poster presentation and conference attendance: ISPOR Europe 2024, 17-20 November 2024, Barcelona
Exploring access and reimbursement of digital medical devices and AI-based SaMD at ISPOR Europe 2024
Reimbursement of digital medical devices (DMD) in Europe remains challenging with few dedicated access pathways and tailored reimbursement schemes. To date, remote care and remote monitoring and to some extend patient-use apps have been at the forefront of payer attention and the creation of access and financing modalities. However, for many DMD that are based on AI, that come to use in the diagnostic field or are used by healthcare professionals, access paths remain much less clear. And – as it is so often the case in market access – the fragmentation across markets is noticeable, even more so here than for other health technologies. The majority of the markets explored in our research give some consideration to digital medical technologies and the methodologies to evaluate them. A strong push for adoption is seen in the UK, certain initiatives in Sweden and the Netherlands and the patient app reimbursement paths in France and Germany are well known in the industry community.
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How to approach reimbursement and access of DMDs?
DMD reimbursement remains a highly dynamic, where complex access options need to be carefully evaluated, followed and potentially re-evaluated. While access strategy needs to be tailored to each device, some general questions for the DMD field should be considered for each evidence generation plan and go-to-market plan:
- Do new DMD access pathways live up to their promises so far? – are their differences across types of products or indications?
- Are France and Germany the frontrunners and most promising markets in digital that they claim they are – how can access be optimised in these markets?
- Which access pathways are appropriate for AI-based technologies?
- Do alternative funding, access and business models present a sustainable approach?
- Does a e-health or digitalisation strategy provide a stable political environment and backdrop for adoption?
Ask the tough questions. Stay on top of policies
Additional access pathways and initiatives are likely to appear in the next few years, while industry organisations and EU-projects push towards more harmonisation of technology evaluation. Only in the last days, these types of research collaborations have resulted in publications that investigate appropriate methods to evaluate AI in healthcare [1]. Likewise, this week, has the German association of digital health industry (Spitzenverband Digitale Gesundheitsversorgung) reiterated the need for these EU-wide standards [2]. Several initiatives (like EdiHTA) are already in place to explore these topics. In the future, the relevance of new EU processes such as the Joint Clinical Assessment (JCA) for DMDs are to be seen. Staying on topic of policy discussions and methods, as well as the first case studies and experiences are to be closely followed.
References
1 Health technology assessment framework for artificial intelligence-based technologies
2 Advancing Digital Health in Europe – A Call for Harmonization
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