OBJECTIVES: We estimated the economic impact of incorporating nivolumab plus ipilimumab into the list of reimbursed medications for treating intermediate and poor-risk aRCC by Costa Rica's social security system. Immunotherapy (IO) has significantly improved survival rates and quality of life versus sunitinib for the treatment of aRCC. Nivolumab plus ipilimumab represents the first and only IO combination demonstrating sustained clinical benefits in first-line treatment.

METHODS: We constructed a budget impact model (BIM) with a 5-year time horizon, considering progressive market share rates across intermediate and poor-risk groups. Additionally, we performed a cost-effectiveness analysis (CEA) comparing nivolumab plus ipilimumab (Intervention) versus pembrolizumab plus axitinib (Comparator) in intermediate and poor-risk aRCC using a 3-state Markov model. We included deterministic and probabilistic sensitivity analyses.

RESULTS: For an estimated first-line IO candidate population of 275 in the BIM, the inclusion of nivolumab plus ipilimumab would result in a budget impact of USD 26.3 million within the defined horizon. This represents a reduction in spending of USD 9.7 million compared with the current scenario. In the CEA "base case," nivolumab plus ipilimumab and pembrolizumab plus axitinib showed an increase in quality-adjusted life-years (QALYs) of 4.06 and 3.40, respectively, with average treatment costs of USD 149,429 and USD 231,226. The incremental cost-effectiveness ratio (ICER) favored nivolumab plus ipilimumab (-129,935 USD/QALY). In the deterministic sensitivity analysis, the "nivolumab plus ipilimumab response rate" parameter exhibited the greatest variability. The probabilistic analysis indicated a 0.98 probability of nivolumab plus ipilimumab being cost-effective, with a willingness-to-pay threshold of 1 GDP (13,365.36 USD)/capita. On the other hand, higher QALYs and lower cost would allow for a nivolumab plus ipilimumab dominates pembrolizumab plus axitinib statement.

CONCLUSIONS: Nivolumab plus ipilimumab represents a cost-saving option for 1L aRCC treatment and a cost-effective regimen for patients with intermediate and poor-risk aRCC in Costa Rica.