Shiraiwa Naoko, Kano Shingo
Graduate School of Frontier Sciences, The University of Tokyo, Department of Medical Informatics and Biosciences, Bio-innovation Policy, Japan.
Heliyon. 2024 Sep 19;10(19):e37867. doi: 10.1016/j.heliyon.2024.e37867. eCollection 2024 Oct 15.
To clarify the cost-effectiveness of comprehensive diagnosis and treatment of metastatic non-small cell lung cancer in Japan, from initial diagnosis to post-standard treatment, using three different strategies.
A decision tree was created using three diagnostic and treatment strategies, assuming that Foundation One CDx (F1CDx), a comprehensive genome panel, was introduced in Japan in June 2019. This comprehensive decision tree includes Markov models, cost-effectiveness analyses (CEA), and cost-utility analyses (CUA) of the three strategies from the perspective of Japanese payers. Specifically, Strategy1 involves single-gene testing at the initial diagnosis and F1CDx after standard treatment; Strategy2 involves only single-gene testing at the initial diagnosis; Strategy3 involves F1CDx at the initial diagnosis. The incremental cost-effectiveness ratios (ICERs) of the three strategies are estimated. Sensitivity analyses were performed to assess the uncertainty of the parameter settings.
Strategy3 was dominated for both CUA and CEA. The ICER/quality-adjusted life year (QALY) for Strategy2 versus Strategy1 was USD 13,734 (JPY 2,080,923, USD 1 = JPY 151.39 on April 1st, 2024), which is less than the willingness to pay of USD 45,900 (JPY 7,500,000), and Strategy2 was more cost-effective than Strategy1. F1CDx was not cost-effective compared to multiple simultaneous single tests at the initial diagnosis, either after standard treatment or at the initial diagnosis. Sensitivity analysis also showed that the most influential factor on the ICER for both CEA and CUA was treatment cost.
From both patient benefit and health economic perspectives, introducing F1CDx after standard treatment in June 2019 was not as cost-effective as multiple simultaneous single tests at the initial diagnosis but was more realistic from a health economic perspective than introducing F1CDx at the time of initial diagnosis. Therefore, the policy at the time of F1CDx introduction in Japan was appropriate from a short-term health-economic perspective.
采用三种不同策略，阐明日本转移性非小细胞肺癌从初始诊断到标准治疗后综合诊断和治疗的成本效益。
假设2019年6月在日本引入了全面基因组检测Foundation One CDx（F1CDx），使用三种诊断和治疗策略创建决策树。这个全面的决策树包括从日本医保支付方角度对这三种策略的马尔可夫模型、成本效益分析（CEA）和成本效用分析（CUA）。具体而言，策略1在初始诊断时进行单基因检测，标准治疗后进行F1CDx检测；策略2仅在初始诊断时进行单基因检测；策略3在初始诊断时进行F1CDx检测。估计这三种策略的增量成本效益比（ICER）。进行敏感性分析以评估参数设置的不确定性。
策略3在CUA和CEA中均占劣势。策略2与策略1相比的ICER/质量调整生命年（QALY）为13,734美元（2,080,923日元，2024年4月1日1美元 = 151.39日元），低于45,900美元（7,500,000日元）的支付意愿，且策略2比策略1更具成本效益。无论是在标准治疗后还是初始诊断时，与初始诊断时同时进行的多项单检测相比，F1CDx不具有成本效益。敏感性分析还表明CEA和CUA中对ICER影响最大的因素是治疗成本。
从患者获益和卫生经济学角度来看，2019年6月在标准治疗后引入F1CDx不如在初始诊断时同时进行多项单检测具有成本效益，但从卫生经济学角度比在初始诊断时引入F1CDx更现实。因此，从短期卫生经济学角度来看，日本引入F1CDx时的政策是合适的。
