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DOI: 10.1055/a-2075-2725
Fäkaler Mikrobiota-Transfer (FMT) in Deutschland – Status und Perspektive
Fecal Microbiota Transfer (FMT) in Germany – Status and Perspective Diese Arbeit wurde von der Ferring Arzneimittel GmbH unterstützt.![](https://www.thieme-connect.de/media/zfg/202404/lookinside/thumbnails/10-1055-a-2075-2725-1.jpg)
Zusammenfassung
Einführung Der Fäkale Mikrobiota-Transfer (FMT) ist eine Behandlung zur Modulation der gastrointestinalen Mikrobiota. Der Einsatz bei rezidivierender Clostridioides-difficile-Infektion (rCDI) ist europaweit etabliert und wird in nationalen und internationalen Leitlinien empfohlen. Der FMT ist in Deutschland im Fallpauschalensystem der Krankenhäuser kodierfähig. Eine auf dieser Kodierung basierende umfassende Erhebung zur Häufigkeit des Einsatzes fehlt bislang.
Material und Methodik Berichte des Instituts für das Entgeltsystem im Krankenhaus (InEK), des Statistischen Bundesamtes (DESTATIS) und Qualitätsberichte der Krankenhäuser 2015–2021 wurden auf FMT-Kodierung hin untersucht und im Rahmen einer strukturierten Expertenkonsultation bewertet.
Ergebnisse Zwischen 2015 und 2021 wurden von 175 Krankenhäusern 1.645 FMT-Verfahren kodiert. Von 2016 bis 2018 waren dies jährlich im Median 293 (274–313) FMT, gefolgt von einem konstanten Rückgang in den folgenden Jahren auf 119 FMT im Jahr 2021. Patienten/-innen mit FMT waren zu 57,7% weiblich, im Median 74 Jahre alt und der FMT wurde zu 72,2% koloskopisch appliziert. Bei 86,8 % der Fälle wurde eine CDI als Hauptdiagnose genannt, gefolgt von 7,6% eine Colitis ulcerosa.
Diskussion In Deutschland wird der FMT seltener eingesetzt als im europäischen Vergleich. Eine Anwendungshürde ist die behördliche Einordnung des FMT als nicht zugelassenes Arzneimittel, die zu erheblich höherem Aufwand bei Herstellung und Verabreichung führt und eine Erstattung erschwert. Die Europäische Kommission hat kürzlich eine Verordnung vorgeschlagen, den FMT als Transplantation einzuordnen. Dies könnte die regulatorische Situation des FMT in Deutschland perspektivisch verändern und so zu einem flächendeckenden Angebot eines in Leitlinien empfohlenen Therapieverfahrens beitragen.
Abstract
Introduction Fecal microbiota transfer (FMT) is a treatment to modulate the gastrointestinal microbiota. Its use in recurrent Clostridioides difficile infection (rCDI) is established throughout Europe and recommended in national and international guidelines. In Germany, the FMT is codeable in the hospital reimbursement system. A comprehensive survey on the frequency of use based on this coding is missing so far.
Material and methodology Reports of the Institute for Hospital Remuneration (InEK), the Federal Statistical Office (DESTATIS), and hospital quality reports 2015–2021 were examined for FMT coding and evaluated in a structured expert consultation.
Results Between 2015 and 2021, 1,645 FMT procedures were coded by 175 hospitals. From 2016 to 2018, this was a median of 293 (274–313) FMT annually, followed by a steady decline in subsequent years to 119 FMT in 2021. Patients with FMT were 57.7% female, median age 74 years, and FMT was applied colonoscopically in 72.2%. CDI was the primary diagnosis in 86.8% of cases, followed by ulcerative colitis in 7.6%.
Discussion In Germany, FMT is used less frequently than in the European comparison. One application hurdle is the regulatory classification of FMT as a non-approved drug, which leads to significantly higher costs in manufacturing and administration and makes reimbursement difficult. The European Commission recently proposed a regulation to classify FMT as a transplant. This could prospectively change the regulatory situation of FMT in Germany and thus contribute to a nationwide offer of a therapeutic procedure recommended in guidelines.
Publication History
Received: 24 December 2022
Accepted after revision: 11 April 2023
Article published online:
15 May 2023
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