Centre for Applied Health Economics, Griffith University, Nathan, Queensland, Australia.
Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia.
Pharmacol Res Perspect. 2021 Oct;9(5):e00862. doi: 10.1002/prp2.862.
The standard approach for dose individualization of chemotherapy in the oncology setting has long been based on body surface area (BSA) as a measure of body size. However, for many anticancer drugs, administration of dosages based on BSA may result in some patients receiving supratherapeutic or subtherapeutic concentrations due to substantial interindividual pharmacokinetic variability. Therapeutic drug monitoring (TDM)-guided dosing aims to ensure that the patient's serum drug concentration is in a target range which has been shown to produce optimal clinical outcomes. The management of several malignancies is now moving away from using traditional intravenous chemotherapy to longer-term treatment with targeted molecular therapies. These targeted anticancer drugs are currently dosed based on a fixed dose for all patients. The pharmacokinetic characteristics of most of these drugs (e.g., tyrosine-kinase inhibitors) support implementation of individualized dosing via TDM. However, prior to adopting TDM-guided dosing in oncology settings, the economic efficiency and value for money of introducing TDM interventions should be critically and systematically examined along with the impacts on patient care and outcomes. Yet, current evidence in this area is limited, and more generally, there is lack of methodological guidance on how to identify, estimate and value clinical and cost information necessary to conduct economic evaluations of TDM interventions. In this paper, we propose a coherent framework for conducting economic evaluation of TDM interventions in oncology settings and discuss some practical challenges of conducting economic evaluations of TDM.
长期以来，肿瘤学中化疗剂量个体化的标准方法一直基于体表面积（BSA）作为身体大小的衡量标准。然而，对于许多抗癌药物，基于 BSA 的剂量给药可能会导致一些患者由于个体间药代动力学的显著变异性而接受超治疗或亚治疗浓度。治疗药物监测（TDM）指导下的给药旨在确保患者的血清药物浓度处于已显示产生最佳临床结果的目标范围内。现在，几种恶性肿瘤的治疗方法正在从使用传统静脉化疗转变为长期的靶向分子治疗。这些靶向抗癌药物目前对所有患者均采用固定剂量给药。大多数这些药物（如酪氨酸激酶抑制剂）的药代动力学特征支持通过 TDM 进行个体化给药。然而，在肿瘤学环境中采用 TDM 指导下的给药之前，应该批判性和系统地检查引入 TDM 干预措施的经济效率和性价比，以及对患者护理和结果的影响。然而，该领域目前的证据有限，更普遍的是，缺乏关于如何确定、估计和评估 TDM 干预措施的经济评估所需的临床和成本信息的方法学指导。在本文中，我们提出了一个用于在肿瘤学环境中进行 TDM 干预经济评估的连贯框架，并讨论了进行 TDM 经济评估的一些实际挑战。
