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.
Keywords: cost-effectiveness analysis; nivolumab; urothelial carcinoma.
Evaluating the cost-effectiveness of nivolumab and chemotherapy for advanced bladder cancer treatment Our study compared a cancer treatment called nivolumab-combination with the standard chemotherapy called gemcitabine-cisplatin for people with a type of cancer called “urothelial carcinoma” that has spread or cannot be removed by surgery. We found that while nivolumab-combination slightly improves quality and length of life, it’s much more expensive. We calculated a number called the “ICER” to help us decide if the extra cost is worth it. The ICER was much higher than what we usually consider a good value, which is $100,000 per extra year of good health. We also discovered that the high drug cost of nivolumab affected the cost-effectiveness most. If all drug prices were like in the UK or Australia, the treatment could be affordable. In short, based on our analysis, nivolumab-combination wasn’t a cost-effective first-line treatment for this cancer from a U.S. healthcare payer’s viewpoint, especially considering the $100,000/QALY threshold. This highlights the need for negotiation on drug pricing and health policy to improve access to affordable treatments.
© The Author(s), 2024.