The Critical Intersect of Regulations, Health Technology Assessment, and Drug Safety Assessments.

ABSTRACT

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.