PURPOSE: We will share a variety of examples on how Patient-Reported Outcomes (PROs) are included in the HTA submission and are evaluated by regulators, to better understand the current place of PROs in the HTA decision process in Europe.
DESCRIPTION: EunetHTA guidelines recently acknowledge the central value of Patient-Reported Outcomes (PROs) as patient-relevant endpoints in the HTA process. Moreover high level representatives of HTA Agencies in Europe do publicly request PRO data in dossiers submitted. However, from the industry perspective, the real place of PRO in defining the value and the added value of a new health product in the HTA decision process seems still disappointing and its consideration remains heterogeneous across the different European HTA agencies. We will discuss about the 1/ potential reasons about this discrepancy of expectation between industry and regulators and we will present 2/ variety of real dossier’ submissions to HTA Agencies in Europe to better understand how PRO data were submitted by applicants and how (if) they were reviewed by regulators. Finally, in order to eventually reconcile the different perspectives (i.e. industry vs. regulators), we will identify approaches for improvements in the measurement of PRO (how to best capture patient experience with high quality especially when measured in real-life and/or observational studies), in order 1/ to achieve high quality studies and clinical study reports incorporating PRO assessment which in turn may mitigate the hesitancy of some HTA regulators to base part of their decision on these endpoints and 2/ to tend to a better harmonization of review by the different HTA agencies. There will be polling asking the audience their beliefs and expectations about the place of PRO in HTA process, approaches to improve the quality of PRO data submitted and its review by regulators, and an opportunity for questions at the end.
