OBJECTIVES: To assess the market access and pricing process for digital health applications in Germany and its applicability into a UK health systems environment.

METHODS: National laws and regulations were assessed via targeted literature research, including official health technology/reimbursement agency websites. Additionally, expert interviews were conducted.

RESULTS: In Germany, a new fast-track process for digital health applications with a risk class I or IIa was implemented in 2020 in which 130 applications were submitted until May 2022. 31 were accepted mostly temporarily based on pilot studies or studies not applicable to the German care context. For those, German DiGA studies are currently executed which will be the basis for the final submission. Within that time German payers reimburse the use of these DiGAs. The first 5 DiGAs went through price negotiations with agreed discounts of up to 67%.

The Office for Digital Health was established within NICE in mid-2021 with a stated aim to ensure that NICE’s appraisal methods, and other processes, are able to accommodate emerging digital health technologies (DHTs). This is part of the NICE 5 year strategy and aims to lead policy on DHTs - including apps, programmes and software - recognising their potential role in transforming health and care. It is expected that the Office for Digital Health will scope out a regulation and access pathway for data-driven technologies in collaboration with the MHRA, which could be implemented as soon as 2023.

CONCLUSIONS: As it can be seen in Germany, an improved pathway through a fast-track path can lead to faster and broader market access and availability to patients. Despite the fact that the UK have not yet developed a standarised pathway digital health reimbursement, they may look to the German approach and assess the impact that such a pathway can generate in scoping out a UK programme.