PHP150 - Practical problems of comparator selection to assess cost-effectiveness of New Drugs for reimbursement decision: a qualitative study in South Korea

Abstract

Under the positive drug listing system, pharmaceutical companies in Korea are required to provide cost-effectiveness (CE) evidence of newly approved drugs for listing on the National Health Insurance (NHI) drug formulary. It has been argued that selection criteria of comparator treatments suggested by the CE guideline are too limited and unrealistic to conduct a valid CE assessment. Therefore, our study was conducted to investigate types of practical problems in comparator selection in order to improve the validity of CE analysis. We conducted focus group interviews (FGI) with experts working in research-based drug companies, charged of submitting CE evidence of their products to NHI. Each participant received an interview question via an e-mail beforehand and presented their opinions at round-table discussion. Examples of the problems associated with selecting appropriate comparators identified from FGI are as follows: drugs with the same indication, but therapeutically nonequivalent, were used as comparators ; there is no guidance on whether to include off-label drugs as comparators; when off-patent products were selected as comparators, the price of the new drug was compared with the price of generic products rather than the initial price of the original products set during the patent period; it is difficult to obtain reliable market share data needed for selecting a comparator; and the best supportive care was selected as a comparator when there’s no appropriate treatment alternatives. We expect that the results of our investigation would contribute to improve the quality of CE guidelines in South Korea as well as other countries, and to improve assessment of the true value of pharmaceutical intervention.