OBJECTIVES: Since the introduction of the positive listing system in 2007, Korea has undergone multiple changes in its drug listing system in the interest of patient access and budget management. However, there has been a lack of studies evaluating the system from an industry perspective. In this study, we examined Korea’s new drug listing system from the perspective of suppliers.

METHODS: We performed an online survey of members of the 3 main industry associations during April 2022. The survey (5-point Likert scale) covered: (i) satisfactory levels of the current new drug listing system, (ii) reform demands in the 3 main new drug pathways: pharmacoeconomic (PE) review, PE exemption (PEE) and risk sharing agreement (RSA); and (iii) necessary introduction of new systems.

RESULTS: A total of 56 respondents participated in the survey consisting of 19 from domestic and 37 from global companies. The satisfaction level for value recognition of new drug was 1.6 (±0.7) points (5 point=very satisfied) and 41.1% responded that reform is most needed for listing of rare disease treatments. The most necessary reform demand for PE, RSA and PEE, were incremental cost-effectiveness ratio threshold (92.9%), reimbursement scope expansion (91.1%) and eligible disease (83.9%), respectively. For oncology, 83.9% responded that reform is needed with the reimbursement scope review committee. Lastly, 83.9% responded that indication-based pricing needs to be introduced in Korea. These responses were not statistically different between local and global companies (p>0.05).

CONCLUSIONS: Respondents viewed that rare disease treatments which are non-life threatening but detrimental to the quality of life are being neglected by the current system. For oncology drugs, the predominant opinion was that government is placing disproportionate/excessive focus on budget impact. The high dissatisfaction of the current system and the strong demand for reform demonstrate that future reforms should consider opinions from various stakeholders, including the suppliers.