BACKGROUND: Over the last year, there have been some significant changes in the digital health sector, which offer new opportunities for the healthcare industry. However, the absence of comprehensive evaluation processes in some markets threatens to limit widespread reimbursement, leading to challenges accessing digital technologies.

OBJECTIVES: To explore changes in the digital health landscape over the past year for US, UK and EU4 markets, focusing on existing market access evaluation processes and latest product reimbursements.

METHODS: The current digital health landscape was reviewed across all scope markets, identifying pathways to reimbursement, criteria for evidence generation, and if applicable, the latest reimbursements per market. Through comparative analysis, similarities and differences were identified across countries. This enabled markets to be ranked based on their digital health advancements, considering both landscape maturity and reimbursement success.

RESULTS: As of June 2024, Germany has permanently reimbursed 56 DiGA across various diseases, a ~19% increase from 47 in June 2023. The UK continues to utilise multiple assessment processes, including NICE’s MTEP route, which allows flexibility for varying evidence requirements by offering three levels of guidance. Recently, three DHTs were recommended via Early Value Assessment. France has more stringent evidence requirements, and assessment is arguably challenging due to difficulties quantifying impact. Spain, Italy and the US continue to experience difficulties with DHT reimbursement due to fragmented decisions at the local level, and lack of standardised evaluation processes. However, the US has recently seen FDA approval of Rejoyn. With backing from a large company, this marks progress towards DHT adoption, despite previous reimbursement challenges for reSET and reSET-O.

CONCLUSIONS: This analysis concludes that DHT landscapes vary in maturity across the US, UK and EU4 markets. Germany, France, and the UK lead with specific evaluation processes, whilst the US shows promise with recent regulatory approvals.