PRACTICAL PROBLEMS OF COMPARATOR SELECTION TO ASSESS COSTEFFECTIVENESS OF NEW DRUGS FOR REIMBURSEMENT DECISION: A QUALITATIVE STUDY IN SOUTH KOREA Hye-Young Kang, Ph.D.1, Hankil Lee, M.S.1, Hyeonseok Cho, B.S.1 1 College of Pharmacy, Yonsei Institute of Pharmaceutical Sciences, Yonsei University South Korea hankil.lee@yonsei.ac.kr BACKGROUND AND OBJECTIVE 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. We believe that identifying the practical gaps in comparator selection for CE assessment should be the first step to improve the CE guidelines and, consequently, the quality of CE evidence. Therefore, our study aimed to investigate the practical problems in comparator selection to conduct a valid CE analysis of drugs in Korea. RESULTS The qualitative analysis of FGIs identified eight practical problems associated with selecting appropriate comparators to conduct valid economic evaluation of innovative drugs for reimbursement decisions (table 1). Table 1. Practical problems identified by focus group interviews 1) Drugs used widely for a long time selected as comparators If a new innovative drug is compared with such an obsolete drug, the resulting ICER could be extremely high because of the rock-bottom price of the old drug, no matter how much superior the treatment effectiveness of the new drug is in comparison to the comparator drug. 2) Therapeutically nonequivalent drugs used as comparators The guideline does not mention whether comparators should have an equivalent therapeutic status and the same indication. 3) Generic product prices used for off-patent products The price of the new drug was compared with generic product prices rather than the original products’ initial prices set during the patent period. 4) No guidance on whether to include off-label medicines as comparators CE guideline did not specify whether off-label or unlicensed medicines can be used as comparators for CE analysis. 5) Best supportive care used as a comparator It would not be appropriate if best supportive care (BSC)4 were selected as a comparator when no treatment alternative with pharmacologic function is available. “BSC is a sort of salvage and cannot be viewed as a treatment.” 6) High level of uncertainty with indirect comparison The level of uncertainty was high when an indirect comparison method was used to compare the efficacy of a new drug with that of a comparator drug either because of the insufficiency of research articles to derive a valid indirect comparison or because of variation in the indirect comparison results, depending on the indirect comparison method used. 7) Difficulty to obtain reliable market share data needed for comparator selection Figuring out market share of each alternative drug is a pre-requisite to identify an appropriate comparator. Most of the participants believed that NHI claim records are perfect data for this purpose. However, they complained of limited access to the data 8) Difficulty to select standard treatment in the face of too many treatment regimens When various regimens are used for a single indication, it is not easy to choose a comparator regimen. METHODS We performed focus group interviews (FGIs) in September 2014 with 10 health technology assessment (HTA) experts working in research-based drug companies in Korea. Each participant was provided with the interview question in advance via e-mail and was asked to present his or her experience and opinions related to the question at a round-table discussion. The interview question was framed as follows: “Please share your experiences of practical difficulties in selecting appropriate comparators in compliance with the HIRA guideline when performing CE analysis or when commissioned to research for the listing of your company’s products on the NHI reimbursement list.” All focus group discussions were audio-recorded digitally, and the participant’s comments were transcribed verbatim(Figure 1)2. Data analysis was conducted using the thematic analysis proposed by Braun and Clarke: 1) data familiarization, 2) generation of initial codes, 3) searching for themes, 4) reviewing themes, and 5) defining and naming themes(figure 2)3. Purposive sampling 10 people; 5 people per group A semi-structured question Approximately 90-120 minutes One interviewer conducted all FGIs All audiotaped interviews were transcribed and proofread DISCUSSION AND CONCLUSION Considering the lack of preliminary knowledge about this issue, we carried out a qualitative study using FGI methods to retrieve experts’ experience and suggestions on this issue. The FGIs elicited eight practical problems with comparator selection. The inappropriate comparators that the focus group pointed out reflect non-comparable alternatives in terms of therapeutic competency or pricing system. 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. Data familiarizati-on Generation of initial codes Searching for themes Reviewing themes Defining and naming themes Figure 1. The procedure of focus group interviews REFERENCES Bae EY, Lee EK. Pharmacoeconomic guidelines and their implementation in the positive list system in South Korea. Value Health 2009;12:s36-41. Morgan D. Planning and research design for focus groups. In: Morgan D, Focus groups as qualitative research. London: Sage Research Methods, 1997 Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol 2006;3:77-101. Zafar SY, Currow D, Abernethy AP. Defining best supportive care. J Clin Oncol 2008;26:5139-40. Figure 2. Data analysis flow of focus group interviews introduced by Braun and Clarke Acknowledgement: This study was funded by Korean Research-based Pharmaceutical Industry Association.