Epidemiology of chronic lymphocytic leukaemia in Germany: A retrospective analysis of administrative claims data.

Chronic lymphocytic leukaemia (CLL), the most common leukaemia in Germany, remains incurable; despite the availability of several systemic treatment options, patients often experience multiple relapses. The aim of this retrospective, observational study was to generate real-world evidence on the epidemiology, patient characteristics and treatment patterns of CLL in Germany, focussing on covalent Bruton's tyrosine kinase inhibitor (cBTKi) and post-cBTKi treatments. Anonymised data from patients diagnosed with CLL (2012-2023) were harvested from one of the mandatory German Statutory Health Insurance sickness funds, AOK PLUS (the study population), and extrapolated to the German national population. There was an increase in CLL prevalence between 2012 and 2022, from 101.7 per 100,000 individuals (95% confidence interval [CI], 100.9-102.4) to 165.4 per 100,000 individuals (95% CI, 164.5-166.4), and incidence remained relatively stable in the German national population. One-third of the study population (n = 1616/4901) received treatment, and multiple treatment lines were common. Use of cBTKis (any line) increased between 2015 and 2022 in the German national population, from 2.4 per 100,000 individuals (95% CI, 2.3-2.5) to 15.7 per 100,000 individuals (95% CI, 15.4-16.0). Among 104 patients in the study population initiating post-cBTKi treatment, the most common (at any time) was another course of same/alternative cBTKi (53.8%), or anti-CD20 antibody (41.3%); 30.8% received venetoclax-based regimens at any time and 19.2% as a first post-cBTKi option. These real-world findings highlight the increasing prevalence of CLL in Germany, the need for multiple lines of treatment and the growing use of cBTKi therapies.