Abstract
The study aimed to assess, from the Spanish National Health System perspective, the incremental cost-effectiveness ratio (ICER) of nivolumab for the adjuvant treatment of adults with melanoma stage III-IV who have undergone complete resection compared to observation ipilimumab and high-dose interferon (HDI). In 28-day cycle length a partitioned survival model comprising recurrence-free, post-recurrence and death was used to estimate the lifetime accumulated cost and benefits in terms of quality-adjusted-life-years (QALYs). Recurrence-free survival (RFS) curves for nivolumab and ipilimumab derived from CheckMate-238. An indirect treatment comparison of CheckMate-238 and CA184-029 was used to estimate RFS for observation and a network meta-analysis (NMA) for HDI RFS. A correlation equation was used to generate nivolumab overall survival (OS) given RFS data. Observation and ipilimumab OS were taken from CA184-029 and HDI OS from the NMA. Subsequent treatments according to recurrence type and adjuvant treatment received were considered. Utilities reflected EQ-5D data from CheckMate-238. Total costs (expressed in €, year 2019 values) included drug cost (exfactory prices) and intravenous administration of adjuvant and subsequent treatments, health-state disease-management and end-of-life costs. A 3% annual discount rate was applied for cost and outcomes. Probabilistic sensitivity analyses (PSA) were performed. Nivolumab provided higher QALYs (11.38) than observation (7.70), ipilimumab (9.28) and HDI (8.21). The lifetime total costs accounted €143,051/patient with nivolumab, versus €98,663 with observation, €246,943 with ipilimumab and €134,621 with HDI. The ICER was €12,052/QALY gained with nivolumab versus observation, and €2,653/QALY versus HDI. Nivolumab resulted a dominant option compared to ipilimumab. In the PSA, 97% (vs observation) and 100% (vs ipilimumab and HDI) of the 1,000 simulations performed were below a €20,000/QALY gained willingness-to-pay-threshold. Nivolumab is a cost-effective option versus observation and HDI and a dominant option compared to ipilimumab for the adjuvant treatment of resected stage III-IV melanoma in Spain.
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