New drug accessibility and budgetary impact in South Korea: policy challenges and implications

To compare the accessibility indicators for new drugs in South Korea with those in the United States, Europe, and Japan, and examine the structure of pharmaceutical expenditures in South Korea. Patient accessibility and budget impacts of new drugs were analyzed using two independent datasets. Accessibility was evaluated for 171 drugs approved between 2013 and 2022 based on reimbursement rates, time to listing post-approval, and international comparisons. Budget impact analysis covered 226 new drugs listed from 2012 to 2021, assessing expenditure patterns with an emphasis on risk-sharing agreements and financial implications for the National Health Insurance budget. Among the 171 new drugs approved between 2013 and 2022, 67.8% were reimbursed as of 1 January 2024. Approval-to-reimbursement timelines varied by drug type and pricing pathway, with drugs listed via the weighted average price pathway receiving faster reimbursement than those evaluated through pharmacoeconomic evaluation. Between 2012 and 2021, new drugs constituted 8.5% of total pharmaceutical expenditures, with oncology drugs incurring the highest annual expenditure per product. Expenditure on new drugs peaked in 2019 but declined thereafter. While South Korea has effectively controlled pharmaceutical expenditures, allocations for new drugs remain low compared to other major countries.