Sotatercept Nears Public Coverage After National Pricing Deal
Merck Canada has completed national pricing negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for WINREVAIR (sotatercept), marking a significant milestone in the therapy’s journey toward broad public reimbursement across Canada. The agreement, announced on November 20, 2025, positions the first-in-class activin signaling inhibitor one step closer to routine funding through provincial, territorial and federal drug plans .
The pCPA, which negotiates on behalf of all publicly funded drug programs, plays a pivotal role in setting the economic framework for medicines entering the Canadian market. Completion of these negotiations does not itself guarantee patient access, but it establishes the national pricing terms that provinces and territories rely on when making individual reimbursement decisions. With the negotiation phase now closed, the file advances to the implementation stage, where each jurisdiction will determine timelines and criteria for coverage.
What You Need To Know
- Merck Canada and pCPA successfully complete national pricing negotiations for WINREVAIR (sotatercept).
- WINREVAIR is indicated for adults with WHO Group 1 PAH in Functional Class II or III.
- Patient and clinical groups highlight the therapy’s importance and novel mechanism in PAH management.
- Provinces, territories and federal drug plans will now determine final reimbursement and implementation.
WINREVAIR is indicated, in combination with standard pulmonary arterial hypertension (PAH) therapy, for adults with WHO Group 1 PAH in Functional Class II or III . PAH is a debilitating, progressive disease in which the arteries supplying the lungs narrow due to scarring and abnormal cell growth, forcing the heart to pump harder and ultimately leading to right-sided heart failure.
Symptoms include shortness of breath, exertional fatigue, edema, chest pain and dizziness, often progress slowly and may be misattributed to other cardiopulmonary or lifestyle factors. Without appropriate treatment, PAH significantly reduces quality of life, mobility and survival.
WINREVAIR represents a mechanistically novel approach for PAH, working by modulating the activin signaling pathway to rebalance vascular proliferation and repair. The therapy drew considerable attention globally following late-stage data demonstrating clinically meaningful improvements in exercise capacity, functional class and time to clinical worsening.
Patient organizations emphasize impact on independence and daily life
The Pulmonary Hypertension Association of Canada welcomed the pCPA milestone, calling it an important step toward equitable access. “PAH is a life-limiting disease that affects patients’ ability to work, engage in daily activities, and maintain independence,” said Jamie Myrah, Executive Director of the association. “Ensuring broad and equitable access to innovative therapies like WINREVAIR is essential.”
Canadian pulmonologists echoed this sentiment, emphasizing the value of therapies that operate through new biological pathways. Dr. Jason Weatherald, a pulmonologist at the University of Alberta, noted that diversification of therapeutic mechanisms is vital as clinicians aim to tailor treatment combinations to individual disease profiles. “Having additional therapeutic options that target different pathways is important for clinicians as we tailor treatment plans to individual patient needs,” he said. “This negotiation is a meaningful step toward improving access for patients living with PAH.”
Provincial and federal reimbursement decisions are the next bottleneck
The next phase involves provinces, territories and federal programs translating the pCPA outcome into concrete reimbursement policies. Each jurisdiction will define eligibility based on criteria outlined by Canadian HTA bodies, including INESSS in Quebec and CADTH at the national level.
This multi-layered process can lead to variability in implementation timelines, but historically, pCPA completion is considered the most substantial gatekeeper to public funding for high-cost specialty therapies. The negotiation outcome signals that WINREVAIR met the alliance’s expectations around therapeutic value and budget impact, giving jurisdictions a standardized framework to move forward.
For a rare, chronic and highly burdensome disease like PAH, the addition of a first-in-class therapy into the public access pipeline is a consequential development. WINREVAIR’s entry aligns with a broader global trend toward diversifying PAH mechanisms beyond vasodilators, and it reinforces Canada’s role in scaling access to next-generation cardiopulmonary biologics.
As jurisdictions begin their reimbursement assessments, the completion of pCPA negotiations puts sotatercept within striking distance of becoming a publicly funded therapeutic option for Canadians living with PAH.
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