MOHW cites budget limits for drugs excluded from fast-track listing

Rep. So-hee Lee calls for measures to improve access for drugs not selected for fast-track listing

Minister Jeong, “Will review around 50 new drugs for reimbursement each year outside the fast-track program”

With the government planning to select 5 at most of the 14 products that applied for its fast-track reimbursement pilot program for rare disease treatments, concerns have been raised that follow-up measures are needed for the remaining unselected items

Lawmakers have also called for the program's performance to be assessed based on the entire time patients wait from regulatory approval to actual reimbursement, rather than solely on the duration of HIRA's assessment and National Health Insurance Service (NHIS) negotiations.

During the Ministry of Health and Welfare (MOHW) NA audit on the 8th, People Power Party lawmaker So-hee Lee questioned the ministry about its plans for products excluded from the fast-track reimbursement pilot program.

Lee said, “Fourteen products applied for the pilot program, but no more than five will be selected. That leaves nine products without a place in the program. What follow-up measures will the government take to ensure patient access to these treatments?

Health and Welfare Minister Eun-kyeong Jeong said the ministry would carefully evaluate the applications before selecting eligible products, but stressed that budget constraints render it difficult to include every treatment in the fast-track program.

Jeong said, “We will thoroughly assess all 14 products before making our selections. We also review new treatments for rare and serious diseases on an ongoing basis, reimbursing around 50 new drugs each year.”

She added, “While we empathize with the desire to expand coverage, financial constraints leave us with no choice but to consider priorities and cost-effectiveness.”

Lee also called for changes to the criteria used to evaluate the pilot program.

“The program should not be judged simply on whether it meets the 100-day target. Instead, we need to assess how much the total waiting time from regulatory approval to actual reimbursement has been reduced and identify any remaining bottlenecks,” Lee said, requesting that the ministry submit a detailed analysis to her office.