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TracleerMedical Mutual

Digital ulcers in systemic sclerosis

Initial criteria

  • The request is for bosentan (Tracleer, generic); AND
  • Patient has tried one vasodilator/prostanoid therapy [examples include epoprostenol injection and alprostadil injection]; OR
  • Patient has tried two other therapies such as calcium channel blockers (amlodipine, felodipine, nifedipine), phosphodiesterase type 5 (PDE5) inhibitors (sildenafil, vardenafil), alpha-adrenergic blockers (prazosin), nitroglycerin, or ACE inhibitors; AND
  • For brand Tracleer, the patient has failed a trial of generic bosentan and/or cannot take generic bosentan due to a formulation difference in inactive ingredients which would result in a significant allergy or serious adverse reaction per the prescribing physician

Approval duration

1 year