Winrevair (sotatercept-csrk) — United Healthcare

Initial criteria

• Diagnosis of pulmonary arterial hypertension (PAH)
• PAH confirmed by right heart catheterization
• Prescriber attestation that other types of pulmonary hypertension (PH) are excluded as a diagnosis
• Pulmonary arterial hypertension is symptomatic OR patient is currently on Winrevair therapy as documented by claims history or submission of medical records (document date and duration of therapy)
• One of the following: (1) Patient has a cardiopulmonary comorbidity (e.g., obesity, hypertension, diabetes mellitus, coronary heart disease) AND patient is currently taking at least one of the following oral therapies: endothelin receptor antagonist (ERA) [e.g., ambrisentan, bosentan, Opsumit (macitentan)] OR phosphodiesterase-5 inhibitor (PDE5i) [e.g., sildenafil, tadalafil] OR (2) Patient does not have a cardiopulmonary comorbidity (e.g., obesity, hypertension, diabetes mellitus, coronary heart disease) AND patient is currently taking oral combination therapy with both an endothelin receptor antagonist (ERA) [e.g., ambrisentan, bosentan, Opsumit (macitentan)] AND one of the following: phosphodiesterase-5 inhibitor (PDE5i) [e.g., sildenafil, tadalafil] OR soluble guanylate cyclase stimulator (sGC) [e.g., Adempas (riociguat)]
• Prescribed by, or in consultation with, a cardiologist, pulmonologist, or rheumatologist

Reauthorization criteria

• Documentation of a positive clinical response to Winrevair therapy (e.g., improvement in symptoms of right heart failure, exercise tolerance, six-minute walk distance [6MWD], resting and ambulatory oximetry)
• Prescribed by, or in consultation with, a cardiologist, pulmonologist, or rheumatologist

Approval duration

12 months