Presentation (CTI)

OBJECTIVES: The aim was to verify how ICERs accepted for drug reimbursement has changed according to the change of health policies for the past 15 years in South Korea.
METHODS: The major change of health policies was the implementation of risk-sharing agreement and threshold-raising of ICER^{(accepted up to twice the GDP per capita at that time)} for severe disease (cancer and rare disease) in 2014. The average ICER was calculated to compare the group before and after the policy. In addition, a univariate regression analysis was conducted to identify the impact of the policy implementation on ICERs.
RESULTS: A total of 72 new drugs (as ingredient) were included in the analysis. Before-policy group^(2007-2013) includes 24 and after-policy group includes 48 ingredients, respectively. The average ICER of after-policy group has nearly doubled than before-policy group (17.91 vs. 34.33 millions KRW/QALY). In addition, as a result of analysis specific for severe disease treatments, the policy implementation was found to be a factor that had a statistically significant effect on new drugs' ICER, and after raising the ICER threshold, the ICER increased by 42.56% (31.60 vs. 45.04 millions KRW/QALY, p<0.0001). The number of ingredients for severe disease appraised to be reimbursed has increased more than five times since the implementation of the policy (n=7 vs. n=37).
CONCLUSIONS: South Korea does not have an explicit threshold for ICER, and flexibly evaluates ICER acceptability by considering the severity of disease, social burden of disease, impact on quality of life, and innovativeness of drug. This analysis showed that since the introduction of the policy to increase the ICER threshold, the average ICER of all new drugs as well as severe diseases treatments has been increased, and it was confirmed that the more severe disease treatments were appraised to be reimbursed after the policy implementation.