OBJECTIVES: The purpose of this analysis was to evaluate the cost-effectiveness of nivolumab as an adjuvant treatment for adults suffering from melanoma with involvement of lymph nodes or metastatic disease, after having undergone complete resection from the Italian healthcare system.

METHODS: A three-state (recurrence-free, post-recurrence, death) partitioned survival de novo global cost-effectiveness model was adapted to the Italian context. The analysis compared nivolumab with observation (wait and watch approach) from the health-care payer perspective, over a 60-year time horizon.

An indirect treatment comparison based on patient-level data from CheckMate 238 and CA184-029 trials informed the efficacy of nivolumab and observation on recurrence free survival (RFS). Overall survival (OS) was modelled using an RFS/OS correlation equation supported by published literature.

Local data informed subsequent therapy distributions in the two arms. Drug acquisition, administration, monitoring, subsequent therapy, adverse events and end-of life costs were sourced from published prices, DRG Italian tariffs and literature. Utility values based on Italian EQ-5D tariffs were obtained from CheckMate 238 collected data. Three percent annual discount rates were applied for costs and benefits.

RESULTS: Nivolumab was associated with higher utility versus observation (11.35 QALY vs 7.66 QALY) and incremental costs (€143,324 for nivolumab vs €94,433 for observation), resulting in an ICUR of €13,273/QALY compared to observation. This suggests that nivolumab is a cost-effective treatment at current published prices.

CONCLUSIONS: Nivolumab is a cost-effective strategy for the adjuvant treatment of melanoma in Italy.