Access to PAH drug Winrevair in Canada advances by ‘critical step’
Merck Canada working to get approved therapy to patients in country
Merck Canada has taken what it called a “critical step” toward making its approved therapy Winrevair (sotatercept-csrk) — which works to improve exercise capacity and reduce the risk of clinical worsening events in people with pulmonary arterial hypertension (PAH) — accessible to eligible patients in the country.
The company announced that it has successfully completed negotiations with the pan‑Canadian Pharmaceutical Alliance (pCPA), a group that negotiates on behalf of the provinces, territories, and federal drug programs in Canada. Merck, known as MSD outside the U.S. and Canada, said the next steps will require provincial/territorial governments and federal drug programs to implement equitable reimbursement to ensure appropriate access to Winrevair.
“Completion of this negotiation is a meaningful step toward improving greater access to therapies with demonstrated benefits for patients living with PAH,” Jason Weatherald, MD, a pulmonologist at the University of Alberta, said in a press release from Merck detailing the company’s efforts in “bringing Winrevair closer to public reimbursement.”
PAH is marked by abnormally high pressure in the vessels that carry blood from the heart through the lungs. The disease is associated with abnormal cell growth within these vessels, which causes them to become narrowed.
Winrevair is designed to block the activity of signaling molecules that drive this abnormal cell growth, thereby slowing PAH progression. The therapy is given by subcutaneous, or under-the-skin, injection every three weeks.
Winrevair shown in clinical trials to improve walking distance for patients
“Having additional therapeutic options that target different pathways is important for clinicians as we tailor treatment plans to individual patient needs with the aim of helping to improve their symptoms, function, quality of life, and overall outcomes,” Weatherald said.
Health Canada approved Winrevair for PAH last year. In Canada, the therapy is specifically indicated for use in combination with standard therapies for patients with World Health Organization (WHO) functional classification 2 or 3. Winrevair was also approved last year in the U.S. and the European Union.
Having additional therapeutic options that target different pathways is important for clinicians as we tailor treatment plans to individual patient needs with the aim of helping to improve their symptoms, function, quality of life, and overall outcomes.
Its approvals were based largely on data from a Phase 3 clinical trial called STELLAR (NCT04576988), which tested the therapy against a placebo in more than 300 people with PAH. That study achieved its primary objective, which was to demonstrate that Winrevair was more effective than the placebo in enhancing the distance patients could walk in six minutes, which is a common measure of exercise capacity.
Data from this trial and the also now-completed ZENITH study (NCT04896008) also indicated that Winrevair may improve heart health and reduce the risk of death among PAH patients.
Jamie Myrah, executive director of the Pulmonary Hypertension Association of Canada, noted that PAH “is a life-limiting disease that affects patients’ ability to work, engage in daily activities, and maintain independence.” Myrah added that “ensuring broad and equitable access to innovative therapies like Winrevair is essential.”
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