Orenitram — 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
• Patient meets one of the following conditions (a or b): a) Patient has tried or is currently receiving at least one oral medication for PAH from the following different categories (either alone or in combination) each for ≥ 60 days: one phosphodiesterase type 5 (PDE5) inhibitor, one endothelin receptor antagonist (ERA), or Adempas (riociguat tablets); OR b) Patient is receiving or has received in the past one PAH prostacyclin therapy or a prostacyclin receptor agonist (i.e., Uptravi [selexipag tablets]); AND
• Medication is prescribed by or in consultation with a cardiologist or a pulmonologist.

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 with a medication for WHO Group 1 PAH; 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 a pulmonologist; AND
• The patient is experiencing a beneficial response to treatment with Orenitram, including any of the following: reduced pulmonary vascular resistance and/or pressure, improved symptoms, and/or improved patient activity.

Approval duration

1 year initial, 1 year reauth