receiving at least one oral PAH medication from a different drug category (phosphodiesterase-5 inhibitor, endothelin receptor antagonist, or riociguat) for ≥ 60 days, unless the patient has received prostacyclin or a prostacyclin receptor agonist as specified below. Provide medication history (dates, drug names, duration) in the documentation.

Step therapy requirement: trial or current use of ≥1 oral PAH agent from a different category (PDE5 inhibitor, ERA, or riociguat) each for ≥ 60 days
Alternative: prior or current use of a prostacyclin therapy or prostacyclin receptor agonist (e.g., selexipag) meets the requirement

Documentation Required

Right Heart Catheterization Documentation Required

Right heart catheterization (RHC) documentation is required to confirm WHO Group 1 PAH for both initial and continuation requests. Acceptable documentation includes the RHC report and relevant chart notes showing hemodynamic measurements and interpretation. If valid RHC documentation has been previously provided with prior authorization coverage review for another PAH medication, that documentation will satisfy this requirement.

Required: copy of right heart catheterization report with hemodynamics
Required: chart notes documenting RHC interpretation and WHO Group 1 PAH diagnosis
Previously submitted RHC documentation for another PAH PA request is acceptable

Documentation Required

Specialist Prescribing or Consultation

Orenitram must be prescribed by, or in consultation with, a cardiologist or pulmonologist. Include the name, specialty, and NPI of the prescribing specialist or the consulting specialist and a brief consult note or documentation of the specialist’s involvement with the authorization request.

Prescriber must be a cardiologist or pulmonologist, or include documentation of specialist consultation
Include specialist name, specialty, NPI, and consult note or documentation with the PA request

Denial Risk

Concurrent Prostacyclin Therapy Not Permitted

Concurrent use of Orenitram with selexipag (Uptravi), inhaled prostacyclin products (e.g., Tyvaso, Tyvaso DPI, Ventavis), or parenteral prostacyclin agents is not permitted.

Concurrent use with selexipag (Uptravi) prohibited
Concurrent use with inhaled prostacyclins (Tyvaso, Tyvaso DPI, Ventavis) prohibited
Concurrent use with parenteral prostacyclin agents (e.g., epoprostenol, treprostinil injection) prohibited

Background on Orenitram and Indication

Orenitram (treprostinil extended‑release tablets) is an oral prostacyclin analog indicated for World Health Organization Group 1 pulmonary arterial hypertension (PAH). It is used to delay disease progression and improve exercise capacity in patients with PAH. Coverage decisions require documentation of appropriate diagnosis and adherence to prescribing restrictions; concurrent use with other prostacyclin agents or prostacyclin receptor agonists (examples include inhaled products such as Tyvaso or Ventavis and parenteral infusions such as epoprostenol or treprostinil infusion) is explicitly noted as not covered.

Definitions and Diagnostic Criteria

Pulmonary arterial hypertension (PAH) - WHO Group 1 diagnostic thresholds (mPAP, PCWP, PVR)

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

Pulmonary arterial wedge pressure (PAWP/PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)> 2 Wood units