国立保健医療科学院 保健医療経済評価研究センター
Center for Outcomes Research and EconomicEvaluation for Health (C2H), National Institute ofPublic Health (NIPH) | URL:https://c2h.niph.go.jp

March 13, 2024

[C2H2206] Summary of cost-effectiveness evaluationof finerenone (Kerendia®)
1. Indications
Chronic kidney disease in type 2 diabetes (except end-stage kidney disease anddialysis)
2. Price of the drug
Finerenone has been reimbursed since May 2022 at JPY 149.10 for 10 mg andJPY 213.10 for 20 mg (as of March 2024). The price was calculated based on acost-calculation method. This product was designated as an H1 cost-effectivenessevaluation item.
3. Scope of cost–effectiveness evaluation
This product is indicated for the treatment of chronic kidney disease in type 2diabetes. The scope of evaluation agreed upon at the first session of the Expert
Committee of Cost-Effectiveness Evaluation (ECCEE) is described below.
People with chronic kidney disease in type 2 diabetes (exceptPopulation

people with end-stage kidney disease and people receiving
dialysis)

Comparator
Other

Standard of care**ACE inhibitors or ARBs
The effectiveness of finerenone should be analyzed based ondata from the Japanese population as well.

4. Evaluation of additional benefits
The manufacturer performed a systematic review of randomized controlled trials(RCTs) and identified five trials. Of these, they used FIDELITY analysis, a pooledanalysis of RCTs (FIDELIO-DKD and FIGARO-DKD) that included Japanese people,
to evaluate additional benefits. They reported the results for the overall
population in the primary analysis. Given the uncertainties in the estimation, theresults for the Japanese population were reported as a scenario analysis(sensitivity analysis). Finerenone showed statistically significant efficacy for thecomposite cardiovascular endpoint and composite kidney endpoint in the overallpopulation; thereafter, the manufacturer insisted on the additional benefits offinerenone over the comparator in the overall population. Also in the Japanese
population, the hazard ratio (point estimate) for the composite cardiovascularendpoint (0.88 [95% CI: 0.52–1.49]) and composite kidney endpoint (0.9985[95% CI: 0.70–1.42]) in the finerenone group was estimated to be < 1. Therefore,
the manufacturer insisted on the additional benefits of finerenone over thecomparators in the Japanese population.
The academic group judged that the additional benefit should not be evaluatedindependently for the overall population and Japanese population but that theresults from both populations should be combined to determine additionalbenefits. The hazard ratio for the composite cardiovascular endpoint in thefinerenone group was estimated to be < 1 in both the overall and Japanese
populations *. Therefore, the academic group concluded that finerenone hasadditional benefits for the composite cardiovascular endpoint. In contrast, in theFIDELITY analysis, the academic group noted that the hazard ratio for thecomposite kidney endpoint was consistently ≥1 in the Japanese population (boththe composite kidney endpoint and its components). Additionally, in the FIDELITY
analysis, FIDELIO-DKD, and FIGARO-DKD trials, hazard ratios were consistently
higher in the Japanese population than in the overall population. Even in theFIDELIO-DKD trial, which set the composite kidney endpoint as the primary
endpoint, the hazard ratio for the composite kidney endpoint was 0.91. This
result may indicate that the treatment effect of finerenone is not necessarily
significant. Thus, the academic group could not determine from the available
evidence whether finerenone had additional benefits for the composite kidney
endpoint.
*The academic group interpreted HR=0.9985 for the composite kidney endpointin the Japanese population of the FIDELITY analysis as synonymous with HR=1.
5. Results of the cost-effectiveness analysis
The manufacturer estimated the cost-effectiveness using the Markov model.

Model parameters, such as the transition probability and effect of finerenone,
were estimated from the results of the FIDELITY analysis in the overall population.
Given that the academic group could not conclude whether finerenone has
additional benefits for the composite kidney endpoint in the currently available
evidence, hazard ratios for treatment effects associated with the kidney endpointin the model were revised to 1.0. Additionally, because previous epidemiologicalstudies and the event rates in the FIDELITY analysis suggest that the risk ofcardiovascular events in the Japanese population with chronic kidney disease islower than those in the United States and Europe, there was concern that thecost-effectiveness of finerenone would be overestimated in the Japanese
population. Therefore, cardiovascular risk factors were modified to include a 25%
reduction in values among the overall population in the FIDELITY analysis. The
value of 25% (correction coefficient: 0.75) was assumed to represent that "atleast the level of risk reduction is certain to exist". The ECCEE accepted thefollowing results:

Population

Comparator

People withAdditional benefit･ Cardiovascular endpoint:chronic kidneyStandard ofAdditional benefit

disease in type 2care･ Kidney endpoint:diabetes

ICER (JPY/QALY)

No additional benefit

7,130,185