Korea is moving to significantly accelerate patient access to rare disease therapies. This is a result of a sweeping overhaul of its national drug pricing and reimbursement system, approved by the Health Insurance Policy Deliberation Committee.
The reform introduces a fast-track pathway that will shorten the reimbursement listing maximum timeline for rare disease drugs to 100 days, down from as long as 240 days now. The change is intended to address long-standing delays in patient access. Drug reimbursement in Korea previously took an average of 18 months after regulatory approval, which is far slower than in peer markets such as Japan and France.
To support faster access, the government plans to simplify both reimbursement reviews and pricing negotiations for rare disease treatments. However, this accelerated entry will be paired with tighter post-listing oversight. Authorities will increasingly rely on real-world evidence and outcome data to reassess therapies after launch.
In parallel, Korea will expand its flexible pricing contract system from the second quarter of 2026. It will cover more drug types, including new drugs, off-patent products, and biosimilars. This mechanism, which allows individualized agreements between the National Health Insurance Service and pharmaceutical companies, is expected to facilitate faster and more predictable reimbursement.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.