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

Research area: HTA-methods & steering instruments

Project leaders: Helene Eckhardt, Gregor Goetz
Duration: Dezember 2020 – August 2021
Language: English (with German summary)

 

How important are evidence and different structural factors for the utilization of new medical devices with uncertain clinical benefit in Germany and Austria? A comparative analysis of selected medical devices in German and Austrian hospitals and possible influencing factors between (2005 and 2017)

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 device in the EU, the question of eligibility for reimbursement is decided at the national or regional level. In German hospitals, every CE-marked technology can be used in inpatient care, except those explicitly excluded by the German Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA; § 137c SGB V). In Austria, the reimbursement process of new ‘extra medical services’ (EMS; German: medizinische Einzelleistung) in hospitals is supported by independent evaluations conducted by the AIHTA [6]. The Austrian Ministry of Health first receives suggestions for new EMS and then prioritises them. To evaluate the comparative effectiveness and safety of each prioritised EMS, the AIHTA produces evidence syntheses for the evaluation of the EMS within 3 to 5 months (Nov to March). These assessments are subsequently utilised as pre-coverage decision support [7].

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 [8].

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. The three selected devices have or had been listed among the new medical devices in both Austria and Germany without a regular reimbursement by a DRG-lump-sum.

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 Germany and Austria in order 1) to understand the relationship between the utilization of new medical devices with uncertain clinical benefit and the aforementioned differences between the two countries and 2) to draw lessons for the two 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 Germany and Austria?

RQ2: How does the utilization of new medical devices relate to available scientific evidence, funding, safety warnings and recommendations in Germany and Austria over time? Which differences and similarities between the two health systems are observable?

RQ3: What lessons can be drawn from the observed differences?

Methods:

RQ1: document analysis, expert survey, or interviews

RQ2: The analysis of the relationship between the development of evidence and the number of cases from the Austrian 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 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-December 2020	Scoping, retrieving of data
January 2021	Document analysis, potentially expert interviews; data analysis of usage data from AT and comparative analysis of usage trends
February - March 2021	Drafting of journal article for submission in peer reviewed journal and drafting of AIHTA
April 2021	Peer review (DP, CW, RB) 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]          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.

[7]          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.

[8]          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.