Evidence map›Paper›PMID 40159494›Full record

ArticleNeurological research and practice2025

Economic burden of disease and mortality of intracranial haemorrhage under oral FXai: a German claims data analysis.

Hagen B Huttner, Felix Scherg, Katarina Kopke, Michael Schultze, Nils Kossack, Stefan T Gerner, Joji B Kuramatsu, Stefan Schwab

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Article in Neurological research and practice, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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5 · Who and what money

Authors and funding

8 authors.

Hagen B HuttnerDepartment of Neurology, University Hospital Giessen, Giessen, Germany.
Felix SchergBioPharmaceuticals Medical, AstraZeneca, Hamburg, Germany.
Katarina KopkeBioPharmaceuticals Medical, AstraZeneca, Hamburg, Germany.
Michael SchultzeZEG - Berlin Center for Epidemiology and Health Research GmbH, Berlin, Germany.
Nils KossackWIG2 - Scientific Institute for Health Economics and Health System Research, Leipzig, Germany.
Stefan T GernerDepartment of Neurology, University Hospital Giessen, Giessen, Germany.
Joji B KuramatsuDepartment of Neurology, University Hospital Erlangen, Erlangen, Germany.
Stefan SchwabDepartment of Neurology, University Hospital Erlangen, Erlangen, Germany. stefan.schwab@uk-erlangen.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntracranial haemorrhage (ICH) is one of the most serious complications of anticoagulant therapy with oral factor Xa inhibitors (FXai). To meet an urgent medical need of optimising treatment pathways, we assessed the frequency of ICH during oral FXai treatment, as well as the associated burden on the German healthcare system.

methodsOur study was based on a claims database comprising over 4 million people with statutory health insurance in Germany. The study included people initiating oral FXai treatment for the first time between 2016 and 2021, and who experienced ICH during a three-year treatment period. For a balanced comparison of hospitalisations, costs, and mortality, propensity score matching between patients with and without ICH was performed.

resultsDuring the study period, 78,086 patients had started oral FXai therapy, of which 530 experienced ICH during the therapy. The incidence rate of ICH was highest within the first 90 days after the start of oral FXai therapy during follow-up with 0.64 events per 100 patient-years (PY; 95% CI: 0.52-0.77%). Three-month mortality rates were significantly higher among patients who had experienced an ICH event (39.4%; 95% CI: 35.4-43.8%), as opposed to patients without ICH (5.9%; 95% CI: 4.2-8.3%). This difference prevailed during follow-up, while mortality increased at roughly equal rates in both patient groups. Patients with ICH were on average hospitalised for 40.4 days/PY (95% CI: 35.7 days - 45.2 days) in the first year after the event; comparable patients without ICH were hospitalised for 10.8 days/PY (95% CI: 8.3 days - 13.2 days). Annual total costs per patient were €37,328 (95% CI: €32,243-€42,412) for patients with ICH, and €10,564 (95% CI: €9,298-€11,831) for patients without ICH. Hospitalisation costs were the main driver with 86.1% versus 50.8%, respectively.

conclusionsIncidence rates of ICH during oral FXai therapy were within the range of other published real-world data. Duration of hospitalisations, associated costs, and mortality were high and significantly higher for patients with ICH than for comparable patients without ICH. The high burden on the healthcare system highlights the need for preventive measures and more efficient treatment pathways for patients with ICH under oral FXai therapy.

Indexed as

AnticoagulationDirect oral anticoagulantDOACICHIntracranial haemorrhageOral factor Xa inhibitorOral FXai

Identifiers

PMID40159494
PMCPMC11956223

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