OBJECTIVES: To assess the cost-effectiveness of nivolumab versus surveillance in Denmark for the adjuvant treatment of patients with muscle-invasive urothelial carcinoma (UC) with high risk of recurrence and tumor cell PD-L1 expression ≥ 1% who have undergone radical resection.

METHODS: A three-state (disease-free, recurrent, death) Markov model with a 20-year time horizon was developed from a limited societal perspective. Outcomes of interest were life-years (LYs), quality-adjusted LYs (QALYs), and incremental cost-utility ratios (ICURs). Patient characteristics, efficacy (disease-free survival) and safety (adverse event frequencies) data, and EQ-5D-5L health state utilities (mapped from the EQ-5D-3L in alignment with the Danish Medicines Council’s guidelines) were derived from the CheckMate 274 study. Postrecurrence outcomes were modelled as one-off total costs and QALYs based on the local shares of first-line therapies available for the treatment of metastatic UC in Denmark. Costs and long-term health outcomes associated with metastatic UC treatments were based on published duration of therapy and survival data or prior health technology appraisals reporting total estimated costs and QALYs. An annual discount rate of 3.5% was applied to costs and health outcomes. Deterministic, probabilistic sensitivity analyses, and scenario analyses were conducted to measure model robustness.

RESULTS: Nivolumab was associated with increased total LYs and QALYs and higher costs (8.14, 6.72, and DKK 928,773, respectively) versus surveillance (6.0, 4.89, and DKK 616,614, respectively). This resulted in an ICUR of DKK 170,871/QALY gained. All tested scenarios and varied inputs in the deterministic sensitivity analyses resulted in less than 15% and 30% changes from the base-case ICUR, respectively. Probabilistic sensitivity analyses confirmed the robustness of the model results (average ICUR DKK 170,595/QALY), with nivolumab having a 97% probability of being cost-effective at a willingness-to-pay threshold of DKK 500,000/QALY gained.

CONCLUSIONS: Nivolumab is estimated to be a life-extending and cost-effective adjuvant treatment for muscle-invasive UC in Denmark.