Management of Clostridioides difficile infection: an Italian Delphi consensus.

BACKGROUND: Clostridioides difficile infection (CDI), a leading cause of nosocomial deaths, is a microbiota-mediated disease. As such, the use of broader spectrum antibiotics, such as vancomycin and metronidazole, can prime the gastrointestinal tract to become more prone to CDI recurrences. Fidaxomicin, a narrow-spectrum antibiotic, has been demonstrated to be superior in preventing recurrence and in preserving the intestinal microbiota; however, widespread employment worldwide has been hindered due to high acquisition costs. OBJECTIVES: To integrate the currently available guidelines on the management of CDI and to shed light on the timeliest employment of fidaxomicin. METHODS: An expert panel was gathered to obtain consensus using Delphi methodology on a series of statements regarding the management of CDI and on appropriate antibiotic use. RESULTS: Consensus was reached on 21 of the 25 statements addressing the management of CDI. CONCLUSIONS: Delphi methodology was used to achieve consensus on the management of CDI, on the identification of patients at risk of recurrences or severe infection, and on the most appropriate use of fidaxomicin, with the final aim of fostering clinical practice application of treatment algorithms proposed by previous guidelines, in absolute synergy. It could be an important tool to promote more appropriate and cost-effective CDI treatments in European settings with limited resources, like Italy.

Implementation of HCV screening in the 1969-1989 birth-cohort undergoing COVID-19 vaccination.

BACKGROUND AND AIM: The World Health Organization (WHO) goal of hepatitis C virus (HCV) elimination by 2030 relies on the scaling-up of both identification and linkage to care of the infected population, worldwide. In Italy, the estimated burden of HCV carriers who are unaware of their infection amounts to 200 000 persons, a projection that reinforces the need for broadening population access to effective screening programmes. METHODS: A pivotal screening programme targeting subjects born between 1969 and 1989 has been conducted in Lombardy, Northern Italy, where point-of-care (POC) testing was offered for free concomitantly to COVID-19 vaccination. RESULTS: Amongst 7219 subjects born between 1969 and 1989 who underwent HCV screening through POC, 7 (0.10%) subjects tested anti-HCV positive: 5 (0.07%) had confirmed anti-HCV positivity (Table 1) and 4 of them (0.05%) were HCV-RNA positive by standard confirmation tests. CONCLUSIONS: This pivotal study demonstrated the feasibility of a POC-based anti-HCV screening programme in young adults undergoing COVID-19 vaccination. The prevalence of HCV infection in subjects born in the 1969-1989 cohort in Italy seems to be lower than previously estimated. Whether the extension of this programme to subjects born before 1969 could lead to improved screening effectiveness should be a matter of debate.

Health technology assessment to employ COVID-19 serological tests as companion diagnostics in the vaccination campaign against SARS-CoV-2.

OBJECTIVES: In scenarios of vaccine scarcity or contexts of organizational complexity, it is necessary to define prioritization strategies for allocating vaccine doses in compliance with the criterion of equity and efficiency of health resources. In this context, the COVIDIAGNOSTIX project, based on the health technology assessment (HTA), assessed the role of SARS-CoV-2 serological tests as a companion diagnostic in the definition of the vaccination strategies for the vaccine administration. To guarantee evidence support for health policy choices, two different vaccine strategies were analyzed, one based on administering the vaccine booster dose to the entire population (VACCINE strategy) and the other based on allocation criteria (TEST&VACCINE strategy). METHODS: The decision-oriented HTA (DoHTA) method, integrated with specific modeling and simulation techniques, helped define the perimeter to make health policy choices. RESULTS: The processing of the scores attributed to the key performance indicators concerning all the evaluation domains shows a performance of 94.34% for the TEST&VACCINE strategy and 83.87% for the VACCINE strategy. CONCLUSIONS: TEST&VACCINE strategy can be the most advantageous in various scenarios due to greater speed from an operational and an economic point of view. The assessment schemes defined by COVIDIAGNOSTIX (i.e., technologies/intended use/settings) can easily and quickly be exported and adapted to respond to similar health "policy questions".

COVIDIAGNOSTIX: health technology assessment of serological tests for SARS-CoV-2 infection.

OBJECTIVE: In vitro diagnostic tests for SARS-COV-2, also known as serological tests, have rapidly spread. However, to date, mostly single-center technical and diagnostic performance's assessments have been carried out without an intralaboratory validation process and a health technology assessment (HTA) systematic approach. Therefore, the rapid HTA for evaluating antibody tests for SARS-COV-2 was applied. METHODS: The use of rapid HTA is an opportunity to test innovative technology. Unlike traditional HTA (which evaluates the benefits of new technologies after being tested in clinical trials or have been applied in practice for some time), the rapid HTA is performed during the early stages of developing new technology. A multidisciplinary team conducted the rapid HTA following the HTA Core Model® (version 3.0) developed by the European Network for Health Technology Assessment. RESULTS: The three methodological and analytical steps used in the HTA applied to the evaluation of antibody tests for SARS-COV-2 are reported: the selection of the tests to be evaluated; the research and collection of information to support the adoption and appropriateness of the technology; and the preparation of the final reports and their dissemination. Finally, the rapid HTA of serological tests for SARS-CoV-2 is summarized in a report that allows its dissemination and communication. CONCLUSIONS: The rapid-HTA evaluation method, in addition to highlighting the characteristics that differentiate the tests from each other, guarantees a timely and appropriate evaluation, becoming a tool to create a direct link between science and health management.

New Highly Active Antiretroviral drugs and generic drugs for the treatment of HIV infection: a budget impact analysis on the Italian National Health Service (Lombardy Region, Northern Italy).

BACKGROUND: In the healthcare sector, it is crucial to identify sustainable strategies in order to allow the introduction and use of innovative technologies. Now, and over the next few years, the expiry of patents for different antiretroviral drugs offers an opportunity to increase the efficiency of resources allocation. The aim of the present study was to assess the impact, on the budget of the Italian National Healthcare Service, of generic antiretroviral drugs and of new antiretroviral drugs entering the market from 2015 to 2019. METHODS: A budget impact model was developed in order to forecast the rate of use of ARTs, based on trends observed within the Lombardy Region (Italy), on clinical experts' opinion, and the consequent impact on the Italian NHS budget in a five year time horizon. Different scenarios were developed, considering the sole introduction of generic drugs, of new drugs, and their cumulative effects. A multivariate sensitivity analysis was also performed. RESULTS: The cumulative use of generic drugs and new drugs would lead to annual savings of 4.6 million € (-0.6 %) in 2015; 16.9 million € (-2.1 %) in 2016; 19.4 million € (-2.4 %) in 2017; 51.1 million € (-6.1 %) in 2018 and -110.3 million € (-12.8 %) in 2019. The impact of new drugs in percentage terms is +2.0 % in 2015, +3.4 % in 2016, +3.9 % in 2017, +5.7 % in 2018 and +7.7 % in 2019. The impact of generic drugs would lead to savings of 4.9 million € in 2015, 18.6 million € in 2016, 22.8 million € in 2017, 76.5 million € in 2018 and 187.4 million € in 2019. The sensitivity analysis showed annual mean savings for the Italian NHS ranging from 12.6 million €, -1.5 % compared to the base case scenario (decreasing all the rates of transition used in the simulation, and increasing the cost of generic drugs) to 76.0 million €, -9.1 % (increasing all the rates of transition used in the simulation, and decreasing the cost of generic and new drugs). CONCLUSIONS: The use of antiretroviral generic drugs may lead to savings that would compensate the expenditure increase due to new, innovative drugs available on the market.

An update on integrase inhibitors: new opportunities for a personalized therapy? The NEXTaim Project.

Thanks to the development of antiretroviral agents to control HIV replication, HIV infection has turned from a fatal disease into a treatable chronic infection. The present work collects the opinions of several experts on the efficacy and safety of recently approved second generation of integrase inhibitors and, in particular, on the role of this new class of drugs in antiretroviral therapy. The availability of new therapeutic options represents an opportunity to ameliorate the efficacy of cART in controlling HIV replication also within viral reservoirs. The personalization of the treatment driven mainly by the management of comorbidities, HIV-HCV co-infections and aging, will be easier with antiretroviral drugs without drug-drug interactions and with a better toxicity and tolerability profile. Future assessment of economic impact for the introduction of new innovative drugs in the field of antiretroviral therapy will likely need some degree of adjustment of the evaluation criteria of costs and benefit which are currently based almost exclusively on morbidity and mortality.

Health technology assessment in the HIV setting: the case of monotherapy.

Despite the success of multiple-drug therapy regimens, the idea of treating human immunodeficiency virus (HIV) infection with fewer drugs is captivating due to issues of convenience, long-term toxicities and costs. This study investigated the impact on a local health budget of the introduction of a protease inhibitor (PI)-based antiretroviral monotherapy. An analysis of 23,721 administrative records of HIV-infected patients and a health technology assessment (HTA) were performed to assess cost-effectiveness, budget, organizational, ethics, and equity impact. Data showed that monotherapy had a annual cost of € 7,076 (patient with undetectable viral load) and € 7,860 (patient with detectable viral load), and that its implementation would realise economic savings of between 12 and 24 million euro (between 4.80% and 9.72% of the 2010 total regional budget expenditure for HIV management) in the first year, with cumulated savings of between 48 and 145 million euro over the following five years. Organizational, ethical and equity impact did not indicate any significant differences. The study suggests that for specific categories of patients monotherapy may be an alternative to existing therapies. Its implementation would not result in higher operating costs, and would lead to a reduction in total expenditure.

Health Technology Assessment for Fast-Track Elective Knee and Hip Arthroplasty in a High-Volume Orthopaedic Hospital in Italy.

Objective: The objective of the analysis presented is to assess the efficacy of a fast-track pathway for elective hip and knee arthroplasty, compared to the traditional approach, adopted within a research hospital located in Milan (Italy), in terms of length of stay reduction and related direct medical costs. Methods: A monocentric observational retrospective study was implemented considering adult subjects who underwent elective primary total hip or knee replacement, with a diagnosis of primary or secondary osteoarthritis. Exclusion criteria were subjects admitted via emergency department, subjects undergoing knee or hip replacement because of fractures or prosthesis revision. The analysis compared the length of stay and the direct medical costs, assuming the hospital perspective, of subjects admitted in the pre-fast-track period (years 2016/2017) and during the fast-track period (years 2018/2019). Results: Knee replacement mean costs are 5,599 € (±1,158.3 €) in the pre-fast-track period and 4,487 € (±978.4 €) in the fast-track period (-1,112 €; -19.9%). Hip replacement mean costs in the pre-fast-track period are 5,364 € (±1,037.2 €) and 4,450 € (±843.7 €) in the fast-track period (-914 €; -17.0%). The adoption of fast-track pathway led to a statistically significant decrease of days of hospitalization of -2.8 (-37.6%) in knee replacement and of -2.9 (-39.2%) in hip replacement. Conclusion: The fast-track pathway adopted proved to be effective, reducing patients' length of stay, and sustainable and efficient, reducing direct medical costs, for both elective hip and knee replacement surgeries.

Health, care or shelter? An exploratory analysis of the factors affecting overall satisfaction with services of residents' relatives in nursing homes.

Residents' relatives are regularly solicited to evaluate the hotel, social- and health-care services that nursing homes provide to the aged in order to preserve their residual cognitive, physical, and social capabilities. In this study we argue that, due to the services' different technical and functional elements, residents' relatives find it easier to assess the quality of the hotel services instead of the other types of services. Based on 2012 responses from residents' relatives in 38 nursing homes in the Northern part of Italy, our results show that satisfaction with hotel services partially mediates the impact of satisfaction with social- and health-care services, above and beyond their direct effect on the overall satisfaction with all services. We conclude by discussing theoretical contributions and managerial implications.

Co-Design as Enabling Factor for Patient-Centred Healthcare: A Bibliometric Literature Review.

Service design and in particular co-design are approaches able to align with the need of healthcare contexts of value-based and patient-centered processing through a participatory design of services. The purpose of this study is to identify the characteristics of co-design and its applicability to the reengineering of healthcare services, as well as to detect the peculiarities of the application of this approach in different geographical contexts. The methodology applied for the review, Systematic Literature Network Analysis (SLNA), combines qualitative and quantitative perspectives. In detail, the analysis applied the paper citation networks and the co-word network analysis to detect the main research trends over time and to identify the most relevant publications. The results of the analysis highlight the backbone of literature on the application of co-design in healthcare as well as the advantages and the critical factors of the approach. Three main literature streams emerged concerning the integration of the approach at meso and micro level, the implementation of co-design at mega and macro level, and the impacts on non-clinical related outcomes. Moreover, the findings underline differences in co-design in terms of impacts and success factors in developed countries and economies in transition or developing countries. The analysis shows the potentially added value of the application of a participatory approach to the design and redesign of healthcare services both at different levels of the healthcare organization and in the contexts of developed countries and economies in transition or developing countries. The evidence also highlights potentialities and critical success factors of the application of co-design in healthcare services redesign.

Cost analysis of dalbavancin versus standard of care for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) in two Italian hospitals.

Objectives: Thanks to its long half-life, dalbavancin qualifies as an optimal drug for saving costs. We aimed to assess the cost and effectiveness of dalbavancin versus the standard of care (SoC). Patients and methods: We conducted a multicentre retrospective study, including all hospitalized or outpatients diagnosed with ABSSSIs at Padua University Hospital, Padua and San Paolo Hospital, Milan (1 January 2016 to 31 July 2020). We compared patients according to antibiotic treatment (dalbavancin versus SoC), the number of lines of dalbavancin treatment, and monotherapy or combination (dalbavancin in association with other antibiotics). Primary endpoints were direct medical costs and length of hospital stay (LOS) associated with ABSSSI management; Student's t-test, chi-squared test and one-way ANOVA were used. Results: One hundred and twenty-six of 228 (55.3%) patients received SoC, while 102/228 (44.7%) received dalbavancin. Twenty-seven of the 102 (26.5%) patients received dalbavancin as first-line treatment, 46 (45.1%) as second-line, and 29 (28.4%) as third- or higher-line treatment. Most patients received dalbavancin as monotherapy (62/102; 60.8%). Compared with SoC, dalbavancin was associated with a significant reduction of LOS (5 ±â€Š7.47 days for dalbavancin, 9.2 ±â€Š5.59 days for SoC; P < 0.00001) and with lower mean direct medical costs (3470 ±â€Š2768€ for dalbavancin; 3493 ±â€Š1901€ for SoC; P = 0.9401). LOS was also reduced for first-line dalbavancin, in comparison with second-, third- or higher-line groups, and for dalbavancin monotherapy versus combination therapy. Mean direct medical costs were significantly lower in first-line dalbavancin compared with higher lines, but no cost difference was observed between monotherapy and combination therapy. Conclusions: Monotherapy with first-line dalbavancin was confirmed as a promising strategy for ABSSSIs in real-life settings, thanks to its property in reducing LOS and saving direct medical costs.

Analysis of the correlation between mortality in nursing homes and among elderly population in Italy during the first phase of COVID-19 pandemic.

Introduction: The objective of the analysis is to investigate whether there is a correlation between deaths occurred within nursing homes in Lombardy Region and those related to the whole elderly population residing in the municipalities of their location at the beginning of the COVID-19 pandemic. Methods: The analysis considered a sample of 17 nursing homes belonging to the same legal entity (with a total of 2,197 beds). The changes occurred in the trend of deaths in 2020 between January the 1st and February the 20th, and between February the 21st and April the 4th, compared with the average number of deaths occurred in the same time intervals of the previous three-year period (2017-2019) were investigated. To verify the presence of a correlation between deaths occurring within nursing homes and those related to the whole elderly population residing in the municipalities of their respective locations, Pearson correlation index was calculated, distinguishing between elderly over 65 years of age and elderly over 85 years of age. Results: A statistically significant correlation was identified between the number of deaths among the overall population and the number of deaths among nursing homes residents between February the 21st and April the 20th, while no correlations were identified between January the 1st and February the 20th. Conclusions: The number of deaths occurred in the nursing homes of the sample considered shows similar trends to those of the elderly population of the municipalities in which they are located.

An observational analysis of costs and effectiveness of an intraoperative compared with a preoperative image-guided system in spine surgery fixation: analysis of 10 years of experience.

BACKGROUND: Image-guided navigation systems are well established technologies; their use in clinical practice is constantly 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: This is a retrospective analysis to assess the overall costs of a series of patients admitted to our Department of Neurosurgery 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 preadmission testing to discharge. RESULTS: The study includes 875 patients. Baseline data, hospitalization and complications were similar for both. Mean cost was € 7305.9 for intraoperative CT scan procedure and € 7666.2 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.

Assessment of the Costs Related to West Nile Virus Monitoring in Lombardy Region (Italy) between 2014 and 2018.

In Italy, the West Nile Virus surveillance plan considers a multidisciplinary approach to identify the presence of the virus in the environment (entomological, ornithological, and equine surveillance) and to determine the risk of infections through potentially infected donors (blood and organ donors). The costs associated with the surveillance program for the Lombardy Region between 2014 and 2018 were estimated. The costs of the program were compared with a scenario in which the program was not implemented, requiring individual blood donation nucleic acid amplification tests (NAT) to detect the presence of WNV in human samples throughout the seasonal period of vector presence. Considering the five-year period, the application of the environmental/veterinary surveillance program allowed a reduction in costs incurred in the Lombardy Region of 7.7 million EUR. An integrated surveillance system, including birds, mosquito vectors, and dead-end hosts such as horses and humans, can prevent viral transmission to the human population, as well as anticipate the detection of WNV using NAT in blood and organ donors. The surveillance program within a One Health context has given the possibility to both document the expansion of the endemic area of WNV in northern Italy and avoid most of the NAT-related costs.

What is the impact of SARS-CoV-2 pandemic on antimicrobial stewardship programs (ASPs)? The results of a survey among a regional network of infectious disease centres.

Discontinuation of antimicrobial stewardship programs (ASPs) and increased antibiotic use were described during SARS-CoV-2 pandemic. In order to measure COVID-19 impact on ASPs in a setting of high multidrug resistance organisms (MDRO) prevalence, a qualitative survey was designed. In July 2021, eighteen ID Units were asked to answer a questionnaire about their hospital characteristics, ASPs implementation status before the pandemic and impact of SARS-CoV-2 pandemic on ASPs after the 1st and 2nd pandemic waves in Italy. Nine ID centres (50%) reported a reduction of ASPs and in 7 cases (38.9%) these were suspended. After the early pandemic waves, the proportion of centres that restarted their ASPs was higher among the ID centres where antimicrobial stewardship was formally identified as a priority objective (9/11, 82%, vs 2/7, 28%). SARS-CoV-2 pandemic had a severe impact in ASPs in a region highly affected by COVID-19 and antimicrobial resistance but weaknesses related to the pre-existent ASPs might have played a role.

Cost of illness of Primary Biliary Cholangitis - a population-based study.

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.

Introduction of concept of cost centre management in a public hospital in South Africa.

BACKGROUND: Information on hospital unit costs is valuable to health policy makers, managers, and researchers. Its importance is recognised internationally by the World Health Organization (WHO) and nationally by the South African Department of Health. Although some projects had attempted to introduce this concept in South Africa, none of them became sustainable. OBJECTIVES: To identify the cost centres in a large public hospital (Johannesburg Hospital) and to determine factors influencing its implementation and lastly, to provide future directions for successful and sustainable operation through transfer of skills. METHODOLOGY: Setting of the study was Johannesburg Hospital, a public sector hospital in South Africa. The study has used context analysis technique to analyze the operational environment of the hospital. RESULTS: The study identified three types of cost centres: Overhead, Intermediate, and Final. The context analysis showed remarkable differences in comparison with Italian public hospitals. Various important factors were identified during this study, which may be classified into three broad categories: external, internal, and process. DISCUSSION: Focus of hospital management should shift from cost minimisation. It should also consider other factors such as number of patients, levels of patients, clinical outcomes, clinical governance, organisational efficiency, and organisational culture, which might play a significant role. This requires expertise in clinical economics, which is not readily available in developing countries like South Africa. Training of hospital staff in the new way of thinking, internal communication, and regular feedback are probably other important factors to its success. CONCLUSION: A stepwise approach based on proper planning and a context analysis should be used for successful implementation of this type of activity in a public hospital setting.

Protocol Implementation for Normothermia in Surgery Settings in Italy: Budget-Impact Analysis.

INTRODUCTION: Hypothermia is a well-known risk of the perioperative period and considered a preventable effect of anesthesia care. Nevertheless, it is not fully controlled, causing a number of adverse outcomes following surgical operations and thus increasing length of stay in hospital and treatment costs. The aim of this study was to assess the budget impact (BI) of the implementation of proactive strategies to prevent inadvertent perioperative hypothermia (IPH) in surgical patients in Italy, as recommended by international guidelines and by a good clinical practice (GCP) guideline of the Italian Society of Anesthesia, Analgesia, Reanimation, and Intensive Care. METHODS: BI was calculated over a 3-year period from the perspective of the Italian National Health Service (NHS). Model inputs were extracted from national literature when available and otherwise from international sources. The reference analytic model was based on the cost-effectiveness analysis of the National Institute for Health and Care Excellence clinical guidance 65. Estimates were based on assessments made about current malpractice in Italy and on a hypothesis of how future practice might change by implementing the GCP. Model output included overall BI results, variations in the number of warmed patients, medical-device average costs and use of mix. RESULTS: The base-case estimate quantified a decrease of 35% in extra days of hospital stay due to IPH and a net BI of -€60.92 million. CONCLUSION: Increasing protocol adoption for preventing IPH would lead to both clinical advantages and significant savings for the NHS. Its large diffusion in Italian hospitals is thus desirable.

Role of Inhaled Methoxyflurane in the Management of Acute Trauma Pain.

Adequate treatment of trauma pain is an integral part of the management of trauma patients, not just for ethical reasons but also because undertreated pain can lead to increased morbidities and worse long-term outcomes. Trauma pain management presents challenges in the pre-hospital setting, particularly in adverse or hostile environments as well as in busy emergency departments (EDs). Inhaled methoxyflurane, administered at analgesic doses via a disposable inhaler, has recently become available in Europe for the emergency treatment of moderate to severe pain in conscious adult trauma patients. A growing body of evidence demonstrates that inhaled methoxyflurane is well tolerated and effective in providing a rapid onset of analgesia. In this paper, we discuss the rationale for methoxyflurane use in trauma pain management, data from clinical trials recently conducted in Europe, its efficacy and safety profile compared to current standard treatments, its place in therapy and organizational impact. We conclude that inhaled methoxyflurane represents an effective treatment option in the different settings where trauma patients require rapid and flexible pain resolution, with potential organizational advantages.

Monocentric Analysis of the Effectiveness and Financial Consequences of the Use of Lenograstim versus Filgrastim for Mobilization of Peripheral Blood Progenitor Cells in Patients with Lymphoma and Myeloma Receiving Chemotherapy and Autologous Stem Cell Transplantation.

PURPOSE: Granulocyte-colony stimulating factors (G-CSFs) are widely used to mobilize CD34+ stem cells and to support the engraftment after hematopoietic stem cell transplantation (HSCT). A budget impact analysis and an incremental cost-effectiveness study of two G-CSFs (Lenograstim and Filgrastim biosimilar), considering engraftment, number of hospitalization days and number of G-CSF vials administered were performed. PATIENTS AND METHODS: Between 2009 and 2016, 248 patients undergoing autologous HSCT have been evaluated and divided into three groups (100 Leno-Leno, 93 Leno-Fil, 55 Fil-Fil) according to the type of G-CSF used for hematopoietic stem cell mobilization and hematopoietic stem cell recovery after transplant. RESULTS: The following statistically significant differences have been observed between Leno-Leno, Leno-Fil, Fil-Fil groups: a higher number of harvested CD34+ cells (10.56 vs 8.00 vs 7.20; p=0.0003) and a lower number of G-CSF vials (8 vs 8 vs 9; p=0.00020) used for full bone marrow recovery favoring Lenograstim. No statistically significant differences were found regarding the number of G-CSF vials used for mobilization, apheresis number and CD34+ cell peak. The post-transplant hematological recovery was faster in Lenograstim group than Filgrastim group: median time to neutrophil count engraftment (>500/mmc) was 12 vs 13 days; median time for platelets recovery (>20.000/mmc) was 12 vs 15 days (p=0.0001). The use of Lenograstim achieved cost savings of €566/patient over Filgrastim biosimilar, related to a decreased number of days of hospitalization (16 vs 17 days; p=0.00012), a lower overall incidence of adverse events, laboratory tests, transfusions for platelet recovery following discharge. CONCLUSION: In our experience, Lenograstim outperforms Filgrastim in terms of effectiveness and lower cost. This study shows a clinical superiority of Lenograstim over Filgrastim suggesting a potential cost savings favoring Lenograstim.