DTx in Belgium: It's Time to Embed Digital Therapeutics in Clinical Pathways
Did you know that Belgium has had an idea for classifying and validating digital therapeutics since 2018? A clear framework was formed with all main stakeholders involved - from health insurance to the industry. So why are we not hearing more about DTx in Belgium?
In this discussion you will hear from Dr. Steven Vandeput - he is the Advisor for Digital MedTech and Services & Technologies Home Assistance in Belgium; he is managing the mHealthBelgium portal and, since 2019, has been a representative for beMedTech, the sector federation that represents the industry of medical technologies in Belgium.
In 2016, the Belgian Minister of Health launched a call for mobile health pilot projects. Out of 24 subsidized projects, it became clear after evaluation that a validation framework was necessary. Thus, the validation pyramid with three layers was established by the end of 2018.
The application classification process has a hierarchical structure. Starting at level one, an app can ascend to higher levels, ultimately aiming for reimbursement at level three. Not all apps that enter at level one will reach level three.
Level one is about fulfilling basic criteria, including CE certification. Level two involves ICT standards, while level three concerns reimbursement and requires demonstrating social and economic benefits.
Between 35 and 40 apps have the ML Belgium quality seal, but currently, none are financed by national insurance.
Summary and Key Points on the Belgian Market:
Collaborative Origin: The Mhealth Belgium initiative started as a joint effort by industry and government, with the aim of raising awareness and providing a government-approved listing of medical apps through the mhealthbelgium.be portal.
Validation Pyramid: A unique validation pyramid classifies apps into three levels, starting with basic CE certification and culminating in potential reimbursement, following stringent ICT and economic value criteria.
Market Challenges: Despite a well-structured framework, financing remains a hurdle. Companies often look beyond Belgium to sustain themselves, with some finding success in foreign markets like the UK and the Netherlands, where different healthcare payment systems are more receptive to digital health technologies.
Podcast show notes:
00:00 - Introduction
01:45 - Digital Therapeutics in Belgium
03:50 - Belgium's Healthcare Framework Development
06:00 - The Validation Pyramid and Reimbursement System
08:00 - Fate of Pilot Projects and Their Impact
10:00 - Utilization of mHealth Belgium Portal
12:00 - Challenges in Reimbursement and Financing
14:00 - Prospects for Digital Therapeutic Companies
16:00 - Belgium's Approach to Financing Digital Health
18:00 - Anticipations for the Digital Health Field
20:00 - The Evolving European Frameworks
22:00 - Impact of Political Decisions and Healthcare System Integration
24:00 - The Future of mHealth Belgium Platform