Abstract

Nivolumab in combination with ipilimumab (NIVO+IPI) is the first immuno-oncology combination to demonstrate significant, long-term overall survival (OS) benefit in previously untreated patients with intermediate- to poor-risk advanced renal cell carcinoma (1L RCC) compared with standard of care (sunitinib). The objective of this study was to assess the cost-effectiveness of NIVO+IPI compared with sunitinib in 1L RCC from the French all payers perspective. A three-state partitioned survival model (progression-free disease, progressed disease and death) was developed with a one-week cycle length and lifetime time horizon. The model used patient characteristics, progression-free survival, OS, safety data and utilities (EQ-5D-3L) from the CheckMate-214 trial (NCT02231749). French costs for drug acquisition, drug administration, monitoring, terminal care, travel and adverse events were sourced from published prices. Treatment-specific utilities were calculated using the French value set. Costs and outcomes were discounted by 4.0% annually. Univariate deterministic and multivariate probabilistic sensitivity analyses (DSA, PSA) assessed robustness of the results. Outcomes of interest were total costs, quality-adjusted life-years (QALYs), life years (LYs), the incremental cost-utility ratio (ICUR), and the incremental cost-effectiveness ratio (ICER). NIVO+IPI was associated with higher total QALYs and LYs (3.53 and 4.95) versus sunitinib (2.71 and 3.87) and increased total cost (€160,751 versus €86,596), all respectively. This resulted in an ICUR of €89,793/QALY gained and an ICER of €68,626/LY gained versus sunitinib. Based on the DSA, key model drivers were drug acquisition costs, QALY discount rate, and variation of OS function parameters (95% confidence interval). The PSA confirmed robustness of the model results, with NIVO+IPI having a 62% probability of being cost-effective at a willingness-to-pay (WTP) threshold of €100,000/QALY. Driven by an increased and sustained OS benefit, NIVO+IPI would be a cost-effective treatment when compared with sunitinib for 1L RCC patients in France at a WTP threshold of €100,000/QALY.

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