How to get your digital health app reimbursed in Europe? Start with Germany, Belgium and France.

Getting your digital health app prescribed by an HCP is something most digital health app vendors want. Three countries in Europe with more than 149 million public health insured citizens make it possible. See how it works in Germany, Belgium and France.

An EU wide initiative to allow HCPs to prescribe digital health apps would brace the reimbursement route as a market entry strategy for many digital health solution providers that seek their DTx solution to get reimbursed by the statutory health insurance. R2G’s “Where is the money in digital health? The roadmap to digital health app reimbursement in Europe.” explains that Germany, Belgium and France are the DTx reimbursement process leaders that have a standardized reimbursement process in place or soon to be launched. Currently, the German DiGA directory consists of 28 apps whereas 34 health apps are present across M1 and M2 levels of mHealth validation pyramid in Belgium. The digital health innovation manufacturers, however, should be aware of the differences among the reimbursement processes in different countries. These differences can be attributed to country-specific regulatory authorities in the EU.

The German DiGA Fast Track process starts with the CE certified app fulfilling two criteria; first, a set of general requirements including data protection, information security, interoperability, and ease of use. Secondly, the solution must prove proof of positive care effects by improving the health of the user. The app which is able to fulfil both criteria is listed in the DiGA directory upon an assessment from BfARM within 3 months. Alternatively, a solution can be preliminarily listed as a DiGA if it only meets the safety and functionality requirements. In this situation, the manufacturer will have a period of 12 months to prove the positive health effects of the solution after which it becomes DiGA listed. Finally, reimbursement price negotiations are carried out by the GKV.

On the other hand, Belgian mHealth Pyramid has 3 levels that evaluate a CE certified app on the basis of risk, interoperability and clinical evidence. A manufacturer registers the mobile app to the Federal Agency for Medicines and Health Products (FAMHP), during which the CE marking and GDPR compliance are checked. The apps that meet the basic criteria of level 1 are approved as M2 where they are subjected to not only risk assessment for data security, medical confidentiality but also interoperability and connectivity assessment ensuring exchange of data between all healthcare stakeholders. The apps that reach M3 level should provide clinical evidence and added socio-economic value after which they are reimbursed by the National Institute for Health and Disability Insurance (NIHDI).

Currently the standard market access route for medical devices is also applied to digital health applications in France which makes individual funding for DTx solutions possible. A more standardized, DiGA replica is expected to be launched in 2022 but as of now the CE marked health apps are first subjected to CNEDIMT’s (Medical device and health technology Evaluation Committee), and the HAS committee’s medico-technic and actual medical benefit (SA) assessment in the opinion phase after which they reach the decision phase. The apps must then provide clinical evidence assessing actual medical and clinical benefit, based on which the solution’s SA is categorized as important, moderate or low. After negotiation of the digital therapeutic price with the Social Security Fund Caisse Primaire d’Assurance Maladie (CPAM), the solution categorized as important receives 65% reimbursement followed by 30% reimbursement for medium SA and 15% reimbursement for a solution that has low SA.

While these reimbursement channels in ‘leader’ countries are a defining moment for digital health innovation; these alone cannot determine whether a solution will be successful even though they provide both a reimbursement model and a quality stamp. Getting in is just the beginning. Companies must think ahead and plan for what comes after listing, including formulation of a distribution strategy, app pricing strategy as well as concepts to train and educate HCPs.

Please also have a look at R2G’s “Where is the money in digital health? The roadmap to digital health app reimbursement in Europe.” to understand more about the 4 groups of EU countries based on the reimbursement process status by the public health insurance system.

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