Evidence-based reimbursement processes in Europe Part 2: A comparative analysis of selected medical devices in Austrian, English. French and German hospitals and possible influencing factors

Research area: HTA-methods & steering instruments

Project leaders: Helene Eckhardt*, Gregor Goetz*
Project team: Helene Eckhardt*, Gregor Goetz*, Hendrikje Lantzsch, Cornelia Henschke, Dimitra Panteli
Duration: October 2020 – August 2021
Language: English

*authors will contribute equally

How important are evidence and different structural factors for the utilization of new medical devices with uncertain clinical benefit in selected European countries? A comparative analysis of selected medical devices in Austrian, English, French and German hospitals and possible influencing factors between 2005 and 2020.

Background: Medical procedures utilising medical devices are comparably less regulated compared to drugs in the European Union (EU). The approval (CE mark) of medical devices in Europe takes place early in the evidence evolvement. Evidence requirements for the reimbursement of high-risk medical devices further differ between countries [1]. Several examples such as metal hip implants show how lax regulation on medical devices (especially in terms of required proof of safety and efficacy) can lead to significant harms to patients [2, 3].

Attempts to harmonise and strengthen regulation also with regard to the role of clinical evidence have been initiated [4]– such as the new EU directive on medical devices (EU-MDR 2017/745) [5].

After approval of a medical devices in the EU, the question of eligibility for reimbursement is decided at the national or regional level. The reimbursement process of medical devices in hospital care in Austria, France and England is supported by scientific evaluations conducted by the Austrian Institute for HTA (AIHTA), Haute Authorité de Santé (HAS) and National Institute for Health Excellence (NICE) respectively [6-10]. On the contrary, in German hospitals every CE-marked technology can be used in inpatient care, except those explicitly excluded by the German Federal Joint Committee [11].

A recent analysis investigated how a new EMS – the transcatheter aortic valve implantation (TAVI) – was used between 2009 and 2016 in the Austrian healthcare system, showing a constant rise in TAVI and a slight fall of its comparator, namely surgical aortic valve replacements [12].

This study builds on work carried out by the Technische Universität Berlin (TUB) to systematically investigate the relationship between utilization of 27 new medical devices in inpatient care in Germany and the evolvement of scientific evidence between 2005 and 2017. To review the evidence of effectiveness and safety, systematic literature searches were conducted in four databases. Additionally, clinical trial registries, Health Technology Assessment (HTA)-databases, different sources of clinical guidelines, funding documentation and adverse event monitoring systems were searched. Publications of evidence levels I-IV (as defined by the G-BA) published between 2003 and 2017 were included in the analysis. Hospital cases were identified through procedure codes in claims data as of 2005. Publications were plotted over time with a LoE I-IV ordinate; the number of cases was then plotted on the same time axis.

Three devices were selected for the comparative investigation in the current study: bioresorbable drug-eluting scaffolds (BRS), mechanical thrombectomy and TAVI.

Aims of the project and research questions: The aim of the current study is to compare the development of utilization in connection with published evidence, reimbursement process, and other structural factors, such as funding, safety warnings and recommendations of clinical guidelines, between Austria, England, France, and Germany in order

1. to understand the relationship between the utilization of new medical devices with

uncertain clinical benefit and the aforementioned differences between these countries and

2)  to draw lessons for the health care systems under investigation.

Based on the aims of our research, we defined the following research questions (RQ):

• RQ1: How does the reimbursement process of new medical devices differ between the four selected European countries?
• RQ2: How does the utilization of new medical devices relate to available scientific evidence, funding, safety warnings and recommendations in the selected countries over time? Which differences and similarities between the four health systems are observable?
• RQ3: What lessons can be drawn from the observed differences?

Methods:

RQ1: document analysis

RQ2: The analysis of the relationship between the development of evidence and the number of cases from the Austrian, English and French hospitals will be performed in a similar way as it was done for the analysis with regard to German hospitals (see above). Hospital cases will be identified through procedure codes in Austrian, English and French claims data since 2005.

The analysis of the relationship between the development of evidence and the number of cases will be carried out descriptively by plotting the publications on a LoE I-IV ordinate over time and the number of cases on a time axis for each country and each medical device.

RQ3: Cross country analysis

Period	Task
October 2020- February 2021	Scoping, retrieving of data
March-June 2021	Document analysis, update of evidence of the three procedures (systematic update search of relevant literature 2018-2020); data analysis of usage data from AT, ENG and FR and comparative analysis of usage trends.
July 2021	Drafting of journal article for submission in peer reviewed journal and drafting or the publication
August 2021	Peer review and submission of journal article

References:

[1]          Krüger L. J. and Wild C. Evidence requirementsfor the authorization and reimbursement of high-risk medical devices in the USA, Europe, Australia and Canada. An analysis of seven  high-risk medical devices. Vienna. Available from: https://eprints.aihta.at/1017/1/HTA-Projektbericht_Nr.73.pdf.

[2]          Godlee F. Why aren’t medical devices regulated like drugs? BMJ : British Medical Journal. 2018;363:k5032. DOI: 10.1136/bmj.k5032.

[3]          Storz-Pfennig P., Schmedders M. and Dettloff M. Trials are needed before new devices are used in routine practice in Europe. BMJ : British Medical Journal. 2013;346:f1646. DOI: 10.1136/bmj.f1646.

[4]          British Standards Institution (BSI). New Medical Devices Regulation and IVD Regulation text published. [cited 30.01.2020]. Available from: https://www.bsigroup.com/en-GB/medical-devices/news-centre/enews/2017-Enews/New-Medical-Devices-Regulation-and-IVD-Regulation-text-published/.

[5]          European Commission. Medical Devices. [cited 30.01.2020]. Available from: https://ec.europa.eu/growth/sectors/medical-devices/new-regulations_en.

[6]          Grossmann N., Wolf S., Rosian K. and Wild C. Pre-reimbursement: early assessment for coverage decisions. Wien Med Wochenschr. 2019;169(11-12):254-262. Epub 2019/02/07. Vorab-Erstattung: Fruhbewertungen fur Erstattungsentscheidungen. DOI: 10.1007/s10354-019-0683-1.

[7]          Mad P., Geiger-Gritsch S., Hinterreiter G., Mathis-Edenhofer S. and Wild C. Pre-coverage assessments of new hospital interventions on Austria: methodology and 3 years of experience. International journal of technology assessment in health care. 2012;28(2):171-179. Epub 2012/05/09. DOI: 10.1017/s0266462312000025.

[8]          Bachner F., Bobek J., Habimana K., Ladurner J., Lepuschutz L., Ostermann H., et al. Austria: Health System Review. Health Syst Transit. 2018;20(3):1-254. Epub 2018/10/03.

[9]          Cylus J., Richardson E., Findley L., Longley M., O'Neill C. and Steel D. United Kingdom: Health System Review. Health Syst Transit. 2015;17(5):1-126. Epub 2016/04/07.

[10]        Chevreul K., Berg Brigham K., Durand-Zaleski I. and Hernandez-Quevedo C. France: Health System Review. Health Syst Transit. 2015;17(3):1-218, xvii. Epub 2016/01/15.

[11]        Busse R. and Blümel M. Germany: Health System Review. 2014 [cited 18.05.2021]. Available from: https://eurohealthobservatory.who.int/publications/i/germany-health-system-review-2014.

[12]        Robausch M. and Emprechtinger R. Perkutaner Aortenklappenersatz in Österreich (Teil II). 2017 [cited 15.12.2020]. Available from: https://eprints.aihta.at/1141/1/HTA-Projektbericht_Nr.95b.pdf.