Multidimensional Results and Reflections on CAR-T: The Italian Evidence

Emanuela Foglia, Elisabetta Garagiola (), Vito Ladisa, Alessandro Rambaldi, Roberto Cairoli, Simona Sammassimo, Emanuela Omodeo Salè, Pier Luigi Zinzani, Marco Esposti, Luisa Alberti, Maria Franca Mulas, Eleonora Melis, Stefania Onnis, Maurizio Marcias, Vittorio Satta and Davide Croce
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Emanuela Foglia: Centre for Research on Health Economics, Social and Health Care Management, LIUC-Università Cattaneo, 21053 Castellanza, Italy
Elisabetta Garagiola: Centre for Research on Health Economics, Social and Health Care Management, LIUC-Università Cattaneo, 21053 Castellanza, Italy
Vito Ladisa: Hospital Pharmacy, IRCCS National Cancer Institute Foundation, 20133 Milan, Italy
Alessandro Rambaldi: Department of Oncology and Hematology, Papa Giovanni XXIII Hospital, 24127 Bergamo, Italy
Roberto Cairoli: Division of Hematology, Grande Ospedale Metropolitano Niguarda Hospital, 20162 Milano, Italy
Simona Sammassimo: Department of Oncology and Hematology-Oncology, European Institute of Oncology, 20141 Milan, Italy
Emanuela Omodeo Salè: Hospital Pharmacy, European Institute of Oncology, 20141 Milan, Italy
Pier Luigi Zinzani: Institute of Hematology “Seragnoli”, IRCCS University Hospital of Bologna, 40139 Bologna, Italy
Marco Esposti: Management Control, Lodi Hospital, 26900 Lodi, Italy
Luisa Alberti: Territorial Pharmaceutical Complex Structure, Regional Health Authority—ARES Sardinia, 09047 Cagliari, Italy
Maria Franca Mulas: General Direction, Policlinico Tor Vergata, 00133 Rome, Italy
Eleonora Melis: Complex Structure for Planning and Management Control, Regional Health Authority—ARES Sardinia, 07100 Sassari, Italy
Stefania Onnis: Territorial District 3—Quartu Parteolla, Local Healthcare Authority—ASL 8, 09126 Cagliari, Italy
Maurizio Marcias: Complex Structure of Pharmacoeconomics and Pharmacovigilance, Regional Health Authority—ARES Sardinia, 09047 Cagliari, Italy
Vittorio Satta: Complex Structure Health Technology Assessment, Regional Health Authority—ARES Sardinia, 09047 Cagliari, Italy
Davide Croce: Centre for Research on Health Economics, Social and Health Care Management, LIUC-Università Cattaneo, 21053 Castellanza, Italy

IJERPH, 2023, vol. 20, issue 5, 1-17

Abstract: The present study aims at defining the economic and organizational impacts of the introduction of chimeric antigen receptor T-cell therapy (CAR-T) in Italy, for the management of diffuse large B-cell lymphoma (DLBCL) patients in third-line therapy, defining the overall level of sustainability for both hospitals and the National Healthcare System (NHS). The analysis focused on CAR-T and Best Salvage Care (in the following BSC), assuming the Italian hospital and NHS perspectives, over a 36-month time horizon. Process mapping and activity-based costing methodologies were applied to collect the hospital costs related to the BSC and CAR-T pathways, including adverse event management. Anonymous administrative data on services provided (diagnostic and laboratory examinations, hospitalizations, outpatient procedures, and therapies) to 47 third-line patients with lymphoma, as well as any organizational investments required, were collected, in two different Italian Hospitals. The economic results showed that the BSC clinical pathway required less resources in comparison with CAR-T (excluding the cost related to the therapy) (BSC: 29,558.41 vs. CAR-T: EUR 71,220.84, −58.5%). The budget impact analysis depicts that the introduction of CAR-T would generate an increase in costs ranging from 15% to 23%, without considering treatment costs. The assessment of the organizational impact reveals that the introduction of CAR-T therapy would require additional investments equal to a minimum of EUR 15,500 to a maximum of EUR 100,897.49, from the hospital perspective. Results show new economic evidence for healthcare decision makers, to optimize the appropriateness of resource allocation. The present analysis suggests the need to introduce a specific reimbursement tariff, both at the hospital and at NHS levels, since no consensus exists, at least in the Italian setting, concerning the proper remuneration for the hospitals who guarantee this innovative pathway, assuming high risks related to timely management of adverse events.

Keywords: diffuse large B-cell lymphoma; CAR-T cells; Best Salvage Care; HTA; organizational impact; economic sustainability; Italy (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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