背景:抗体-药物缀合物最近已被引入作为晚期尿路上皮癌的治疗方法。EV-301研究表明,与常规化疗相比,enfortumabvedotin(EV)改善了总体生存率。从支付者的角度评估EV在中高收入国家治疗晚期尿路上皮癌(UC)的成本效益。
方法:开发了一个决策分析模型来评估EV作为疾病进展后的后续一线治疗在已经接受PD-1或PD-L1抑制剂治疗的晚期尿路上皮癌患者中的疗效和经济可行性。从已发表的文献和可用的数据库获得临床和效用值。成本数据是从美国的付款人角度获得的,英国,和中国。使用质量调整生命年(QALYs)来衡量健康结果,以及用于与美国的支付意愿相比评估成本效益的增量成本效益比(ICER),英国,和中国。进行了单向敏感性分析和概率敏感性分析以评估模型的鲁棒性。
结果:与化疗相比,EV将收益增加了0.16-0.17个QALYs,在美国,每个QALY的ICER为2,168,746.71美元,2,164,494.38美元和1,775,576.56美元,英国,和中国,分别。单向敏感性分析表明,对结果的最大影响是无进展生存期的效用值。概率敏感性分析表明,EV具有成本效益的概率为0%。
结论:EV为晚期尿路上皮癌患者提供了超过化疗的额外健康益处,但在美国,从支付者的角度来看,EV并不具有成本效益。英国,或者中国。
BACKGROUND: Antibody-drug conjugates have recently been introduced as a treatment for advanced urothelial carcinoma. The EV-301 study demonstrated that enfortumab vedotin (EV) improved overall survival compared with conventional chemotherapy. To assess the cost-effectiveness of EV for the treatment of advanced urothelial carcinoma (UC) from a payer perspective in middle- and high-income countries.
METHODS: A decision analysis model was developed to assess the efficacy and economic viability of EV as a subsequent-line treatment following disease progression in patients with advanced urothelial carcinoma already treated with PD-1 or PD-L1 inhibitors. Clinical and utility values were obtained from the published literature and available databases. Cost data were obtained from payer perspectives in the United States, United Kingdom, and
China. Quality-adjusted life-years (QALYs) were used to measure health outcomes, and incremental cost-effectiveness ratios (ICERs) used to evaluate cost-effectiveness in comparison to willingness-to-pay in the United States, United Kingdom, and
China. One-way sensitivity analysis and probabilistic sensitivity analysis were performed to assess the robustness of the model.
RESULTS: Compared with chemotherapy, EV increased the benefit by 0.16-0.17 QALYs, resulting in ICERs of $2,168,746.71, $2,164,494.38, and $1,775,576.56 per QALY in the United States, United Kingdom, and
China, respectively. One-way sensitivity analysis indicated that the largest effect on outcome was the utility value for progression-free survival. Probabilistic sensitivity analysis demonstrated that the probability of EV being cost-effective was 0%.
CONCLUSIONS: EV provides an additional health benefit over chemotherapy for patients with advanced urothelial carcinoma but is not cost-effective from a payer perspective in the United States, United Kingdom, or
China.