Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Centre for Connected Care, Oslo University Hospital, Oslo, Norway.
Int J Technol Assess Health Care. 2020 Oct;36(5):481-485. doi: 10.1017/S0266462320000756. Epub 2020 Oct 28.
Early health technology assessment (HTA), which includes all methods used to inform industry and other stakeholders about the potential value of new medical products in development, including methods to quantify and manage uncertainty, has seen many applications in recent years. However, it is still unclear how such early value assessments can be integrated into the technology innovation process. This commentary contributes to the discussion on the purposes early HTA can serve. Similarities and differences in the perspectives of five stakeholders (i.e., the hospital, the patient, the assessor, the medical device industry, and the policy maker) on the purpose, value, and potential challenges of early HTA are described. All five stakeholders agreed that integrating early HTA in the innovation process has the possibility to shape and refine an innovation, and inform research and development decisions. The early assessment, using a variety of methodologies, can provide insights that are relevant for all stakeholders but several challenges, for example, feasibility and responsibility, need to be addressed before early HTA can become standard practice. For early evaluations to be successful, all relevant stakeholders including patients need to be involved. Also, nimble, flexible assessment methods are needed that fit the dynamics of medical technology. Best practices should be shared to optimize both the innovation process and the methods to perform an early value assessment.
早期卫生技术评估（HTA）包括所有用于向行业和其他利益相关者通报新开发的医疗产品潜在价值的方法，包括量化和管理不确定性的方法，近年来已经得到了广泛应用。然而，目前尚不清楚如何将此类早期价值评估纳入技术创新过程。本文述评有助于讨论早期 HTA 可以发挥的作用。描述了五个利益相关者（即医院、患者、评估者、医疗器械行业和政策制定者）对早期 HTA 的目的、价值和潜在挑战的看法，即相似点和不同点。所有五个利益相关者都认为，将早期 HTA 纳入创新过程有可能塑造和完善创新，并为研发决策提供信息。早期评估使用各种方法，可以提供对所有利益相关者都相关的见解，但需要解决一些挑战，例如可行性和责任问题，然后早期 HTA 才能成为标准做法。为了使早期评估取得成功，包括患者在内的所有相关利益相关者都需要参与。此外，还需要灵活、适应性强的评估方法，以适应医疗技术的动态性。应分享最佳实践，以优化创新过程和进行早期价值评估的方法。
