TITLE: Recent Developments and Innovations in Health Technology Assessment
SPEAKERS: Weili He, AbbVIe and Xiang Zhang, CSL Behring
MODERATOR: Bill Wang
Abstract :
Health Technology Assessment (HTA) is crucial for evaluating clinical and economic (and sometimes humanistic) values of new healthcare technologies to the related healthcare system, including medications, devices, and prevention strategies. It provides national health authorities with evidence-based information for informed decisions on reimbursement and pricing relative to other marketed therapies. Despite varying country requirements, HTA’s core principles consistently highlight the importance of statisticians’ involvement. To address this need, the ASA Biopharmaceutical Section’s HTA Scientific Working Group (SWG) conducted a global assessment of the HTA landscape. In this session, we present insights from Phase I of the HTA SWG’s work. We will outline the HTA framework, explore its history, examine requirements of different HTA bodies, discuss consolidation of PICOs (Population, Intervention, Comparator, Outcome) under new EU HTA regulations, and highlight challenges and opportunities in HTA submissions, focusing on statisticians’ leadership roles in addressing these challenges and utilizing those opportunities. The tutorial’s second part will discuss early integration of HTA/payer needs in trial design to enhance the ability to generate fit-for-purpose evidence by identifying and addressing evidence gaps during study design, along with HTA methodologies for evaluating clinical effectiveness, cost-effectiveness, and quality of life of new health technologies.
Instructors’ Biography:
Dr. Weili He has over 25 years of experience working in the biopharmaceutical industry. She is currently a Distinguished Research Fellow and head of Medical Affairs and Health Technology Assessment (HTA) statistics at AbbVie. She has a PhD in Biostatistics. Weili’s areas of expertise span across clinical trials, real-world studies and evidence generations, statistical methodologies in clinical trials, observational research, innovative adaptive designs, and benefit-risk assessment. She is the lead or co-author of more than 60 peer-reviewed publications in statistics or medical journals and lead editor of three books on adaptive design, benefit-risk assessment, and RWE, respectively. She is the co-founder and co-chair of the American Statistical Association (ASA) Biopharmaceutical Section (BIOP) Real-world Evidence Scientific Working Group (SWG) from 2018 to 2022. She is also the founder and co-chair of a newly formed ASA BIOP HTA SWG. Weili is the BIOP Chair-Elect, Chair, and Past Chair from 2020-2022. She is also an Associate Editor of Statistics in Biopharmaceutical Research since 2014, and an elected Fellow of ASA since 2018.
Xiang Zhang is the Head of Medical Affairs and HTA Statistics at CSL Behring, where he leads a team of statisticians focused on generating evidence to support product launches and commercialization efforts, including HTA submissions and non-interventional studies. He also co-leads the Forum for Observational Research Excellence at CSL Behring, which offers expertise to internal stakeholders on leveraging real-world data (RWD) and real-world evidence (RWE) for clinical development, regulatory submissions, and product commercialization. Dr. Zhang’s research interests center on the development and application of methodologies for real-world data analysis. He has authored or co-authored over 40 peer-reviewed publications and a book titled “Real World Health Care Data Analysis: Causal Methods and Implementation Using SAS.” He holds a Ph.D. in Statistics from the University of Kentucky.