Role of Global Indirect Treatment Comparison (ITC) Programs in Supporting Europe’s Joint Clinical Assessments (JCA): Insights From Global and EU Experts
Speaker(s)
Moderator: Chris G Cameron, MSc, PhD, EVERSANA, Sydney, NS, Canada
Panelists: Shannon Cope, MSc, Precision AQ, VANCOUVER, Canada; Justin Doan, MSc, MPH, DrPH, Global HTA, Value & Evidence, Pfizer, Inc., New York, NY, USA; Uwe Siebert, MD, MPH, MSc, ScD, Institute of Public Health, Medical Decision Making and Health Technology Assessment; Department of Public Health, Health Services Research and Health Technology Assessment, UMIT TIROL - University for Health Sciences and Technology, Austria, Center for Health Decision Science and Dept. of Epidemiology and Health Policy & Management, Harvard T.H. Chan School of Public Health, Institute for Technology Assessment and Department of Radiology; Massachusetts General Hospital; Harvard Medical School, Boston, USA
ISSUE:
The pharmaceutical and medical device industry strategically develop global indirect treatment comparison (ITC) programs to support product launches by providing nuanced understanding of a new intervention’s efficacy and safety in relation to existing treatments. Global ITC programs have evolved over time in terms of complexity and now include systematic reviews, ITC feasibility assessments, and various ITC analyses including network meta-analyses, matching adjusted indirect treatment comparisons, and real-world evidence (RWE)-based external control arm studies. Given the complex nature of global ITC programs and intricacies of global market access, global ITC programs have become instrumental in providing comparative and causally valid evidence for new products to payers and health technology assessment (HTA) bodies. Notably, insights gleaned from global ITC programs extend to EU’s joint clinical assessments (JCAs) where European Parliament aimed to substitute the parallel evaluations of clinical data conducted by multiple country-specific HTA bodies with a single harmonized relative effectiveness assessment. Well-designed global ITC programs can ensure that EU HTAs have high-quality comparative evidence for JCAs where head-to head trial data are unavailable.OVERVIEW:
This panel will discuss the role of global ITC programs in supporting European JCAs. Dr. Chris Cameron will moderate and provide an overview of global ITC programs and HTA requirements for EU’s JCAs, and pose key questions for the panelists to debate, including:- What are the opportunities with leveraging global ITCs for EU JCAs?
- What are the challenges with leveraging global ITCs for EU JCAs?
- How do multiple PICOS across EU increase complexities?
- Why might well-designed global ITC programs be more acceptable for EU JCAs?
- What are the challenges with harmonizing ITCs to support EU JCAs?
Code
231
Topic
Health Technology Assessment