Macitentan and Tadalafil (Opsynvi)

CADTH reimbursement reviews are comprehensive assessments of the clinical effectiveness and cost-effectiveness, as well as patient and clinician perspectives, of a drug or drug class. The assessments inform non-binding recommendations that help guide the reimbursement decisions of Canada's federal, provincial, and territorial governments, with the exception of Quebec. This review assesses macitentan plus tadalafil fixed-dose combination, film-coated tablets (10 mg and 40 mg) for oral administration. Indication: 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. Macitentan and tadalafil should be used in patients who are currently treated concomitantly with stable doses of macitentan 10 mg and tadalafil 40 mg (20 mg × 2) as separate tablets.