Winrevair (sotaterept-csrk) — Medica

Initial criteria

• age ≥ 18 years
• Patient has had a right heart catheterization and results confirmed the diagnosis of WHO Group 1 PAH [documentation required]
• Patient is in Functional Class II, III, or IV
• Patient meets ONE of the following:
• • Patient is currently receiving at least two other PAH therapies from the following different pharmacologic categories each for > 60 days [documentation required]: phosphodiesterase type 5 inhibitors (PDE5i), endothelin receptor antagonists (ERAs), soluble guanylate cyclase stimulator (sGCs), and prostacyclins
• • OR patient is currently receiving at least one other PAH therapy for > 60 days and is intolerant to combination therapy with a PDE5i, ERA, sGC, or prostacyclin [documentation required]
• Medication is prescribed by or in consultation with a cardiologist or a pulmonologist

Reauthorization criteria

• Patient has had a right heart catheterization and results confirmed the diagnosis of WHO Group 1 PAH (prior to starting therapy with a medication for WHO Group 1 PAH)
• Medication is prescribed by or in consultation with a cardiologist or a pulmonologist

Approval duration

Initial: 6 months; Reauthorization: 1 year