TRACLEER (bosentan)
Self-Administration - oral tablets
Diagnosis considered for coverage:
- Pulmonary Arterial Hypertension (PAH): Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group I): 1) In adults to improve exercise ability and to decrease clinical worsening. 2) In pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.
Coverage Criteria:
For diagnosis of pulmonary arterial hypertension (PAH):
- Dose does not exceed 125 mg twice daily, AND
- Diagnosis of PAH, AND
- PAH is symptomatic, AND
- One of the following (A or B):
- A) Diagnosis of PAH was confirmed by right heart catheterization, or
- B) Patient is currently on any therapy for the diagnosis of PAH, AND
- Prescribed by or in consultation with a cardiologist or pulmonologist, AND
- For brand Tracleer tablets (not for suspension) only: Trial and failure or intolerance to generic bosentan tablet
Reauthorization Criteria:
For diagnosis of pulmonary arterial hypertension (PAH):
- Dose does not exceed 125 mg twice daily, AND
- Documentation of positive clinical response to therapy
Coverage Duration:
- Initial: 6 months
- Reauthorization: 1 year
Dosing:
Patient < 40 Kg
- Tracleer: 62.5 mg twice a day
- Maximum dose: 125 mg per day
Patient > 40 Kg
- Tracleer: Start at 62.5 mg twice a day for 4 weeks, then 125 mg twice a day
- Maximum dose: 250 mg per day; adjust dose for impaired liver function
Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
Policy Updates:
- 2/24/2020 – New policy approved by P&T.
- 3/01/2024 – Policy updated, generic medication added, reauthorization criteria added.
References:
1. Tracleer Prescribing Information. Actelion Pharmaceuticals US, Inc. Titusville, NJ. July 2022.
Last review date: March 1, 2024