Prediction of chronic lymphocytic leukaemia incidence in Germany and of patients ineligible for standard chemotherapy

Chronic lymphocytic leukaemia (CLL) patients often remain asymptomatic for several years after diagnosis. When the disease becomes symptomatic or progressive, chemotherapy with fludarabine in combination with an anti-CD20 antibody (FCR) is recommended as standard therapy, except for patients with relevant comorbidity or with del(17p13) oder TP53 mutation. We predict the number of prevalent CLL patients in 2011–2020 who need first-line therapy but are ineligible for FCR treatment. The input parameters of the Markov model are the estimated total CLL incidence (based on German cancer registry data) and clinical data on disease progression and patient characteristics (obtained by a systematic literature research). Plausibility ranges for the estimation of the total CLL incidence are given by the following: (1) inclusion of small lymphocytic lymphoma and (2) an alternative handling of death-certificate-only cases. The number of patients ineligible for FCR treatment increases from approximately 1200 in 2011 to approximately 1450 in 2020. The inclusion of small lymphocytic lymphoma cases results in 10% higher estimates, the alternative handling of death-certificate-only cases in 8% lower estimates. Recently, several new and targeted agents have been approved for CLL patients ineligible for standard treatment. Estimation of patient numbers is a prerequisite for planning of health care and for calculating the costs of treatment.