OBJECTIVES: The objective of this study was to assess the cost-effectiveness of nivolumab as an adjuvant treatment of adult patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, in Greece.

METHODS: A partitioned survival de novo global cost-effectiveness model was adapted to the Greek setting. The analysis was done from a healthcare payer perspective, over a 20-year time horizon. Recurrence-free survival (RFS) was estimated through an indirect treatment comparison (ITC) based on patient-level data from CheckMate 238 and CA184-029 clinical trials. Overall survival (OS) for nivolumab was modelled using a RFS/OS correlation equation based on an analysis using published literature.

Nivolumab was compared to observation (watch and wait), ipilimumab (10 mg/kg), pembrolizumab, high-dose interferon, low-dose interferon and dabrafenib plus trametinib. The ITC and a network meta-analysis were used for modelling clinical efficacy of those comparators not included in the CheckMate 238.

Utility values based on UK EQ-5D tariffs were derived from CheckMate 238 data. Information on drug acquisition, administration, monitoring, subsequent therapy and adverse events costs were sourced from published prices, literature review and clinical expert input. An annual discount rate of 3.5% was applied for both costs and effects. Input parameters’ uncertainty was tested in sensitivity analyses.

RESULTS: Nivolumab presents an incremental cost-utility ratio of €8,611, €4,405 and €521 per QALY gained when compared to observation, high-dose interferon and low-dose interferon, respectively. Nivolumab was dominant when compared with ipilimumab (10 mg/kg), dabrafenib plus trametinib and pembrolizumab.

CONCLUSIONS: Nivolumab has approximately 54.8% and 77.6% probability of being cost-effective treatment at a willingness to pay threshold of €10,000 and €12,000, respectively versus all comparators and 99% at a threshold of €34,000, which is lower than two times the GDP per capita in Greece.