OBJECTIVES

Digital health (DH) products are accepted as necessary to improve healthcare service delivery. Despite this, pathways to market access are not well-established and are complex and costly to navigate. The aim of this study was to benchmark and compare market access processes in 9 healthcare markets across Europe, highlighting barriers to adoption and reimbursement.

METHODS

Seven study partners across Europe were recruited. A mixed methods methodology benchmarked DH market access pathways in UK, Germany, France, Spain, Italy, Sweden, Netherlands, Denmark, and Portugal. Primary research (semi-structured interviews) was carried out with regulatory and reimbursement experts and DH innovators (n=10). In addition, Secondary research (a structured desk-based review) of market structure, regulations and reimbursement processes was carried out to contextualise the outputs. Findings were developed into a single framework (www.e-maps.net).

RESULTS

Analysis highlighted differences in regulation, policy and the maturity of reimbursement processes in different markets. Robust frameworks for evaluation and certification were reported from organisations in the UK, Spain, Netherlands and Denmark. These have been focused on usability, security, technical and clinical issues but not health economics. Value assessments of DH products were in most markets taken care of by Med-Tech appraisal processes, with few markets having developed specific DH pathways. Significant changes to policy environments were also reported, with numerous changes and plans identified as part of this work that might address barriers to market access.

CONCLUSIONS

This study offers a comparison of 9 EU digital health markets. A key finding was that reimbursement processes across these markets were often unable to deal with the specific needs of DH solutions. Whilst policies and initiatives in some markets had made progress in supporting the path to market, there were still few examples of widespread adoption and reimbursement of DH products. Further development is required if we are to realise the full potential of DH.