Abstract

Nivolumab in combination with 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 compared with sunitinib in 1L RCC from a healthcare system perspective in Italy. A three-state partitioned survival model (progression-free disease, progressed disease, death) was developed with a 40-year time horizon and a one-week cycle length. Survival, adverse event, and treatment-specific utility (EQ-5D-3L) data were sourced from the CheckMate-214 trial (NCT02231749); survival was extrapolated over the model time horizon. Costs for adverse events, drug acquisition, drug administration, monitoring and subsequent therapies were obtained from the published literature, DRG tariffs and AIFA; while 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 effects. Outcomes of interest were total costs, life years (LYs), quality-adjusted life-years (QALYs), incremental cost-effectiveness ratio (ICER) and incremental cost-utility ratio (ICUR). Furthermore, as a confidential discount already applies in Italy for both nivolumab and ipilimumab, two scenarios investigated the required price reduction on nivolumab+ipilimumab to reach an ICUR of €30,000/QALY and €20,000/QALY. Nivolumab+ipilimumab was associated with higher total LYs and QALYs (5.66 LYs and 4.89 QALYs) versus sunitinib (4.32 LYs and 3.63 QALYs) at increased total cost (€115,095 versus €61,226, respectively). This resulted in an ICER of €40,143/LY and an ICUR of €42,521/QALY versus sunitinib. Price reduction of 9.91% and 30.06% for nivolumab+ipilimumab would be required to reach ICURs of €30,000/QALY and €20,000/QALY, respectively. Driven by the increased and sustained OS benefit seen in CheckMate-214, nivolumab+ipilimumab is cost-effective versus sunitinib for the treatment of previously untreated 1L RCC in Italy.

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