Use of Real-World Data and Evidence (RWD/E) to Support Evidence Gaps in HTA Submissions on Medical Devices When Direct Comparative Evidence Is Not Available

In high-risk Medical Devices (class IIb and III), Randomized Controlled Trials (RCTs) are not always an option due to various reasons such as ethical standards, problems with randomization or blinding, etc. As comparative effectiveness is not required for regulatory approval, clinical comparative evidence in Medical Devices (MDs) is rare and therefore often not fulfills the HTA authority’s demands. On the one hand market access is granted, and the devices are used in routine care, on the other hand the informed choice of patients and professionals is still limited. Where does the comparative evidence come from, as demanded/needed in HTA submissions? How can real world data (RWD) be used to close this evidence gap? In this forum, Dr. Petra Schnell-Inderst will open the session by providing a brief overview of the upcoming topic. Dr. Frank Hulstaert will address key evidence gaps in HTA submissions on medical devices when direct comparative evidence is not available. Professor Piotr Henryk Skarżyński will explain the current standard in pre- and post-market clinical study performance on MDs. Dr. Michael Urban will assess the challenges from the industry perspective on HTA submissions when direct comparative evidence is not available.