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Belgian KCE published a report on the evidence gaps at market entry in Europe for drugs and medical devices
On December 17, 2021, the Belgian Health Care Knowledge Center (KCE) published a health services research report “Evidence gaps for drugs and medical devices at market entry in Europe and potential solutions”. In this report, KCE examined the lack of comparative evidence health technology assessment (HTA) agencies and payers face in evaluating new medicinal products and high-risk medical devices at market entry.
This project attempted to clarify the evidence requirements and the evidence gaps from various perspectives and with the aid of various information sources. For every source, a specific methodology was followed that was explained in the relevant chapters. The report includes the following data: an overview of the legal framework concerning the evidence requirements for putting high-risk medical devices and medicinal products on the European market; a brief overview of the evidence gaps reported by the National Institute for Health and Disability Insurance (INAMI/RIZIV) in the evaluation dossiers of medical devices or medicinal products; a literature study of the evidence gaps for high-risk medical devices and medicinal products; discussion of possible solutions.
A consultation with the group of experts in the field of medicinal products or high-risk medical devices from selected public HTA/payment institutes in Austria, Belgium, France, Germany, Ireland, Norway, the Netherlands, and the UK was performed. A similar consultation was also conducted with a group of experts in the field of legislation, ethics, and regulation and a group of physicians. The report provides a number of recommendations for different stakeholders to complete the lacking evidence and to avoid the evidence gaps in the future.
See the details in English here.
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