Pharmacoeconomic Analysis of CAR-T Cell Therapy in Diffuse Large B-Cell Lymphoma and B-Lineage Acute Lymphoblastic Leukemias

Abstract

Genetically modified Т-lymphocytes with chimeric antigen receptors (CAR-T cells) represent a new treatment strategy in relapsed/refractory B-cell malignant neoplasms. In 20172018 two CAR-T cell drugs, tisagenlecleucel and axicabtagene ciloleucel, were approved by the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for clinical use in patients with refractory acute lymphoblastic leukemia and relapsed/refractory B-cell lymphomas. Due to its high efficacy, CAR-T cell therapy is increasingly becoming an integral part of clinical practice. However, this method of chemotherapy is very expensive. The mean cost of tisagenlecleucel is $475,000 and that of axicabtagene ciloleucel is $373,000. It is worth noting that these are only the drug prices which exclude other therapy-related costs. In the studies of 2018-2020 groups of researchers attempted to estimate the CAR-T cell therapy-associated costs. The aim of the present review is to analyze these studies and to assess the total treatment cost and expense structure, as well as to discuss the factors underlying the increasing costs and to explore opportunities to improve availability of the CAR-T technology, on the whole. The results showed that the mean cost of tisagenlecleucel therapy in B-cell lymphoma was $515,150 and that of axicabtagene ciloleucel therapy was $503,955. The treatment cost in acute lymphoblastic leukemia was $580,459. The major factors affecting the total therapy cost were CAR-T cell drug prices, severity of adverse events, and high tumor load prior to CAR-T cell drug infusion. It is agreed that the main opportunities to rise affordability of the CAR-T cell therapy lie in reducing the drug prices (for example, by means of medical facility-based production at its own expense), further therapy improvement aimed at less toxicity, and its implementation at earlier stages of tumor disease.