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Background Change is an ongoing process in any organizations. Over years, healthcare organizations have been exposed to multiple external stimuli to change (eg, ageing population, increasing incidence of chronic diseases, ongoing Sars-Cov-2 pandemic) that pointed out the need to convert the current healthcare organizational model. Nowadays, the topic is extremely relevant, rendering organizational change an urgency. The work is structured on a double level of analysis. In the beginning, the paper collects the overall literature on the topic of organisational change in order to identify, on the basis of the citation network, the main existing theoretical approaches. Secondly, the analysis attempts to isolate the scientific production related to the healthcare context, by analysing the body of literature outside the identified citation network, divided by clusters of related studies. Methodology This review adopted a quantitative-based method that employs jointly systematic literature review and bibliographic network analysis. Specifically, the study applied a citation network analysis (CNA) and a co-occurrence keywords analysis. The CNA allowed detecting the most relevant papers published over time, identifying the research streams in literature. Results The study showed four main findings. Firstly, consistent with past studies, works reviewed pointed out a convergence on the micro-level perspective for change's analysis. Secondly, an organic viewpoint whereby individual, organization and change's outcome contribute to any organizational change's action has been found in its early stage. Thirdly, works reported change combined with innovation's concept, although the structure of the relationship has not been outlined. Fourth, interestingly, contributions have been limited within the healthcare context. Conclusion Human dimension is the primary criticality to be managed to impede failure of the re-organizational path. Individuals are not passive recipients of change: individual change acceptance has been found a key input. Few papers discussed healthcare professionals' behaviour, and those available focused on technology-led changes perspective. In this view, individual acceptance of change within the healthcare context resulted being undeveloped and offers rooms for further analyses.

CONTEXTthe current increasing demand for rehabilitation among people with Non-Communicable Diseases (NCDs) requires the identification of home-based digital solutions alternative to conventional in-clinic interventions.OBJECTIVEthis protocol proposes to test the effectiveness of an individualized telerehabilitation platform (SIDERA^B), with respect to the traditional face-to-face rehabilitation, in ensuring the continuity of care in patients with NCDs.DESIGN, SETTING, AND SUBJECTSthis randomized, single-blind, controlled two-period crossover trial will involve about 150 outpatients with NCDs (N=40 with Chronic Heart Failure – CHF, N=60 with Chronic Obstructive Pulmonary Disease – COPD, and N=50 with Parkinson’s Disease – PD) from the rehabilitation units of IRCCS Fondazione Don Carlo Gnocchi of Milan. Each participant will experience, consequently, two different types of interventions: rehabilitation with the SIDERA^B system (SIDERA^B – S), which allow for both tele-rehabilitation activities and tele-monitoring of vital parameters, and rehabilitation as usual (Usual Care – U) including a manual of rehabilitative exercises and self-monitoring of vital parameters.INTERVENTIONSsubjects will be randomly assigned to one of the two specified sequences of interventions: U/S/U (the USU group), and S/U (the SU group). Both groups will be assessed at the baseline (T1), after the first intervention (T2), and after the second intervention (T3), with a follow-up evaluation (T4) scheduled only for the USU group.MAIN OUTCOME MEASURESa multifaceted evaluation including quality of life and clinical/functional measures will be conducted at each time-point of assessment. The primary outcome measures will be 1) change in activation of patients measured by the Patient Activation Measure scale, and 2) change in subject’s level of activity and participation measured by the WHO Disability Assessment Schedule 2.0.CONCLUSIONSIDERA^B could represent a promising innovative digital solution able to support the ongoing migration of rehabilitation care from the clinic to the patient’s home, for the optimal long-term management of NCDs.Trial registrationThe SIDERA^B trial was registered in the clinicaltrials.gov database (identifier NCT04041193) on August 1, 2019.

This article gives a personal, historical, account of the impact of the COVID-19 pandemic on transplantation services. The content is based on discussions held at two webinars in November 2020, at which kidney transplantation experts from prestigious institutions in Europe and the United States reflected on how the pandemic affected working practices. The group discussed adaptations to clinical care (i.e., ceasing, maintaining and re-starting kidney transplantations, and cytomegalovirus infection management) across the early course of the pandemic. Discussants were re-contacted in October 2021 and asked to comment on how transplantation services had evolved, given the widespread access to COVID-19 testing and the roll-out of vaccination and booster programs. By October 2021, near-normal life and service delivery was resuming, despite substantial ongoing cases of COVID-19 infection. However, transplant recipients remained at heightened risk of COVID-19 infection despite vaccination, given their limited response to mRNA vaccines and booster dosing: further risk-reduction strategies required exploration. This article provides a contemporaneous account of these different phases of the pandemic from the transplant clinician’s perspective, and provides constructive suggestions for clinical practice and research.

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.

Rolando Innocenti,1 Luigi Rigacci,1,2 Umberto Restelli,3,4 Barbara Scappini,1 Giacomo Gianfaldoni,1 Rosa Fanci,1 Francesco Mannelli,1 Francesca Scolari,3 Davide Croce,3,4 Erminio Bonizzoni,5 Tania Perrone,6 Alberto Bosi1 1Hematology Department, University of Florence and AOU Careggi, Florence, Italy; 2Hematology Unit and Bone Marrow Transplant Unit, San Camillo Forlanini Hospital, Rome, Italy; 3Center for Health Economics, Social and Health Care Management, LIUC – Università Cattaneo, Castellanza (VA), Italy; 4School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 5Section of Medical Statistics and Biometry “GA Maccacaro”, Department of Clinical Science and Community, University of Milan, Milan, Italy; 6Medical Affairs Department, Italfarmaco SpA, Milan, Italy Purpose: We conducted a retrospective study to evaluate the efficacy and related costs of using two different molecules of granulocyte-colony stimulating factor (G-CSF) (lenograstim – LENO or filgrastim – FIL) as primary prophylaxis of chemotherapy-induced neutropenia in a hematological inpatient setting. Methods: The primary endpoints of the analysis were the efficacy of the two G-CSFs in terms of the level of white blood cells, hemoglobin and platelets at the end of the treatment and the per capita direct medical costs related to G-CSF prophylaxis. Results: Two hundred twelve patients (96 LENO, 116 FIL) have been evaluated. The following statistically significant differences have been observed between FIL and LENO: the use of a higher number of vials (11 vs 7; P

Background The economic burden of Primary Biliary Cholangitis (PBC) has not been investigated at population-level. Aim of this study was to estimate the cost of illness of PBC in Lombardy, Italy. Methods Individuals with PBC were identified through ICD-9-CM code 571.6 and/or medical exemption code 008.571.6, from the Banca Dati Assistito of Lombardy. Only health services (outpatient, inpatient activities and drugs) related to PBC were considered to estimate direct medical costs in 2017. Results We identified 970 adult patients (83.5% females) with a mean age of 61 years. Global annual costs were equal to € 913,763 (€ 942 per patient), with € 459,506 (50.3%, € 474 per patient) deriving from hospitalizations (mostly due to liver transplantation, 30.5%, and cirrhosis complications, 20.6%). Costs from outpatient activities were € 109,090 (11.9%, € 112 per patient). Conclusions This study provides an overview of the costs attributed to PBC care and management, mainly related to hospitalizations for cirrhosis complications, which is necessary for assuring cost-effective introduction of novel therapies. Additional studies focused on indirect cost, e.g. overall loss of productivity, are warranted.

Health Technology Assessment (HTA) is a widely implemented technical tool used to inform the decision-making process...

Background Since HIV+ treatment has become more effective, the average age of people living with HIV (PLWHIV) has increased, and consequently the incidence of developing comorbidities, making the clinical and economic management of HIV+ patients more complex. Limited literature exists regarding the management of comorbidities costs. This study is aimed at defining and comparing the total annual costs of comorbidities, in an Italian cohort of HIV and HIV/HCV patients, from the National Healthcare Service perspective. The authors hypothesised that there are higher costs, for patients with multiple comorbidities, and a greater consumption of resources for HIV/HCV co-infected patients versus HIV mono-infected patients. Methods An observational retrospective multi-centre health-economics study, enrolling HIV+ and HIV/HCV consecutive patients with at least one comorbidity, was conducted. The consecutive cases, provided by three Italian infectious diseases centres, were related to the year 2016. The enrolled patients were on a stable antiviral therapy for at least six months. Demographic and clinical information was recorded. Costs related to HIV and HCV therapies, other treatments, medical examinations, hospitalizations and outpatient visits were evaluated. Data from mono-infected and co-infected groups of patients were compared, and the statistical analysis was performed by t-tests, chi-square and ANOVA. A sub-analysis excluding HCV therapy costs, was also conducted. The hierarchical sequential linear regression model was used to explore the determinants of costs, considering the investigated comorbidities. All analyses were conducted with a significant level of 0.05. Results A total of 676 patients, 82% male, mean age 52, were identified and divided into groups (338 mono-infected HIV+ and 338 co-infected HIV/HCV patients), comparable in terms of age, gender, and demographic characteristics. A trend towards higher annual costs, for patients with multiple comorbidities was observed in HIV mono-infected patients (respectively € 8272.18 for patients without comorbidities and € 12,532.49 for patients with three or more comorbidities, p-value: 0.001). Excluding anti-HCV therapies costs, HIV/HCV co-infected patients generally required more resources, with statistically significant differences related to cardiovascular events (€10,116.58 vs €11,004.28, p-value: 0.001), and neurocognitive impairments events (€7706.43 vs €11,641.29 p- value: Conclusions This study provides a differentiated and comprehensive analysis of the healthcare resources needed by HIV and HIV/HCV patients with comorbidities and may contribute to the decision process of resources allocation, in the clinical management of different HIV+ patient populations.

© The Author(s) 2020., [Background and Objective]: Schizophrenia is a low-prevalence mental disorder with a global age-standardized prevalence of 21 million people (2016). Second-generation antipsychotics (lurasidone and quetiapine XR) are recommended as the first-line treatment for schizophrenia. It is interesting to investigate how the results of clinical studies translate into direct medical costs. The objective of this analysis was to assess the direct medical costs related to pharmaceutical treatments and the management of relapses in patients affected with schizophrenia treated with lurasidone (74 mg) vs quetiapine XR (300 mg) assuming the Italian and Spanish National Health Service perspective. [Methods]: A health economic model was developed based on a previously published model. The analysis considered direct medical costs related to the pharmacological therapies and inpatient or outpatient management of relapses (direct medical costs referred to 2019). The probability of relapses and related costs were derived from two systematic reviews. A deterministic sensitivity analysis was implemented to test the robustness of the results. [Results]: The use of lurasidone (74 mg) compared with quetiapine XR (300 mg) would lead to a reduction in direct medical costs in Italy and Spain, with a lower cost per patient of − 163.7 € (− 9.0%) and − 327.2 € (− 22.7%), respectively. In detail, it would lead to an increase in the cost of therapy of + 53.8% and of + 30.5% in Italy and Spain, respectively, to a decrease in the cost of relapses with hospitalization of − 135.7%, and to an increase in the cost of relapses without hospitalization of + 24.5%. [Conclusions]: The use of lurasidone (74 mg) for the treatment of patients affected with schizophrenia, compared with quetiapine XR (300 mg), would be a cost-saving strategy in the two contexts investigated assuming the National Health Service point of view., This analysis was funded by an unconditional grant from Angelini SpA.

Background It is well established that single pill combination (SPC) therapies have the potential to improve patient adherence versus multi-pill regimens, thereby improving blood pressure control and clinical outcomes in populations with hypertension. Purpose To develop a microsimulation model, capturing different treatment pathways, to project the impact on clinical outcomes of using single pill combination therapies for the management of hypertension in five countries (Italy, Russia, China, South Korea and Mexico). Methods The model was designed to project health outcomes between 2020 and 2030 for populations with hypertension managed according to four different treatment pathways: current treatment practices [CTP], single drug with dosage titration first then sequential addition of other agents [start low and go slow, SLGS], free choice combination with multiple pills [FCC] and combination therapy in the form of a single pill [SPC]. Model inputs were derived from Global Burden of Disease 2017 dataset, including demographics, health status/risk factors, transition probabilities and treatment attributes/healthcare utilization, and the model incorporated real-world challenges to healthcare delivery such as access to care, SBP measurement error, adherence and therapeutic inertia. Simulated outcomes of mortality, incidence of chronic kidney disease (CKD), stroke and ischemic heart disease (IHD), and disability-adjusted life years (DALYs) due to these conditions were estimated for population of 1,000,000 simulated patients for each treatment pathway and country. Results SPC therapy was projected to improve health outcomes over SLGS, FCC and CTP over 10 years in all five countries. SPC was forecast to reduce mortality by 5.4% (Italy), 4.9% (Russia), 4.5% (China), 2.3% (South Korea) and 3.6% (Mexico) versus CTP and showed greater projected reductions in mortality than SLGS and FCC. DALYs were projected to be reduced with SPC therapy by between 5.7% (Italy) and 2.2% (South Korea) compared with CTP and reductions in the incidence of clinical events were also projected with SPC therapy, with decreases in the range of 11.5% (Italy) to 4.9% (South Korea) versus CTP. Conclusions Ten-year projections of clinical outcomes associated with different anti-hypertensive treatment pathways in five countries indicated that both combination therapies (FCC and SPC) are likely to reduce the disease burden of hypertension compared with conventional management approaches, with SPC showing the greatest overall benefits due to improved adherence. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Sanofi, Gentilly, France

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

The WHO estimates that more than 185 million people are infected with hepatitis C virus (HCV) worldwide. The aim of the study is to assess the incremental cost-effectiveness ratio (ICER) of the use of daclatasvir (DCV) + sofosbuvir (SOF) + ribavirin (RBV) for 12 and 16 weeks vs SOF + RBV for 16 and 24 weeks for the treatment of genotype 3 HCV infected cirrhotic patients from the Italian National Health Service (NHS) perspective. A published cohort-based Markov model was used to perform the analysis estimating the lifetime direct medical costs associated with the management of the pathology and the quality adjusted life years gained by patients. Deterministic and probabilistic sensitivity analyses were performed to test the robustness of the results. SOF + RBV for 16 weeks was excluded from the analysis due to the significant lower effectiveness, compared with SOF + RBV for 24 weeks (51% vs 79%). DCV + SOF + RBV would increase QALYs and costs in all the comparisons: the ICERs obtained comparing DCV + SOF + RBV for 12 and 16 weeks with SOF + RBV for 24 weeks (reference scenario) are 38,572 €/QALY and 16,436 €/QALY, respectively, both below the 40,000 €/QALY threshold identified by the Italian Health Economics Association. Sensitivity analyses confirmed the robustness of the results. The use of DCV + SOF + RBV is likely to be cost-effective compared with SOF + RBV (for 24 weeks) for the treatment of cirrhotic patients infected with genotype 3 HCV considering a threshold value of 40,000 €/QALY.

ObjectiveThe aim of the analysis is to assess the organisational and economic consequences of adopting an early discharge strategy for the treatment of acute bacterial skin and skin structure infection (ABSSSI) and osteomyelitis within infectious disease departments.SettingInfectious disease departments in Greece, Italy and Spain.ParticipantsNo patients were involved in the analysis performed.InterventionsAn analytic framework was developed to consider two alternative scenarios: standard hospitalisation care or an early discharge strategy for patients hospitalised due to ABSSSI and osteomyelitis, from the perspective of the National Health Services of Greece, Italy and Spain. The variables considered were: the number of annual hospitalisations eligible for early discharge, the antibiotic treatments considered (ie, oral antibiotics and intravenous long-acting antibiotics), diagnosis-related group (DRG) reimbursements, number of days of hospitalisation, incidence and costs of hospital-acquired infections, additional follow-up visits and intravenous administrations. Data were based on published literature and expert opinions.Primary and secondary outcome measuresNumber of days of hospitalisation avoided and direct medical costs avoided.ResultsThe total number of days of hospitalisation avoided on a yearly basis would be between 2216 and 5595 in Greece (−8/−21 hospital beds), between 15 848 and 38 444 in Italy (−57/−135 hospital beds) and between 7529 and 23 520 in Spain (−27/−85 hospital beds). From an economic perspective, the impact of the early discharge scenario is a reduction between €45 036 and €149 552 in Greece, a reduction between €182 132 and €437 990 in Italy and a reduction between €292 284 and €884 035 in Spain.ConclusionsThe early discharge strategy presented would have a positive organisational impact on National Health Services, leading to potential savings in beds, and to a reduction of hospital-acquired infections and costs.

Background Image-guided navigation systems are well establish technologies; their use in clinical practice is growing. To date many publications have demonstrated their accuracy and safety. However, the acquisition and maintenance costs are high. In an era in which health expenditures are rising exponentially, analyses of the economic impact of new technologies are mandatory to assess their sustainability. Methods A retrospective analysis to assess the overall costs of a series of patients admitted to our Neurosurgical Department for spinal instrumentation. We compared two different types of spinal navigation systems: based on preoperative CT scan (January 2003-April 2009) and on intraoperative CT-like scan (April 2009-March 2013). We used a micro-costing approach by a hospital perspective considering all the phases of the treatment process, from pre admission testing to discharge. Results The study includes 875 patients. Baseline data, hospitalization and complications were similar for both. Mean cost was 7,305.9 € for intraoperative CT scan procedure and 7,666.2 € for preoperative image-guided system. The effectiveness, in terms of screw accuracy was similar. Higher costs were related to implanted materials, human resources, and disposable. Conclusions There was a statistically significant difference between the two groups in terms of costs. A break-even point for the acquisition of an intraoperative image system is calculated in almost 130 procedures. Moreover, nowadays this system is used for more than only screw insertion reducing the financial impact of this technology on a Hospital.

The aim of this study is to analyze the potential advantages of emtricitabine/tenofovir alafenamide (FTC/TAF) introduction, creating evidence-based information to orient strategies to reduce costs, thus preserving effectiveness and appropriateness. An Health Technology Assessment (HTA) was implemented in the years 2017&ndash, 2018 comparing the dual backbones available in the Italian market: FTC/TAF, FTC/TDF (tenofovir disoproxil fumarate/emtricitabine) and ABC/3TC (abacavir/lamivudine). From an efficacy point of view, FTC/TAF ensured a higher percentage of virologic control and a better safety impact than FTC/TDF (improving the renal and bone safety profile, as well as the lipid picture). From an economic point of view, the results revealed a 4% cost saving for the Italian National Healthcare Service NHS with FTC/TAF introduction compared with the baseline scenario. Qualitative perceptions&rsquo, results showed that FTC/TAF would decrease the burden of adverse events management, increasing the accessibility of patients to healthcare providers (FTC/TAF: 0.95, FTC/TDF: 0.10, ABC/3TC: 0.28, p-value: 0.016) and social costs (FTC/TDF: &minus, 0.23, FTC/TAF: 1.04, ABC/3TC: 0.23, p-value &lt, 0.001), improving patient quality of life (FTC/TDF: 0.31, FTC/TAF: 1.85, ABC/3TC: 0.38, 0.001). Healthcare services may consider the evidence provided by the present study as an opportunity to include HIV patients in a more adequate antiretroviral treatment arm, guaranteeing a personalized clinical pathway, thus becoming more efficient and effective over time.

Background The advent of new HCV drugs has generated widespread economic concerns, particularly within the Italian setting, characterized by continuous linear cuts and spending review actions. The overall trade-off between investments and savings needs an in depth analysis. Aims The study aimed to estimate the budget impact of the introduction of the novel drugs approved during the year 2015, compared with the historical situation based on the different treatment options available prior to 2015. Methods A three-year budget impact model was developed, taking into consideration the Lombardy Region (Northern Italy) Health Service perspective. The degree of liver fibrosis, genotypes, presence of only HCV or HIV/HCV co-infections, presence or absence of sustained virological response, and direct healthcare total costs were the variables of the model. Results With the introduction of the novel regimens, a higher number of HCV patients achieved a sustained virological response (+20%). Further analysis showed that an investment in innovative technologies would have given the Regional System significant economic savings within the 36-month period (−6.64%/−7.15%). Conclusions Treating HCV-infected persons in the Lombardy Region with the new drugs would reduce healthcare expenditure on this specific disease, in each forecast implemented, thus reducing the economic burden of the pathology.

Aim Little scientific evidence is available on the costs of targeted genetic testing and surveillance programmes for the identification of hereditary colorectal cancers (HCRC). The present study is a cost analysis of an intensive surveillance programme with and without the use of genetic testing, carried out in a province of northern Italy. Additionally, cancer care using an intensive surveillance programme for gene carrier subjects was compared to cancer care in subjects not selected for genetic testing who followed unselective clinical surveillance. Methods A model based on epidemiological factors was developed to estimate the incidence of gene carriers for Lynch Syndrome. A hypothetical cohort of 98 healthy people with a high cancer risk (due to being carriers of a pathogenetic MMR mutation) was followed over a period of ten years. To evaluate the economic burden of using genetic testing, a cost analysis was performed. Results Despite genetic testing causing an initial increase in costs, their use within an intensive surveillance programme generated a saving of 24%, thanks to a better selection of individuals at high risk of colorectal cancers (CRC). This resulted in reduced resource consumption and in an overall saving of 36%, when considering the treatment of patients developing a genetic cancer, as compared to an unselective clinical surveillance. Conclusions Identification of HCRC led to surveillance that is more effective and could prevent premature death of patients affected by the most common hereditary forms of CRC. This, in the long-term, could result in an overall reduction of cancer care costs.

Purpose – The purpose of this paper is to develop a benchmarking framework for assessing the performance of the distribution models adopted by the local branches of National Health Services (NHSs) for delivering health technologies to patients at a local level, and to derive prescriptions for enhancing design and optimal management of the distribution models. Design/methodology/approach – The authors focussed the study on the distribution of absorbent devices for incontinence, adopting the analytic hierarchy process as a tool for developing the benchmarking framework. The authors applied the framework to the context of the Italian NHS with respect to the Lombard Local Health Authorities, assessing their performance in terms of operational efficiency and service quality. Findings – The developed framework constitutes a novel contribution, and it allows for generating prescriptions. Through its application to the context studied the authors found that a “one-size-fits-all” distribution model cannot be proposed, as regards both efficiency and effectiveness, since process standardization does not provide benefits or savings in all contexts. Rather, a total landed cost approach in the evaluation of the distribution practices must be adopted. Practical implications – This paper offers to managers and decision makers an innovative approach to the design of distribution models for health technologies. It provides policy makers with prescriptions to develop regulations fostering a comprehensive view of the factors for an optimal health technologies distribution at a local level. Originality/value – Given the dearth of scientific publications focussed on the distribution at the local level of health technologies, this paper significantly contributes to the existing body of knowledge and it offers an innovative framework which can be proficiently replicated in manifold contexts.

Umberto Restelli,1,2 Massimiliano Fabbiani,3 Simona Di Giambenedetto,3 Carmela Nappi,4 Davide Croce,1,21Center for Health Economics, Social and Health Care Management, LIUC – Università Cattaneo, Castellanza, Italy; 2School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 3Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart, 4Health Economics, Bristol Myers Squibb S.r.l., Rome, ItalyIn 2017, the authors published an article to assess the financial consequences for the Italian National Health Service, over a 5-year period, of the adoption of a simplification strategy to atazanavir (ATV) + ritonavir (r) + lamivudine (3TC) dual therapy of HIVpositive patients receiving ATV plus two nucleoside reverse transcriptase inhibitors (NRTIs) starting from data of the Atlas-M trial at 48 weeks.1Consequently to the publication of the clinical results of the Atlas-M trial at 96 weeks, we updated the model implemented for the analysis, considering the most recent evidence.2The model was adapted considering the transitions among antiretroviral therapies (ARTs) observed in the trial, as reported in Figure 1, for years 1 and 2, and maintaining for years 3, 4, and 5 the same differential effectiveness (percentage of patients without virologic failure) observed between 48 and 96 weeks. In detail, the percentage of virologic failures considered in year 1 were 4.51% for ATV+r+2 NRTI and 0.76% for ATV+r+3TC; and in each following year were 8.66% for ATV+r+2 NRTI and 3.05% for ATV+r+3TC.

Umberto Restelli,1,2 Davide Croce,1,2 Valeria Pacelli,1 Fabio Ciceri,3,4 Corrado Girmenia51Center for Health Economics, Social and Health Care Management, LIUC - Università Cattaneo, Castellanza, VA, Italy; 2School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 3Hematology and BMT Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; 4University Vita-Salute San Raffaele, Milan, Italy; 5Department of Haematology, Oncology and Dermatology, Azienda Policlinico Umberto I, Sapienza University, Rome, ItalyBackground: The aim of the analysis is to assess the efficiency of the allocation of economic resources related to the use of letermovir cytomegalovirus (CMV) prophylaxis in adult seropositive recipients (R+) patients receiving an allogenic hematopoietic stem cell transplantation (HSCT), compared with a no-prophylaxis strategy, assuming preemptive antiviral administration in both groups from the perspective of the Italian National Health Service (NHS), through a cost-effectiveness analysis.Methods: The model used is based on a decision tree which simulates on a lifetime horizon the progression of CMV infection, considering two alternatives: the use of letermovir CMV prophylaxis, followed by preemptive therapy in case of clinically significant CMV infection, or the avoided use of letermovir CMV prophylaxis, considering direct medical costs (referred to 2018) and quality-adjusted life years (QALYs), both discounted considering a 3% annual rate. Two scenarios were considered, representing the differences related to regional contexts and clinical practice of different typologies of hospitals (public or private accredited with Regional Health Services).Results: The use of letermovir prophylaxis compared with no prophylaxis strategy would lead to an increase of QALYs and direct medical costs in the two scenarios considered, with a mean increase of 0.45 QALYs, and an increase of direct medical costs of 10,222.4 € and of 10,809.9 € in the two scenarios. The incremental cost-effectiveness ratios are equal to 22,564 €/QALY and 23,861 €/QALY. The probabilistic sensitivity analysis conducted showed a percentage of results below the threshold of 40,000 €/QALY of 67.4% and 71.3%; and below a threshold of 25,000 €/QALY equal to 50.4% and to 53.0%.Conclusions: The use of letermovir CMV prophylaxis in adult R+ patients receiving allogenic HSCT, compared with a no-prophylaxis strategy, would be cost-effective for the Italian NHS considering the incremental cost-effectiveness thresholds of 40,000 €/QALY and of 25,000 €/QALY.Keywords: cytomegalovirus, letermovir, allogenic hematopoietic stem cell transplantation, cost-effectiveness analysis

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

Innocenti R, Rigacci L, Restelli U, et al J Blood Med. 2019;10:21–27.On page 24, Figure 2, the key for the figure was incorrect. Read the original article

Hepatitis C (HCV) is a liver inflammation which, through the activation of the immune defense system, causes the death of liver cells (liver necrosis). Like Hepatitis B, it can become chronic, turning into a long term pathology. The aim of the present study was to evaluate a new technology useful to diagnose HCV, based on a serological kit HCVAg, comparing it with the standard technology, according to a multi-dimensional approach. In order to analyze the differences between the two technologies, three dimensions were considered: (i) process costs, (ii) organizational aspects and (iii) budget impact. Data were collected by observational analysis and supported with administrative data. Activity Based Costing methodology (ABC), and a Budget Impact Analysis approach (BIA) were implemented. The new technology reduced the time needed to complete a medical report to 90 minutes, with a positive organizational impact, and allowed an immediate definition of the presence or absence of HCV infection, with quantitative results. Data showed that its introduction would bring economic savings to the Regional and National Health Service: a hospital could reduce the direct and indirect costs by 47.90% each and contribute to a reduction in funding at Regional or National level by 26.96%. The introduction of the new technology, if compared with the standard one, would give similar effectiveness, with a lower organizational and economic impact, both for a hospital and for a Regional/National Health Service, with a good equity impact for HCV infected patients.

Purpose: The study aims at assessing the organizational and economic impact related to the use of a new portable syringe pump (Pompa Infonde®, Italfarmaco S.p.A., Cinisello Balsamo, Italy) at a hospital level. Methodology: Based on the HTA approach, the analysis assessed the organizational and economic impact of the new device at hospital level, using the traditional methods of Iloprost infusion as comparator. After a pilot evaluation, the organizational impact was assessed within 24 Italian hospitals. Structured interviews were conducted with clinicians and nurses. According to the Hospital-Based HTA approach, a questionnaire assessed the impact on human resources, training activities, internal meetings, spaces needed, facilities, clinical practice implications. Using Activity Based Costing approach, the economic evaluation was performed within the pilot center “Ospedale Civile” of Legnano, Italy. Findings: The new device leads to a positive managerial impact, with a substantial reduction of time to monitor patients by nurses. This resulted in a better management of human resources and in a reduction in nursing cost. Although a mild negative impact on training time for personnel, the structured interviews allowed the identification of three main areas of positive impact: (i) efficiency of internal processes, (ii) clinical pathways, (iii) synergies between wards. Originality: The organizational impact of Pompa Infonde®, showed that it is an efficient alternative to traditional methods, with benefits in the management of patients administered with Iloprost.

Objectives: Hospital Based Health Technology Assessment (HBHTA) practices, to inform decision making at the hospital level, emerged as urgent priority for policy makers, hospital managers, and professionals. The present study crystallized the results achieved by the testing of an original framework for HBHTA, developed within Lombardy Region: the IMPlementation of A Quick hospital-based HTA (IMPAQHTA). The study tested: (i) the HBHTA framework efficiency, (ii) feasibility, (iii) the tool utility and completeness, considering dimensions and sub-dimensions.Methods: The IMPAQHTA framework deployed the Regional HTA program, activated in 2008 in Lombardy, at the hospital level. The relevance and feasibility of the framework were tested over a 3-year period through a large-scale empirical experiment, involving seventy-four healthcare professionals organized in different HBHTA teams for assessing thirty-two different technologies within twenty-two different hospitals. Semi-structured interviews and self-reported questionnaires were used to collect data regarding the relevance and feasibility of the IMPAQHTA framework.Results: The proposed HBHTA framework proved to be suitable for application at the hospital level, in the Italian context, permitting a quick assessment (11 working days) and providing hospital decision makers with relevant and quantitative information. Performances in terms of feasibility, utility, completeness, and easiness proved to be satisfactory.Conclusions: The IMPAQHTA was considered to be a complete and feasible HBHTA framework, as well as being replicable to different technologies within any hospital settings, thus demonstrating the capability of a hospital to develop a complete HTA, if supported by adequate and well defined tools and quantitative metrics.

Umberto Restelli,1,2 Massimiliano Fabbiani,3 Simona Di Giambenedetto,3 Carmela Nappi,4 Davide Croce,1,2 1Centre for Research on Health Economics, Social and Health Care Management (CREMS), LIUC – Università Cattaneo, Castellanza, Italy; 2School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 3Institute of Clinical Infectious Diseases, Catholic University of Sacred Heart, 4Health Economics, Bristol-Myers Squibb S.r.l., Rome, Italy Background: This analysis aimed at evaluating the impact of a therapeutic strategy of treatment simplification of atazanavir (ATV)+ ritonavir (r) + lamivudine (3TC) in virologically suppressed patients receiving ATV+r+2 nucleoside reverse transcriptase inhibitors (NRTIs) on the budget of the Italian National Health Service (NHS).Methods: A budget impact model with a 5-year time horizon was developed based on the clinical data of Atlas-M trial at 48 weeks (in terms of percentage of patients experiencing virologic failure and adverse events), from the Italian NHS perspective. A scenario in which the simplification strategy was not considered was compared with three scenarios in which, among a target population of 1,892 patients, different simplification strategies were taken into consideration in terms of percentage of patients simplified on a yearly basis among those eligible for simplification. The costs considered were direct medical costs related to antiretroviral drugs, adverse events management, and monitoring activities.Results: The percentage of patients of the target population receiving ATV+r+3TC varies among the scenarios and is between 18.7% and 46.9% in year 1, increasing up to 56.3% and 84.4% in year 5. The antiretroviral treatment simplification strategy considered would lead to lower costs for the Italian NHS in a 5-year time horizon between –28.7 million € and –16.0 million €, with a reduction of costs between –22.1% (–3.6 million €) and –8.8% (–1.4 million€) in year 1 and up to –39.9% (–6.9 million €) and –26.6% (–4.6 million €) in year 5.Conclusion: The therapy simplification for patients receiving ATV+r+2 NRTIs to ATV+r+3TC at a national level would lead to a reduction of direct medical costs over a 5-year period for the Italian NHS. Keywords: protease inhibitor, economic evaluation, cost, de-intensification, antiretroviral therapy, Italian National Health Service

Umberto Restelli,1,2 Giovanni Luca Ceresoli,3 Davide Croce,1,2 Laura Evangelista,4 Lorenzo Stefano Maffioli,5 Letizia Gianoncelli,3 Emilio Bombardieri6 1Center for Health Economics, Social and Health Care Management, LIUC – Università Cattaneo, Castellanza, Italy; 2School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 3Medical Oncology Department, Thoracic and Urologic Oncology Unit, Cliniche Humanitas Gavazzeni, Bergamo, 4Nuclear Medicine and Molecular Imaging Unit, Veneto Institute of Oncology IOV – IRCCS, Padova, 5Nuclear Medicine Department, Cancer Centre – ASST Ovest Milanese, Legnano, 6Nuclear Medicine Department, Cliniche Humanitas Gavazzeni, Bergamo, Italy Background: Prostate cancer (PCa) accounts for 20% of all cancers in subjects over 50 years in Italy. The majority of patients with PCa present with localized disease at the time of diagnosis, but many patients develop recurrent metastatic disease after treatment with curative intent. Androgen deprivation therapy is the standard of care for metastatic PCa patients; unfortunately, most of them progress to castrate-resistant prostate cancer (CRPC) within 5 years. Metastatic CRPC (mCRPC) heavily affects patients in terms of quality of life, side effects, and survival, and greatly impacts economic costs. The approval of new effective agents in recent years, including cabazitaxel, abiraterone acetate, enzalutamide, and radium-223, has dramatically changed patient management.Materials and methods: Here, we aimed to estimate the current costs of illness of mCRPC in Italy. All patients affected by mCRPC and treated with a single agent in an annual time horizon were considered. Therefore, the analysis was not focused on the management pathway of single patients through different lines of treatment. Direct medical costs referred to therapy, adverse event management, and skeletal-related event management were analyzed. A bottom-up approach was used to estimate the resource consumption: through national guidelines and expert opinions, the mean cost per patient was estimated and then multiplied by the total number of patients diagnosed with mCRPC. Results: Direct medical costs ranged from €196.5 million to €228.0 million, representing ~0.2% of the financing of the Italian National Health Service in 2016. The main cost driver was the cost of treatment, which represented more than 77% of the overall economic burden.Conclusion: Our analysis, reflective of real clinical practice, shows for the first time the high economic cost of mCRPC in Italy. Keywords: metastatic castrate-resistant prostate cancer, cost analysis, resource consumption, Italy, skeletal related events, oncology

Purpose Diabetic macular edema (DME) is a leading cause of vision loss and blindness. The aim of this study was to evaluate the economic benefits of introducing additional alternative technologies (Dexamethasone intravitreal implant - DEX - and Aflibercept injections), compared with the historical scenario of Ranibizumab intravitreal injections. Methods A 3-year budget impact model was developed, taking into consideration the perspective of the Lombardy Region Healthcare Service (LRHS). Total administration costs (real-life data retrieved from clinical practice at three Departments of Ophthalmology) as well as costs related to the management of potential adverse events (information collected from the literature) were analysed. Results Over a 36-month horizon, the results showed that a higher consumption of DEX could lead to significant economic savings for the Regional Healthcare Service, ranging from a minimum of -4.35% (if DEX were used only in the second-line of treatment) to a maximum of -12.97% (if DEX were used in both the first-line and second-line), including the potential impact of adverse events. Therapy costs with Aflibercept and Ranibizumab were similar. Conclusions This study demonstrates that concentrating all eligible patients within the Ranibizumab regimen is unlikely to represent a cost-effective strategy. Indeed, significant economic advantages would be achieved by introducing the other licensed alternatives, Dexamethasone implant and Aflibercept, thus optimising DME Italian healthcare expenditure. The results demonstrate DEX as an advantageous technological alternative for the target population affected by DME, both as a first- and second-line treatment option, reducing the economic burden of the pathology for the Regional/National Health Service.

Umberto Restelli,1,2 Massimo Andreoni,3 Andrea Antinori,4 Marzia Bonfanti,2 Giovanni Di Perri,5 Massimo Galli,6 Adriano Lazzarin,7 Giuliano Rizzardini,8,9 Davide Croce1,2 1Department of Community Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 2Centro di Ricerca in Economia e Management in Sanità e nel Sociale (CREMS), Università Carlo Cattaneo – LIUC, Castellanza (VA), Italy; 3Clinical Infectious Diseases, Tor Vergata University (PTV), Rome, Italy; 4Clinical Department, National Institute for Infectious Diseases "L. Spallanzani," Rome, Italy; 5Department of Medical Sciences, Infectious Diseases, Amedeo di Savoia Hospital, Turin, Italy; 6Third Division of Infectious Diseases, "Luigi Sacco" Hospital, Milan, Italy; 7Department of Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy; 8First and Second Divisions of Infectious Diseases, "Luigi Sacco" Hospital, Milan, Italy; 9School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Background: Deintensification and less drug regimen (LDR) antiretroviral therapy (ART) strategies have proved to be effective in terms of maintaining viral suppression in human immunodeficiency virus (HIV)-positive patients, increasing tolerability, and reducing toxicity of antiretroviral drugs administered to patients. However, the economic impact of these strategies have not been widely investigated. The aim of the study is to evaluate the economic impact that ART LDR could have on the Italian National Health Service (INHS) budget. Methods: A budget impact model was structured to assess the potential savings for the INHS by the use of ART LDR for HIV-positive patients with a 3 year perspective. Data concerning ART cost, patient distribution within different ARTs, and probabilities for patients to change ART on a yearly basis were collected within four Italian infectious diseases departments, providing ART to 13.7% of the total number of patients receiving ART in Italy. Results: The LDR investigated (protease inhibitor-based dual and monotherapies) led to savings for the hospitals involved when compared to the "do nothing" scenario on a 3 year basis, between 6.7% (23.11 million €) and 12.8% (44.32 million €) of the total ART expenditures. The mean yearly cost per patient is reduced from 9,875 € in the do nothing scenario to a range between 9,218 € and 8,615 €. The use of these strategies within the four departments involved would have led to a reduction of ART expenditures for the INHS of between 1.1% and 2.1% in 3 years. Conclusion: ART LDR simplification would have a significant impact in the reduction of ART-related costs within the hospitals involved in the study. These strategies could therefore be addressed as a sustainable answer to the public financing reduction observed within the INHS in the last year, allowing therapies to be dispensed without affecting the quality of the services provided. Keywords: antiretroviral therapy, Italy, budget impact model, monotherapy, dual therapy, cost

Umberto Restelli,1,2 Massimo Andreoni,3 Andrea Antinori,4 Marzia Bonfanti,2 Giovanni Di Perri,5 Massimo Galli,6 Adriano Lazzarin,7 Giuliano Rizzardini,8,9 Davide Croce1,2 1Department of Community Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; 2Centro di Ricerca in Economia e Management in Sanità e nel Sociale (CREMS), Università Carlo Cattaneo – LIUC, Castellanza (VA), Italy; 3Clinical Infectious Diseases, Tor Vergata University (PTV), Rome, Italy; 4Clinical Department, National Institute for Infectious Diseases "L. Spallanzani," Rome, Italy; 5Department of Medical Sciences, Infectious Diseases, Amedeo di Savoia Hospital, Turin, Italy; 6Third Division of Infectious Diseases, "Luigi Sacco" Hospital, Milan, Italy; 7Department of Infectious Diseases, San Raffaele Scientific Institute, Milan, Italy; 8First and Second Divisions of Infectious Diseases, "Luigi Sacco" Hospital, Milan, Italy; 9School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa Background: Deintensification and less drug regimen (LDR) antiretroviral therapy (ART) strategies have proved to be effective in terms of maintaining viral suppression in human immunodeficiency virus (HIV)-positive patients, increasing tolerability, and reducing toxicity of antiretroviral drugs administered to patients. However, the economic impact of these strategies have not been widely investigated. The aim of the study is to evaluate the economic impact that ART LDR could have on the Italian National Health Service (INHS) budget. Methods: A budget impact model was structured to assess the potential savings for the INHS by the use of ART LDR for HIV-positive patients with a 3 year perspective. Data concerning ART cost, patient distribution within different ARTs, and probabilities for patients to change ART on a yearly basis were collected within four Italian infectious diseases departments, providing ART to 13.7% of the total number of patients receiving ART in Italy. Results: The LDR investigated (protease inhibitor-based dual and monotherapies) led to savings for the hospitals involved when compared to the "do nothing" scenario on a 3 year basis, between 6.7% (23.11 million €) and 12.8% (44.32 million €) of the total ART expenditures. The mean yearly cost per patient is reduced from 9,875 € in the do nothing scenario to a range between 9,218 € and 8,615 €. The use of these strategies within the four departments involved would have led to a reduction of ART expenditures for the INHS of between 1.1% and 2.1% in 3 years. Conclusion: ART LDR simplification would have a significant impact in the reduction of ART-related costs within the hospitals involved in the study. These strategies could therefore be addressed as a sustainable answer to the public financing reduction observed within the INHS in the last year, allowing therapies to be dispensed without affecting the quality of the services provided. Keywords: antiretroviral therapy, Italy, budget impact model, monotherapy, dual therapy, cost

Objectives To assess the clinical and the economic impacts of intraprocedural use of contrast-enhanced ultrasound (CEUS) in patients undergoing percutaneous radiofrequency ablation for small (