Evaluating Reimbursement Pathway of Digital Health Technologies (DHT) Across Five European Countries

OBJECTIVES: DHT represents a rapidly evolving sector with significant potential to improve healthcare outcomes. However, pricing and reimbursement (P&R) policies across major EU markets have not been well researched. This study aimed to understand the P&R policies for DHT across France, Germany, Italy, Spain, and the United Kingdom (UK).

METHODS: A review of literature via MEDLINE® and P&R policy documents from 2020 to 2024 was conducted. A descriptive analysis was used to identify similarities and differences in the reimbursement pathways.

RESULTS: Fourteen records were identified. The included records highlighted that Germany, Italy and UK were among the first countries to develop P&R policies for DHT in 2019. Germany, France, and Italy have structured processes for evaluating and integrating DHT into their healthcare systems, emphasizing clinical benefits and quality. France and the UK feature multiple layers of assessment and regional involvement in decision-making while Italy and Germany maintain some level of national oversight in the approval and integration of DHT.

Germany has a defined fast-track approval process, whereas Spain lacks a specific reimbursement process and relies on regional discretion. France has a centralized committee for evaluation and price negotiation, while Italy's integration is influenced by regional tariffs and pilot projects. The UK's reliance on regional decision-making without a national reimbursement pathway contrast with other countries.

In January 2022, the EU’s Health Technology Assessment Regulation came into force and will apply from January 2025. Joint Clinical Assessments (JCA) will include selected medical devices depending on DHT type, their medical device risk class, and whether they meet JCA review criteria.

CONCLUSIONS: The study highlights significant variability in the P&R policies for DHT. These disparities could impact healthcare systems by delaying access or causing inconsistencies in reimbursement requirements. Future research should consider impact on delay in patient access and impact on reimbursement due to this variability.