Presentation (CTI)

OBJECTIVES: Digital therapeutics (DTx) represent novel treatment options that can offer effective patient care and support efficient healthcare delivery. However, reimbursement and uptake remain key barriers to DTx adoption. Our aim was to conduct a scoping review of reimbursement and access pathways for DTx in major European markets, based on real-world insights from stakeholders operating in roles supporting market access activities for DTx and the published literature. By identifying common challenges associated with these processes, we aimed to develop a structured framework to support market access planning for DTx.
METHODS: Qualitative primary research (structured interviews based on a discussion guide) was conducted with 13 stakeholders based in six countries (Belgium, Italy, Netherlands, Portugal, Spain, United Kingdom). Additionally, secondary research in the form of a targeted literature search was conducted to identify publications on DTx policy and reimbursement in Europe.
RESULTS: Most European countries lack established pathways for assessment and reimbursement of DTx, with funding secured through multiple, fragmented routes (e.g. at an individual hospital level). Additionally, the unique characteristics of DTx means routes to access can vary product-to-product. Evidence requirements of decision-makers can be challenging to meet as many DTx are not supported by comprehensive clinical programs. Taking account of these challenges, a framework is proposed to provide a systematic basis for planning reimbursement and uptake activities for DTx. It is structured by key market access considerations for DTx, with flexibility for country and product differences.
CONCLUSIONS: Despite variation in market access pathways and DTx readiness of different countries, common challenges were identified including a need to establish a clearer understanding about the role and nature of DTx at all levels of healthcare systems. The proposed framework takes account of the challenges to define a structured approach to support DTx reimbursement and access activities across European markets.