PS42: Recent Developments and Innovations in Health Technology Assessment

Health Technology Assessment (HTA) is an essential tool for evaluating the incremental value of healthcare technologies, including medications, medical devices, and prevention strategies, within the healthcare system. It incorporates medical, economic, social, and ethical dimensions to provide national health authorities with evidence-based information for informed decisions on reimbursement and pricing. While countries may have varying requirements, the fundamental principles of evidence-based decision-making in HTA remain largely consistent. This process involves synthesizing evidence from multiple sources, where statistical principles and approaches are essential to ensure valid evidence synthesis, highlighting the need for greater involvement from statisticians. To address this need, the American Statistical Association (ASA) Biopharmaceutical Section (BIOP) Health Technology Assessment (HTA) Scientific Working Group (SWG) has undertaken a global assessment of the HTA landscape. This is the first known cross-industry effort to systematically examine the evidence requirements of various HTA agencies and the design and analysis approaches for evidence generation. In this session, we will present insights from the HTA SWG Phase I work through three speakers: 1. The first speaker will provide a comprehensive review of the HTA framework, key guidance documents, and the diverse evidence needs of major health authorities. 2. The second speaker will focus on generating early HTA evidence through study designs and explore advanced statistical methodologies, such as indirect treatment comparisons, survival extrapolation, and treatment switching. 3. The third speaker will summarize the SWG's efforts, discuss challenges, opportunities and future work, and highlight areas where statisticians can play a critical role in developing robust and reliable assessments for healthcare decision-making. By the end of the session, the audience will have an overview of the HTA framework and requirements, an understanding of the importance of early evidence planning and generation for HTA, and insight into key concepts and methods for addressing complex HTA analytic needs.