Reimbursement still very different in Europe

CC – 04/2022

There are now numerous Digital Health Applications on the European market but not all are reimbursable. While the statutory health insurance now reimburses 31 apps on prescription in Germany, one health app has now made it into the Belgian health insurance benefits catalogue. The picture in Europe is still heterogeneous as a matter of course.

For the first time, the Belgian National Health Insurance (Institut national d'assurance maladie-invalidité - Inami) will reimburse the costs of a digital health app. The e-health app moveUP aims to support the rehabilitation of people with an artificial knee or hip joint. The reimbursement of the app by the statutory health insurance is a milestone for Belgium.

The Belgian system

In Belgium, reimbursement of digital health applications by the statutory health insurance is linked to a three-step approval process via the eHealthBelgium system. The legislative framework for medical app funding was developed in 2016 and not finalised until January 2021.

Belgium evaluates digital health applications based on a three-tier system. The higher the level, the stricter the conditions to be met. Thus, at each level, manufacturers must demonstrate whether the DiGA meets the necessary requirements in terms of quality, safety and efficacy. To receive government funding, an app must achieve the highest level of approval.

Parallels with Germany: Fast-track system

As in Germany, apps that reach the highest level of approval and for which sufficient data is not yet available can be provisionally reimbursed. The decisive factor in the system of provisional financing is whether added health-related economic value could be demonstrated at the time of approval. The added value is linked clinical evidence and a balanced cost-benefit ratio, i.e. fewer follow-up visits, fewer complications, and fewer hospitalisations. The fast-track approval system is intended to enable prompter market launch of new medicinal products.

In Belgium, too, the competent authorities previously had to define which medical devices and thus, also medical apps are approved and reimbursed under which conditions on the basis of the European Medical Device Regulation (MDR), which came into force in 2017. From May 2021, all medical devices must be placed on the market in accordance with the new law and be listed in the central database for medical devices EUDAMED with information on intended purpose, risk class and proof of benefit. The MDR was intended to create more transparency and safety in the placing of medical devices on the market and higher quality requirements for their clinical evaluation.

Germany as a European role model and pioneer

For Belgium, the recognition and reimbursement of medical health apps is a breakthrough. There, two more apps are already on the home stretch to the highest level of approval and thus, to reimbursability. Germany, on the other hand, is already quite ahead. Thus, the first medial app went through the fast-track approval process in October 2020 and was successfully listed in the “DiGA directory” created for this purpose. Thus, the requirement as a component of standard care was fulfilled.

The German system of reimbursement of medical apps is also a model in other countries such as France, the Netherlands and Sweden and is to be introduced in cooperation with the health insurance system.

The fact that the first medical app has now been approved and reimbursed in Belgium is not only an important step for the country, but also an important step for digitisation in the healthcare sector across Europe.