成本效益评估:从西班牙参考中心的角度对下一代测序与单基因检测在转移性非小细胞肺癌患者分子诊断中的比较。
Cost-Effectiveness of Next-Generation Sequencing Versus Single-Gene Testing for the Molecular Diagnosis of Patients With Metastatic Non-Small-Cell Lung Cancer From the Perspective of Spanish Reference Centers.
发表日期:2023 Mar
作者:
Edurne Arriola, Reyes Bernabé, Rosario García Campelo, Michele Biscuola, Ana Belén Enguita, Fernando López-Ríos, Rafael Martínez, Laura Mezquita, Sarai Palanca, María Jesús Pareja, Jon Zugazagoitia, Natalia Arrabal, J Francisco García, David Carcedo, Enrique de Álava
来源:
BIOMEDICINE & PHARMACOTHERAPY
摘要:
本研究目的在于评估在西班牙参考中心中使用下一代测序(NGS)与单基因检测(SgT)检测晚期非小细胞肺癌(NSCLC)患者的遗传分子亚型和致癌标记的成本效益。研究采用决策树和分区生存模型相结合的联合模型。进行了两轮共识小组会议,以描述西班牙参考中心的临床实践,提供有关检测率、异常的患病率、反应时间和治疗路径的数据。治疗效能数据和效用价值从文献中获取。只包括来自西班牙数据库的直接成本(欧元,2022年)。考虑终身范围,因此考虑未来成本和效果的3%贴现率。进行了确定性和概率敏感性分析以评估不确定性。估计了有9,734名晚期NSCLC患者的目标人群。如果使用NGS代替SgT,则会发现1,873个更多的异常,并且可能有82个患者参加临床试验。从长期来看,使用NGS与SgT相比,为目标人群提供了1,188个额外的优化生命年(QALYs)。另一方面,在终身范围内,NGS与SgT相比的增量成本为21,048,580欧元(仅诊断阶段为1,333,288欧元)。所得到的增量成本效益比为25,895欧元每获得一个QALY,低于标准成本效益阈值。在西班牙参考中心中使用NGS诊断转移性NSCLC患者的分子诊断将是一种具有成本效益的策略,超过SgT。
The aim of this study was to assess the cost-effectiveness of using next-generation sequencing (NGS) versus single-gene testing (SgT) for the detection of genetic molecular subtypes and oncogenic markers in patients with advanced non-small-cell lung cancer (NSCLC) in the setting of Spanish reference centers.A joint model combining decision tree with partitioned survival models was developed. A two-round consensus panel was performed to describe clinical practice of Spanish reference centers, providing data on testing rate, prevalence of alterations, turnaround times, and treatment pathways. Treatment efficacy data and utility values were obtained from the literature. Only direct costs (euros, 2022), obtained from Spanish databases, were included. A lifetime horizon was considered, so a 3% discount rate for future costs and outcomes was considered. Both deterministic and probabilistic sensitivity analyses were performed to assess uncertainty.A target population of 9,734 patients with advanced NSCLC was estimated. If NGS was used instead of SgT, 1,873 more alterations would be detected and 82 more patients could potentially be enrolled in clinical trials. In the long term, using NGS would provide 1,188 additional quality-adjusted life-years (QALYs) in the target population compared with SgT. On the other hand, the incremental cost of NGS versus SgT in the target population was €21,048,580 euros for a lifetime horizon (€1,333,288 for diagnosis phase only). The obtained incremental cost-utility ratios were €25,895 per QALY gained, below the standard cost-effectiveness thresholds.Using NGS in Spanish reference centers for the molecular diagnosis of patients with metastatic NSCLC would be a cost-effective strategy over SgT.