OBJECTIVES: Kidney cancer is the 14^th most common cancer worldwide. RCC is the most common malignancy in Kidney cancers accounting for 75-80% of all incidents. Pembrolizumab is reimbursed in the and metastatic setting of Renal Cell Carcinoma(RCC) in Greece,-further the European Association of Urology recommends Pembrolizumab for patients with a recurrence risk as defined in the Keynote-564 trial. This study aims to assess the cost-effectiveness of pembrolizumab for the adjuvant treatment of patients with RCC who have undergone nephrectomy in Greece.

METHODS: A markov cohort model with four health states (event-free, locoregional-recurrence, distant-metastasis, death) was adapted from a Greek payer perspective over a 45-year time horizon. Utility values, safety, and efficacy data applied in the model were extracted from the KEYNOTE-564 clinical trial. In the absence of Pembrolizumab reimbursement- the standard of care (SoC) for RCC patients who had undergone nephrectomy was observation- hence it was used as a comparator in this analysis. Primary outcomes were quality-adjusted life-years (QALYs), total costs and incremental cost-effectiveness ratios (ICER)s per QALY gained. Both costs and outcomes were discounted at 3.0% per-annum. Α Deterministic-Sensitivity-Analysis(DSA) was conducted to identify the input parameter’s impact on ICER and a probabilistic sensitivity analysis (PSA) to account for collective parameter’s uncertainty.

RESULTS: The total cost of Pembrolizumab and SoC, were €92,715 and €47,469 respectively. Pembrolizumab was more effective than SoC with 13.02 LYG compared to 11.14 LYG, which translated to 10.52 and 8.97 QALY’s respectively. Incremental LYG and QALY’s were 1.88 and 1.56, respectively. The ICER per LYG was €24,126 and €29,088 per QALY-gained versus SoC alone. The DSA indicated that the most influential parameters did not significantly change the analysis results. PSA confirmed the DSA results.

CONCLUSIONS: The present economic evaluation indicates that Pembrolizumab is a cost-effective option (under the 52,770€/QALY threshold) compared to observation in the adjuvant RCC setting in Greece.