Authors' objectives: The academic technology assessment group (ATAG) reviewed a report submitted by the manufacturer of finerenone (Bayer Yakuhin, Ltd) on additional benefits and cost-effectiveness of finerenone compared to standard of care (SoC) in patients with chronic kidney disease in type 2 diabetes. This report summarizes the results of a review and reanalysis by the ATAG. In assessing additional benefits of finerenone over SoC, the manufacturer submitted data from the FIDELITY analysis, a pooled analysis of randomized controlled trials (FIDELIO-DKD and FIGARO-DKD) that included Japanese patients. They reported the results for the overall population in the base-case analysis. The results for the Japanese population were reported in a sensitivity analysis. In the overall population, finerenone showed statistically significant efficacy for composite cardiovascular and composite kidney endpoints. Also in the Japanese population, hazard ratio (HR) for the composite cardiovascular endpoint was 0.88 (95% confidence interval (95% CI): 0.52?1.49) and the composite kidney endpoint was 0.9985 (95% CI: 0.70?1.42) in the finerenone group compared to SoC. Based on these results, the manufacturer insisted on the additional benefits of finerenone over SoC in both the overall and Japanese populations. The ATAG considered that results from both the overall and Japanese populations should be evaluated comprehensively to determine the additional benefits of finerenone. HR for the composite cardiovascular endpoint in the finerenone group was estimated to be less than 1.0 in both the overall and Japanese populations. Therefore, the ATAG concluded that finerenone had additional benefits for the composite cardiovascular endpoint. In contrast, from the FIDELITY analysis, the ATAG noted that HR for the composite kidney endpoint consistently exceeded 1.0 in the Japanese population. Additionally, in each trial, HRs were consistently higher in the Japanese population than in the overall population. Even in the FIDELIO-DKD trial, which set the composite kidney endpoint as the primary endpoint, HR for the composite kidney endpoint was 0.91. This result may indicate that the treatment effect of finerenone is not necessarily significant. The ATAG could not determine from the available evidence that finerenone had additional benefits for the composite kidney endpoint. Based on the additional benefits for the composite cardiovascular endpoint, as performing a cost-effectiveness analysis was appropriate, the ATAG examined the manufacturer's analysis. The manufacturer estimated the cost-effectiveness using the Markov model. Model parameters, such as the transition probability and treatment effect of finerenone, were estimated from the results of the FIDELITY analysis in the overall population. In the reanalysis by the ATAG, the HRs for treatment effects associated with the kidney endpoint in the model were revised to 1.0. Additionally, because previous epidemiological studies and the event rates in the FIDELITY analysis suggested that the risk of cardiovascular events in the Japanese population was lower than those in the United States and Europe, the cardiovascular risks were modified to include a 25% reduction from the values among the overall population of the FIDELITY analysis to avoid overestimating the cost-effectiveness of finerenone in the Japanese population. As a result, the ATAG's base-case analysis showed that finerenone incurred additional costs of JPY 386,067 and conferred an additional 0.054 quality-adjusted life years (QALYs) compared to SoC. This resulted in an incremental cost-effectiveness ratio (ICER) of JPY 7,130,185 per QALY gained. In conclusion, for patients with chronic kidney disease in type 2 diabetes, the results of the ATAGfs analysis suggested that the ICERs for finerenone compared to SoC were likely to belong to the interval between JPY 5 and 7.5 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: 2024

URL for published report: https://c2h.niph.go.jp/en/results/C2H2206.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