Intra- and Extra-Hospitalization Monitoring of Vital Signs-Two Sides of the Same Coin: Perspectives from LIMS and Greenline-HT Study Operators.

BACKGROUND: In recent years, due to the epidemiological transition, the burden of very complex patients in hospital wards has increased. Telemedicine usage appears to be a potential high-impact factor in helping with patient management, allowing hospital personnel to assess conditions in out-of-hospital scenarios. METHODS: To investigate the management of chronic patients during both hospitalization for disease and discharge, randomized studies (LIMS and Greenline-HT) are ongoing in the Internal Medicine Unit at ASL Roma 6 Castelli Hospital. The study endpoints are clinical outcomes (from a patient's perspective). In this perspective paper, the main findings of these studies, from the operators' point of view, are reported. Operator opinions were collected from structured and unstructured surveys conducted among the staff involved, and their main themes are reported in a narrative manner. RESULTS: Telemonitoring appears to be linked to a reduction in side-events and side-effects, which represent some of most commons risk factors for re-hospitalization and for delayed discharge during hospitalization. The main perceived advantages are increased patient safety and the quick response in case of emergency. The main disadvantages are believed to be related to low patient compliance and an infrastructural lack of optimization. CONCLUSIONS: The evidence of wireless monitoring studies, combined with the analysis of activity data, suggests the need for a model of patient management that envisages an increase in the territory of structures capable of offering patients subacute care (the possibility of antibiotic treatments, blood transfusions, infusion support, and pain therapy) for the timely management of chronic patients in the terminal phase, for which treatment in acute wards must be guaranteed only for a limited time for the management of the acute phase of their diseases.

The transcatheter aortic valve implantation: an assessment of the generalizability of the economic evidences following a systematic review.

OBJECTIVES: Scientific literature debates on the economic affordability of transcatheter aortic valve implantation (TAVI) in order to give a useful support to decision makers aiming at establishing a reimbursement scheme for TAVI. For this reason, it is important to assess the quality and the generalizability of the existing economic evidences. METHODS: The first step was to run a literature search according to a predefined population, intervention, comparator, and outcome on the cost and effectiveness of the TAVI procedure in comparison to medical therapy and traditional surgery. Second, a manual search was carried out on the Web sites of the main HTA agencies. Third, the checklist developed by Augustovski et al. was applied in order to assess the quality and the generalizability of the articles resulting from the selection process. RESULTS: Overall, 106 articles were obtained. Of these, sixty-five articles were excluded since the title was not consistent with the objective. Further selection took place after abstract and full-text reading. In the end, thirty-one documents were included for the review. According to the checklist, none of the articles was considered generalizable and only one was considered transferable which compares the TAVI procedure with Medical Management in inoperable patients. CONCLUSIONS: Despite the overall quality of the selected studies was considered good, there is still a lack of evidence on whether evidences generated in different contexts can be considered generalizable. Further research on resource consumption and preferences is needed in order to provide decision makers with more robust evidences.

New frontiers in e-health. Policies and the Doctor@Home case study. / La frontiera delle cure a distanza. Assetto normativo ed il caso Doctor@Home.

INTRODUCTION: In recent years, and even more following the need for social distancing generated by the global COVID-19 pandemic, e-health has become an increasingly widespread reality in clinical practice, especially for those clinicians operating in the front-line, like nurses. Its growing importance has been followed by increasing attention both by the literature as well as in the generation of specific rules aimed at regulating the phenomenon. METHODS: A regulatory review of the literature aims to outline the current regulatory framework relating to telemedicine. Telemedicine, especially in a pandemic context, calls for regulation that runs parallel to the rapid evolution of the phenomenon itself. The paper traces the European, Italian, and Regional legislation, focusing then on a practical experience of telemedicine, called Doctor @ Home, active at the IRCCS National Cancer Center in Aviano (Italy). DISCUSSION: First, the need for regulatory harmonization emerges. Secondly, the potential of co-production and co-learning processes for healthcare professionals and patients arises to adapt to the outpatient needs of patients in a post-pandemic "new normal," exploiting the new technological tools made available by the National Health Service.

Estimating the fiscal impact of three vaccination strategies in Italy.

OBJECTIVES: When assessing the economic value of vaccines, decision makers should adopt a full societal perspective. One approach for estimation of the fiscal impact of a disease is to use the human capital method to determine productivity losses. The aim of this study was to test an analytical framework developed for the estimation of the fiscal impacts of vaccination programs for influenza (FLU), pneumococcus (PC), and herpes zoster (HZ), in Italy. METHODS: We tested the framework in a two-stage analysis. First, we estimated the fiscal impact of the disease, second we performed a cost-benefit analysis of the individual benefits of vaccination against the cost of the vaccine. To estimate the fiscal impact of the diseases, the human capital approach was used. Epidemiological data were extrapolated from the literature. A Monte Carlo simulation enabled exploration of the uncertainty in the model variables. RESULTS: For FLU, assuming 2.1 million people infected, the total expected impact was EUR 999,371,520; the estimated fiscal impact was EUR 159,563,520. For PC, assuming 90,000 people infected, the total impact was EUR 148,055,040 and the estimated fiscal impact was EUR 23,639,040. For HZ, assuming 6,400 people infected, the total impact was EUR 4,777,200, with EUR 630,000 resulting from a decrease in fiscal taxation. CONCLUSIONS: In conclusion, our work shows how traditional methods aimed at estimating the cost of illness from a social perspective can be improved by additionally considering the fiscal impact, which accounts for the decrease in fiscal revenues due to illness.

Long-term albumin administration in decompensated cirrhosis (ANSWER): an open-label randomised trial.

BACKGROUND: Evidence is scarce on the efficacy of long-term human albumin (HA) administration in patients with decompensated cirrhosis. The human Albumin for the treatmeNt of aScites in patients With hEpatic ciRrhosis (ANSWER) study was designed to clarify this issue. METHODS: We did an investigator-initiated multicentre randomised, parallel, open-label, pragmatic trial in 33 academic and non-academic Italian hospitals. We randomly assigned patients with cirrhosis and uncomplicated ascites who were treated with anti-aldosteronic drugs (≥200 mg/day) and furosemide (≥25 mg/day) to receive either standard medical treatment (SMT) or SMT plus HA (40 g twice weekly for 2 weeks, and then 40 g weekly) for up to 18 months. The primary endpoint was 18-month mortality, evaluated as difference of events and analysis of survival time in patients included in the modified intention-to-treat and per-protocol populations. This study is registered with EudraCT, number 2008-000625-19, and ClinicalTrials.gov, number NCT01288794. FINDINGS: From April 2, 2011, to May 27, 2015, 440 patients were randomly assigned and 431 were included in the modified intention-to-treat analysis. 38 of 218 patients died in the SMT plus HA group and 46 of 213 in the SMT group. Overall 18-month survival was significantly higher in the SMT plus HA than in the SMT group (Kaplan-Meier estimates 77% vs 66%; p=0·028), resulting in a 38% reduction in the mortality hazard ratio (0·62 [95% CI 0·40-0·95]). 46 (22%) patients in the SMT group and 49 (22%) in the SMT plus HA group had grade 3-4 non-liver related adverse events. INTERPRETATION: In this trial, long-term HA administration prolongs overall survival and might act as a disease modifying treatment in patients with decompensated cirrhosis. FUNDING: Italian Medicine Agency.

Modeling cost-effectiveness and health gains of a "universal" versus "prioritized" hepatitis C virus treatment policy in a real-life cohort.

We evaluated the cost-effectiveness of two alternative direct-acting antiviral (DAA) treatment policies in a real-life cohort of hepatitis C virus-infected patients: policy 1, "universal," treat all patients, regardless of fibrosis stage; policy 2, treat only "prioritized" patients, delay treatment of the remaining patients until reaching stage F3. A liver disease progression Markov model, which used a lifetime horizon and health care system perspective, was applied to the PITER cohort (representative of Italian hepatitis C virus-infected patients in care). Specifically, 8,125 patients naive to DAA treatment, without clinical, sociodemographic, or insurance restrictions, were used to evaluate the policies' cost-effectiveness. The patients' age and fibrosis stage, assumed DAA treatment cost of €15,000/patient, and the Italian liver disease costs were used to evaluate quality-adjusted life-years (QALY) and incremental cost-effectiveness ratios (ICER) of policy 1 versus policy 2. To generalize the results, a European scenario analysis was performed, resampling the study population, using the mean European country-specific health states costs and mean treatment cost of €30,000. For the Italian base-case analysis, the cost-effective ICER obtained using policy 1 was €8,775/QALY. ICERs remained cost-effective in 94%-97% of the 10,000 probabilistic simulations. For the European treatment scenario the ICER obtained using policy 1 was €19,541.75/QALY. ICER was sensitive to variations in DAA costs, in the utility value of patients in fibrosis stages F0-F3 post-sustained virological response, and in the transition probabilities from F0 to F3. The ICERs decrease with decreasing DAA prices, becoming cost-saving for the base price (€15,000) discounts of at least 75% applied in patients with F0-F2 fibrosis. CONCLUSION: Extending hepatitis C virus treatment to patients in any fibrosis stage improves health outcomes and is cost-effective; cost-effectiveness significantly increases when lowering treatment prices in early fibrosis stages. (Hepatology 2017;66:1814-1825).

Economic Evaluation of the Hepatitis C Virus Treatment Extension to Early-Stage Fibrosis Patients: Evidence from the PITER Real-World Cohort.

OBJECTIVES: To conduct a cost-effectiveness analysis of two planning strategies of the second-generation direct-acting antiviral interferon-free regimens for the treatment of chronic hepatitis C virus infection. METHODS: A lifetime multicohort model comprised 8125 real-life patients enrolled in the PITER (Italian platform for the study of viral hepatitis) registry, implemented by the ISS (Istituto Superiore di Sanità). Two treatment planning strategies were compared: 1) policy 1-treat all patients regardless of the stage of fibrosis (F0-F4) with second-generation direct-acting antivirals and 2) policy 2-treat patients at F3/F4 stage and those who are prioritized by the scientific guidelines first, and the remaining patients when they reach the F3 stage. Clinical outcomes and costs were evaluated by using a lifetime horizon Markov model and adopting the third-party payer perspective. Health outcomes were expressed in terms of quality-adjusted life-years (QALYs). A sensitivity analysis was run to explore first- and second-order uncertainty and heterogeneity. An expected value of perfect information analysis was also conducted. RESULTS: Policy 1 exhibits an incremental cost-effectiveness ratio of €8,775/QALY gained and remains less than €30,000/QALY in 94% of realizations produced by the Monte-Carlo simulation. Such a proportion increases to 97% when adopting a threshold of €40,000/QALY gained. CONCLUSIONS: Moving from the urgency criterion to evidence-based escalating strategies when prioritizing the access to new anti-hepatitis C virus treatments is a good investment in health, whose affordability should be explored through context-specific budget impact analyses.

Preventing mobility disability in Europe: a health economics perspective from the SPRINTT study.

In a global context of population aging, gaining better knowledge of the mechanisms leading to loss of autonomy has become a major objective, notably with the aim of implementing effective preventive health policies. The concept of frailty, originally introduced in gerontology and geriatrics as a precursor state to functional dependency, appears as a useful tool in this specific context. The "Sarcopenia and Physical fRailty IN older people: multi-componenT Treatment strategies" (SPRINTT) project will provide a unique opportunity to explore health economics issues associated with frailty. In terms of health economics, the loss of autonomy approach retained here focuses on the economic and social causes and consequences of the onset of frailty in older adults, and examines the challenges not only in terms of health system efficiency but also in terms of social protection.

[The economic value of vaccinations: a systematic review of Italian economic evaluations and HTA reports]. / Le implicazioni economiche delle vaccinazioni: una revisione sistematica delle valutazioni economiche e di HTA condotte in Italia.

INTRODUCTION: Decision-making in healthcare should rely on evidence-based approaches able to make possible a transparent and robust assessment of all the aspects related to health technologies. One of the assessment elements is represented by the efficiency that is the specific objective of economic evaluations and also of Health Technology Assessment (HTA). The collection and synthesis of evidence is the first indispensable step in order to foster a proper convey of scientific knowledge to the decision-makers. This work, carried out within a broader project on the transfer of evidence from the scientific to the decision making world, is aimed to release an overview of economic evaluations and HTA on vaccines conducted in Italy. The project was carried out within the activities of the ISPOR Italy-Rome Chapter. METHODS: A systematic review of Italian economic evaluations and HTA performed on vaccines and published up to May 2015 was carried out. PubMed, Scopus and the NIHR HTA databases were queried and a hand-search was performed on key journals in the field (Global & Regional Health Technology Assessment; PharmacoEconomics Italian Research Articles; Giornale italiano di HTA; Politiche Sanitarie; HTA Focus - Pills of Clinical Governance; Pillole di Farmacoeconomia; Giornale Italiano di Farmacoeconomia e Farmacoutilizzazione; IJPH; Quaderni dell'IJPH). Studies were considered eligible if showing the results of a full economic evaluations and if performed in Italy. RESULTS: The literature search yielded 10 HTA reports and 33 economic evaluations. Among the latter, 20 (60,6%) were cost-effectiveness analyses. Ten studies (23,3%) assessed the vaccination against S. pneumoniae figuring out that it is cost-effectiveness and even costsaving in cases of newborns and subjects at risk. Nine studies (20,9%) addressed influenza vaccination and demonstrated its dominance on non-vaccination in the elderly. Eight studies (18,6%) evaluated the HPV vaccines concluding that they are cost-effective. Five studies (11,6%) devoted to anti-rotavirus vaccination showing its dominance on non-vaccination, in particular from the society perspective. Vaccination against pertussis, hepatitis B, chicken pox, measles, rubella, mumps were eventually shown cost-saving. The vaccine against Neisseria meningitidis was considered potentially cost-effective. CONCLUSION: The Italian scientific evidence on efficiency of vaccination is broad and allows concluding that vaccinations are value for money interventions.

COST-EFFECTIVENESS ANALYSIS OF HERPES ZOSTER VACCINATION IN ITALIAN ELDERLY PERSONS.

OBJECTIVES: Herpes zoster (HZ) is characterized by a painful skin rash. Its main complication is postherpetic neuralgia (PHN), pain persisting or occurring after the rash onset. HZ treatment aims to reduce acute pain, impede the onset complications, and disease progression. The aim of this study was to assess the cost-effectiveness of HZ vaccination compared with no vaccination strategy, within the Italian context. METHODS: The natural history of HZ and PHN was mapped through a Markov model with lifetime horizon. A population of patients aged between 60 and 79 years was hypothesized. Third party payer (Italian National Health Service, I-NHS) and societal perspectives were adopted. Data were derived from literature. RESULTS AND CONCLUSIONS: The incremental cost-effectiveness ratio of the vaccination equaled EUR 11,943 per quality-adjusted life-year (QALY) under the I-NHS perspective and EUR 11,248 per QALY under the societal perspective. Considering a cost-effectiveness threshold of EUR 30,000/QALY, the multi-way sensitivity analysis showed that vaccination is cost-effective regardless of the perspective adopted, in 99 percent of simulations.

Do Probability and Certainty Equivalent Techniques Lead to Inconsistent Results? Evidence from Gambles Involving Life-Years and Quality of Life.

BACKGROUND: Within the standard gamble approach to the elicitation of health preferences, no previous studies compared probability equivalent (PE) and certainty equivalent (CE) techniques OBJECTIVE: This study aimed to explore the differences between CE and PE techniques when payoffs are expressed in terms of life-years or quality of life. METHODS: Individuals were interviewed through both CE and PE techniques within an experimental setting. Inferential statistics and regression analysis where applied to process data. Order and sequence effect were also investigated. RESULTS: On average, the elicitation technique did not affect individuals' risk attitude significantly. Individuals proved to be risk averse in gambles concerning life-years and risk seekers in those concerning quality of life. No order or sequence effect was observed. Risk premium, measuring the strength of risk attitude as the percentage variation between the individual's estimated PE or CE and the risk neutral PE or CE, was affected by the kind of gamble that the interviewee is presented with. It increased in gambles concerning health profiles, denoting a stronger risk propensity, and decreased in gambles concerning life years, denoting a stronger risk aversion. CONCLUSION: The choice of the elicitation technique did not affect the individuals' risk attitude significantly, which instead was sensitive to the kind of gamble.

Investigating the Generalizability of Economic Evaluations Conducted in Italy: A Critical Review.

OBJECTIVES: To assess the methodological quality of Italian health economic evaluations and their generalizability or transferability to different settings. METHODS: A literature search was performed on the PubMed search engine to identify trial-based, nonexperimental prospective studies or model-based full economic evaluations carried out in Italy from 1995 to 2013. The studies were randomly assigned to four reviewers who applied a detailed checklist to assess the generalizability and quality of reporting. The review process followed a three-step blinded procedure. The reviewers who carried out the data extraction were blind as to the name of the author(s) of each study. Second, after the first review, articles were reassigned through a second blind randomization to a second reviewer. Finally, any disagreement between the first two reviewers was solved by a senior researcher. RESULTS: One hundred fifty-one economic evaluations eventually met the inclusion criteria. Over time, we observed an increasing transparency in methods and a greater generalizability of results, along with a wider and more representative sample in trials and a larger adoption of transition-Markov models. However, often context-specific economic evaluations are carried out and not enough effort is made to ensure the transferability of their results to other contexts. In recent studies, cost-effectiveness analyses and the use of incremental cost-effectiveness ratio were preferred. CONCLUSIONS: Despite a quite positive temporal trend, generalizability of results still appears as an unsolved question, even if some indication of improvement within Italian studies has been observed.

A pharmacoeconomic analysis of phosphate binders cost-effectiveness in the RISCAVID study.

BACKGROUND: A pharmacoeconomic analysis of the RISCAVID database aimed at assessing the cost effectiveness of phosphate binders in preventing CV mortality and morbidity over 7 years was performed. METHODS: Morbid or fatal events occurring in 750 chronic HD patients were recorded. Statistical analysis evaluated the distribution of variables and the effect of sevelamer on survival. A cost-effectiveness evaluation was performed using a probabilistic model based on a Markov chain. RESULTS: Multivariate analysis showed that treatment with sevelamer was associated with a reduced stroke incidence by 52% (p = 0.04) and reduced levels of C-reactive protein (p < 0.01). Cost-effectiveness evaluation evidenced a 33% decrease in hospital-days for patients treated with sevelamer, with and without comorbidities compared to patients undergoing calcium binders treatment. CONCLUSION: Treatment with sevelamer was associated with a reduced risk of stroke in HD patients, with a clear saving on disease-related costs for the Italian National Healthcare System.

Sevelamer is cost-saving vs. calcium carbonate in non-dialysis-dependent CKD patients in italy: a patient-level cost-effectiveness analysis of the INDEPENDENT study.

OBJECTIVES: To conduct a cost-effectiveness analysis of sevelamer versus calcium carbonate in patients with non-dialysis-dependent CKD (NDD-CKD) from the Italian NHS perspective using patient-level data from the INDEPENDENT-CKD study. METHODS: Patient-level data on all-cause mortality, dialysis inception and phosphate binder dose were obtained for all 107 sevelamer and 105 calcium carbonate patients from the INDEPENDENT-CKD study. Hospitalization and frequency of dialysis data were collected post hoc for all patients via a retrospective chart review. Phosphate binder, hospitalization, and dialysis costs were expressed in 2012 euros using hospital pharmacy, Italian diagnosis-related group and ambulatory tariffs, respectively. Total life years (LYs) and costs per treatment group were calculated for the 3-year period of the study. Bootstrapping was used to estimate confidence intervals around outcomes, costs, and cost-effectiveness and to calculate the cost-effectiveness acceptability curve. A subgroup analysis of patients who did not initiate dialysis during the INDEPENDENT-CKD study was also conducted. RESULTS: Sevelamer was associated with 0.06 additional LYs (95% CI -0.04 to 0.16) and cost savings of EUR -5,615 (95% CI -10,066 to -1,164) per patient compared with calcium carbonate. On the basis of the bootstrap analysis, sevelamer was dominant compared to calcium carbonate in 87.1% of 10,000 bootstrap replicates. Similar results were observed in the subgroup analysis. RESULTS were driven by a significant reduction in all-cause mortality and significantly fewer hospitalizations in the sevelamer group, which offset the higher acquisition cost for sevelamer. CONCLUSIONS: Sevelamer provides more LYs and is less costly than calcium carbonate in patients with NDD-CKD in Italy.

[Clinical and economical evaluation of new analgesics for the management of chronic pain]. / Valutazione clinica ed economica di nuovi analgesici per la gestione del dolore cronico.

The management of chronic pain still represent a challenge for physicians. Opioids are the main stem in the treatment of chronic severe pain, not only for their potency, but as they act as central drugs. The main limit to their utilization in clinical practice is the prevalence of side effects, in particular in the gastrointestinal tract, whose constipation represents the most common. Two new formulations are nowadays available on the market: tapentadol PR (TAP PR) and oxycodone/naloxone (OXN). A recent meta-analysis showed that both drugs have a better tolerability profile than a tradizional opioid, such as oxycodone CR (OXY CR), but TAP PR reduces by 47% (RR=0.53) the percentage of patients discontinuing treatment because of side effects, compared to 24% (RR=0.76) of OXN. A similar advantage has been reported in the reduction of the risk of developing nausea and/or vomiting: TAP PR reduces the risk by 47% (RR=0.53), while OXN reduces the risk by only by 10% (RR=0.90). Both drugs reduced by about 40% the risk of constipation (RR=0.61 for TAP PR and for OXN). These results have been recently confirmed by a direct comparison of the two formulations (TAP PR vs OXN) in patients with chronic low back pain with neuropathic component. Both drugs were reported to be effective in reducing pain intensity and neuropathic symptoms, however TAP PR resulted superior to OXN in terms of analgesic efficacy, quality of life, and tolerability, in particular regarding constipation and adherence to treatment. A pharmacoeconomic analysis can be useful to understand the costs of these clinical advantages, and can be done by using a probabilistic analisys and by populating a Markov model that simulates the transition in time of 100 patients through 4 different possible health states: 1) still on treatment; 2) presence of adverse events; 3) discontinuation; 4) death. Both treatments (TAP PR and OXN) have been shown to have an excellent cost-effectiveness profile. In the case of OXN, in one year, 0.29 QALYs were gained compared to the use of OXY CR at an additional cost of € 138 resulting in a cost per QALY gained of € 475 (€ 138/0.29). In the case of TAP PR, instead, 0.31 QALYs were gained with additional savings due to the reduction of drug side effects, hospitalizations and emergency department access. Therefore, the use of TAP PR implies an average saving of € 31.6 per patient. These data are the results of a pharmacoeconomic model and require a further validation in clinical practice.

Cost-effectiveness of boceprevir or telaprevir for previously treated patients with genotype 1 chronic hepatitis C.

BACKGROUND & AIMS: Randomised controlled trials (RCTs) show that triple therapy (TT) with peginterferon alfa, ribavirin, and boceprevir (BOC) or telaprevir (TVR) is more effective than peginterferon-ribavirin dual therapy (DT) in the treatment of genotype 1 (G1) chronic hepatitis C (CHC) patients with previous relapse (RR), partial response (PAR), and null-response (NR). We assess the cost-effectiveness of TT compared to no therapy in the treatment of patients previously treated with G1 CHC. METHODS: The available published literature provided the data source. The target population was made up of previously treated Caucasian patients with G1 CHC and these were evaluated over a lifetime horizon by Markov model. The study was carried out from the perspective of the Italian National Health Service. Outcomes included discounted costs (in euro at 2012 value), life years gained (LYG), quality adjusted life year (QALY), and incremental cost-effectiveness ratio (ICER).The robustness of the results was evaluated by one-way deterministic and multivariable probabilistic sensitivity analyses. RESULTS: In RR patients, ICER per LYG compared to no therapy was €9555 for BOC-LEAD-IN-RR and €7910 for TVR-LEAD-IN-RR, being BOC dominated by TVR. In PAR patients, ICER for LYG was €11,947 for BOC-LEAD-IN-PAR and €14,931 for TVR-PAR, being TVR cost-effective compared to BOC (ICER for QALY €22,258). In NR patients, ICER for LYG was €26,499 for TVR-LEAD-IN-NR. The models were sensitive to likelihood of sustained virological response and to BOC/TVR prices. CONCLUSIONS: 1st generation HCV PI is highly cost-effective compared to no therapy in RR and PAR G1 CHC patients. TVR dominated BOC in RR, and was cost-effective compared to BOC in PAR patients. In NR patients an assessment of the response after a lead-in period should be performed to improve safety and cost-effectiveness.

Economic assessment of an anti-HCV screening program in Italy.

BACKGROUND: The progression of hepatitis C virus (HCV) disease usually occurs over a 10-year period. HCV-related complications as well as the highly debilitating effects on patients represent a significant item of expenditure for the National Health Service. Early detection of HCV infection is an excellent opportunity to improve patients' quality of life and to rationalize resource allocation. OBJECTIVE: The aim of this study was to provide a cost-effectiveness evaluation of an anti-HCV screening program in the Italian National Health Service perspective. METHODS: We built a Markov model made up of two arms. The ''Test Strategy'' arm involves a screening program based on the enzyme immunoassay for detection of antibodies as first-level test and the research of HCV RNA as second-level detection; patients with positive test results are treated with peg-interferon alfa in combination with ribavirine. Parameters were derived from the literature and validated through experts' opinion. Costs and benefits were discounted by 3.5%. Results were expressed as cost/quality-adjusted life-year (QALY) gained through the screening program compared with the treatment of symptomatic patients. Deterministic and probabilistic sensitivity analysis was performed. RESULTS: The incremental cost-effectiveness ratio of the ''Test Strategy'' is €5171/QALY, definitively below the cost/QALY of other approved treatments in Italy. Model results turned out as sensitive to the age of the target population, the prevalence of HCV infection, and the time horizon adopted. CONCLUSIONS: The anti-HCV screening program is a valid health-related investment improving patients' quality of life and survival with an acceptable expenditure increase for the National Health Service.

On the Frontline-A bibliometric Study on Sustainability, Development, Coronaviruses, and COVID-19.

The COVID-19 pandemic has placed the world's population in a state of unprecedented public health and global health vulnerability. Risks to public and global health have escalated due to COVID-19 contamination. This has raised the statistics of inequity and environmental concerns. A possible outlook entails reducing the pandemic consequences by prioritizing development, biodiversity, and adaptability, offering buffer solutions. It contains vital methods for studying, comprehending, and unraveling events-examining early responses to COVID-19, sustainability, and development, relating them with overall Coronaviruses reaction. This study maps out environmental, socioeconomic, and medical/technological issues using as statistical techniques multiple correspondence analysis and validated cluster analysis. The findings encourage rapid, long-term development policy involvement to address the pandemic. The resulting crises have highlighted the necessity for the revival of health justice policies anchored in distinctive public health ethical patterns in response to them. As a general rule, resilience and preparedness will be targeted at developing and vulnerable nations and are prone to include access to vaccines, public health care, and health investment. Our findings show the relevance of innovating on sustainable development routes and yardsticks. Sustainable global health requires crucial measures in prevention, preparation, and response. Long-term policy recommendations are needed to address pandemics and their interrelated crises and foster sustained growth and socioecological protection.

Casirivimab and imdevimab: Cost-effectiveness analysis of the treatment based on monoclonal antibodies on outpatients with Covid-19.

BACKGROUND AND OBJECTIVES: In 2020, the world was profoundly affected by the spread of SARS-CoV-2, a novel coronavirus first identified in December 2019, that was the causative agent of coronavirus disease 2019 (Covid-19), a severe respiratory disease classified as a pandemic by the World Health Organization (WHO) in March 2020. Covid-19 had a significant negative impact on the healthcare facilities and the economies of many countries. A need for pharmacological treatments for Covid-19 patients rapidly emerged to limit the damage caused by the disease and allow for more efficient management of hospital resources. A possible alternative treatment that has achieved encouraging results on Covid-19 is the use of monoclonal antibodies. This research aims to evaluate the cost-effectiveness of a type of monoclonal antibody, specifically the combination of casirivimab and imdevimab, and assess its impact on the Italian healthcare system. METHODS: The casirivimab and imdevimab treatment efficacy on outpatients with Covid-19 was tested using a predictive Markov model. Research endpoints include hospitalizations, Intensive Care Unit (ICU) admissions, and deaths. This was translated into terms of benefits (savings) and costs for the Italian National Health Service (NHS). The model operates on a predictive time frame of 20 weeks starting from September 2021 until January 2022. The data used to populate the model comes from international academic studies and open-access resources on online databases. RESULTS: The model estimates the effects that can be achieved by administering casirivimab and imdevimab treatment on outpatients with Covid-19. According to the estimates, the treatment can prevent approximately 4,000 hospitalizations, 3,589 ICU admissions, and 1,500 deaths in the considered 20-week period. The potential cost savings amount to EUR 78 million, mainly attributable to the reduction in the number of hospitalizations and access to ICU. More specifically, a difference of EUR 15,4 million can be observed due to the reduction in the number of hospitalizations, a difference of EUR 59,3 million due to the reduction in the number in intensive care, and a difference of EUR 20,3 million due to the reduction in deaths as a consequence of the reduction of hospitalizations. These results are already very significant, considering that in Italy, only 4.76% of the population is eligible for monoclonal antibody treatment. CONCLUSION: The administration of casirivimab and imdevimab in outpatients with Covid-19 can accelerate recovery from the disease for patients, make hospital resource management more efficient and significantly reduce costs for healthcare facilities.

Polypharmacy Management in a Gender Perspective: At the Heart of the Problem: Analysis of Major Cardiac Diseases, SARS-CoV-2 Affection and Gender Distribution in a Cohort of Patients in Internal Medicine Ward.

BACKGROUND: COVID-19 patients with any pre-existing major cardio-vascular disease (CVD) are at the highest risk of viral infection and of developing severe disease. The pathophysiological mechanism is characterized by the viral link to angiotensin-converting enzyme 2 (ACE2) and the involvement of the endothelial system with the release of cytokines and the inflicting of direct damage to the myocardium, the induction of microthrombosis, and the initiation of alterations in oxygen diffusion. The aim of the study is to analyze the clinical course and outcomes in patients (gender-stratified) with pre-existing major CVD. METHODS: Out of the 1833 (973 M/860 F) patients admitted to the Internal Medicine COVID-19 Unit of "Castelli Hospital", Lazio, Italy, from 1 January 2021 to 31 December 2021, 600 patients (320 M/280 F) with a mean age of 77 (78.6 M/75.1 F) previously had CVD. Demographic characteristics, length of the stay (LOS) and oxygen therapy were evaluated. RESULTS: All of the CVD COVID-19 patients underwent non-invasive ventilation (NIV). CVD was linked with increased LOS (21 days F/22 M) compared to no CVD (19 days). In total, 32.7% of total patients had major CVD. CONCLUSIONS: Timely identification and evaluation of patients with pre-existing major CVD are fundamental for adequate treatment based on gender, severity, state of illness and for risk reduction.