Abstract
The anti-PD1 nivolumab, as monotherapy, is indicated for adjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. We conducted a cost-utility analysis with the objective of evaluating nivolumab efficiency in France. A 3-state partitioned survival model, comprising recurrence-free survival (RFS), post-recurrence survival and death simulated a cohort of French patients within the adjuvant indication over 20 years. Standard recommended comparators, matching the population of indication, were observation and low dose interferon (LD-IFN). The model used clinical data from pivotal phase III trial Checkmate 238 comparing nivolumab to ipilimumab. Ipilimumab, not approved for adjuvant treatment of melanoma in Europe, was used as connecting strategy within the network meta-analysis used to estimate relative efficacy of nivolumab versus comparators. RFS and overall survival (OS) were extrapolated with parametric distributions using as reference the placebo arm from study CA184-029. As OS data is not available in CheckMate 238 to date, a predictive model based on RFS-OS correlation equation was used; as scenario, nivolumab OS was conservatively assumed equivalent to ipilimumab OS in CA184-029. Utilities were derived from EQ-5D data collected in Checkmate 238. Costs consisted of acquisition and administration, monitoring, subsequent therapies, palliative care, adverse events and transportation. Costs for active treatments were based on drug public prices. In both base case and conservative scenarios, nivolumab respectively resulted in a discounted total of 9.62 and 8.47 life-years and 7.76 and 6.97 quality-adjusted life years (QALY). The efficiency frontier consisted of observation, LD-IFN and nivolumab. The incremental cost-utility ratio (ICUR) of nivolumab was respectively 34,620 €/QALY and 68,928 €/QALY versus LD-IFN (incremental costs: 44,992 € and 35,667 €, incremental QALY: 1.30 and 0.52). Using two different scenarios, this analysis suggested that nivolumab was a cost-effective strategy as adjuvant treatment of adults with melanoma in France.
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