Why new drugs are still not reimbursed within 150 days

Bylvay listed after more than a year… Winrevair’s reimb under review for 200 days since approval

Longer survival paradoxically weakens cost-effectiveness… structural limitations persist

Questions continue to surround the effectiveness of Korea’s pilot program for parallel approval, assessment, and price negotiation.

The Ministry of Health and Welfare has operated the parallel ‘approval–assessment–negotiation’ pilot program since 2023 to improve access to treatments for life-threatening severe and rare intractable diseases. The program’s core objective is to shorten the time required for new drugs to be listed on the National Health Insurance (NHI) reimbursement scheme by running regulatory approval, reimbursement assessment, and price negotiations in parallel. The stated goal is to reduce the reimbursement listing timeline, which used to take a maximum of over 300 days, to 150 days.

As of 2026, expectations for the Approval-Evaluation-Negotiation pilot project were high, but the results appear to be less than satisfactory.

The first pilot program, launched in 2023, concluded after nearly two years, which was longer than originally planned. Among the drugs included, Bylvay (odevixibat), the last to secure reimbursement status, took more than a year to listing.

Similarly, the drugs selected for the second pilot project in December 2024—▲‘ Winrevair(sotatercept)’, ▲‘Rimqarto (anbal-cel)’, ▲‘Fintepla (fenfluramine)’—have not shown significant progress even though nearly a year has passed since the program began.

At the start of the new year, the government announced plans to strengthen support for rare and severe intractable diseases, stating the intent to “reduce the reimbursement listing period for rare disease treatments, which previously took over a year, to 100 days through streamlining reimbursement appropriateness evaluations and negotiations.” However, skepticism remains within the pharmaceutical industry, questioning, “Given that even the ‘150 days’ target of the pilot project was rarely met, is this really feasible?”

If the existing cost-effectiveness evaluation method remains unchanged, for chronic rare and intractable diseases requiring lifelong treatment, the longer a patient survives, the longer they must continue taking the medication. This means that while the drug improves survival and quality of life, the associated drug costs also increase.

This structure makes it inherently disadvantageous to demonstrate cost-effectiveness and, in extreme cases, creates a dilemma in which a patient’s earlier death would paradoxically improve cost-effectiveness outcomes.

A representative example is Winrevair, a pulmonary arterial hypertension (PAH) therapy included in the second pilot program. Winrevair is the first approved activin signaling inhibitor (ASI) in this therapeutic area, where drug development is particularly challenging. Unlike existing therapies focused on vasodilation, Winrevair improves vascular remodeling, the fundamental cause of the disease.

Consequently, no comparable therapeutic alternative is available. If Winrevair is evaluated within the existing economic assessment framework, it would be compared to treatments developed two decades ago. This situation naturally delays the listing process. This challenge is not unique to Winrevair but is one commonly faced by drugs included in the parallel pilot program. Nearly 200 days have already passed since Winrevair received approval from Korea’s Ministry of Food and Drug Safety.

Moreover, pulmonary arterial hypertension is a rare, severe, and chronically progressive disease. The longer patients receive sustained treatment to reach a low-risk group and maintain a favorable condition, the longer the drug is used. This creates the irony that proving cost-effectiveness becomes difficult precisely because the drug ‘keeps patients alive longer’. This is why flexible application of the ICER threshold is necessary.

A representative from a multinational pharmaceutical company commented, “The parallel approval–assessment–negotiation pilot program was introduced to recognize the value of innovative medicines, yet it continues to apply conventional comparative evaluation criteria. The system was designed to improve access to innovative therapies for rare and severe intractable diseases, but it lacks evaluation standards capable of reflecting that innovation.”