Data Science Center, Fu Jen Catholic University, No. 510, Zhongzheng Rd., Xinzhuang Dist., New Taipei City, 242062, Taiwan, R.O.C.
Health Outcomes and Technology Teaching and Education Alliance, Taipei City, Taiwan, R.O.C.
Drug Saf. 2024 Apr;47(4):289-299. doi: 10.1007/s40264-023-01386-1. Epub 2023 Dec 19.
Health technology assessment (HTA) is a multidisciplinary process that determines the value of health technology at different points in its lifecycle. Safety issues have become more important since regulatory authorities are increasingly adopting flexible standards, processes, and evidentiary requirements for drug approval. In this article, we compared the different role of regulatory authorities and HTA agencies. Additionally, the experience of regulatory-HTA collaboration for assessment and/or decision-making on safety issues in the lifecycle of a health technology is illustrated, including olmesartan (angiotensin II receptor antagonist) and the direct-acting hepatitis C virus (HCV) antiviral agents. Post-licensing data can be derived from various sources such as electronic health records, medical claims, drug and disease registries, post-authorization safety studies (PASS) or post-authorization safety efficacy studies (PAES), periodic benefit-risk assessment reports, as well as HTA reassessment reports, which incorporate utilization information from patients in a real-world setting and provide crucial evidence for various purposes. With the ongoing accumulation of safety and efficacy information during post-regulatory approval, a standardized process for continuous data collection and active reassessment of risk and benefit becomes crucial for managing the lifecycle of health technologies. In order to define evidence requirements clearly, reduce uncertainty, and minimize delays in HTA approval, early engagement and collaboration of HTA agencies in the regulatory review processes have become more common. However, there is currently limited interaction and collaboration between regulatory authorities and HTA agencies. This article aims to identify the challenges faced by regulators and HTA agencies today, emphasizing the significance of conducting regulatory reviews and health technology assessments throughout a technology's lifecycle, underlining the value of utilizing real-world data and evidence, and emphasizing the necessity of enhancing collaboration between regulatory authorities and HTA agencies, all within the overarching context of drug safety.
卫生技术评估（HTA）是一个多学科的过程，它确定了卫生技术在其生命周期的不同阶段的价值。由于监管机构对药物批准采用了更加灵活的标准、程序和证据要求，安全性问题变得更加重要。在本文中，我们比较了监管机构和 HTA 机构的不同作用。此外，还说明了监管机构-HTA 合作在卫生技术生命周期中的评估和/或决策安全性问题方面的经验，包括奥美沙坦（血管紧张素 II 受体拮抗剂）和直接作用的丙型肝炎病毒（HCV）抗病毒药物。上市后数据可以来自各种来源，如电子健康记录、医疗索赔、药物和疾病登记、上市后安全性研究（PASS）或上市后安全性疗效研究（PAES）、定期获益风险评估报告，以及 HTA 重新评估报告，这些报告纳入了现实环境中患者的使用信息，并为各种目的提供了重要证据。随着监管后安全性和疗效信息的不断积累，建立一个标准化的持续数据收集和主动评估风险和获益的过程对于管理卫生技术的生命周期变得至关重要。为了明确证据要求，降低不确定性，并最大限度地减少 HTA 批准的延迟，HTA 机构在监管审查过程中的早期参与和合作变得更加常见。然而，监管机构和 HTA 机构之间目前的互动和合作有限。本文旨在确定监管机构和 HTA 机构目前面临的挑战，强调在技术生命周期内进行监管审查和卫生技术评估的重要性，强调利用真实世界数据和证据的价值，并强调加强监管机构和 HTA 机构之间的合作的必要性，所有这些都在药物安全的总体背景下进行。
