Analysis of the Drug Price Level of Anticancer and Rare Disease Drugs after the Implementation of Economic Evaluation Exemption in South Korea

OBJECTIVES: This research aims to analyze the level of new drug price evaluated as reimbursement recommendation in South Korea compared to the adjusted price of seven reference countries (A7 countries: France, Germany, Italy, Japan, Switzerland, UK, and USA) for anticancer and rare disease drugs after the implementation of the economic evaluation exemption.

METHODS: We analyzed cost-effectiveness evaluation method (economic evaluation, economic evaluation exemption) and the level of drug price compared to the adjusted price of A7 countries for anticancer and rare disease drugs that evaluated as positive reimbursement recommendation from the introduction of the economic evaluation exemption (June 2015) to June 2022.

RESULTS: Since the introduction of economic evaluation exemption, a total of 182 drugs have been evaluated as positive reimbursement recommendation among anticancer and rare disease drugs. Among them, 52 and 46 drugs were evaluated through economic evaluation (cost-effectiveness/utility analysis) and economic evaluation exemption, respectively. In particular, the number of drugs evaluated through economic evaluation has been on the decline since 2017, and all 7 drugs evaluated in the first half of 2022 were evaluated through economic evaluation exemption. The level of drug price compared to the A7 lowest adjusted price of the drugs exempted from economic evaluation was significantly higher than that of the drugs with economic evaluation by about 18% (p<0.001).

CONCLUSIONS: The drugs exempted from economic evaluation were priced higher than the drugs with economic evaluation, even though they were exempted from submitting economic evaluation data. The number of drugs exempted from economic evaluation is increasing, and the transparency of foreign drug prices is declining due to the increase in risk-sharing drugs. Therefore, it is necessary to reexamine the evaluation criteria for drugs exempted from economic evaluation.