Reimbursement for a medical device in Belgium

A medical device company, active in the field of cardiovascular diseases wanted to apply for national reimbursement in Belgium.

The company asked Vivactis-HM3A to prepare and file the national reimbursement dossier in Belgium.
The reimbursement landscape in Belgium is challenging. Hence, Belgium served as a pilot before proceeding with the submission in other EU countries.

Assessment phase

Our consultants collected relevant scientific and clinical information from the client and the public space: CE marking, the results of the conducted studies, declaration of conformity, …

After evaluation of the complete data set and gauging the therapeutic and economic value of the proposed technology, we presented the action plan to the client and the class under which this device could be submitted.

Execution Phase

Our market access specialist extracted all relevant information in order to complete the template from RIZIV/INAMI. In parallel, our health economist built a Budget Impact Model (BIM) and ran a Budget Impact Analysis (BIA). In addition, a mapping was done of the reimbursement status in other EU member states.

Our consultant fostered close collaboration and short communication lines with the client, which has been a key element in the process.

In a couple of months the reimbursement dossier has been finalized and submitted to RIZIV/INAMI.
RIZIV/INAMI had no questions and reimbursement has been approved.
The client is planning to apply for reimbursement in other EU countries in collaboration with Vivactis-HM3A. In addition, a Global Value Dossier is being prepared based on the Belgian dossier.