Winrevair (sotaterept-csrk subcutaneous injection – Merck) — Cigna

Initial criteria

• Patient age ≥ 18 years; AND
• Patient has had a right heart catheterization [documentation required]; AND
• Results of right heart catheterization confirmed diagnosis of WHO Group 1 PAH; AND
• Patient is in Functional Class II, III, or IV; AND
• Patient meets ONE of the following (a or b):
• a) 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
• b) 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]; AND
• Medication is prescribed by or in consultation with a cardiologist or pulmonologist.

Reauthorization criteria

• Patient had a right heart catheterization prior to starting therapy with a medication for WHO Group 1 PAH; AND
• Results of the right heart catheterization confirmed the diagnosis of WHO Group 1 PAH; AND
• Medication is prescribed by or in consultation with a cardiologist or pulmonologist.

Approval duration

initial 6 months; reauthorization 1 year