Study 2019-08 (HSR) Evidence gaps at market entry in Europe for drugs and medical devices

Ongoing study - New medical products (medicines, medical devices) only become accessible for the large majority of the Belgian patients when they are reimbursed by the Belgian health insurance (INAMI-RIZIV). For this, the manufacturer of the product must submit an application file to the competent INAMI-committee. This committee often reports large uncertainties with regard to effectiveness/cost-effectiveness of these products as well as their potential budget impact. This lack of evidence delays or even hampers a positive reimbursement decision of often innovative products.

In the current project, KCE will examine a number of recent reimbursement files for innovative medicines and medical devices, and look at the evidence made available by the manufacturer. The strengths and weaknesses of this evidence, which have already been identified by the INAMI committee, will be analysed. Based on this analysis, solutions will be explored, together with the various stakeholders, to complete the lacking evidence and to avoid these evidence gaps in the future.

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