PURPOSE: To present a partial solution to HTA agencies’ reluctance to use real world evidence and data (RWE/D), particularly on relative effectiveness, to reach reimbursement decisions

DESCRIPTION: Greater use of RWE/D would enable more streamlined decision making regarding reimbursement of medicines by HTA agencies. Evidence suggests that reimbursement decisions rarely use RWE for assessing relative effectiveness. A key problem is that data are rarely perfect in the particular case for which they are being used. Problems arise that are particular to the combination of question being asked and the data source(s) and decision makers are unsure whether the lack of perfection matters. General guidance on the principles of how to use RWD cannot cover all eventualities. A maintained repository to record uses of RWD in HTA decision making which would facilitate informed dialogue between payers and manufacturers on what is adequate evidence in the particular case, would enable agreement on solutions before a committee has to make a decision. A taxonomy for such a repository has been developed and the details of its construction have been accepted for publication in a Special Supplement of Value in Health (publishing March 2023). Two organisations have shown interest in hosting it.

1. Ron will summarise the reasoning behind the creation of a RWD/E taxonomy (15 mins)
2. Linda will present the taxonomy itself, describing its generation, contents and how it is intended to be used (15 mins)
3. Shahid will discuss the requirements, issues and benefits of hosting the repository using audience feedback if he wishes and his broad perspective particularly from GetReal (15 mins)
4. Karen will discuss how and whether the HTA community will embrace this solution - using audience feedback and her broad HTA and RWE experience (15 mins)