CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

bosentan (Tracleer) — Coverage Criteria for Pulmonary Arterial Hypertension

Covers medical benefit authorization criteria for bosentan (Tracleer) for treatment of pulmonary arterial hypertension (PAH) including indications, required diagnostic confirmation, prescriber specialty, and duration of authorization. Applies to members of Neighborhood Health Plan of Rhode Island governed by this document.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policybosentan (Tracleer) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy N/A

Change TypeMinor — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months when coverage criteria are met; ensure prescriber is a pulmonologist or cardiologist and document hemodynamic confirmation of PAH.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization period

WHO Group 1indication group covered

mPAP>20; PCWP<15; PVR>2 WUhemodynamic thresholds

age ≥3 yrspediatric indication

Coverage Criteria for bosentan (Tracleer)

Initial therapy (PAH)

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

Indication: Member has pulmonary arterial hypertension (WHO Group 1) as defined in the policy (includes idiopathic, heritable, connective tissue disease–associated, congenital heart disease–associated, and other WHO Group 1 etiologies).

Supported by FDA‑approved indications

Diagnostic confirmation: PAH was confirmed by either: (1) pretreatment right heart catheterization demonstrating 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 (2) for infants < 1 year, a Doppler echocardiogram when right heart catheterization cannot be performed.mPAP > 20 mmHg; PCWP < 15 mmHg; PVR > 2 WU; PVRI > 3 WU·m2 for pediatrics

Hemodynamic confirmation required

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

Policybosentan (Tracleer) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy N/A

Change TypeMinor — no material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for up to 12 months when coverage criteria are met; ensure prescriber is a pulmonologist or cardiologist and document hemodynamic confirmation of PAH.

SourceLink

On This Page

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Key Definitions

Hemodynamic confirmation of PAH

Diagnostic methodRight heart catheterization demonstrating required hemodynamics (mPAP > 20 mmHg, PCWP < 15 mmHg, PVR > 2 WU)

Pediatric adjustmentPVRI > 3 Wood units·m2 is acceptable for pediatric members

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

WHO Group 1 (PAH) — included causes

ScopeWHO Group 1: Pulmonary arterial hypertension (PAH) — covered group

Included etiologiesIdiopathic, heritable, long-term responders to calcium channel blockers

Associated causesDrug- and toxin-associated; PAH associated with connective tissue disease, HIV, congenital heart disease, portal hypertension, schistosomiasis

OtherPersistent pulmonary hypertension of the newborn; PAH with venous/capillary involvement (PVOD/PCH)

Prescriber Requirements, Documentation, and Authorization

Prior Authorization

Prior Authorization Duration

Prior authorization for 12 months may be granted when all coverage criteria are met. Continuation authorization may also be granted for 12 months for members currently receiving the medication who are experiencing clinical benefit (disease stability or improvement).

Documentation Required

Prescriber Requirement

Medication must be prescribed by or in consultation with a pulmonologist or cardiologist.

Documentation Required

Required Documentation

Required documentation must include WHO Group classification and hemodynamic confirmation of PAH. Hemodynamic confirmation should be documented by pretreatment right heart catheterization showing all of the following: 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 acceptable). For infants under one year of age, a Doppler echocardiogram may be used if right heart catheterization cannot be performed.

Documentation Required

Prescriber and Benefit Documentation

Prescriber specialty (pulmonologist or cardiologist) must be documented. For continuation of therapy, documentation must also demonstrate clinical benefit from the medication, evidenced by disease stability or improvement.

Denial Risk

Insufficient Diagnostic Confirmation — Denial Risk

Lack of hemodynamic confirmation as specified (for example: mPAP ≤ 20 mmHg, PCWP ≥ 15 mmHg, or PVR ≤ 2 Wood units) or absent/insufficient diagnostic documentation may result in denial of authorization.

OpenPayer

bosentan (Tracleer) — Coverage Criteria for Pulmonary Arterial Hypertension

Coverage Criteria for bosentan (Tracleer)

Hemodynamic and Diagnostic Definitions

Key Definitions

Prescriber Requirements, Documentation, and Authorization

Background