OBJECTIVES

: Evidence requirements for medical devices have increased over the past years as budgetary pressures and needs for value demonstration have become more prominent. Furthermore, concepts of value-based procurement (VBP) have been introduced into practice to ensure appropriate incentives awarding innovation and the consideration of patient outcomes. We aim to assess the impact of evidence-focused policy changes on the availability of clinical evidence for medical devices and their use in purchasing.

METHODS

: We conducted a structured review of clinical trial (https://clinicaltrials.gov/) and tender (http://ted.europa.eu) repositories between 2004 and 2017 to assess the number of clinical trials and Most Economically Advantageous Tender (MEAT) utilization in Europe. Data were analyzed descriptively and related to the introduction of major policy changes, such as the introduction of EU directive 2014/24, which aims to encourage taking the full life-cycle costs into account when awarding tender contracts.

RESULTS

: Across all EU countries, the median use of MEAT vs. lowest price tender award criteria increased from 49% before to 69% after 2014. Belgium and Ireland used MEAT in over 90% of the cases in this timespan; the EU5 between 67% and 88%. We observed the lowest utilization of MEAT (2%) in Romania, Malta, and Lithuania. The recorded number of started clinical trials for devices in Europe increased on average by 20% annually from 2004 to 2014, where it reached its peak. While the amount of trials differs among countries, no country deviates from the overall trend visibly.

CONCLUSIONS

: The review of tenders revealed extreme differences of procurement priorities among the EU members, but nevertheless indicates that the 2014 EU directive has a positive effect on the utilization of MEAT VBP. Despite this shift towards a procurement model considering patient outcomes, evidence repositories currently don’t reflect this policy change.