OBJECTIVES: To describe treatment patterns, survival outcomes and direct healthcare costs charged to the Italian National Healthcare Service (SSN) of patients newly diagnosed with diffuse large B-cell lymphoma (DLBCL) from 2018 to 2021 and first-line treated (i.e., rituximab+polychemotherapy).

METHODS: From the Fondazione ReS (Ricerca e Salute) database (administrative healthcare data of ~5.4 million inhabitants/year), among new adult cases of DLBCL from 01/01/2018 to 12/31/2021 (index date: first in-hospital diagnosis), patients first-line treated within 6 months after index date were selected. Demographics and comorbidities were described at baseline (from 4 to 8 years preceding index date). Patient distributions by line of therapy (including hemopoietic stem cell transplantation - HSCT) overall survival and per capita mean annual direct healthcare costs reimbursed by the SSN were assessed from 1 to 4 years following index date.

RESULTS: Overall, 206 new cases of DLBCL first-line treated (annual incidence: from 0.9 to 1.7 x100,000 adults) were identified from 2018 to 2021. Of them, 56% were males and 52% had ≥2 comorbidities, mostly cardio-metabolic. Median age was 68 (56; 75) years. Of the 2018 cohort, during the 4-year follow-up available: the survival probability was 56%; 38% patients received a second-line therapy, 15% a third line, 5% a fourth line, 4% a fifth line. At least one HSCT after the first line was performed to 0.2%, 17% and 6% of new cases in 2018, 2020 and 2021, respectively. During the first follow-up year, on average, the SSN spent from €20,000 to €30,000 per patient, of which antineoplastic treatments accounted for 40-53%. Costs reduced with time in favour of other drugs and HSCT.

CONCLUSIONS: This study of a subpopulation of new cases of DLBCL first-line treated in Italy provided the rate of refractory/relapsed DLBCL patients and their direct healthcare burden on the universal-coverage SSN.