The market for Digital Health
Applications in Europe is huge. However, the fact that such Apps are reimbursed by health insurance companies only applies to a few
of those on offer. One reason for this is that evaluating digital medical
technology for possible reimbursement is a major challenge. This is stated in
the 217-page Evaluation
of digital medical technologies report that was released by the Belgian
Knowledge Centre for Healthcare on 13 January.
Reimbursement for Digital Health Applications
The Belgian National Institute for Sickness and
Invalidity Insurance (Institut national d'assurance maladie-invalidité) commissioned the study. The object of the study was to
find out how specific EU member states are proceeding in order to make Digital Health
reimbursable by health insurance companies. The Belgian National
Health Insurance first reimbursed a Health App (see
DSV News 04/2022) back in April last year. Nevertheless, questions appear
to remain unanswered. This is not surprising, according to the Belgian
Knowledge Centre for Healthcare. Digital Health
Applications are ill-suited for use with traditional
evaluation and decision-making procedures. No well-developed procedure for Health App reimbursement currently exists in Belgium
The pioneer is Germany
Germany is one of the pioneers here and has
created the basis through the Digital Healthcare Act (DVG) that has been testing how
Applications can be reimbursed by health insurance since September 2020. This
involves their efficacy being tested by the Federal Institute for Drugs and
Medical Devices (BfArM) against defined criteria and they are then included in a Digital Health Application directory.
It currently includes around 40 products.
Many were initially included in the list of reimbursable Digital Health
Applications under a trial
scheme (a fast-track process), but were then removed when no added benefit was
evident. Therefore the eligibility for reimbursement is initially just
Evaluation procedures differ significantly
The report also looked at what is being
done in England, France, Finland and the Netherlands as well as Germany. All of
them have well-developed Digital Health
Applications evaluation and registration procedure. However, differences exist with regard to the
length of registration procedure as they are particularly fast at two to three
months in Finland and Germany.
Differences were also found with regard to
the proof of evidence specifications. The evidence requirements are openly
formulated in Finland and the Netherlands to allow a more flexible approach.
The procedures also differ as to whether price negotiations take place as part
of the evaluation or not. This only happens afterwards in France. Here in
Germany the manufacturer determines the price during the first year after
market approval. Only then are prices negotiated, taking into account cost-benefit
considerations. England, on the other hand, requires
cost-effectiveness evidence before registration procedure, whereas simple price and cost
information is often sufficient in Finland.