The mHealth validation pyramid: The climb towards reimbursement

Adobe Stock 299236053 min
BLOG - 19 juillet 2022

mHealth applications, defined as “software applications with a medical purpose that enable patients to share health-related data with healthcare providers from their environment,” have the potential to revolutionise healthcare delivery. Revolution, however, comes at a cost, and work remains to increase mHealth’s adoption to become an accessible and engaging form of patient care that results in more efficient and effective delivery of better healthcare-related outcomes.

One essential aspect is to ensure appropriate financing in the form of reimbursement. Reimbursement of medical services is an integral and regulated part of the Belgian healthcare system. With its expertise in the healthcare system and its financial flows, and expertise in health economics and market access strategy, Hict is perfectly positioned to provide support for the mHealth manufacturer or distributor.

Mobile Health - mHealth in short - is gaining traction in response to the changing telehealth landscape and the ever-increasing digitisation of healthcare. Health-focused mobile applications that enable patients to share health-related data with healthcare providers from their environment might accommodate critical challenges the current healthcare system faces, such as the understaffing of medical personnel or the increased need for patient autonomy.

To support reimbursement for mobile health applications, the Belgian federal government established the mHealth Belgium platform and the mHealth validation pyramid (see figure below) as a framework for reimbursement of mHealth applications.

The mHealth app manufacturer/distributor enters the validation pyramid to perform pre-determined actions (such as CE-marking) to meet reimbursement requirements, ultimately up to level M3 (M3- or M3+), which secures temporary or permanent reimbursement for the mHealth app. With its extensive experience in market access for pharmaceuticals and medical devices and knowledge of Mobile health, Hict can be a vital partner for innovative mHealth solutions reaching level M3. The support Hict can provide ranges from performing preliminary submission analyses (i.e., determining the feasibility of reimbursement of the application, developing a submission strategy) to completing the relevant and appropriate health economic analyses.

Final mhealth validation pyramid

To reach M3, and be eligible for reimbursement, a dossier for reimbursement application needs to be developed. This dossier should minimally include a description of how the mHealth app integrates with a pre-existing or newly developed care pathway, as reimbursement centers around the use of the technology within this care pathway. Furthermore, the application's budgetary impact (and, if relevant, the cost-effectiveness) within this care pathway needs to be calculated and presented for evaluation to the RIZIV/INAMI.

Hict has experience in developing integrated mHealth care pathways and establishing the clinical and socio-economical added value of the application within this pathway. Our ‘value cascade’ approach helps determine the business case and feasibility of reimbursement of the new technology and can consequently be translated into a budget impact model that clearly shows the impact on the different budgets of the RIZIV/INAMI. If a cost-effectiveness analysis is an essential aspect of your reimbursement submission, we can also support developing a new or adaptation of an existing cost-effectiveness model.

Hict provides support tailored to your needs and resources, whether you are a mobile health app manufacturer considering entering the validation pyramid or need specific health-economic analyses to support your reimbursement dossier. Whether you want full support throughout the reimbursement process or struggle to set up and perform a particular aspect within the process, Hict can provide you with a solution to your problem. Our general approach is modular and adjustable to your needs. Whatever the situation, we always strive to deliver easy-to-interpret deliverables that meet governmental standards. Our goal is to provide optimal customer support in the reimbursement process.

If you are looking to gain more insight into the process of reimbursement for mHealth, or you want to have an open-ended conversation with our experts to see where Hict’s knowledge and expertise could be of support in your endeavours to get reimbursement for your solution, do not hesitate to contact our MedTech consultant Cedric at