The Clean Care Contest: promoting hand hygiene among healthcare and medical students.

INTRODUCTION: Despite continuing efforts, compliance rates and knowledge of best practices in hand hygiene remain disappointing. Recognizing that conventional educational tools seem out of touch with young people and that the med and messages contents need refreshing, the Italian Study Group of Hospital Hygiene of the Italian Society of Hygiene, Preventive Medicine and Public Health devised a novel approach to promote the creation of innovative educational tools for improving knowledge of, and compliance with, hand hygiene rules among healthcare and medical students. METHODS: A contest in creating educational material on hand hygiene practices involved university students of nursing and medicine, and of other healthcare degrees. Students from the universities of the GISIO network were invited to create educational material (e.g., videos, posters, presentations, leaflets, and screensavers) to be presented by May 5th 2019 during the World Hand Hygiene Day / Save Lives: Clean Your Hands Global Annual Initiative of the World Health Organization). A local and a national winners were awarded. RESULTS: Three different local and national contests were performed during 2016, 2017 and 2018. During the three-year period, more than 270 educational tools have been developed: 130 (48%) were judged useful for hand hygiene promotion campaigns. The most frequent projects participating in the contests were videos (39%), posters (29%), leaflets (14%), and others (18%) submitted by more than 1,500 students of nursing (40%), medicine (31%), dentistry (7%), and of other healthcare courses in 14 universities. Products were evaluated by a local committee and, subsequently, local winners represented their University in a national contest. CONCLUSIONS: The contest provided a framework for the creation of innovative and potentially effective educational tools via an engaging approach that leveraged student creativity. Given the need to improve compliance rates, this study suggests that new ways can be advantageously explored to teach hand hygiene procedures and increase awareness of the importance of their consistent use among healthcare and medical students.

Polio and measles: reasons of missed vaccination in Italy, 2015-2017.

BACKGROUND: Also in Italy, a flourishing evidence confirms the recent spread of vaccine hesitancy movements resulting in approximately 4-7% of the paediatric population not immunised every year against polio and approximately 9-15% against measles in the last few years. The aim of this paper is to describe the reasons of polio and measles missed vaccination in Italy, in the period 2015-2017, and to analyse any potential effect of the 2017 mandatory vaccination law. METHODS: Number of missed vaccinations in children younger than 24 months, stratified by reason, were collected separately for measles and polio with a regional level of detail. Data were collected using an electronic form developed using Microsoft Excel®. RESULTS: The most frequent reason for missed polio vaccination was "definitive informed dissent" with a mean value 1.5%, followed by "found/contacted, but did not attend the appointment" with a mean value 1.3%. Inversely, "acquired immunity subsequent to previous disease or vaccination performed elsewhere" and "excused in a permanent way for health conditions" were the less frequent with a mean value 0.03% for both. For measles vaccination the reason "found/contacted, but did not attend the appointment" was the most frequent (mean value 3.2%), followed by "definitive informed dissent" (mean value 2.9%). CONCLUSIONS: Percentage of missed vaccination showed a remarkable reduction in 2017. This decrease is likely due to the introduction of mandatory vaccination law. In point of fact, "Dissent" decreased for both polio and measles during the study period. While, "Delay" increased during the 3-years. It seems that hesitant parents prefer to postpone vaccinations instead of refusing them. Counselling, parents' empowerment and vaccine education are central to contrast vaccination postponing. Thus, for parents who refuse vaccines ("Dissent"), monitoring the trend is important as well as trying to understand their reasons.

An outbreak of severe invasive meningococcal disease due to a capsular switched Neisseria meningitidis hypervirulent strain B:cc11.

OBJECTIVES: The aim was to investigate an outbreak of invasive meningococcal disease (IMD) in Southern Sardinia. METHODS: Epidemiological and microbiological investigations were performed. The latter included antimicrobial susceptibility testing and whole-genome sequencing (WGS). RESULTS: Seven individuals with severe IMD were found to be infected with serogroup B (MenB) Neisseria meningitidis in the first quarter of 2018. Five of the seven cases (five males; mean age 19 years; range 18-21 years; CFR 40%) were due to a unique strain B:P1.5-1,10-8:F3-6:ST-11(cc11), probably switched from the hypervirulent C-cc11, as confirmed by WGS. All five patients had attended the same nightclub in the 2 weeks prior to symptom onset. Public health measures, including chemoprophylaxis of contacts and active immunization against MenB, were implemented. CONCLUSIONS: We observed five IMD cases due to the same switched MenB strain. The hypervirulent B:P1.5-1,10-8:F3-6:ST-11(cc11) strain, probably switched from C-cc11, is of concern due to the observed high virulence and case fatality rates. All the patients shared the same place of probable exposure. The molecular characterization of the invasive strain allowed the outbreak to be confirmed, which was then controlled through timely public health action.

Childhood vaccine coverage in Italy after the new law on mandatory immunization.

BACKGROUND: The Italian National Immunization Prevention Plan (PNPV) identifies vaccines actively offered free of charge to target populations within the National Health Service. Despite this, childhood immunization coverage has been declining in Italy in recent years. As a response, the Italian Parliament in July 2017 approved law n. 119 extending mandatory childhood vaccines from four to ten, this stimulating a lively debate at both the scientific and policy level. METHODS: We analysed and critically interpreted 2000-2017 Italian national childhood immunization coverage trends, by different vaccine, target population, birth cohort and by Region. In particular, in order to preliminarily assess the impact of the new law, we computed percentage changes in 2016-2017 vaccine coverage for both mandatory and recommended vaccine programs. Data were provided by the Directorate General of Health Prevention of the Italian Ministry of Health. RESULTS: In 2017 national-level vaccine coverage at 24 months of age was 94.5% for Polio and 91.7% for Measles, this representing, respectively 1.2% and 4.4% increase, as compared to 2016. Conjugate Pneumococcal and Meningococcal C vaccines coverage increased, respectively, by +2.5% and +2.4% between 2016 and 2017. National-level polio vaccine coverage remained above the 95% PNPV coverage target between 2000 and 2013 and has remained below since then. In particular, it has had been steadily declining between 2011 and 2016 (-2.8%). Measles coverage remained well below the 95% coverage target for the entire study period. In recent times, it declined by 4.8% between 2011 and 2015 with the lowest coverage rate reported for year 2015 (85.3%). There is high heterogeneity in coverage within Regions for both mandatory and recommended vaccines. CONCLUSION: Preliminary data show that childhood immunization coverage increased since the approval of the new law on mandatory vaccination. Nonetheless, as additional data are accumulating and will make it possible to further assess the impact of the new law, strengthened efforts are needed in Italy to promote informed and proactive vaccine uptake.

Immunisation Registries at regional level in Italy and the roadmap for a future Italian National Registry.

BACKGROUND: Immunization Information Systems, or Immunisation registries (IRs), are essential to monitor and evaluate the accessibility, quality and outcomes of immunisation programmes both at local and national level. STUDY DESIGN: We conducted a cross-sectional survey in order to investigate and map the level of IRs implementation obtained by the 21 Italian Regional Health Authorities. On this basis we defined a roadmap towards implementing an Italian National IR. METHODS: We designed an online questionnaire. Data were collected from July to September 2016 from all the 21 Regional Health Authorities in charge of infectious diseases control and immunization management. RESULTS: 18/21 Italian Regions have fully implemented an IR, out of them, 11 use the same software for all Local Health Units. Two Regions have partially implemented their IRs and one Region is not yet computerised. CONCLUSION: The decentralization of the Italian Health System is reflected also on the IRs characteristics and functionalities in terms of fragmented implementation of IRs and diversity in the software systems and data flows in place. Future efforts should not only aim not only to clarify the functionalities of Regional IRs, but should also aim to define how aggregation of data at national level can be optimised.

The end of measles and congenital rubella: an achievable dream?

BACKGROUND: Despite substantial progress towards measles and rubella control, outbreaks continue to threaten elimination goals worldwide. STUDY DESIGN: This paper aims to document progress towards the global eradication of measles and rubella. In particular, it investigates the major challenges faced by Italy in reaching the elimination goals. METHODS: A review of the most important literature was carried out. Furthermore, a systematic review of the scientific literature on measles and rubella in the Italian setting was performed for the period 2000-2016. RESULTS: In the National Plan 2010-2015, Italy renewed its commitment to eliminate measles and rubella by 2015. However, Italy recently experienced a high measles burden (2,205 cases in 2013, 1,694 in 2014). Between June 2015 and May 2016, 515 cases were reported, accounting for 28% all cases in Europe. Immunization coverage decreased in recent years, with no Region reaching the 95% target. The systematic review included a total of 175 papers, with an upward trend in the number of published articles, which demonstrates an increasing interest in the field of measles and rubella. The review highlights the need to improve the commitment of the Italian Regions to the elimination goals; to promote Supplementary Immunization Activities (SIAs); to improve the communication skills of health care workers; to improve the health literacy of citizens; and to enhance integrated measles and rubella surveillance. CONCLUSION: Elimination of measles and rubella in Italy will require a substantial improvement in both commitment of the 21 Regions and activity of the whole country towards the WHO goals.

Trial-based cost-effectiveness of abatacept for rheumatoid arthritis patients in Italy.

INTRODUCTION: Rheumatoid arthritis (RA) is a chronic, inflammatory disorder leading to disability and reduced quality of life. Effective treatment is a significant economic burden on the Italian healthcare system. Economic models in RA are commonly based on indirect treatment comparisons. METHODS: This study assessed the cost-effectiveness of abatacept relative to adalimumab for RA in Italy based on a head-to-head trial by means of a cost-consequence analysis. RESULTS: Health benefits based on the most stringent efficacy criteria were in favor of abatacept compared to adalimumab. Rates for more costly adverse events were higher for adalimumab compared to abatacept, which was reflected in the lower costs for abatacept (-€237,246 or -€237per patient). CONCLUSION: The health economic value of abatacept compared with adalimumab from the perspective of the Italian NHS depends on the choice of health outcome. Health gains with abatacept were generally based on more stringent criteria and lower total costs.

[Improving vaccination measures]. / Migliorare l'oferta vaccinale.

Despite the benefits of routine vaccination of newborns are known and widely documented, in recent years we are observing a gradual increase in the number of parents who express doubts and concerns about the safety of vaccines and the real need to submit their children to vaccinations included in the national recommendations. This attitude is reinforced by the current epidemiological profile, in Western countries, of many vaccine preventable diseases, accompanied by a low risk perception among parents. Institutions and all the actors involved in vaccination programs have a duty to investigate the reasons for the loss of confidence in vaccination among the population in order to identify and implement appropriate and effective interventions. The improvement of vaccination should, theoretically, goes on a double track, placing side by side the provision of effective vaccines, safe and necessary, and interventions designed to increase demand for vaccination among the population, improve access to vaccination services, improve the system as a whole. But to actually improve the vaccinations' offer it is necessary also to provide interventions aimed at regaining the confidence of the population in relation to vaccination and the institutions that promote them. Particular attention should be given to the aspects of communication and risk communication.

Epidemiology of pertussis in Italy: disease trends over the last century.

We reviewed the epidemiology of pertussis in Italy over the last 125 years to identify disease trends and factors that could have influenced these trends. We described mortality rates (1888-2012), case fatality rates (1925-2012), cumulative incidence rates (1925-2013) and age-specific incidence rates (1974-2013). We compared data from routine surveillance with data from a paediatric sentinel surveillance system to estimate under-notification. Pertussis mortality decreased from 42.5 per 100,000 population in 1890 to no reported pertussis-related death after 2002. Incidence decreased from 86.3 per 100,000 in 1927 to 1 per 100,000 after 2008. Vaccine coverage increased from 32.8% in 1993 to about 96% after 2006. As for under-notification, mean sentinel/routine surveillance incidence ratio increased with age (from 1.8 in <1 year-olds to 12.9 in 10-14 year-olds). Pertussis mortality decreased before the introduction of immunisation. Incidence has decreased only after the introduction of pertussis vaccine and in particular after the achievement of a high immunisation coverage with acellular vaccines. Routine surveillance does not show an increase in cumulative incidence nor in ≥ 15 year-olds as reported by other countries. Underrecognition because of atypical presentation and the infrequent use of laboratory tests may be responsible for under-notification, and therefore affect incidence reports and management of immunisation programmes.

Analysis of national measles surveillance data in Italy from October 2010 to December 2011 and priorities for reaching the 2015 measles elimination goal.

From 1 October 2010 to 31 December 2011, Italy experienced high measles burden with 5,568 measles cases (37.4% laboratory-confirmed) reported to the enhanced measles surveillance system (cumulative incidence in the 15-month reference period: 9.2/100,000 population). Adolescents and young adults were especially affected, and the median age of cases was 18 years. Most cases (95.8%) were either unvaccinated or incompletely vaccinated. Complications were reported for 20.3% of cases, including 135 cases of pneumonia, seven of encephalitis and one case of Guillain­Barré syndrome. One death occurred in an immunocompromised adult. Over 1,300 cases were hospitalised. Identified priorities for reaching the measles elimination goal include evidence-based interventions such as reminder/recall for both doses of measles vaccine, supplementary immunisation activities aimed at susceptible age cohorts, and vaccinating healthcare workers.

Immunisation registers in Italy: a patchwork of computerisation.

In Italy, the 21 regional health authorities are in charge of organising and implementing their own vaccination strategy, based on the national vaccine plan. Immunisation coverage varies greatly among the regions for certain vaccines. Efforts to increase childhood immunisation coverage have included initiatives to develop and implement computerised immunisation registers in as many regions as possible. We undertook a cross-sectional online survey in July 2011 to provide an updated picture of the use, heterogeneity and main functions of different computerised immunisation registers used in the Italian regions and to understand the flow of information from local health units to the regional authorities and to the Ministry of Health. Comparing current data with those obtained in 2007, a substantial improvement is evident. A total of 15 regions are fully computerised (previously nine), with 83% of local health units equipped with a computerised register (previously 70%). Eight of the 15 fully computerised regions use the same software, simplifying data sharing. Only four regions are able to obtain data in real time from local health units. Despite the progress made, the capacity to monitor vaccination coverage and to exchange data appears still limited.

Pharmacoeconomic evaluation of tiotropium bromide in the long-term treatment of chronic obstructive pulmonary disease (COPD) in Italy.

The randomized, double-blind trial UPLIFT(®) demonstrated in 5,993 patients with moderate to very severe COPD that 4 years of tiotropium bromide therapy were associated with improvements in lung function, exacerbations, quality of life, and mortality compared with placebo. The pharmacoeconomic evaluation was performed through a probabilistic, patient-level simulation Markov model. Routine COPD care (RC) was compared with the inclusion of tiotropium bromide on it. The analysis was conducted over a lifetime horizon, with 1 year cycles and a 3.5% annual discount rate. Patients were characterized by gender, age, height, smoking status, and forced expiratory volume in 1 s (FEV1). FEV1 time trend was modeled according to the annual decline recorded in UPLIFT®. Mortality derived from that of the general Italian population was adjusted by smoking status and FEV1. Health utilities derived from published Italian observational studies and were varied in time according to UPLIFT® data. Exacerbation rates were derived from a published Italian observational prospective study. The cost perspective was that of the Italian National Health Service. Healthcare resource consumption for RC and exacerbations derived from Italian observational studies were valued according to current price and tariffs. Simulated patients in the tiotropium arm gained an average (95% CI) 0.50 (-1.63 to 6.27) Life Years (LYs) and 0.42 (-0.25 to 3.05) Quality-Adjusted Life Years (QALYs). The incremental lifetime cost resulted €3,357 (-€10,669 to €29,820). The incremental cost-effectiveness ratio (ICER) was €6,698/LY and €7,916/QALY. In the cost-effectiveness acceptability curve (CEAC), tiotropium had a 90% probability of being cost-effective for a willingness to pay (WTP) threshold of € 10,000/QALY.

Measles in Italy, July 2009 to September 2010.

Outbreaks of measles continue to occur in Italy, as in other European countries. We present here details of cases reported through the Italian enhanced measles surveillance system from July 2009 to September 2010. In total, 2,151 cases were reported, 42% (n=895) of which were laboratory confirmed. The median age of cases was 18 years and 1,709 of 1,856 cases (92%) were unvaccinated. Many cases with complications were reported (n=305), including three with encephalitis. A total of 652 of 1,822 cases (36%) were hospitalised. Molecular characterisation revealed circulation of a limited number of measles virus genotypes (D4, D8 and B3), which is consistent with the current epidemiology of the disease in Italy. A national measles elimination plan was approved in 2003 with the aim of interrupting endemic measles transmission by 2007. Since elimination was not achieved, the target date was recently moved to 2015. The emphasis of the new elimination plan, approved in March 2011, is on strengthening surveillance, implementing evidence based-interventions to increase measles-mumps-rubella vaccine uptake in children, adolescents and young adults, and implementing communication activities related to the vaccine. The strategies proposed by the plan should be implemented fully and appropriately by all regions in order to meet the elimination goal by 2015.

Pharmacoeconomic evaluation of the MF59--adjuvanted influenza vaccine in the elderly population in Italy.

INTRODUCTION: Influenza vaccination has proven effective in the reduction of influenza-like illness (ILI) cases and influenza-related hospitalizations, drug consumption, primary care consultations and deaths in the elderly population. The aim of this study is the assessment of the financial budget impact of a seasonal vaccination program based on the use of the MF59 adjuvanted vaccine as compared with the traditional vaccine or the absence of vaccination in Italian elderly population. METHODS: A pharmacoeconomic simulation model was developed to simulate the effect of the three different vaccination programs during a single influenza season. Health economics and demographic data were taken from specific Italian sources, and vaccine effectiveness data derived from published literature. Direct medical costs were considered according to current Italian prices and tariffs. RESULTS: About 83% of the 12 million people of at least 65 years of age currently resident in Italy can be considered at high risk for influenza complications due to underlying chronic diseases. Absence of vaccination could lead to more than 2 million ILl cases, and 29,000 related deaths. The vaccination program with a coverage rate of 65.6% would lead to an estimated 1.5 million ILl cases (26.9% reduction) with a standard vaccine and to 1.3 million (35.8% reduction) with the MF59 adjuvanted vaccine with a relative increase of avoided cases of 33,1%. The standard vaccination program produced a moderate direct cost increase of about 50 million Euro (+4.6%), whereas the adjuvanted vaccine provided an estimated saving of about 74 million Euro (-6.8%), both compared to the non vaccination. Cost savings were mainly related to hospital admissions avoided in the elderly population (>or=65 years of age). CONCLUSIONS: The vaccination with the MF59 adjuvanted vaccine resulted more effective and cost saving when compared with the standard vaccination and with no vaccination, thus representing the optimal strategy for the elderly population. The standard vaccine, even though a light cost increase, still proved to be effective compared to the null option, with the initial cost for the vaccination program nearly offset by healthcare resources savings obtained during the season.

Cost-utility of add-on omalizumab in difficult-to-treat allergic asthma in Italy.

OBJECTIVE: Omalizumab (OM), an innovative biological treatment for difficult asthma with perennial sensitisations, is an humanized monoclonal anti-IgE antibody that binds free circulating IgE; inhibits mast cell and basophil activation by combining free IgE, leads to IgE receptor down-regulation, thus blocking the inflammatory cascade. AIM OF THE STUDY: To assess real-world cost-utility ofadd-on OM in Italy. METHODS: changes in clinical and economical outcomes, and in quality of life (QoL) associated with add-on OM in adults (n=23) with severe dfficult asthma were compared with those recorded before OM in the same subjects. Variables were: lung function; IgE levels; health status; ACT score; QoL (SGRQ); n. GP and specialist visits; emergency visits; hospitalizations, and concomitant pharmacological treatments. Further indices were: changes in Health-related QoL; total health-care costs, and incremental cost/utility. Data were statistically compared (Student's T test), and p < 0.01 was accepted for statistical significance. RESULTS: asthma clinical outcomes and patients' health-related quality of life improved significantly by adding OM, and both costs for drugs and hospital care dropped significantly (p < 0.01). The net economic effect was a 350 Euro increase in overall monthly costs; when related to health benefits, it corresponded to an incremental cost/utility ratio ofabout 26,000 Euro/QALY, which represents a quite favourable figure in terms of willingness to pay for health benefits in industrialised countries. CONCLUSIONS: Omalizumab added to an optimised therapy significantly improves clinical outcomes in difficult-to-treat, persistent allergic asthma. Costs also increased, but proved justified by health benefits achieved.

Cost-effectiveness analysis of LHRH agonists in the treatment of metastatic prostate cancer in Italy.

OBJECTIVES: Luteinizing hormone-releasing hormone (LHRH) agonists represent one of the main cost factors in the management of patients with metastatic prostate cancer. We compared the cost-effectiveness of the five different 3-month formulations of LHRH agonists currently available for advanced prostate cancer in Italy, because these differ both in their capacity to suppress testosterone and in their acquisition costs. METHODS: A probabilistic, patient-level simulation model was developed to compare the cost-effectiveness, from the perspective of the Italian National Health Service (INHS), of leuprorelin 11.25 mg and 22.5 mg, triptorelin 11.25 mg, buserelin 9.9 mg, and goserelin 10.8 mg. The model incorporated testosterone-dependent progression-free and cancer-specific survival functions, LHRH agonist effectiveness data, and national costs and tariffs. Cox's proportional hazard models were used to compute total and progression-free survival functions based on clinical data from 129 patients with metastatic prostate cancer treated in an Italian center. Bayesian random effects models were employed to summarize evidence from published literature on testosterone suppression obtained with the available LHRH agonists. RESULTS: Estimated total survival was ≈5 years, with a maximum difference between treatment options of ≈2 months. There was a mean difference of almost €2,500 in lifetime total costs between the least costly option (leuprorelin 22.5 mg) and the most expensive (goserelin). In the incremental cost-effectiveness analysis, leuprorelin 22.5 mg dominated all alternatives except buserelin, which had an incremental cost-effectiveness ratio versus leuprorelin 22.5 mg of ≈€12,000 per life-month gained. CONCLUSIONS: Based on modelling with meta-analysis of comparative survival data, leuprorelin 22.5 mg was the most cost-effective treatment of the available depot formulation LHRH agonists.

Rituximab in the treatment of rheumatoid arthritis patients in Italy: a budget impact analysis.

OBJECTIVES: The objective of this Budget Impact Analysis is to evaluate the financial implications of a rituximab-based sequencing strategy in the treatment of rheumatoid arthritis in the perspective of the Italian National Health Service. METHODS: Yearly patients who were eligible for a second-line biological DMARD in Italy were entered into a 5-year model. A Markov chain reproduced the course of this cohort under a number of alternative strategies, including anti-TNF-α cycling and rituximab or abatacept as second and third line agents. The dynamic of the simulation was given by first biological drug failure data, mortality rates, and survival-on-treatment data from published literature. Drug acquisition, administration and monitoring costs were assessed. RESULTS: Italian patients refractory to a first anti-TNF-α therapy resulted to be about 650 per year, giving a cumulative number of treated patients in five years of 3,240. The anti-TNF-α cycling had a total direct cost which rose from €8.2 million in the first year to €33.8 million in the fifth. The cost per patient of rituximab was lower than the average cost of the anti-TNF-α therapies; the annual difference was around € 4,300. The savings gained from lower individual costs with rituximab were partially offset by the increasing number of patients receiving active medication, resulting in a substantial cost equivalence between third line rituximab and anti-TNF-α cycling scenarios; rituximab, as a second line therapy, produced a savings in total costs of -31.8%. Strategies including abatacept shared the same dynamics, but with higher costs. CONCLUSIONS: The introduction of rituximab in clinical practice could allow an increase in the number of patients receiving an active rheumatoid arthritis treatment without inflating therapy costs.

Economic evaluation of treatment with orlistat in Italian obese patients.

UNLABELLED: The XENDOS study showed that behavioural and pharmacological therapy can decrease the risk of metabolic disorders in obese patients. METHODS: A probabilistic Bayesian Markov model simulating the outcomes of orlistat treatment on the obese Italian population has been developed with the WinBUGS software. The model integrates an algorithm to estimate cardiovascular risk based on Framingham Heart Study equations. Analyses adopted the societal cost perspective, including direct medical costs borne by both the National Health Service and the patient, since orlistat is not included in the Italian reimbursement list. RESULTS: The simulation on the Italian obese population estimated an average increase in quality-adjusted life expectancy, a reduction of cardiovascular events and new diabetes cases. The average incremental cost-utility ratio is euro75.3 (7.6-180.6) x 1000/QALY. The subgroup analysis showed that the benefits are relatively greater in older patients and in patients with impaired glucose tolerance (IGT). Two hypotheses have been explored to estimate the impact of a potential reimbursement decision by the Italian NHS: (1) orlistat is given to every obese patient; (2) orlistat is given only to obese IGT patients with a previous glucose tolerance general screening program to assess their eligibility. The cost utility of the strategies are euro42.3 (-22.16-108.7) and euro10.16 (-60.4-38.76) x 1000/QALY, respectively. CONCLUSION: Orlistat shows a good pharmacoeconomic profile and, in particular, the strategy of a screening programme to identify and treat the IGT subgroup has a cost-utility value of about euro10000/QALY. This value is lower than that of several therapeutic strategies commonly accepted and reimbursed in developed countries.

Cost-effectiveness and healthcare budget impact in Italy of inhaled corticosteroids and bronchodilators for severe and very severe COPD patients.

Current practice guidelines for the treatment of COPD recommend the use of combined inhaled corticosteroids and long-acting bronchodilators in severe and very severe patients (GOLD stages III and IV). The aim of this study was to evaluate, through a simulation model, the economic consequences of this recommendation in Italy. We developed a cost-effectiveness analysis (CEA) on five alternative therapeutic strategies (salmeterol/fluticasone, SF; formoterol! budesonide, FB; salmeterol alone, S; fluticasone alone, F; control, C). Published data on the Italian COPD population and efficacy data from international reference trials were fitted in a disease progression model based on a Markov chain representing severity stages and death. The yearly total direct costs of treating COPD patients in Italy was estimated at approximately Euro 7 billion, with a mean cost per patient per year of around Euro 2450. Mean survival of the cohort is 11.5 years. The C and F strategies were dominated (ie, are associated with worse outcomes and higher costs) by all alternatives. SF and FB were the most effective strategies, with a slight clinical superiority of SF, but they were also marginally more expensive than S. Incremental cost-effectiveness of SF vs S was Euro 679.5 per avoided exacerbation and Euro 3.3 per symptom-free day. Compared with current practice, the recommended use of combined inhaled corticosteroids and long-acting bronchodilators for severe and very severe COPD patients has the potential for improving clinical outcomes without increasing healthcare costs.