Cost-effectiveness of nivolumab combined with chemotherapy as a first-line therapy for patients with unresectable or metastatic urothelial carcinoma.

BACKGROUND

Urothelial carcinoma is a significant health concern in the United States (US), with high mortality and economic burdens. The CheckMate-901 trial showed promising survival benefits for nivolumab combined with gemcitabine and cisplatin followed by nivolumab maintenance therapy (nivolumab-combination) as first-line treatment of unresectable or metastatic urothelial carcinoma (UC), but its cost-effectiveness is unclear.

OBJECTIVES

This study aimed to evaluate the cost-effectiveness of the nivolumab-combination versus standard chemotherapy (gemcitabine-cisplatin) for advanced UC from the perspective of healthcare payers in the US.

DESIGN

A model-based pharmacoeconomic evaluation.

METHODS

Based on the CheckMate-901 study, a three-state Markov model (progression-free, progression, and death) was developed to evaluate the cost-effectiveness of nivolumab-combination versus gemcitabine-cisplatin as a first-line treatment for unresectable or metastatic UC. The model's outputs included quality-adjusted life years (QALYs) and costs and were used to calculate the incremental cost-effectiveness ratio (ICER). Costs included drug prices, adverse event management, and healthcare resource utilization from a US healthcare payer's perspective. State utilities were derived from published literature. One-way sensitivity analysis and probabilistic sensitivity analysis were used to test model robustness. Scenario analyses for drug costs in the UK and Australian health systems were performed.

RESULTS

Compared with gemcitabine-cisplatin, the nivolumab-combination resulted in an additional 0.416 QALYs at an incremental cost of $90,523, yielding an ICER of $217,527 per QALY. Sensitivity analyses indicated significant impacts from the cost of nivolumab maintenance therapy.

CONCLUSION

Compared with gemcitabine-cisplatin, nivolumab-combination therapy is not cost-effective for unresectable or metastatic UC at a $100,000 per QALY threshold. High drug prices in the US significantly impact cost-effectiveness, highlighting the need for price negotiations and healthcare policy adjustments to balance innovation incentives and patient affordability.