OP50 European Assessments Of Medical Devices: Avenues For Improvement

Abstract

INTRODUCTION:

European collaboration in Health Technology Assessments (HTAs) has gained increasing recognition in recent years, not only on pharmaceutical products but also on high-risk medical devices. For medical devices, quality assessments of efficacy and safety are particularly important due to the weak market authorization in Europe. Strengthening efforts towards better collaboration thus plays a pivotal role to reduce overlap and save resources. This study explored the level of redundancy in HTA assessments of medical devices in Europe in order to identify areas for better collaboration.

METHODS:

We performed an analysis of European HTA reports of medical devices regarding their timing in relation to market authorization, the respective level of evidence used and the overlaps in topics. The ADVANCE HTA database from 2014 was used to select a cohort group of ten high-risk medical devices. A systematic search was conducted to identify all relevant, European HTA reports investigating the ten devices within a time span of 12 years (2003-2015). We analysed the number of annual assessments per technology and evaluated activity patterns, late and early assessors, and minimum evidence requirements.

RESULTS:

The results revealed the amount of redundancies in European HTA production: the number of reports per technology ranged from a minimum of five to a maximum of twenty-two over a time-span of 12 years. Within a single year, one technology was assessed up to six times by different HTA institutes in Europe. Out of fourteen countries included in the evaluation, two countries assessed each technology, and seven countries assessed more than seven out of the ten technologies.

CONCLUSIONS:

The findings indicate that more efficient collaboration is needed to save scarce resources and time of HTA institutes. Efficient collaboration as such needs to shift the focus beyond the time span of one year, and start building on each others work from previous assessments.