Diaceutics PLC, Belfast, UK.
Queen's Management School, Queen's University Belfast, UK.
Mol Oncol. 2021 Oct;15(10):2672-2687. doi: 10.1002/1878-0261.13038. Epub 2021 Jul 19.
Precision diagnostic testing (PDT) employs appropriate biomarkers to identify cancer patients that may optimally respond to precision medicine (PM) approaches, such as treatments with targeted agents and immuno-oncology drugs. To date, there are no published systematic appraisals evaluating the cost-effectiveness of PDT in non-small-cell lung cancer (NSCLC). To address this gap, we conducted Preferred Reporting Items for Systematic Reviews and Meta-Analyses searches for the years 2009-2019. Consolidated Health Economic Evaluation Reporting Standards were employed to screen, assess and extract data. Employing base costs, life years gained or quality-adjusted life years, as well as willingness-to-pay (WTP) threshold for each country, net monetary benefit was calculated to determine cost-effectiveness of each intervention. Thirty-seven studies (50%) were included for analysis; a further 37 (50%) were excluded, having failed population-, intervention-, comparator-, outcomes- and study-design criteria. Within the 37 studies included, we defined 64 scenarios. Eleven scenarios compared PDT-guided PM with non-guided therapy [epidermal growth factor receptor (EGFR), n = 5; programmed death-ligand 1 (PD-L1), n = 6]. Twenty-eight scenarios compared PDT-guided PM with chemotherapy alone (anaplastic lymphoma kinase, n = 3; EGFR, n = 17; PD-L1, n = 8). Twenty-five scenarios compared PDT-guided PM with chemotherapy alone, while varying the PDT approach. Thirty-four scenarios (53%) were cost-effective, 28 (44%) were not cost-effective, and two were marginal, dependent on their country's WTP threshold. When PDT-guided therapy was compared with a therapy-for-all patients approach, all scenarios (100%) proved cost-effective. Seven of 37 studies had been structured appropriately to assess PDT-PM cost-effectiveness. Within these seven studies, all evaluated scenarios were cost-effective. However, 81% of studies had been poorly designed. Our systematic analysis implies that more robust health economic evaluation could help identify additional approaches towards PDT cost-effectiveness, underpinning value-based care and enhanced outcomes for patients with NSCLC.
精准诊断检测（PDT）采用适当的生物标志物来识别可能对精准医学（PM）方法（如靶向药物和免疫肿瘤学药物治疗）产生最佳反应的癌症患者。迄今为止，尚无已发表的系统评价评估 PDT 在非小细胞肺癌（NSCLC）中的成本效益。为了解决这一差距，我们对 2009 年至 2019 年的文献进行了系统评价和荟萃分析的首选报告项目搜索。采用综合健康经济评估报告标准进行筛选、评估和提取数据。使用基本成本、获得的生命年或调整后的生命年，以及每个国家的意愿支付（WTP）阈值，计算净货币收益以确定每种干预措施的成本效益。有 37 项研究（50%）被纳入分析；另外 37 项研究（50%）因不符合人群、干预、比较、结果和研究设计标准而被排除在外。在纳入的 37 项研究中，我们定义了 64 种情况。11 种情况比较了 PDT 指导的 PM 与非指导治疗[表皮生长因子受体（EGFR），n=5；程序性死亡配体 1（PD-L1），n=6]。28 种情况比较了 PDT 指导的 PM 与单独化疗（间变性淋巴瘤激酶，n=3；EGFR，n=17；PD-L1，n=8）。25 种情况比较了 PDT 指导的 PM 与单独化疗，同时改变 PDT 方法。34 种情况（53%）具有成本效益，28 种情况（44%）不具有成本效益，两种情况（3%）取决于其国家的 WTP 阈值。当 PDT 指导的治疗与所有患者治疗方法进行比较时，所有情况（100%）均具有成本效益。37 项研究中有 7 项研究结构合理，可用于评估 PDT-PM 的成本效益。在这 7 项研究中，所有评估的情况均具有成本效益。然而，81%的研究设计不佳。我们的系统分析表明，更有力的健康经济评估可以帮助确定 PDT 成本效益的其他方法，为非小细胞肺癌患者提供基于价值的护理和改善的结果。
