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Emanuela Foglia,1 Federica Asperti,1 Grazia Antonacci,2,3 Yogini H Jani,4 Elisabetta Garagiola,1 Daniele Bellavia,1 Lucrezia Ferrario1 1LIUC - University Cattaneo, Healthcare Datascience LAB, Castellanza, Varese, 21053, Italy; 2Department of Primary Care and Public Health, Imperial College London, National Institute of Health Research (NIHR) Applied Research Collaboration (ARC) Northwest London, London, UK; 3Business School, Centre for Health Economics and Policy Innovation (CHEPI), Imperial College London, London, UK; 4Centre for Medicines Optimisation Research and Education, University College London Hospitals NHS Foundation Trust, London, UKCorrespondence: Elisabetta Garagiola, Healthcare Datascience Laboratory - HD LAB, LIUC-Università Cattaneo, Corso G. Matteotti, 22, Castellanza, VA, 21053, Italy, Tel +39.0331.572.467, Email egaragiola@liuc.itBackground: Automated Drug Dispensing (ADD) systems are considered to be strategic hospital assets used to reduce errors and enhance economic and organizational sustainability. With regards to efficacy and safety, the literature evidence demonstrates the incremental benefits of centralised or decentralised systems compared to manual dispensing. Analyses about organisational and economic sustainability are still lacking and the present study aims to perform a Health Technology Assessment (HTA), producing multidimensional evidence on the use of ADD systems within hospitals.Methods: In 2023, a comprehensive HTA draws insights from healthcare professionals across six European nations: Italy, France, Germany, the Netherlands, the United Kingdom, and Belgium. This appraisal juxtaposed four drug dispensing scenarios: manual methods, centralized ADD systems, decentralized ADD systems, and integrated solutions employing cutting-edge technologies in both central pharmacies and wards. The study deployed an Activity-Based Costing approach that was combined with a cost-effectiveness and Budget Impact Analysis to evaluate economic impacts. Qualitative questionnaires were implemented to assess ethical, legal, organizational, safety, and efficacy aspects.Results: From a multidimensional perspective, healthcare professionals acknowledged ADD manifold advantages of ADD systems. From an organizational perspective and within a 12-month timeframe, transitioning to automation may face initial challenges that are attributed to potential resistance from professionals and significant investments. However, 36 months past its adoption, automation’s superiority over manual methods was recognized. Economically, savings burgeoned from +17.9% in UK to +26.6% in Belgian hospitals that adopted integrated systems in comparison to traditional manual approaches.Conclusion: Compared to traditional methods, implementing ADD systems could improve the logistic management of drug in the hospital setting, thereby enhancing safety and efficacy, streamlining the healthcare professionals’ workflow, and bolstering financial stability.Keywords: automated drug dispensing systems, HTA, economic impact, drug logistic management, efficiency

Lucrezia Ferrario,1 Fabrizio Schettini,1 Angelo Avogaro,2 Chiara Bellia,3 Federico Bertuzzi,4 Graziella Bonetti,5 Antonio Ceriello,6 Marcello Ciaccio,3,7 Massimiliano Corsi Romanelli,8,9 Elena Dozio,9 Luca Falqui,10 Angela Girelli,11 Antonio Nicolucci,12 Gianluca Perseghin,13,14 Mario Plebani,15 Umberto Valentini,11 Martina Zaninotto,15 Silvana Castaldi,9,16 Emanuela Foglia1 1Centre for Health Economics, Social and Health Care Management, Università Carlo Cattaneo - LIUC, Castellanza, Italy; 2Department of Medicine, University-Hospital of Padova, Padova, Italy; 3Section of Clinical Biochemistry and Clinical Molecular Medicine, Department of Biopathology and Medical Biotechnologies, University of Palermo, Palermo, Italy; 4Diabetology Unit, Grande Ospedale Metropolitano Niguarda Hospital, Milan, Italy; 5Department of Medicine Services, Valcamonica Hospital, Esine, Italy; 6Department of Cardiovascular and Metabolic Diseases, Multimedica Research Institute, Milan, Italy; 7Department of Laboratory Medicine, University-Hospital of Palermo, Palermo, Italy; 8Service of Laboratory Medicine 1-Clinical Pathology, Policlinico San Donato, Milan, Italy; 9Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy; 10Department of Medicine, Diabetes and Endocrinology, Multimedica Research Institute, Milan, Italy; 11Diabetes Care Unit, Spedali Civili Hospital, Brescia, Italy; 12Center for Outcomes Research and Clinical Epidemiology, Pescara, Italy; 13Department of Medicine and Surgery, Università degli Studi di Milano Bicocca, Milan, Italy; 14Department of Medicine and Rehabilitation, Unit of Metabolic Medicine, Policlinico di Monza, Monza, Italy; 15Department of Laboratory Medicine, University-Hospital of Padova, Padova, Italy; 16Fondazione Ca’ Granda Ospedale Maggiore Policlinico Research Institute of Milano, Milano, ItalyCorrespondence: Lucrezia FerrarioCentre for Health Economics, Social and Health Care Management, Università Carlo Cattaneo – LIUC, Corso Matteotti 22, Castellanza, 21053, VA, ItalyTel +39 033 1572504Fax +39 033 1572513Email lferrario@liuc.itPurpose: To investigate the glycated albumin (GA) introduction implications, as an add-on strategy to traditional glycemic control (Hb1Ac and fasting plasma glucose – FPG) instruments, considering insulin-naïve individuals with type 2 diabetes mellitus (T2DM), treated with oral therapies.Methods: A Health Technology Assessment was conducted in Italy, as a multi-dimensional approach useful to validate any innovative technology. The HTA dimensions, derived from the EUnetHTA Core Model, were deployed by means of literature evidence, health economics tools and qualitative questionnaires, filled-in by 15 professionals.Results: Literature stated that the GA introduction could lead to a higher number of individuals achieving therapeutic success after 3 months of therapy (97.0% vs 71.6% without GA). From an economic point of view, considering a projection of 1,955,447 T2DM insulin-naïve individuals, potentially treated with oral therapy, GA introduction would imply fewer individuals requiring a therapy switch (− 89.44%), with a 1.06% in costs reduction, on annual basis, thus being also the preferable solution from a cost-effectiveness perspective (cost-effectiveness value: 237.74 vs 325.53). According to experts opinions, lower perceptions on GA emerged with regard to equity aspects (0.13 vs 0.72, p-value> 0.05), whereas it would improve both individuals (2.17 vs 1.33, p-value=0.000) and caregivers quality of life (1.50 vs 0.83, p-value=0.000). Even if in the short term, GA required additional investments in training courses (− 0.80 vs 0.10, p-value = 0.036), in the long run, GA could become the preferable technology (0.30 vs 0.01, p-value=0.018) from an organisational perspective.Conclusion: Adding GA to traditional glycaemic control instruments could improve the clinical pathway of individuals with T2DM, leading to economic and organisational advantages for both hospitals and National Healthcare Systems.Keywords: glycated albumin, type 2 diabetes mellitus, T2DM, Health Technology Assessment, economic evaluation, multidimensional approach

Lucrezia Ferrario,1 Fabrizio Schettini,1 Elisabetta Garagiola,1 Adriana Cecchi,2 Lucia Lugoboni,3 Paolo Serra,4 Emanuele Porazzi,1 Emanuela Foglia1 1Carlo Cattaneo – LIUC University and LIUC Business School, Castellanza, Italy; 2ARCS – Azienda Regionale di Coordinamento per la Salute, Udine, Italy; 3Bee Care, Lugano, Switzerland; 4Brotzu Hospital, Cagliari, ItalyCorrespondence: Lucrezia FerrarioCarlo Cattaneo – LIUC University and LIUC Business School, Corso Matteotti 22, Castellanza, VA 21053, ItalyTel +39 033 1572504Fax +39 033 1572513Email lferrario@liuc.itPurpose: To evaluate the incremental benefits concerning the implementation of closed-system medical devices for the preparation and administration of chemotherapy agents (integrated or not with traceable workflow), within an Italian clinical practice, in which the use of such technologies is not standardized.Methodology: Four Scenarios, implying different levels of technologies introduction, were analyzed, based on the presence and/or absence of closed systems and traceable workflow, in the preparation and in the administration phase. A literature review was conducted, in order to retrieve efficacy and safety measures. Economic and organizational benefits, assuming a hospitals perspective, were assessed by means of health-economics tools, considering 27,660 (± 695.86) drugs on average prepared, on an annual basis, by 12 hospitals involved. The typology of medical devices and other devices/equipment used, the human resources involved, and the time spent for the preparation and administration phases were collected.Results: Literature stated that the introduction of advanced technologies (CSTDs in the preparation phase, closed-system in the administration phase, both integrated by a traceable workflow) could: i) decrease surface contamination (12.24% vs 26.39%, P< 0.001) and ii) improve the capability to identify dosage errors (7% vs 0.096%, P< 0.05). The above technologies presented the best trade-off between cost sustained and efficacy gained. Despite marginal investments (ranging from +1% to +6%) being required for their acquisition, an organizational saving equal to more than 1,000 working hours emerged, which could be spent on other hospital activities.Conclusion: The implementation of closed systems, integrated with a traceable workflow grounding on gravimetric control, may be considered a valid technological alternative within the investigated setting. The marginal incremental costs could be absorbed already in the first year after their introduction, in particular, because of the potential time saving in using closed systems in both the preparation and administration phases, demonstrating the sustainability and feasibility of such advanced technologies.Keywords: closed-system medical device, chemotherapy agents, safety, economic evaluation, HTA, organisational benefits

Alberto Bretoni, Lucrezia Ferrario, Emanuela FogliaCentre for Health Economics, Social and Health Care Management, LIUC – Università Cattaneo, Castellanza, ItalyPurpose: To investigate the implications of the introduction of two hormonal therapies, abiraterone acetate + prednisone (AA+P) and enzalutamide (ENZA), for the treatment of naïve patients with metastatic castration-resistant prostate cancer (mCRPC) in the Italian setting.Methods: In 2017–2018, a Health Technology Assessment was conducted in Italy, considering the National Healthcare Service (NHS) perspective. Data were retrieved from literature evidence, economic evaluations, and qualitative questionnaires, considering the 9 EUnetHTA dimensions, and a final multi-criteria approach.Results: On the basis of mCRPC prevalence and incidence rates in Italy, the analysis considered 11,212 males eligible to either AA+P or ENZA treatments. Both drugs led to an improvement of the patients’ overall survival, with respect to the standard of care, composed of docetaxel chemotherapy. However, AA+P showed a higher rate of drug-related moderate adverse events and a monitoring activities incidence superior to ENZA (+70%, p-value=0.00), which led to a major resources absorption (€ 1,056.02 vs € 316.25, p-value=0.00), whereas ENZA showed a better cost-effectiveness average value (CEV: 54,586.12 vs 57,624.15). Economic savings ranging from 1.46% to 1.61% emerged for the NHS, as well as organizational advantages, with fewer minutes required for the mCRPC management (AA+P: 815 mins vs ENZA: 500 mins). According to experts’ perceptions, based on a 7-item Likert scale (ranging from −3 to +3), similar results emerged on ethical and social impact (ENZA: 1.35 vs AA+P: 1.48, p-value>0.05), and on legal dimension (ENZA: 0.67 vs AA+P: 0.67, p-value>0.05), since both drugs improved the patients’ quality of life and received approval for use. High-level perceptions related to ENZA adoption emerged with regard to equity (ENZA: 0.69 vs AA+P: 0.25, p-value

Tiziana Galli,1 Paolo Mirata,2 Emanuela Foglia,3 Davide Croce,3,4 Emanuele Porazzi,3 Lucrezia Ferrario,3 Elena Ricci,5 Elisabetta Garagiola,3 Roberta Pagani,3 Giuseppe Banfi6,7 1Department of Functional Recovery and Re-education, Hospital of Saronno, Hospital Authority “ASST Valle Olona”, Saronno, Italy; 2Department of Functional Recovery and Re-education, Hospital of Busto Arsizio, Hospital Authority “ASST Valle Olona”, Busto Arsizio, Italy; 3Centre for Research on Health Economics Social and Health Care Management (CREMS), LIUC - Università Cattaneo, Castellanza, Italy; 4School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 5Department of Infectious Diseases, Fatebenefratelli Sacco Hospital, Milan, Italy; 6Orthopaedics Institute, IRCCS Galeazzi, Milan, Italy; 7San Raffaele Scientific Institute, Milan, Italy Purpose: The aim of the present study was to compare 2 clinical assessment tools, the Modified Barthel Index (currently administered to patients admitted into inpatient rehabilitation units after elective hip or knee arthroplasty) with the World Health Organization Disability Assessment Schedule (WHODAS) 2.0 scale, in order to identify which tool is more suitable for assessing the disability and the “recovery rate”.Patients and methods: A perspective multicenter observational study was developed, involving 2 hospital authorities in Italy. Eighty consecutive cases of inpatients were enrolled. Patient’s disability was evaluated using both of the aforementioned tools, before and after the rehabilitation program.Results: The WHODAS 2.0 score was, on average, 12.21% higher than the Modified Barthel Index, before the surgical intervention. Modified Barthel Index measures could be considered as a determinant and a predictor of length of stay.Conclusion: The Modified Barthel Index is limited, since it does not consider a patient’s perspective. The WHODAS 2.0 scale fully considers a patient’s perception of disability. Therefore, both assessment scales should be administered in clinical practice, in order to provide integration of clinical information with a patient’s reported outcome measures. Keywords: disability, Modified Barthel Index, WHODAS 2.0, orthopedics, rehabilitation

Emanuela Foglia,1 Lucrezia Ferrario,1 Elisabetta Garagiola,1 Giuseppe Signoriello,2 Gianluca Pellino,3 Davide Croce,1,4 Silvestro Canonico3 1Centre for Health Economics, Social and Health Care Management - LIUC University, Castellanza, Italy; 2Department of Mental Health and Preventive Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy; 3School of Medicine, University of Campania “Luigi Vanvitelli”, Naples, Italy; 4School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Purpose: Surgical-site complications (SSCs) affect patients’ clinical pathway, prolonging their hospitalization and incrementing their management costs. The present study aimed to assess the economic and organizational implications of a portable device for negative-pressure wound therapy (NPWT) implementation, compared with the administration of pharmacological therapies alone for preventing surgical complications in patients undergoing general, cardiac, obstetrical–gynecological, or orthopedic surgical procedures.Patients and methods: A total of 8,566 hospital procedures, related to the year 2015 from one hospital, were evaluated considering infection risk index, occurrence rates of SSCs, drug therapies, and surgical, diagnostic, and specialist procedures and hematological exams. Activity-based costing and budget impact analyses were implemented for the economic assessment.Results: Patients developing an SSC absorbed i) 64.27% more economic resources considering the length of stay (€ 8,269±2,096 versus € 5,034±2,901, p

Giuliano Rizzardini,1 Umberto Restelli,2 Paolo Bonfanti,3 Emanuele Porazzi,2 Elena Ricci,1 Emanuela Foglia,2 Laura Carenzi,1 Davide Croce21First Infectious Diseases Department, "Luigi Sacco" Hospital, Milan; 2Centre for Research on Health Economics, Social, and Health Care Management, Università Carlo Cattaneo, Castellanza; 3Infectious Diseases Department, "Alessandro Manzoni" Hospital, Lecco, ItalyBackground: In recent years, the increased efficacy and effectiveness of antiretroviral treatment has led to longer survival of patients infected with human immunodeficiency virus (HIV), but has also raised the question of what happens to consumption of resources. Early highly active antiretroviral treatment (HAART), management of hepatitis C virus (HCV) coinfection, and expensive newly marketed drugs may affect the economic sustainability of treatment from the point of view of the National Healthcare Services. The present study aimed to provide information on the economic burden of HIV-positive patients resident in the Lombardy region using a three-year time horizon.Methods: This was a retrospective, observational, budget impact study, based on information collected for the period 2007–2009, including hospitalizations, outpatient services, and HAART and non-HAART drug utilization. Patients with confirmed HIV infection, aged ≥ 18 years, resident in the Lombardy region, and followed at the "L Sacco" Hospital in Milan from 2007 to 2009 were eligible.Results: A total of 483 patients (mean age 44.1 years) were included in the study. The mean CD4+ cell count increased over the study period from 462 ± 242 cells/mm3 in 2007, to 513 ± 267 cells/mm3 in 2008, to 547 ± 262 cells/mm3 in 2009. In total, 162 subjects (33.5%) were coinfected with HCV. Hospitalizations and HAART costs increased from 2007 to 2009, whereas outpatient visits and non-HAART drug costs decreased slightly over time. The total cost increase was also significant when limiting the analysis to experienced patients, HCV-negative patients, and experienced HCV-negative patients.Conclusion: CD4+ cell count, a major predictor of costs, increased over the study period. However, immunological improvement was achieved by greater expense in the short term. Whether this may be compensated by a long-term decrease in opportunistic infections and in the costs of management of HIV-related events is an area still to be investigated.Keywords: health care costs, human immunodeficiency virus infection, risk factors, retrospective study