With national health insurance coverage for the new pulmonary arterial hypertension (PAH) treatment Winrevair (active ingredient: sotatercept) remaining in limbo, medical societies and patient advocacy groups are calling on the South Korean government to move the drug into its newly launched "100-day fast-track listing" system.
In a joint statement issued on the 12th, the Korean Society of Pulmonary Hypertension, the Korea Pulmonary Arterial Hypertension Patients Association, the Korea Congenital Heart Disease Patients Association, and the Korea Alliance for Rare and Intractable Diseases urged the Ministry of Health and Welfare and MSD Korea to transfer Winrevair from an existing parallel-review pilot program to the new rare-disease fast-track listing pilot program.
The groups pointed out that 550 days have elapsed since the reimbursement application for Winrevair was submitted, yet the treatment has not even been placed on the agenda of the Drug Reimbursement Evaluation Committee under the Health Insurance Review and Assessment Service (HIRA). Despite being selected for a previous pilot program designed to expedite patient access to new therapies, actual insurance listing has stalled.
Winrevair was included in the "pilot program for parallel approval-evaluation-negotiation" in December 2024. The initiative was designed to shorten insurance listing times by concurrently running drug approval by the Ministry of Food and Drug Safety (MFDS), reimbursement evaluation by HIRA, and price negotiations with the National Health Insurance Service (NHIS).
Under that framework, Winrevair gained MFDS approval on July 23, 2025. However, more than a year after approval, a decision on national health insurance coverage has yet to be finalized.
Pushing for the New "100-Day" Fast-Track System
The alternative championed by medical and patient groups is a newly introduced pilot program specifically designed to fast-track reimbursement for rare disease treatments.
This new initiative aims to streamline the listing timeline for rare disease therapies by postponing certain cost-effectiveness evaluations until after reimbursement through real-world evidence assessment, while simplifying price and spending cap negotiations via pre-agreed contract terms.
Through this system, the government aims to reduce the average insurance listing timeline from approximately 240 days to a maximum of 100 days. The Ministry of Health and Welfare has been accepting corporate applications since July, with the submission deadline set for August 31. Up to five drugs will be selected based on criteria such as the availability of alternative treatments, disease severity, financial impact on national health insurance, and supply stability.
Participation is not automatic; MSD Korea must formally submit an application, which the government will then evaluate. The joint statement pressed both the ministry and MSD Korea to initiate the transition immediately.
"Although Winrevair was previously selected for a rapid-listing initiative, its reimbursement has been delayed for an extended period," the groups stated. "It should be designated as a priority candidate for review under the new fast-track system."
A Novel Mechanism Targeting Vascular Remodeling
Pulmonary arterial hypertension is a rare and progressive condition in which the arteries carrying blood from the heart to the lungs narrow and thicken, leading to elevated vascular resistance. As the disease advances, the right side of the heart must work significantly harder to pump blood, ultimately risking right-sided heart failure.
Although treatment outcomes have improved in recent years, patient access to recommended therapies remains constrained. According to a domestic observational study released in February by the Korea Disease Control and Prevention Agency (KDCA), the one-year and three-year survival rates for Korean PAH patients were 96% and 87%, respectively. While half of the patients required combination therapy by their third year of treatment, only 26% received care aligned with international standard guidelines. The KDCA noted that domestic medical conditions—including strict health insurance reimbursement criteria—hinder the proactive use of necessary treatments.
Winrevair operates through a distinct mechanism compared to existing therapies. While conventional PAH drugs primarily act as vasodilators to open blood vessels, Winrevair targets activin signaling—a pathway that drives the excessive cell proliferation causing arterial walls to thicken. Rather than merely expanding vessel diameter, it directly addresses abnormal vascular remodeling.
In South Korea, Winrevair was approved as an add-on therapy to improve exercise capacity in adult patients with World Health Organization (WHO) functional class II to III PAH.
In the global Phase 3 STELLAR trial involving 323 patients on background PAH therapy, the sotatercept group demonstrated a 40.8-meter median improvement in six-minute walk distance over placebo after 24 weeks. The trial also met key secondary endpoints, showing significant reductions in clinical worsening and mortality risks.
Reported adverse events associated with sotatercept included epistaxis (nosebleeds), dizziness, telangiectasia, elevated hemoglobin levels, reduced platelet counts, and hypertension, highlighting the need for routine blood tests and safety monitoring during administration.
Concluding their statement, the medical and patient coalition also urged authorities to address systemic delays and expand health insurance coverage for other essential pulmonary hypertension treatments currently restricted or unavailable in South Korea.
