WHAT IS THE CANADA’S DRUG AGENCY REIMBURSEMENT RECOMMENDATION FOR WINREVAIR?: Canada’s Drug Agency (CDA-AMC) recommends that sotatercept (Winrevair) should be reimbursed by public drug plans for the treatment of patients with WHO Group 1 pulmonary arterial hypertension (PAH) if certain conditions are met. WHICH PATIENTS ARE ELIGIBLE FOR COVERAGE? Winrevair should only be covered as add-on therapy in patients with confirmed WHO Group 1 PAH based on guidelines-approved diagnostic procedure including right-heart catheterization (RHC). WHAT ARE THE CONDITIONS FOR REIMBURSEMENT? Winrevair should only be reimbursed as an add-on therapy in patients who are not at low risk, currently treated with optimal background therapy for at least 3 months, and if the cost of Winrevair is reduced. WHY DID CDA-AMC MAKE THIS RECOMMENDATION? • Evidence from 1 randomized trial demonstrated that in patients with symptomatic PAH in WHO functional class (FC) II or III who were receiving stable doses of background PAH therapy for at least 3 months before enrolment, Winrevair, when added to optimal background therapy, significantly improved clinical outcomes, such as the 6-minute walk distance (6MWD), WHO FC, improved health-related quality of life (HRQoL), and reduced PAH-specific hospitalizations, compared to placebo. • Based on our assessment of the health economic evidence, Winrevair does not represent good value to the health care system at the public list price. A price reduction is therefore required. • Based on public list prices, Winrevair is estimated to cost public drug plans approximately $285 million over the next 3 years.
WHAT IS PAH? PAH is a serious condition where the blood pressure in the arteries of the lungs is abnormally high, making it harder for the heart to pump blood through the lungs and leading to symptoms like shortness of breath, fatigue, and heart strain. It is a rare disease affecting approximately 7 to 8 people per 100,000 of the population in Canada. The life expectancy of patients with PAH decreases sharply over time, with the 1-, 3-, and 5-year survival rates in Canada reported to be 89.2%, 75.6%, and 56.0%, respectively. UNMET NEEDS IN PAH: Patients with PAH need access to treatments with an acceptable safety profile that slow disease progression and improve exercise capacity, functional status, and HRQoL. HOW MUCH DOES WINREVAIR COST? Treatment with Winrevair is expected to cost approximately $199,249 per patient per year in the first year, and $202,155 per patient per year in subsequent years, assuming a patient weight of 70 kg.
