Authors' objectives: The Academic Technology Assessment Group (ATAG) reviewed a report by the manufacturer (Gilead Sciences Inc.) on the additional benefits and cost-effectiveness of sacituzumab govitecan in patients with hormone receptor-negative and Human Epidermal growth factor Receptor type2(HER2)-negative inoperable or recurrent breast cancer who received prior chemotherapy. This report summarised the ATAG review and re-analysis. The target population were patients with hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer who had received prior chemotherapy, and the comparator was eribulin. The manufacturer had conducted a systematic review (SR) to assess the additional benefits of sacituzumab govitecan and identified a pivotal trial (ASCENT trial), a randomized controlled trial comparing sacituzumab govitecan and treatment of physician's choice (TPC), which included eribulin. From the results of the ASCENT trial, the manufacturer noted improvements in overall survival and progression-free survival in the sacituzumab govitecan group compared with those in the TPC group, which included those treated with eribulin. Furthermore, subgroup analyses by chemotherapy included in the TPC regimens also demonstrated consistent efficacy of sacituzumab govitecan. On basis of these findings, the manufacturer concluded that compared with eribulin, sacituzumab govitecan has additional benefits. The ATAG independently conducted the SR. The ATAG identified the ASCENT trial, as did the manufacturer, and determined that the manufacturer's interpretation of the trial results and their assessment of the additional benefits were valid. Consequently, the ATAG concluded that sacituzumab govitecan has demonstrated the additional benefits compared with eribulin. The manufacturer developed a partitioned survival model that considered three health states-progression-free survival, progressive disease, and death-for the cost-effectiveness evaluation of sacituzumab govitecan in the target population and conducted a cost-effectiveness analysis using eribulin as the comparator and quality-adjusted life year (QALY) as the outcome. In this analysis, parameters were estimated based on data obtained from the intention-to-treat population in the ASCENT trial. The ATAG conducted a re-analysis owing to the several challenges identified in the analysis by the manufacturer. Regarding the quality of life (QOL) values used in the analysis, the manufacturer mapped patient-reported outcomes to QOL values. Based on the results of multivariable analysis, the manufacturer adopted different QOL values for the same health state depending on the treatment. The ATAG determined that it was appropriate to conduct the analysis using the same QOL values for the same health states. Because previous research on QOL values applicable to the target population is limited, the ATAG decided to use the mapping results from the ASCENT trial provided by the manufacturer, and performed a re-analysis using the average QOL values for both groups for each health state. The re-analysis of the ATAG showed the administration of sacituzumab govitecan led to an incremental effectiveness of 0.396 QALYs and an incremental cost of JPY 13,741,192 compared to eribulin, resulting in an incremental cost-effectiveness ratio (ICER) of JPY 34,735,200 per QALY. In conclusion, for patients with hormone receptor-negative and HER2-negative inoperable or recurrent breast cancer who received prior chemotherapy, the results by the ATAG suggested that the ICER for sacituzumab govitecan compared to eribulin was likely to be classified within the range "more than JPY 15 million per QALY" from the perspective of public healthcare payers in Japan.

Project Status: Completed

URL for project: https://c2h.niph.go.jp/en/

Year Published: 2026

URL for published report: https://c2h.niph.go.jp/en/results/C2H2409.html

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Japan

Organisation Name: Center for Outcomes Research and Economic Evaluation for Health

Contact Address: 2-3-6 Minami, Wako-shi, Saitama 351-0197 Japan

Contact Name: Takeru Shiroiwa

Contact Email: t.shiroiwa@gmail.com