Working Group on HTA & regulatory interactions holds meeting, identifying key challenges to the use & development of digital endpoints

On 15 February, Neuronet hosted an online meeting of its Working Group on Health Technology Assessment (HTA) and Regulatory interactions, moderated by Diana O’Rourke from the National Institute for Health and Care Excellence (NICE). The main focus of this meeting was on the considerations and issues for the use of digital endpoints in HTA submissions for new health technologies and in other guidance. To support these discussions, 3 external HTA experts (Anja Schiel (NoMA), Niklas Hedberg (TLV/EUnetHTA) and Sheela Upadhyaya (NICE)) were invited to the meeting to provide their perspectives in relation to a number of questions.

Diana kicked off the meeting with a brief introduction to Neuronet and an overview of the role and objectives of the Working Group. Next, David Nobbs (IDEA-FAST), Lynn Rochester (Mobilise-D) and Gul Erdemli (RADAR-AD) each delivered short presentations describing the development of digital endpoints within their respective projects. Following the presentations, Anja, Niklas and Sheela answered questions relating to HTA bodies’ experiences of the use of digital endpoints as evidence in HTA submissions, and the requirements and expectations of HTA bodies in relation to using digital endpoints. The Working Group also discussed the potential opportunities for informal engagement with HTA bodies within the context of Innovative Medicines Initiative-funded research projects where discussions can take place much earlier in the process and are not related to a specific health technology.

The discussions from the Working Group meeting will inform the development of a white paper on the challenges faced by technology developers in engagement with regulatory and HTA agencies.