OBJECTIVES: Patients with recurrent cervical cancer have a poor response to standard chemotherapy. Although cemiplimab, new anti-PD-1 drug, showed superiority over chemotherapy in improving overall survival, its cost-effectiveness is not necessarily clarified. This study aimed to evaluate the cost-effectiveness of cemiplimab for recurrent cervical cancer from the payer’s perspective in Japan.

METHODS: A partitioned survival analysis model was developed to predict costs and quality-adjusted life years (QALYs) in cemiplimab and chemotherapy group. Survival data were derived from the Phase-3 RCT. Drug prices for cemiplimab were estimated based on foreign prices. Cost parameters other than drug cost were estimated by using the JMDC claims database. Utilities were derived from previous studies. Lifetime horizon and discount rate of 2% was applied. The incremental cost-effectiveness ratio (ICER) of cemiplimab compared with chemotherapy was estimated. Sensitivity analyses were performed to assess heterogeneity and parameter uncertainty.

RESULTS: Cemiplimab incurred an additional cost of 12,476,074 and conferred an additional 0.581 QALY. This resulted in the ICER of 21,472,662 per QALY gained. Subgroup analyses showed the ICER was JPY20,554,164/QALY and JPY19,647,357/QALY in squamous-cell carcinoma and adenocarcinoma, respectively. Deterministic sensitivity analysis indicated that Utility of cemiplimab in progression state had the greatest impact on base case. The ICER ranged from JPY17,853,048 to JPY21,842,638/QALY. The ICERs remained higher than JPY15 million/QALY over the full range of model parameters.

CONCLUSIONS: Applying the willingness to pay threshold of JPY15 million/QALY, cemiplimab therapy was not cost-effective. Further research is required on utilities of Japanese patients with recurrent cervical cancer.