Health technology assessment (HTA) evaluates the benefits of medical technologies and helps determine the value of a diagnostic or medical intervention and whether it should be made available in a health system. Real World Evidence (RWE) provides insights on how technologies are used and perform in a real world setting and is becoming increasingly important for reimbursement and regulatory decision making.

HTA submissions typically use generic frameworks for assessing medical innovations, which are not specific for diagnostics or medical devices, and may hinder how their value is measured and evaluated. Additionally, these frameworks may not include RWE, which is important to enable a complete evaluation of evidence, particularly for medical devices.

This forum aims to highlight opportunities for improvements to HTA frameworks to more fully capture the value of diagnostics and medical devices. Case studies will be used to illustrate uses of RWE and the importance of including a tailored evidence evaluation framework for diagnostics and medical devices. The forum will also include a state of the art discussion on the methods to evaluate diagnostic tests (Dr. Lavinia Ferrante), a presentation on the current challenges experienced by HTAs for the assessment on these technologies (Mr. David Tamblyn), and a discussion with two medical device companies (representatives: Lindsay Bockstedt and Chiara Capobianco) presenting their approaches in using RWE, and sharing how evidence standards may evolve as RWE becomes more widely accepted. The panel will conclude with questions from the moderator and the audience.