REAL-WORLD DATA AND REAL-WORLD EVIDENCE IN LATIN AMERICA- IT TAKES TWO TO TANGO
Author(s)
Marcelo Eidi Nita, MD, MSc, PhD, IECS, HAOC, and FIPE, Sao Paulo, Brazil; David Thompson, PhD, inVentiv Health, Burlington, USA; Paulo Vaz, PhD, HEADS, Sao Paulo, Brazil
Presentation Documents
PURPOSE: Many of the Health Technology Assessment (HTA) agencies in Latin America (LatAm) have been patterned after comparable agencies in mature markets, such as NICE UK, and now require submission of real-world evidence (RWE) at a comparable level of scientific rigor. The objective of this workshop is to identify challenges and highlight best practices for RWE generation in the LatAm.
DESCRIPTION: HTA agencies in LatAm—including CONITEC in Brazil, IETS in Colombia, and CENETEC in Mexico—demand RWE on local trends in disease epidemiology, treatment patterns, and medical-care costs to understand the potential health system impact of new interventions. It is generally accepted that RWE insights are derived from application of rigorous analytic methods to RWD. But what happens when robust RWD sources are lacking, as is the case for much of the LatAm? This workshop will focus on approaches for generation of high-quality RWE in a data-limited and budget-constrained environment. The presenters will provide an overview of HTA in the region, discuss examples of RWE requirements from LatAm HTA agencies, present examples of retrospective RWD sources, and demonstrate cost-effective prospective RWD collection approaches. A variety of important issues will be addressed, including how RWE is impacting the HTA decision making process in LatAm, what kinds of RWD analyses (retrospective and prospective) are being submitted to HTA agencies, and what methods are being employed to bridge the gap between the rigorous RWE requirements in LatAm and the limited availability of robust RWD. A survey will be administered to workshop attendees on their experience in RWD in LatAm that will be used as a basis for group discussion and further interaction. It takes two to tango, as the saying goes, but the dance in LatAm is particularly difficult when one partner (RWD) has trouble keeping up with the other (RWE).
Conference/Value in Health Info
2016-05, ISPOR 2016, Washington DC, USA
Code
W10
Topic
Health Technology Assessment, Real World Data & Information Systems