Asia MSD will participate in the government’s pilot program for the fast-track listing of rare disease treatments to accelerate coverage under the National Health Insurance program for Winrevair, a pulmonary arterial hypertension treatment containing sotatercept.
Asia MSD announced on September 2 that it applied on July 31 to participate in the Ministry of Health and Welfare’s “Pilot Program for the Fast-Track Listing of Rare Disease Treatments” with Winrevair.
The pilot program considers the characteristics of rare disease treatments, for which long-term clinical outcomes can be difficult to confirm in a short period. The program focuses on evaluating clinical utility and conducts post-listing assessments based on real-world clinical outcomes after coverage is granted.
Through the program, the government aims to shorten the time required to list rare disease treatments for National Health Insurance coverage from the current 240 days to no more than 100 days.
Winrevair is the first pulmonary arterial hypertension treatment with a novel mechanism of action to emerge in more than 20 years, targeting signals involved in vascular proliferation. In a clinical trial involving adults with pulmonary arterial hypertension, the treatment was shown to reduce the risk of clinical worsening, including death, by 84%.
In Asia, Winrevair was approved in July last year and was also selected for the pilot program that allows the approval, evaluation and reimbursement negotiation processes to proceed in parallel, as well as the Ministry of Food and Drug Safety’s Global Innovative Products Fast Track (GIFT) support program.
Asia’s MSD representative said, “We are keenly aware of the urgent need to improve access to treatment for patients and their families who are waiting for Winrevair to receive National Health Insurance coverage. We will faithfully cooperate with the relevant procedures and do our utmost to ensure that patients can access the benefits of innovative treatments more quickly.”