Cost-Effectiveness of Adjuvant Nivolumab in Adults With High-Risk Muscle-Invasive Urothelial Carcinoma (MIUC) With Tumor Cell-Pd-L1-Expression ≥ 1% in Austria

OBJECTIVES: One of the most common malignant tumors is urinary bladder carcinoma which accounts for approximately 3%-4% of all malignant cancers. MIUC is a subtype of urinary bladder carcinoma. Standard-of-care treatment for most patients with MIUC are radical cystectomy and associated lymph node resection. The aim of this analysis was to evaluate the cost-effectiveness of adjuvant nivolumab versus observation in adult MIUC patients with tumor cell-PD-L1-expression ≥ 1% and with a high risk of recurrence after radical resection of MIUC in Austria.

METHODS: A three health-state (disease free, recurrent, and death) Markov cohort model with a lifetime horizon of 30 years and a cycle length of seven days was adapted to the Austrian context. Clinical data were taken from CheckMate 274, a phase 3 clinical trial. Resource utilization and direct costs (2024 €) were derived from published sources using the Austrian payer’s perspective. A willingness-to-pay threshold of 40,000€ per quality-adjusted life-year (QALY) gained was incorporated. Deterministic and probabilistic sensitivity analyses (PSA) were performed. Costs were discounted at 5%, while QALYs and life-years (LYs) were discounted at 3% annually.

RESULTS: Base case cost over a lifetime horizon for nivolumab and observation were 90,859€ and 46,486€, respectively, leading to incremental cost of nivolumab of 44,373€. Compared to observation, nivolumab was associated with an incremental gain of 2.11 QALYs (6.79 versus 4.68). This led to an incremental cost-utility ratio of 21,046€. In a Monte Carlo PSA with 1,000 second-order simulations, nivolumab versus observation was cost-effective in approximately 92% of all cases.

CONCLUSIONS: In Austria, adjuvant nivolumab in adult MIUC patients with tumor cell-PD-L1-expression ≥ 1% and with a high risk of recurrence after radical resection of MIUC is a cost-effective therapy option which leads to a significantly longer disease-free survival compared to observation.