Chair of Healthcare Management and Health Services Research, University of Bayreuth, Parsifalstraße 25, 95445, Bayreuth, Germany.
Medical Clinic A, Haematology, Haemostaseology, Oncology and Pulmonology, University Hospital Münster, Albert-Schweitzer-Campus 1, 48149, Münster, Germany.
J Cancer Res Clin Oncol. 2023 Apr;149(4):1495-1511. doi: 10.1007/s00432-022-04034-w. Epub 2022 May 9.
Targeted therapies are effective therapeutic approaches in advanced stages of NSCLC and require precise molecular profiling to identify oncogenic drivers. Differential diagnosis on a molecular level contributes to clinical decision making. Liquid biopsy (LB) use has demonstrated its potential to serve as an alternative to tissue biopsy (TB) particularly in cases where tissue sampling is not feasible or insufficient. We aimed at evaluating the cost-effectiveness of ctDNA-based LB use (molecular multigene testing) according to German care guidelines for metastatic NSCLC.
A Markov model was developed to compare the costs and clinical benefits associated with the use of LB as an add-on to TB according to the guidelines for NSCLC patients. Usual care TB served as comparator. A microsimulation model was used to simulate a cohort of non-squamous NSCLC patients stage IV. The parameters used for modelling were obtained from the literature and from the prospective German CRISP registry ("Clinical Research platform Into molecular testing, treatment, and outcome of non-Small cell lung carcinoma Patients"). For each pathway, average direct medical costs, and QALYs gained per patient were used for calculating incremental cost-effectiveness ratios (ICER).
The use of LB as an add-on was costlier (€144,981 vs. €144,587) but more effective measured in QALYs (1.20 vs. 1.19) for the care pathway of NSCLC patients (ICER €53,909/QALY). Cost-effectiveness was shown for EGFR-mutated patients (ICER €-13,247/QALY).
Including LB as an add-on into the care pathway of advanced NSCLC has positive clinical effects in terms of QALYs accompanied by a moderate cost-effectiveness.
靶向治疗是晚期 NSCLC 的有效治疗方法，需要精确的分子谱分析来确定致癌驱动因素。分子水平的鉴别诊断有助于临床决策。液体活检（LB）的应用已证明其作为组织活检（TB）替代方法的潜力，尤其是在组织采样不可行或不足的情况下。我们旨在根据德国转移性 NSCLC 护理指南评估基于 ctDNA 的 LB （分子多基因检测）的成本效益。
开发了一个马尔可夫模型，以根据 NSCLC 患者的指南，比较根据指南将 LB 作为 TB 的附加手段使用的成本和临床效益。常规 TB 作为对照。使用微模拟模型来模拟非鳞状 NSCLC 患者 IV 期的队列。用于建模的参数是从文献和前瞻性德国 CRISP 登记处（“非小细胞肺癌患者的临床研究平台，进入分子检测、治疗和结局”）中获得的。对于每个途径，使用每位患者的平均直接医疗成本和 QALYs 来计算增量成本效益比（ICER）。
LB 作为附加手段的使用（€144981 对 €144587）更昂贵，但在 NSCLC 患者的护理途径中，在 QALYs 方面（1.20 对 1.19）更有效（ICER €53909/QALY）。在 EGFR 突变患者中显示出成本效益（ICER €-13247/QALY）。
将 LB 作为晚期 NSCLC 护理途径的附加手段纳入具有积极的临床效果，在 QALYs 方面具有适度的成本效益。
