Opsynvi (macitentan/tadalafil) — Medica

Initial criteria

• Patient has a diagnosis of World Health Organization (WHO) Group 1 pulmonary arterial hypertension (PAH)
• Patient has had a right heart catheterization [documentation required]
• Results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH
• The 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)
• Patient has had a right heart catheterization (performed prior to starting therapy with a medication for WHO Group 1 PAH)
• Results of the right heart catheterization confirm the diagnosis of WHO Group 1 PAH
• The medication is prescribed by or in consultation with a cardiologist or a pulmonologist

Approval duration

1 year