OBJECTIVES: Nivolumab is the first immuno-oncology drug to demonstrate statistically significant improvement in disease-free survival for the adjuvant treatment of patients with muscle-invasive urothelial carcinoma (MIUC), who are at high risk of recurrence after undergoing radical resection, and who are at high risk of recurrence, compared to placebo (Checkmate 274). The objective of this study was to assess the cost-effectiveness of nivolumab vs surveillance, a proxy of placebo, in MIUC for patients with tumour cell PD-L1≥1% (expressed as tumor proportion score) in Greece.

METHODS: A 3-state (disease-free, recurrence, death) Markov model was used to conduct an analysis from the Greek healthcare system perspective, over a 30-year time horizon with a one-week cycle length. Patient characteristics, efficacy (for disease-free and recurrence), safety and utilities (EQ-5D-3L) were derived from CheckMate 274 or literature. Outcomes of interest were life-years (LYs), quality-adjusted (QALYs), and incremental cost-utility ratio (ICUR). Costs (€, cost year: 2022, Greek specific) and outcomes were discounted at a rate of 3.5%. Deterministic and probabilistic sensitivity analyses (DSA and PSA, respectively) and different scenarios (on modelling assumptions) were conducted to quantify uncertainty.

RESULTS: Nivolumab was associated with higher total LYs and QALYs, and increased costs (8.3, 6.7, and €48,658) vs surveillance (5.5, 4.4 and €27,834), all respectively. This resulted in an ICUR of €9,042/QALY gained. Most LYs and QALYs were observed in the DF health state for both nivolumab (94%) and surveillance (87%). All tested scenarios and inputs in the deterministic sensitivity analysis resulted in <20% changes from the base case ICUR. Probabilistic sensitivity analysis confirmed robustness of the model results (mean ICURs ~€9,400/QALY), with nivolumab having a 99.6 % probability of being cost-effective at a willingness-to-pay) threshold of €35,000/QALY gained.

CONCLUSIONS: Adjuvant treatment with nivolumab for MIUC is estimated to be life-extending and cost-effective compared with surveillance in Greece.