Abstract

Two biosimilars (Truxima® and Rixathon®) from the reference product Mabthera® (rituximab) indicated in non-Hodgkin’s lymphoma (nHL) and chronic lymphocytic leukaemia (CLL) were introduced in France by the end of 2017. The objective of this study was to describe the financial impact of the introduction of these two biosimilars in France. The EGB (Echantillon Généraliste de Bénéficiaires) database, a 1/97th random sample of the French healthcare insurance database linked with the hospital discharge database (PMSI) was used. Patients were identified for the years 2017 and 2018 through admissions with haematologic diagnosis (follicular lymphoma, non-follicular lymphoma, non-Hodgkin’s lymphoma, malignant immunoproliferative diseases and chronic lymphocytic leukaemia). The impact was assessed by comparing market shares of the reference product from 2017 to 2018 in terms of number of unique patients and total number of admissions. The financial impact was extrapolated to the national level from the national health insurance perspective. The study identified 195 and 215 patients for 2017 and 2018 respectively, with either a diagnosis of nHL or CLL and receiving at least one dose of rituximab. In 2017, Mabthera® was administered mostly to patients with other non-follicular lymphoma (40%) and follicular lymphoma (26%). The cost of Mabthera® was estimated at €472 million in 2017. By 2018, unique patients who were administered Mabthera® decreased by 35%, and financial cost by 65% (€303 million). In 2018, biosimilars were administered for 53% in other non-follicular lymphoma, 33% in follicular lymphoma, 66% in CLL, 52% in other non-Hodgkin's lymphoma, and 77% in Malignant immunoproliferative diseases, for cost of €202 million. Biosimilars were administered only in regional public hospitals and mostly in outpatient admissions. These results show that introduction of biosimilars of rituximab induced €100 million savings from the national health insurance perspective.

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