Limited Coverage Drugs - Bosentan

Generic Name

bosentan

Strength

62.5 mg, 125 mg
Form tablet

Special Authority Criteria

Approval Period

As monotherapy, for the treatment of World Health Organization (WHO)/New York Heart Association (NYHA) functional class III or IV pulmonary arterial hypertension (PAH).  The usual dose of bosentan should be limited to a maximum of 125mg twice daily. 

1 year

 

Practitioner Exemptions

  • Designated specialist physicians experienced in the diagnosis and treatment of PAH have been invited to apply for individual specialist exemption from completing SA forms, by entering into a Collaborative Prescribing Agreement.

Special Notes

  1. The diagnosis of PAH should be confirmed by right heart catheterization.
  2. Conventional therapy (including calcium channel blockers, anticoagulation with warfarin to maintain INR 1.5-2.5, loop diuretics, digoxin, supplemental oxygen) is considered first-line therapy for select patients with PAH. An inadequate response to maximal appropriate conventional therapy is required for these patients prior to consideration of any other treatment for PAH.
  3. Due to the potential for hepatotoxicity, ongoing monitoring of liver function tests is strongly recommended, and should be done in accordance with the guidelines in the product monograph.
  4. For patients who do not meet established criteria, exceptional cases may be considered where the physician provides additional documentation in a supporting letter. For example, exceptional case requests for combination therapy with two PAH drugs should be accompanied by details of inadequate response and duration of monotherapy. These exceptional case requests will be reviewed by the PAH Drug Benefit Adjudication Advisory Committee.

Special Authority Request Form(s)