The economic and fiscal impact of incremental use of cell-based quadrivalent influenza vaccine for the prevention of seasonal influenza among healthcare workers in Italy.

BACKGROUND: Seasonal influenza has a significant impact on public health, generating substantial direct healthcare costs, production losses and fiscal effects. Understanding these consequences is crucial to effective decision-making and the development of preventive strategies. This study aimed to evaluate the economic and the fiscal impact of implementing an incremental strategy for seasonal influenza prevention using the cell-based quadrivalent influenza vaccine (QIVc) among healthcare workers (HCWs) in Italy. METHODS: To estimate the economic impact of implementing this strategy, we performed a cost analysis that considered direct healthcare costs, productivity losses and fiscal impact. The analysis considered a 3-year time horizon. A deterministic sensitivity analysis was also conducted. RESULTS: Assuming a vaccination coverage rate of 30% among HCWs, the analysis considered a total of 203 018 vaccinated subjects. On analysing the overall differential impact (including direct costs, indirect costs and fiscal impact), implementing QIVc vaccination as a preventative measure against influenza among HCWs in Italy would yield societal resource savings of €23 638.78 in the first year, €47 277.56 in the second year, and €70 916.35 in the third year, resulting in total resource savings of €141 832.69. CONCLUSIONS: The study demonstrated that implementing the incremental use of QIVc as part of a preventive strategy for seasonal influenza among HCWs in Italy could yield positive economic outcomes, especially in terms of indirect costs and fiscal impact. The resources saved could be utilized to fund further public health interventions. Policy-makers should consider these findings when making decisions regarding influenza prevention strategies targeting HCWs.

Epidemiology and burden of respiratory syncytial virus in Italian adults: A systematic review and meta-analysis.

OBJECTIVE: Respiratory syncytial virus (RSV) is a common respiratory pathogen not only in children, but also in adults. In view of a recent authorization of adult RSV vaccines in Italy, our research question was to quantify the epidemiology and burden of RSV in Italian adults. METHODS: Observational studies on the epidemiology and clinical burden of laboratory-confirmed or record-coded RSV infection in Italian adults of any age were eligible. Studies with no separate data for Italian adults, modeling and other secondary publications were excluded. A literature search was performed in MEDLINE, Biological Abstracts, Global Health, Scopus and Web of Science on 22 November 2023. Critical appraisal was performed by means of a Joanna Briggs Institute checklist. Random-effects (RE) meta-analysis was performed to obtain pooled estimates and the observed heterogeneity was investigated by subgroup and meta-regression analyses. The protocol was prospectively registered (doi.org/10.17504/protocols.io.5qpvo32odv4o/v1). RESULTS: Thirty-five studies were identified, most of which had at least one possible quality concern. RSV seasonal attack rates ranged from 0.8 ‰ in community-dwelling older adults to 10.9% in hematological outpatients. In the RE model, 4.5% (95% CI: 3.2-5.9%) of respiratory samples tested positive for RSV. This positivity prevalence was higher in older adults (4.4%) than in working-age adults (3.5%) and in outpatient (4.9%) than inpatient (2.9%) settings. According to the meta-regression, study location and sample size were also significant predictors of RSV detection frequency. The pooled estimate of in-hospital mortality was as high as 7.2% (95% CI: 4.7-10.3%). Data on other indicators of the diseases burden, such as complication and hospitalization rates, were unavailable. CONCLUSION: RSV poses a measurable burden on Italian adults, especially those of older age and with some co-morbidities. However, several data on the natural history of RSV disease are missing and should be established by future large-scale studies.

Public attitudes, knowledge and educational needs toward genetic testing and omics sciences: a pilot survey conducted in Italy.

Advancements in genomics have significant implications for public health, making citizens' education vital for informed decision-making. Based on two literature reviews' findings and a survey conducted with experts from the Italian Network of Genomics in Public Health, we conducted a pilot survey on Italian citizens' attitudes, knowledge and educational needs toward genetic testing and omics sciences. Our results demonstrate a widespread interest in genetic testing and uncertainties regarding associated risks, with 99% of participants acknowledging insufficient knowledge of genetic testing. There is an urgent need for educational tools to improve citizens' literacy and engagement in this rapidly evolving field.

Cost-utility of cardiac contractility modulation in patients with heart failure with reduced ejection fraction in Italy.

AIMS: Cardiac contractility modulation (CCM) is a device therapy for heart failure, based on the delivery of high-voltage biphasic impulses to the right ventricular septum during the myocardial absolute refractory period. This study evaluated the cost-effectiveness of CCM therapy plus optimal medical therapy (OMT) vs. OMT alone in patients with heart failure with reduced ejection fraction. METHODS AND RESULTS: A Markov model with a lifespan time horizon was developed to assess the cost-utility using the FIX trials as main data sources. A deterministic sensitivity analysis and a probabilistic sensitivity analysis were run to analyse the decision uncertainty in the model through cost-effectiveness acceptability curve (CEAC) and cost-effectiveness acceptability frontier (CEAF). Value of information analysis was also conducted computing the expected value of perfect information (EVPI) and the expected value of partial perfect information. The base case results showed that the CCM plus OMT option was highly cost-effective compared with OMT alone with an incremental cost-utility ratio of €7034/quality-adjusted life year (QALY). The CEAC and CEAF illustrated that for all willingness to pay levels above €5600/QALY, tested up to €50 000/QALY, CCM plus OMT alternative had the highest probability of being cost-effective. The EVPI per patient was estimated to be €124 412 on a willingness to pay threshold of €30 000/QALY. CONCLUSIONS: For patients with heart failure with reduced ejection fraction, CCM therapy could be cost-effective when taking a lifetime horizon. Further long-term, post-approval clinical studies are needed to verify these results in a real-world context, particularly concerning the effect of CCM therapy on mortality.

Epidemiological Impact of Metabolic Syndrome in Overweight and Obese European Children and Adolescents: A Systematic Literature Review.

The prevalence of overweight and obesity is continuously increasing, both in the adult and pediatric populations, posing a substantial challenge to public health. Understanding the epidemiological burden of metabolic syndrome (MetS) among children, particularly regarding its complications and long-term effects in adulthood, is crucial for identifying effective preventive measures and enhancing the clinical care of obese children. Therefore, by searching two databases, a systematic review was conducted in order to evaluate studies that specifically addressed the epidemiological MetS impact among overweight/obese European children and adolescents. Overall, 15 studies were considered. The epidemiological data concerning the MetS impact were contingent on the diagnostic criteria used and varied across countries, resulting in a prevalence range of 1.44% to 55.8%. Spanish studies were the most numerous (34%), revealing a country prevalence rate ranging from 2.5% to 19.6%. Males (prevalence range: 1.4-55.8%) and subjects with overweight/obesity (prevalence range: 12.9-55.8%) were mainly affected. Obesity emerged as the main risk factor in the MetS development and the consequent onset of cardiovascular complications and diabetes. Knowing the MetS burden and its risk factors could improve their prevention, detection, and treatment, and guide the development of targeted public health interventions to appropriately address the health needs of younger patients.

The Impact of Vaccination on COVID-19 Burden of Disease in the Adult and Elderly Population: A Systematic Review of Italian Evidence.

COVID-19 is a major global health threat, with millions of confirmed cases and deaths worldwide. Containment and mitigation strategies, including vaccination, have been implemented to reduce transmission and protect the population. We conducted two systematic reviews to collect nonrandomized studies investigating the effects of vaccination on COVID-19-related complications and deaths in the Italian population. We considered studies conducted in Italian settings and written in English that contained data on the effects of vaccination on COVID-19-related mortality and complications. We excluded studies that pertained to the pediatric population. In total, we included 10 unique studies in our two systematic reviews. The results showed that fully vaccinated individuals had a lower risk of death, severe symptoms, and hospitalization compared to unvaccinated individuals. The review also looked at the impact of vaccination on post-COVID-19 syndrome, the effectiveness of booster doses in older individuals, and nationwide adverse events. Our work highlights the crucial role that vaccination campaigns have played in reducing the burden of COVID-19 disease in the Italian adult population, positively impacting the pandemic trajectory in Italy.

What Type of Person Should I Be? About the Appeal to Virtues in Public Health Interventions.

In line with how ethics has developed for the last three centuries, public health ethics has been widely dominated by a deontological as well as a utilitarian approach. The latter is a version of consequentialism, which states that maximizing utility is the primary goal of the majority of individuals or group action, while, on the other hand, virtue ethics, or at least the appeal to virtues, has been largely marginalized. The aim of this article is twofold. Firstly, we aim to highlight the political and ethical nature of public health interventions, often interpreted and presented as mere scientific enterprises. Secondly, we try to highlight the need to integrate or at least recognize the value of appeal to virtues in public health measures. The analysis will reference the Italian COVID-19 vaccination program as a case study. Initially, we will explore the political and ethical nature of any public health measure, using the implementation of the COVID-19 vaccination program in Italy as an example. Subsequently, we will illustrate the deontological approach to ethics, the utilitarian one, and the virtues one, focusing on the dynamic of the agent's perspective. Lastly, we will briefly analyze both the Italian COVID-19 vaccination program and the communication campaign that promoted it.

Incremental Net Benefit and Incremental Cost-Effectiveness Ratio of COVID-19 Vaccination Campaigns: Systematic Review of Cost-Effectiveness Evidence.

SARS-CoV-2 vaccination has been the most effective tool to prevent COVID-19, significantly reducing deaths and hospitalizations worldwide. Vaccination has played a huge role in bringing the COVID-19 pandemic under control, even as the inequitable distribution of vaccines still leaves several countries vulnerable. Therefore, organizing a mass vaccination campaign on a global scale is a priority to contain the virus spread. The aim of this systematic review was to assess whether COVID-19 vaccination campaigns are cost-effective with respect to no vaccination. A systematic literature search was conducted in the WHO COVID-19 Global literature database, PubMed, Web of Science, Embase, and Scopus from 2020 to 2022. Studies assessing the COVID-19 vaccination campaign cost-effectiveness over no vaccination were deemed eligible. The "Drummond's checklist" was adopted for quality assessment. A synthesis of the studies was performed through the "dominance ranking matrix tool". Overall, 10 studies were considered. COVID-19 vaccination was deemed cost-effective in each of them, and vaccination campaigns were found to be sustainable public health approaches to fight the health emergency. Providing economic evaluation data for mass vaccination is needed to support decision makers to make value-based and evidence-based decisions to ensure equitable access to vaccination and reduce the COVID-19 burden worldwide.

Cervical cancer elimination in Italy: Current scenario and future endeavors for a value based prevention.

Background: Cervical Cancer (CC) is a vaccine-preventable disease, and it is treatable if diagnosed early and managed properly. However, it is the fourth most common cancer in women worldwide with about 604,127 cases and 341,831 deaths in 2020. In Italy, it represents the fifth most common cancer in women under 50 years of age with about 2,400 new cases in 2020. The CC elimination is today a global public health goal published by the World Health Organization (WHO) in 2020 and a commitment of the European Union that has included it in Europe's Beating Cancer Plan. Therefore, urgent action is needed, at international and national level, to implement value-based interventions regarding vaccination, screening and timely management of the disease. Our study aims to describe the state of the art of Human Papilloma Virus (HPV) prevention in Italy and to get a consensus on indicators for monitoring the progress toward CC elimination at national level. Methods: The study envisaged the following activities: research and synthesis of the evidence on strategies and actions for CC elimination at regional Italian level; identification of indicators to monitor such strategies/actions; organization of a multi-stakeholder consensus to reach the agreement on main indicators to be used in Italy. Results: As for HPV vaccination coverage, the last Italian available data (December 31st, 2020) showed that it was way below the target (95%) with full cycle vaccination coverage ranging from 6 to 61.7% in female adolescents and from 5.4 to 55.4% in male adolescents (2008 birth cohorts). The coverage rate of CC screening is variable with a range of 61.7-89.6%. Furthermore, coverage rates due to organized screening programs (excluding out-of-pocket screening) shows a range from 20.7 to 71.8%. The mapping of the Italian Regions highlighted an important regional heterogeneity in respect to organizational/operational issue of HPV vaccination and CC screening. Indicators for monitoring CC elimination strategies have been drawn from the Australian experience and distinguished by disease outcomes, vaccination coverage, screening participation and treatment uptake. The highest consensus was reached for the following indicators: CC incidence; detection of high-grade cervical disease; CC mortality; full cycle vaccination coverage; screening participation; high-grade cervical disease treatment rates; CC treatment rates. Conclusions: The assessment of the current status of CC elimination as overarching goal beyond the achievement of vaccine, screening and treatment targets represents the first step for the identification of interventions to be implemented to accelerate the path toward CC elimination. Based on this and following the WHO call, a value-based approach is proposed to untangle the full benefit of HPV-related cancers elimination strategies and identify priority and best practices.

Factors Influencing the Choice to Advise for or against COVID-19 Vaccination in the Physicians and Dentists of an Italian Region.

Healthcare workers (HCWs), particularly physicians, are a relevant and trusted source of information for patients, especially when health-related choices such as vaccination are concerned. Between July and November 2022, we administered a web-based survey to physicians and dentists living in the Latio region of Italy to explore whether their background might affect their willingness to recommend the COVID-19 vaccination to their patients (RCVtoPat) and their relatives (RCVtoRel). We performed a multivariable logistic regression to study the association between the two outcomes (RCVtoPat and RCVtoRel) and their potential determinants in our sample (n = 1464). We found that being a dentist, an increasing fear of COVID-19, and having been previously vaccinated against flu are positively associated with both RCVtoPat and RCVtoRel, while a better self-rated knowledge of COVID-19 vaccines is associated only with RCVtoRel. No role was found for age, sex, civil status, education level, information sources, previous SARS-CoV-2 infection, and chronic diseases. A sub-group analysis of physicians alone (n = 1305) demonstrated a positive association with RCVtoRel of being specialized in diagnostic/therapeutic services and a negative effect on RCVtoPat of being trained in general practice. We provide useful insights about the factors that should be addressed to ensure HCWs exert a positive influence on their patients and communities.

Knowledge, attitudes, and behaviors toward COVID-19 vaccination in a sample of Italian healthcare workers.

Vaccine hesitancy in healthcare workers (HCWs) has been studied for various contagious diseases, but there is still insufficient knowledge about this phenomenon for COVID-19. We developed and validated a knowledge, attitude, and practice survey of 39 questions to assess Italian HCWs' hesitancy toward vaccination in general (general hesitancy), COVID-19 vaccination (COVID-19 hesitancy), and public health injunctive measures (refusal of obligations). The survey was administered through a web platform between July and November 2021. Three multivariable logistic regressions were performed to evaluate the association between the explored dimensions of hesitancy and the potential determinants investigated. Out of 2,132 respondents with complete answers, 17.0% showed to be generally hesitancy toward vaccination, 32.3% were hesitant on COVID-19 vaccination, while 18.8% were categorized as refusing obligations. A significant protective effect against all three dimensions of hesitancy was found for increasing fear of COVID-19, advising COVID-19 vaccination to relatives and patients, having received flu vaccination in the previous year and having higher levels of education. Better self-rated knowledge about COVID-19 vaccines and reading up institutional sources were significantly protective against general and COVID-19 hesitancy, while being a physician rather than another healthcare professional was protective only against COVID-19 hesitancy. Conversely, increasing age and referring to colleagues to expand knowledge about COVID-19 were positively associated with COVID-19 hesitancy. The determinants of general hesitancy, COVID-19 hesitancy and the refusal of obligations are mostly overlapping. Given the great influence they exert on patients and communities, it is pivotal to limit HCWs vaccine hesitancy through appropriate training activities.

Influenza Vaccination Assessment according to a Value-Based Health Care Approach.

BACKGROUND: Seasonal influenza has a considerable public health impact, and vaccination is the key to preventing its consequences. Our aim was to describe how the value of influenza vaccination is addressed in the scientific literature considering a new value framework based on four pillars (personal, allocative, technical, and societal value). METHODS: A systematic review was conducted by querying three databases. The analysis was performed on international studies focused on influenza vaccination value, and the four value pillars were taken into consideration for their description. RESULTS: Overall, 40 studies were considered. Most of them focused on influenza vaccination in the general population (27.5%), emphasizing its value for all age groups. Most studies addressed technical value (70.4%), especially in terms of economic models and cost drivers to be considered for the economic evaluations of influenza vaccines, and societal value (63%), whereas few dealt with personal (37%) and allocative values (22.2%). CONCLUSIONS: The whole value of influenza vaccination is still not completely recognized. Knowledge and communication of the whole value of influenza vaccination is essential to guide value-based health policies. To achieve this goal, it is necessary to implement initiatives that involve all relevant stakeholders.

The Economic and Fiscal Impact of Influenza Vaccination for Health Care Workers in Italy.

Influenza has a significant impact on the health care system and also on production and economic systems. Vaccinated health care workers (HCWs) are more likely to have improved productivity compared to unvaccinated workers. The study aim was to estimate the economic and fiscal impact of an influenza vaccination program for HCWs in Italy. We performed a cost analysis aimed to estimate the indirect costs (productivity losses due to working days lost) and the increase in tax revenues derived from the increase in vaccination coverage among HCWs. Assuming an incremental increase in vaccination coverage of 10% per year over a period of 5 years, total savings could be obtained in terms of a reduction in productivity losses equal to -€4,475,497.16 and an increase in tax revenues of €327,158.84. This revenue could be used to finance other health interventions. Our results are fundamental in view of the sustainability of health systems and of a value-based allocation of health resources. Therefore, a complete social perspective, including the fiscal impact of flu vaccination, should be adopted to assess the economic value of influenza vaccines. Currently, health policies based on the whole value of flu vaccination are needed.

Economic Aspects in the Management of Diabetic Macular Edema in Italy.

Background: Diabetic Macular Edema (DME) is the most common cause of vision loss in diabetic patients. Currently, the Vascular Endothelial Growth Factor inhibitors (anti-VEGFs) are used as the first line of DME treatment and corticosteroid implants are usually used as a second-line treatment. These implants are a safe and effective therapeutic option that can improve the quality of life of DME patients by reducing the intravitreal injections number. We determined the economic impact related to DME, also from the social perspective, and the consequences of the increased use of the dexamethasone implant. Methods: The analysis compares two scenarios: the first based on the current rate of recourse to the therapeutic alternatives available in the Italian healthcare setting (as is) and the second based on the assumption of an increased recourse to dexamethasone implants (to be). The results are expressed both in terms of the resource absorption associated with the two scenarios and in terms of the cost differential yielded by their comparison. Results: The increased use of the dexamethasone implant allows considerable savings in terms of healthcare professionals' time, follow-up and productivity lost by patients/caregivers. These savings would reduce healthcare costs for the management of DME patients in Italy by €2,058,238 in 5 years. Conclusions: To optimize the healthcare resources allocation, it is necessary to implement treatments that yield not only cost reductions but also a clinical benefit for patients. The dexamethasone implant use is an example of DME management that generates value for patients, health system and society.

The New Quadrivalent Adjuvanted Influenza Vaccine for the Italian Elderly: A Health Technology Assessment.

BACKGROUND: The elderly, commonly defined as subjects aged ≥65 years, are among the at-risk subjects recommended for annual influenza vaccination in European countries. Currently, two new vaccines are available for this population: the MF59-adjuvanted quadrivalent influenza vaccine (aQIV) and the high-dose quadrivalent influenza vaccine (hdQIV). Their multidimensional assessment might maximize the results in terms of achievable health benefits. Therefore, we carried out a Health Technology Assessment (HTA) of the aQIV by adopting a multidisciplinary policy-oriented approach to evaluate clinical, economic, organizational, and ethical implications for the Italian elderly. METHODS: A HTA was conducted in 2020 to analyze influenza burden; characteristics, efficacy, and safety of aQIV and other available vaccines for the elderly; cost-effectiveness of aQIV; and related organizational and ethical implications. Comprehensive literature reviews/analyses were performed, and a transmission model was developed in order to address the above issues. RESULTS: In Italy, the influenza burden on the elderly is high and from 77.7% to 96.1% of influenza-related deaths occur in the elderly. All available vaccines are effective and safe; however, aQIV, such as the adjuvanted trivalent influenza vaccine (aTIV), has proved more immunogenic and effective in the elderly. From the third payer's perspective, but also from the societal one, the use of aQIV in comparison with egg-based standard QIV (eQIV) in the elderly population is cost-effective. The appropriateness of the use of available vaccines as well as citizens' knowledge and attitudes remain a challenge for a successful vaccination campaign. CONCLUSIONS: The results of this project provide decision-makers with important evidence on the aQIV and support with scientific evidence on the appropriate use of vaccines in the elderly.