OBJECTIVES

: According to the results of Japanese HTA system, nivolumab monotherapy was not cost-effective for advanced renal-cell carcinoma (aRCC), but the combination of nivolumab plus ipilimumab (NIV+IPI) is increasingly being applied in clinical practice. The purpose of this analysis was to evaluate the cost-effectiveness of NIV+IPI for aRCC, comparing with sunitinib (SUN).

METHODS

: A partitioned survival model was developed to predict costs and quality-adjusted life years (QALYs) in NIV+IPI and SUN arms. Direct medical costs were considered from the perspective of the Japanese healthcare system. Time horizon and cycle length of the model was set to 42 years and 1 month, respectively. An annual discount rate of 2% for both costs and QALYs was applied. Data on overall survival and progression-free survival was derived from the long-term follow-up of CheckMate 214 trial. Cost parameters were estimated by using the JMDC, real world claims database in Japan. Utilities were derived from published sources other than Japan. The incremental cost-effectiveness ratio (ICER) of NIV+IPI compared with SUN was estimated. Sensitivity analysis was performed to assess heterogeneity and parameter uncertainty.

RESULTS

: Compared with SUN, NIV+IPI incurred an additional cost of USD 316,049 and conferred an additional 1.299 QALY. This resulted in the ICER of USD 243,385 per QALY gained. Subgroup analysis showed that International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate/poor (I/P)-risk and favorable (FAV)-risk groups had ICERs of USD 228,278 and 578,587 per QALY, respectively. Utilities for progression-free state had a relatively large impact on the base case result, but the ICERs remained higher than USD 150,000 per QALY over the full range of model parameters.

CONCLUSIONS

: Applying the willingness to pay threshold of USD 150,000 per QALY, NIV+IPI therapy might not be cost-effective even if in patients with I/P-risk. Further research is required on utilities of Japanese patients with aRCC.