Health Economic Aspects of Chimeric Antigen Receptor T-cell Therapies for Hematological Cancers: Present and Future

Abstract

Since 2018, 2 chimeric antigen receptor (CAR) T-cell therapies received approval from the European Medicine Agency, with list prices around 320 000 Euro (€) (EUR) per treatment. These high prices raise concerns for patient access and the sustainability of healthcare systems. We aimed to estimate the costs and budget impact associated with CAR T-cell therapies for current and future indications in hematological cancers from 2019 to 2029. We focused on the former France, Germany, Spain, Italy and the United Kingdom (EU-5) and the Netherlands. We conducted a review of list prices, health technology assessment reports, budget impact analysis dossiers, and published cost-effectiveness analyses. We forecasted the 10-year health expenditures on CAR T-cells for several hematological cancers in selected European Union countries. Nine cost-effectiveness studies were identified and list prices for CAR T-cell therapies ranged between 307 200 EUR and 350 000 EUR. Estimated additional costs for pre- and post-treatment were 50 359 EUR per patient, whereas the incremental costs of CAR T-cell therapy (when compared with care as usual) ranged between 276 086 EUR and 328 727 EUR. We estimated market entry of CAR T-cell therapies for chronic mantle cell lymphoma, follicular lymphoma, chronic lymphocytic leukemia, multiple myeloma, and acute myeloid leukemia in 2021, 2022, 2022, 2022, and 2025, respectively. Cumulative expenditure estimates for existing and future indications from 2019 to 2029 were on average 28.5 billion EUR, 32.8 billion EUR, and 28.9 billion EUR when considering CAR T-cell therapy costs only, CAR T-cell therapy costs including pre- and post-treatment, and incremental CAR T-cell therapy costs, respectively. CAR T-cell therapies seem to be promising treatment options for hematological cancers but the financial burden on healthcare systems in the former EU-5 and the Netherlands will contribute to a substantial rise in healthcare expenditure in the field of hematology.

CAR T-Cell Therapies in Italy: Patient Access Barriers and Recommendations for Health System Solutions

“…638 DLBCL patients (14%) are estimated to have relapsed or have been refractory after two lines of systemic therapy, which corresponds to the EMA-approved indication for CAR T-cell therapies (Belleudi et al, 2021;Di Rocco et al, 2021). Of note, other estimations for Italy (Heine et al, 2021) as well as from the French Haute Autorité de Santé (HAS, 2021b; 2021a) report a higher percentage (17%) of DLBCL patients relapsed or refractory after two lines of systemic therapy, which would correspond to 775 Italian patients in 2020. For centers to receive reimbursement for CAR T-cell therapies provided, specific patient selection criteria defined by AIFA and based on the registrational trial inclusion/exclusion criteria must be applied (Table 2) (AIFA, 2019c; 2021c).…”

Budget Impact Analysis of CAR T-cell Therapy for Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma in Germany

“…Although this analysis attempted to portray the incremental costs of CAR T-cell therapies, no adequate BIA was conducted. 39 …”

Resource utilization for chimeric antigen receptor T cell therapy versus autologous hematopoietic cell transplantation in patients with B cell lymphoma

“…Estimates on the overall cost of CAR-T therapy for all hematological cancers range between 11.1 billion EUR (12.5 billion USD) and 88.8 billion EUR (100 billion USD) for the period from 2019 to 2029 [24,25]. Such high costs present a major challenge to the health care system and to society.…”