Exemption system for economic evaluation data submission for pharmaceuticals in South Korea: Achievements and Challenges.

Abstract

Background: Since the implementation of the positive listing system in South Korea in 2007, new and improved drugs have been reimbursed based on economic evaluation. However, concerns have arisen about reduced accessibility to some drugs. To address this, an exemption system for economic evaluation data submission (EEE) was introduced in 2015 to improve access to drugs with uncertainties in evidence generation.

Objectives: This study aims to assess the institutional and budgetary impact of EEE.

Methods: A descriptive analysis was conducted of the status of EEE-listed drugs. The institutional impact was assessed by examining changes in listing rates, time to listing and cost-effectiveness assessment schemes. The budgetary impact was analyzed by comparing EEE-listed drugs with those listed under other schemes.

Results: The EEE system has positively influenced accessibility, as seen in increased listing rates. By September 2023, 33 ingredients had been listed under the EEE, including 23 for cancer and 6 for rare diseases, with 20 available controlled clinical data. The implementation of the EEE has significantly weakened the role of economic evaluations, especially for cancer and rare disease treatments. The cost per person for EEE-listed drugs were 2.13 to 8.52 times higher, and the number of patients treated with EEE follow-on drugs was substantially larger than those under other schemes.

Discussion: Given the negative impact of the EEE on deriving appropriate drug values through economic evaluations, there is an imminent need for improved cost management. This can be achieved by implementing a reliable cost-effectiveness evaluation framework that addresses various uncertainties.