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Austrian Institute for Health Technology Assessment (AIHTA) publishes a new systematic analysis (second update of an analysis from 2016) on the nature and interest of non-interventional studies or post-marketing surveillance studies in Austria.
Non-interventional studies (NIS) or post-marketing surveillance studies are observational studies and evaluate medicinal products and medical devices in routine care after market approval for their approved use. For some years now, there has been a critical debate about their role: whether they are a valuable source of knowledge or merely a marketing tool. In Austria, NIS are not subject to approval, but to notification. The NIS must be registered in a study registry, in which some (but not all) information is also made publicly available. The AIHTA now analysed again the questions of how many NIS are conducted in Austria, who is responsible for them and what their research interests are. For this purpose, the information available in July 2021 in the partially public database of the BASG/AGES (https://www.basg.gv.at/gesundheitsberufe/klinische-studien/nicht-interventionell...) on the recorded NIS, including the published summaries of the final reports, was evaluated. Critical aspects were the unusually high number of participants, the large number of studies on already well-tested medicinal products, and the redundancy with regard to several NIS on the same medicinal product. As in the previous analyses, the registry was again found to have formal deficiencies meaning that the registry in its current form does not contribute to supporting the critical public interested in NIS.
As of 11 June 2021, 462 NIS with a planned number of patients of 757,948 were registered in the BASG/AGES NIS registry. Of these, 55,708 persons are reported as Austrian patients. In the reports from 2016 and 2017, this information could not yet be taken from the registry. Compared to the initial report from 2016 the total number of NIS increased by 84% (2016: 251 NIS) and the number of patients increased by 86% (2016: 406,831 patients). However, there is still no adjustment of the number of patients initially planned with the number of patients actually included according to the final study report. This circumstance was already criticised by the AIHTA in the first two analyses.
The initiators of the NIS are still for the most part the pharmaceutical companies themselves. In concrete figures, 292 of the 462 NIS (i.e. 63%) originated from these organisations - in the initial report, this share was 76%. According to the analysis, the 15 most active pharmaceutical companies in NIS are responsible for more than one third of the NIS (164 of the 462 NIS, 36%). The five pharmaceutical companies Novartis, Amgen, AbbVie, Sanofi-Aventis and Astellas with more than 15 NIS each stand out particularly here. University institutions accounted for 34 NIS (2016/2017: 37), while other (private or non-profit) research institutions were represented in the registry with 128 NIS (share: 28%, 2016/2017: 23).
With regard to the content of the NIS, the analysis of the AIHTA based on the evaluation of 156 final reports (of the 161 completed NIS) showed that the majority were post-marketing surveillance studies that explored questions of efficacy under everyday conditions, tolerability and practicability, as well as the long-term safety of the study medication. One of the biggest hurdles in the evaluation was the nature of the registry itself: The AIHTA criticised that titles and research questions were only specified in the final reports (not beforehand). Therefore, the registry owner - BASG/AGES - is likely to carry out no or only a very superficial, formal check of the submitted data sets. The AIHTA already came to this conclusion in its initial report and update.
In 2020, the (German) National Association of Statutory Health Insurance Physicians (KBV) listed four aspects according to which NIS should be critically evaluated. Three of these aspects (unusually high number of participants, studies on long established and well tested drugs, several different/ very similar NIS on the same drug) could be deduced from the Austrian NIS registry. Regarding the fourth aspect (unusually high reimbursements), there is no publicly available information. The Drug Commission of the German Medical Association (AkdÄ) now explicitly advises against participation in such NIS. The reasons: Little gain in knowledge and enforced use of expensive drugs when alternatives exist aiming at gaining market share. An analysis of NIS and post-marketing surveillance studies conducted in Germany in 2015 found that every tenth doctor in private practice participates in post-marketing surveillance studies and as a result prescribes study drugs 7-8% more often than his or her colleagues.
Ozren Sehic, B.A. ozren.sehic@aihta.at
Sehic, O. and Wild, C. (2021): Non-interventional studies (NIS) in Austria, 2nd update of systematic analyses 2016 & 2017. AIHTA Policy Brief 010. https://eprints.aihta.at/1333/
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