Cancer Control Research, BC Cancer, Vancouver, BC, Canada.
Faculty of Health Sciences, Simon Fraser University, Vancouver, BC, Canada.
Expert Rev Pharmacoecon Outcomes Res. 2024 Dec;24(10):1115-1132. doi: 10.1080/14737167.2024.2388814. Epub 2024 Aug 11.
Next-generation sequencing (NGS) identifies genetic variants to inform personalized treatment plans. Insufficient evidence of cost-effectiveness impedes the integration of NGS into routine cancer care. The complexity of personalized treatment challenges conventional economic evaluation. Clearly delineating challenges informs future cost-effectiveness analyses to better value and contextualize health, preference-, and equity-based outcomes.
We conducted a scoping review to characterize the applied methods and outcomes of economic evaluations of NGS in oncology and identify existing challenges. We included 27 articles published since 2016 from a search of PubMed, Embase, and Web of Science. Identified challenges included defining the evaluative scope, managing evidentiary limitations including lack of causal evidence, incorporating preference-based utility, and assessing distributional and equity-based impacts. These challenges reflect the difficulty of generating high-quality clinical effectiveness and real-world evidence (RWE) for NGS-guided interventions.
Adapting methodological approaches and developing life-cycle health technology assessment (HTA) guidance using RWE is crucial for implementing NGS in oncology. Healthcare systems, decision-makers, and HTA organizations are facing a pivotal opportunity to adapt to an evolving clinical paradigm and create innovative regulatory and reimbursement processes that will enable more sustainable, equitable, and patient-oriented healthcare.
下一代测序(NGS)可识别遗传变异,为个性化治疗方案提供信息。由于成本效益证据不足,NGS 难以融入常规癌症治疗。个性化治疗的复杂性给传统的经济评估带来了挑战。明确界定挑战,为未来的成本效益分析提供信息,以更好地评估和理解健康、偏好和公平为基础的结果。
我们进行了范围界定审查,以描述肿瘤学中 NGS 经济评估的应用方法和结果,并确定了现有挑战。我们从 PubMed、Embase 和 Web of Science 中搜索到了自 2016 年以来发表的 27 篇文章。确定的挑战包括定义评估范围、管理证据局限性,包括缺乏因果证据、纳入偏好为基础的效用以及评估分布和公平影响。这些挑战反映了为 NGS 指导干预措施生成高质量的临床有效性和真实世界证据(RWE)的困难。
采用方法学方法并使用 RWE 开发全生命周期卫生技术评估(HTA)指南,对于在肿瘤学中实施 NGS 至关重要。医疗保健系统、决策者和 HTA 组织面临着一个关键的机会,可以适应不断发展的临床模式,并创建创新的监管和报销流程,从而实现更可持续、公平和以患者为中心的医疗保健。