Nivolumab plus ipilimumab (nivolumab+ipilimumab) is the first immuno-oncology combination that has shown significant, long-term overall survival (OS) benefit for the first-line treatment of adult patients with intermediate- or poor-risk advanced renal cell carcinoma (1L RCC) compared with standard of care (sunitinib). This study assessed the cost-effectiveness of nivolumab+ipilimumab versus sunitinib in 1L RCC patients in Spain. A three-state partitioned survival model was developed (progression-free, progressed disease and death) with a lifetime horizon (40 years) and one-week cycle length. Progression-free survival, OS, time to treatment discontinuation, adverse event and treatment-specific utility data (EQ-5D-3L) was obtained from CheckMate-214 (NCT02231749; 30 months minimum follow-up). Spanish costs for adverse events and drug acquisition were obtained from Isla (2017) and CGCOF, respectively. Costs for drug administration, monitoring and subsequent therapies were taken from ESALUD (2018) ; associated resource use was based on CheckMate-214 and obtained through clinical expert input. An annual discount of 3.0% was applied to both costs and outcomes. Outcomes of interest were total costs, life years (LYs), quality-adjusted life-years (QALYs), and the incremental cost-utility ratio (ICUR). Furthermore, deterministic and probabilistic sensitivity analyses (DSA and PSA) were assessed for robustness of the results. Nivolumab+ipilimumab was associated with higher QALYs versus sunitinib (4.86 versus 3.54, respectively) at increased total cost (€142,450 versus €104,085, respectively). This resulted in an ICUR of €29,146/QALY versus sunitinib. Based on the DSA, the key ICUR drivers were the proportion of patients receiving treatment after sunitinib and the maximum treatment duration for nivolumab+ipilimumab. The model’s robustness was further confirmed by the PSA; nivolumab+ipilimumab had a 54% and 95% probability of being cost-effective at willingness-to-pay thresholds of €30,000/QALY and €50,000/QALY, respectively. Driven by the increased and sustained OS benefit demonstrated in CheckMate-214, nivolumab+ipilimumab is a cost-effective treatment when compared to sunitinib for 1L RCC patients in Spain, considering a willingness-to-pay of €30,000/QALY.
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