CurrentMass General Brigham Health PlanPolicy N/A

Tracleer (bosentan) — Coverage Criteria for Pulmonary Arterial Hypertension

Defines prior authorization, quantity limit, and specialty pharmacy requirements for Tracleer (bosentan) for commercial/exchange members; covers initial and continuation authorization criteria for PAH (WHO Group 1).

Policy Summary

PayerMass General Brigham Health Plan

PolicyTracleer (bosentan) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy N/A

Change TypeOperational update

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Tracleer under the pharmacy benefit; initial and renewal approvals may be granted for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Policy administration was switched from SGM to Custom effective 01/01/2024 following Dec P&T review.

Prior Auth + QLProgram types applied

PharmacyBenefit type

12 moApproval duration

WHO Group 1PAH population

SpecialtyDispensing limitation

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Coverage Criteria for Tracleer (bosentan)

Initial Therapy

Covered when ALL of the following are met

Initial Authorization for Tracleer: 1) Member has pulmonary arterial hypertension (WHO Group 1).

Refer to Appendix for WHO Group 1 definition.

PAH diagnostic confirmation

Option A: Right heart catheterization: Pretreatment right heart catheterization showing all of: mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units.mPAP > 20 mmHg; PCWP ≤ 15 mmHg; PVR ≥ 3 Wood units
Option B: Infant alternative: For infants <1 year, PAH confirmed by Doppler echocardiogram if right heart catheterization cannot be performed.

Prescriber requirement: The requested medication is prescribed by or in consultation with a pulmonologist or cardiologist.

Transition allowance: Authorization may be granted for members new to the plan who are currently receiving the requested medication (excluding products obtained as samples or via manufacturer's patient assistance programs).

Continuation Therapy

Covered when ALL of the following are met

Reauthorization for Tracleer: 1) Member has an indication listed in this policy (WHO Group 1 PAH); 2) Member is currently receiving the requested medication through a paid pharmacy or medical benefit; 3) Member is experiencing benefit from therapy as evidenced by disease stability or improvement; 4) Renewal may be authorized for up to 12 months.

This policy excludes coverage for members who are new to the plan and are not currently receiving the medication; however, authorization may be granted for members new to the plan who are currently receiving treatment with the requested medication. Coverage does not extend to products obtained as samples or through the manufacturer's patient assistance programs.

Diagnostic and Coding Criteria

Hemodynamic thresholds

Mean pulmonary artery pressure (mPAP)> 20 mmHg

Pulmonary capillary wedge pressure (PCWP)≤ 15 mmHg

Pulmonary vascular resistance (PVR)≥ 3 Wood units

PAH diagnostic hemodynamic criteria (Right heart catheterization)

Confirmation methodPretreatment right heart catheterization showing all listed hemodynamic criteria (or Doppler echocardiogram for infants <1 year if RHC cannot be performed)

mPAP requirementmPAP > 20 mmHg

PCWP requirement

Provider Requirements and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization is required for this medication. Typical approval duration is up to 12 months for initial approvals and reauthorizations.

Program Type: Prior Authorization required
Typical approval duration: 12 months

Step Therapy

No step therapy requirements apply for this medication; members do not need to fail other therapies before approval.

Documentation Required

Required Clinical Documentation

Submit documentation to support diagnosis of pulmonary arterial hypertension (PAH) and the medical necessity of the requested therapy.

Background

Pulmonary arterial hypertension (PAH, WHO Group 1) is a progressive condition treated with targeted therapies such as Tracleer (bosentan). For authorization purposes, the policy requires confirmation that the member has WHO Group 1 PAH and documents whether the member is already receiving the requested medication. Prior authorization is required under the pharmacy benefit, and the policy allows transition approvals for members who are currently receiving therapy, while excluding coverage of samples and medications obtained via manufacturer assistance programs.

Definitions

Confirmatory RHC thresholds — definition

Definition — confirmatory RHCPAH confirmed by pretreatment right heart catheterization demonstrating mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 3 Wood units

Alternative for infants <1 yearDoppler echocardiogram may be used if right heart catheterization cannot be performed

Prescriber requirementRequested medication must be prescribed by or in consultation with a pulmonologist or cardiologist

Revision History

2024-01-01administrativeLatest

Policy administration was switched from SGM to Custom effective 01/01/2024 following Dec P&T review.

2023-12-13review

Reviewed at Dec P&T (decision to change administration to Custom effective 01/01/2024).

Policy Summary

PayerMass General Brigham Health Plan

PolicyTracleer (bosentan) — Coverage Criteria for Pulmonary Arterial Hypertension

Policy CodePolicy N/A

Change TypeOperational update

Effective DateJan 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization for Tracleer under the pharmacy benefit; initial and renewal approvals may be granted for up to 12 months.

SourceLink

On This Page

PVR requirementPVR ≥ 3 Wood units

Documented diagnosis of PAH (WHO Group 1)
Confirmation of PAH by one of the following: pretreatment right heart catheterization showing mPAP > 20 mmHg, PCWP ≤ 15 mmHg, and PVR ≥ 3 Wood units; OR for infants <1 year, Doppler echocardiogram if catheterization cannot be performed
Provider specialty: prescription by or consultation with a pulmonologist or cardiologist
For continuation: evidence of benefit from therapy (disease stability or improvement) and records showing current receipt of the medication through a paid pharmacy or medical benefit

Documentation Required

Dispensing Documentation / Specialty Pharmacy

This medication is designated specialty and must be dispensed through a contracted specialty pharmacy. Ensure specialty pharmacy dispensing records are provided when requested.

Fill at contracted specialty pharmacy only
Provide specialty pharmacy dispensing records for members currently receiving therapy

Denial Risk

Common Denial Triggers

Requests may be denied if required documentation is missing, clinical criteria are not met, or the medication is obtained only as samples or through manufacturer patient assistance programs.

Missing or incomplete documentation to confirm PAH (including lack of hemodynamic data or acceptable echocardiographic confirmation for infants)
Diagnosis does not meet WHO Group 1 PAH criteria
Requested prescriber is not a pulmonologist or cardiologist and no consultation is documented
Medication obtained only as samples or via manufacturer's patient assistance program (not eligible for coverage)