TRACLEER (bosentan)

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.