IHR Seminar: Using Real Word Evidence (RWE) in Health Technology Assessment (HTA) Decision Making – Challenges & Potential

In HTA decision making much emphasis is often put upon evidence from Randomised Controlled Trials (RCTs). However, both changes in the way RCTs are undertaken (especially for pharmaceutical regulation) and a desire for earlier HTA decisions, means that such evidence will become increasingly more limited in both nature and scale – for example smaller (possibly adaptive) trials with shorter followup and using surrogate endpoints. Thus, other sources of evidence will be required in order that decisions can be made in a timely manner.

The use of RWE has been advocated as a way of addressing some of these issues, but it is not without its challenges. These will be illustrated, using recent examples from National Institute for Health & Care Excellence (NICE), by considering how RWE can be used in estimating Relative Effectiveness (RE) by augmenting RCT evidence, including within a Network Meta-Analysis (NMA), mapping between outcomes, and also extrapolating health effects over time.

Finally, other potential areas for the use of RWE in HTA will be discussed as well as the ongoing Innovative Medicines Initiative (IMI) GetReal project which is evaluating the potential use of RWE in HTA.

Please email Helen Davey if you wish to attend: h.e.davey@exeter.ac.uk