Tracleer — Medical Mutual

Initial criteria

• Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH); AND
• Patient has had a right heart catheterization; AND
• Results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH; AND
• The agent is prescribed by or in consultation with a cardiologist or pulmonologist; AND
• If the request is for brand Letairis or Tracleer, the patient has failed a trial of the respective generic product and/or the patient cannot take the respective generic product due to a formulation difference in the inactive ingredient(s) [e.g., dyes, fillers, preservatives] which would result in a significant allergy or serious adverse reaction per the prescribing physician

Reauthorization criteria

• Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH); AND
• Patient has had a right heart catheterization prior to starting therapy; AND
• Results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH; AND
• The medication is prescribed by or in consultation with a cardiologist or pulmonologist; AND
• The patient is currently experiencing a beneficial response as determined by the physician (e.g., improvement in functional class or quality of life, or other hemodynamic or clinical parameters); AND
• If the request is for brand Letairis or Tracleer, the patient has failed a trial of the respective generic product and/or cannot take it due to a formulation difference that would result in a significant allergy or serious adverse reaction per the prescribing physician

Approval duration

1 year