Evaluation and reg­is­tra­tion pro­ce­dure in Europe

UM – 01/2023

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 Appli­ca­tions 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 Dig­i­tal Health 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 provisional.

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.