OBJECTIVES: To assess the market access and pricing processes for digital health applications EU-4 (France, Germany, Italy and Spain) + UK and determine the key decision making criteria.

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 was implemented in 2020 in which 130 applications were submitted as of May 2022. 31 were accepted temporarily. The first 5 DiGAs went through price negotiations with agreed discounts of up to 67%. In Spain, some regional health authorities have developed assessment frameworks for mobile applications, such as in Andalusia in whose catalogue 39 applications are included. In Italy, the services provided by the National Health Service (NHS) are only those identified in the “Essential Levels of Care”. Some Italian regions recognise “televisits” reimbursement by considering the tariff for F2F visits. In France, there is no specific pricing and reimbursement (P&R) pathway for digital health applications. Since 2020, MOOVECARE® is the only reimbursed digital health app. An important change could be the temporary coverage in the first year of launch after which the standard reimbursement pathway would need to be followed. In the UK, the P&R process for digital health technologies (DHTs) is decentralised, hence their final P&R decisions are made at a clinical commissioning group (CCG) level. The National Institute for Health and Care Excellence (NICE) has developed an evidence standard framework to support the NHS with determining the value of DHTs.

CONCLUSIONS: Although there are similarities between the EU4 + UK for the market access of digital health applications, processes vary between countries. As it can be seen in Germany, an improved pathway through a fast-track path can lead to faster and broader market access to patients.