In February, the panCanadian Pharmaceutical Alliance entered into formal pricing negotiations with the manufacturer of Opsyvni (macitentan and tadalafil). Opsyvni is a fixed dose combination of macitentan and tadalafil. Macitentan is an ERA and tadalafil is a PDE5 inhibitor; both have Health Canada indications for the treatment of patients with WHO Group 1 PAH and WHO functional class (FC) II or III.
Opsyvni is the first fixed dose combination therapy for the treatment of PAH. The indication is for the long-term treatment of PAH (WHO Group 1) to reduce morbidity in patients of WHO FC II or III whose PAH is either idiopathic or heritable or associated with connective tissue disease or congenital heart disease. Opsyvni should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg x 2) as separate tablets.
CADTH recommended Opsyvni be reimbursed with clinical criteria and/or conditions in December 2021.