Kohei Kaku1, Masakazu Haneda2, Hiroyuki Sakamaki3, Atsutaka Yasui4, Tatsunori Murata5, Anastasia Ustyugova6, Rina Chin7, Tetsuaki Hirase7, Tsunehisa Shibahara8, Naoyuki Hayashi8, Anuraag Kansal9, Stefan Kaspers6, Tomoo Okamura8. 1. Kawasaki Medical School, Okayama, Japan. 2. Asahikawa Medical University, Asahikawa, Japan. 3. Kanagawa University of Human Services School of Health Innovation, Kawasaki, Japan. 4. Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan. Electronic address: atsutaka.yasui@boehringer-ingelheim.com. 5. CRECON Medical Assessment Inc, Tokyo, Japan. 6. Boehringer Ingelheim International GmbH, Ingelheim/Rhein, Germany. 7. Eli Lilly Japan K.K., Kobe, Japan. 8. Nippon Boehringer Ingelheim Co Ltd, Tokyo, Japan. 9. Evidera, Bethesda, MD, USA.
Abstract
PURPOSE: The goal of this study was to assess the cost-effectiveness of empagliflozinin Japan based on the Asian subpopulation in the EMPA-REG OUTCOME trial. METHODS: The trial has shown a reduction in the risk for cardiovascular (CV) and renal events with empagliflozin in patients with type 2 diabetes mellitus and established CV disease. A cost-effectiveness analysis based on the overall population of the EMPA-REG OUTCOME trial was reported previously by using a lifetime discrete event simulation model. The same modeling frame was adapted to evaluate the cost-effectiveness of treatment with empagliflozin added to standard of care (SoC) compared with SoC alonein Japan. The time to relevant clinical events and the hazard ratios were derived from an Asian subpopulation in the EMPA-REG OUTCOME trial. The costs for each event were estimated from a Japanese medical claims database. Direct medical costs, life expectancy, and quality-adjusted life years (QALYs) were calculated from the public health care perspective. FINDINGS: Treatment with empagliflozin was estimated to increase life expectancy by 6.2 years and 2.7 QALYs, whereas total cost increased by 1,115,475 yen compared with treatment with SoC alone. The incremental cost-effectiveness ratio was 415,849 yen/QALY. In the sensitivity analysis, there was no case that was in excess of the reference value of the incremental cost-effectiveness ratio in the pilot introduction for price revision in Japan (ie, 5 million yen/QALY). IMPLICATIONS: Based on the Asian subpopulation in the EMPA-REG OUTCOME trial, our results suggest that empagliflozin added to SoC is highly cost-effective compared with SoC alonein Japan.
RCT Entities:
PURPOSE: The goal of this study was to assess the cost-effectiveness of empagliflozin in Japan based on the Asian subpopulation in the EMPA-REG OUTCOME trial. METHODS: The trial has shown a reduction in the risk for cardiovascular (CV) and renal events with empagliflozin in patients with type 2 diabetes mellitus and established CV disease. A cost-effectiveness analysis based on the overall population of the EMPA-REG OUTCOME trial was reported previously by using a lifetime discrete event simulation model. The same modeling frame was adapted to evaluate the cost-effectiveness of treatment with empagliflozin added to standard of care (SoC) compared with SoC alone in Japan. The time to relevant clinical events and the hazard ratios were derived from an Asian subpopulation in the EMPA-REG OUTCOME trial. The costs for each event were estimated from a Japanese medical claims database. Direct medical costs, life expectancy, and quality-adjusted life years (QALYs) were calculated from the public health care perspective. FINDINGS: Treatment with empagliflozin was estimated to increase life expectancy by 6.2 years and 2.7 QALYs, whereas total cost increased by 1,115,475 yen compared with treatment with SoC alone. The incremental cost-effectiveness ratio was 415,849 yen/QALY. In the sensitivity analysis, there was no case that was in excess of the reference value of the incremental cost-effectiveness ratio in the pilot introduction for price revision in Japan (ie, 5 million yen/QALY). IMPLICATIONS: Based on the Asian subpopulation in the EMPA-REG OUTCOME trial, our results suggest that empagliflozin added to SoC is highly cost-effective compared with SoC alone in Japan.
Authors: Odette S Reifsnider; Anuraag R Kansal; Jennifer Franke; Joseph Lee; Jyothis T George; Martina Brueckmann; Stefan Kaspers; Sarah B Brand; Anastasia Ustyugova; Stephan Linden; Matthew Stargardter; Nikco Hau Journal: ESC Heart Fail Date: 2020-09-10