bluuebunny/crossref_metadata_2025 huggingface dataset:
Valutazione economica dei costi associati al trattamento di pazienti in ossigenoterapia a lungo termine, con o senza monitoraggio telemetrico domiciliare
Authors: Ravasio Roberto , Negro Roberto W. Dal , Lucioni Carlo
Published: June 2016

Long term oxygen treatment (LTOT) represents an helpful, even though costly, therapeutic strategy for managing severe chronic respiratory diseases at home. The aim of the present study was to assess the economic impact of adding the home telemetric monitoring of some vital signs to the traditional domiciliary LTOT in this kind of patients. Two samples of severe chronic respiratory patients (COPD patients in 89% of cases, managed at home without, n=20, and with, n= 61, telemetric home monitoring) were compared for a 24-month period, and the corresponding outcomes measured. In the tele-monitored group of subjects, both the mean number and the mean duration of hospitalisations dropped along the two-year study, together with the n. exacerbations/ patient/year. The mean annual cost for the tele-monitored group of patients was lower by 28% in the first year, and by 33% in the second year of the study. The home tele-LTOT management of patients with severe chronic respiratory disease, mostly COPD, allows a better clinical control of the disease, with a corresponding 50% reduction of exacerbations leading to hospitalisation. Finally, the home tele-LTOT contributes substantially in minimizing the economic impact of these severe chronic respiratory diseases.
Gli antagonisti del recettore GPIIb/IIIa: farmacologia, clinica ed economia nelle sindromi coronariche acute NSTEMI e nelle rivascolarizzazioni per via percutanea
Authors: Pradelli Lorenzo
Published: June 2016

Inhibition of platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor prevents platelet aggregation by controlling its final common pathway, the cross-binding of fibrinogen, bridging across adjacent platelets. Three pharmacological agents capable of inhibiting GP IIb/IIIa are available for use in Italy: abciximab, eptifibatide and tirofiban. In this paper, some relevant studies on the pharmacology of GP IIb/IIIa inhibitors are summarized, as well as the main clinical trials assessing their use in the management of unstable angina (UA) and during percutaneous coronary interventions (PCI). Furthermore, the recommendations on their appropriate use in UA and PCI issued by authoritative scientific societies are presented. Finally, some of the pharmacoeconomic evidence published in the international literature is reviewed and implications in the Italian health care setting are discussed.
Analisi Costo-Efficacia di Amfotericina B Liposomiale (L-AmB) versus Amfotericina B Complesso Lipidico (ABLC) nel trattamento empirico della neutropenia febbrile
Authors: Eandi Mario
Published: June 2016

Current international guidelines for the management of immuno-compromised patients with febrile neutropenia recommend a systemic antimicrobial therapy if fever hasn’t receded after three days of antibiotic treatment. Amphotericin B remains the gold standard because of its broad spectrum fungicidal action and minimal resistance development risk. Nonetheless, therapeutic use of the standard formulation, Amphotericin B deoxycholate, is limited by its toxicity, especially on the kidneys. To counteract this, amphotericin B has been encapsulated in liposomes, a process which reduces its toxicity and allows higher doses to be given. Three lipid formulations have been developed and are now available in most countries: amB colloidal dispersion (ABCD), amB lipid complex (ABLC), and liposomal amB (L-AmB). These lipid formulations differ in pharmacodynamics and pharmacokinetics, and can’t therefore be considered interchangeable. Besides, they are more expensive than Amphotericin B deoxycholate. Aim of the study is to perform a cost/effectiveness analysis (CEA) comparing L-AmB (3mg/kg/die or 5mg/kg/ die) and ABLC (5mg/kg/die) as first-line antimicrobial empirical treatments in immuno-compromised patients with febrile neutropenia resistant to broad spectrum antibiotics. Secondly, we present a cost-minimization analysis (CMA) of the considered alternatives, assuming the same efficacy for all treatments. At the end we value the principal cost items from the point of view of the Italian Health Service, with a particular focus on the economic burden caused by adverse reactions.
Health care costs of comorbidities in patients with HIV infection in Italy. An estimate using a Delphi panel
Authors: Lucioni Carlo , Mazzi Silvio , Bensi Giuliano
Published: June 2016

In HIV affected patients, co-morbidities (also termed opportunistic infections or AIDS-defining events) characterise the disease progression, resulting from deteriorating immunologic status. They are the commonest cause of morbidity and mortality among such patients and may account for a major share of the overall health cost of HIV. Given the paucity of published data about co-morbidities costs in Italy, an estimation was targeted and then reached using a Delphi panel. A questionnaire, the same for each of the 22 co-morbidities considered, was designed where type and quantity of resources used (which and how many lab tests, hospital admissions, drugs) were to be reported concerning three steps (diagnosis, acute treatment, follow-up within one year) in each comorbidity. Six experts, belonging to as many infectious diseases centres located all over Italy, were involved to independently complete the questionnaires. Information about resources in physical terms, collected from the first round of the panel, was converted into monetary terms, aggregated (a cost for each co-morbidity was estimated averaging the corresponding six costs deriving from the centres), and sent back to the experts. Each expert received also the costs per co-morbidity data as resulting from the others’ answers (though in anonymous form) and was invited to confirm or revise the answers he had previously given. The same processing was then performed when information was available from the second round. A substantial convergence among the final data from the different experts came into evidence. According to this Delphi panel results, the overall average cost for a HIV co-morbidity in Italy is 8,967 euros; the most expensive co-morbidity is CMV retinitis (27,946 euros) and the cheapest is herpes simplex (2,057 euros).
Cost-effectiveness analysis of darbepoetin after switch from epoetin-beta in patients on hemodialysis: an Italian single-center retrospective study
Authors: Eandi Mario , Giotta Nicola , Russo Roberto , Gianino Maria Michela
Published: June 2016

Darbepoetin (DARB), a human erythropoietin with improved pharmacological parameters (longer half life and a dose-response relationship independent from the route of administration) is a new treatment option for chronic nephropathy-induced anemia that in many Italian dialysis centers is substituting older erythropoietins, mainly due to greater ease of use. At current prices and at the theoretical and recommended 200:1 dose conversion factor, DARB pharmaceutical cost ranges from –9% to +17% of EPO cost. In this monocentric study, real drug consumption and related actual costs of a pre-switch semester with EPO were analysed and compared to the first two post-switch semesters with DARB therapy. Furthermore, erythropoetic response was recorded and related to drug exposition levels, in order to establish a real life EPO:DARB dose conversion factor. In this experience, the conversion factor was estimated in at least 250-280:1, depending on the method adopted for the estimation. The initial dose, chosen on the basis of the recommended conversion factor, induced an excessive erythropoietic response, which was generally followed by a dose reduction and successive titration to target desired Hb levels, generating the spiraliform dose-response curve associated with delayed feed-back mechanisms. The pharmacoeconomical analysis, conducted in the perspective of the public health service, indicated that the choice of substituting DARB for EPO in the treatment of chronic kidney failure-associated anemia is univocally convenient, the former being less costly and more effective.
Bayesian statistic methods and theri application in probabilistic simulation models
Authors: Zaniolo Orietta , Eandi Mario
Published: June 2016

Significant advances in the management of hypercholesterolemia have been made possible by the development of statins, 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors. More recently, statins have demonstrated benefit in primary and secondary prevention of cardiovascular disease also in patients without hypercholesterolemia. Therefore statins help to reduce the impact of cardiovascular disease on morbility, mortality and social costs. Statins inhibit HMG-CoA reductase competitively, reduce LDL levels more than other cholesterol-lowering drugs, and lower triglyceride levels in hypertriglyceridemic patients. Prescribing statins as first line therapy in management of hypercholesterolemia as a part of a more comprehensive prevention program of cardiovascular disease is widely recommended by international guidelines (e.g. National Cholesterol Education Program - NCEP - Adult Treatment Panel - ATP- III reports). Currently in Italy there are five available statins: atorvastatin, fluvastatin, pravastatin, rosuvastatin and simvastatin; each of them presents some differences in physical and chemical characteristics (solubility), pharmacokinetics (absorption, proteic binding, metabolism and excretion) and pharmacodinamics (pleiotropic effects). Compared to other statins, fluvastatin extended-release (RP) 80 mg provides an equal efficacy in lowering total cholesterol and low-density lipoprotein cholesterol (LDL-C), with an important action on triglyceride (TG) levels and superior increases in HDL-C levels, reducing the incidence of major adverse cardiac events (MACE). Aim of this study is to outline an updated therapeutic and pharmacoeconomic profile of fluvastatin, particularly regarding extended-release (RP) 80 mg formulation.
Pharmacoeconomic profile of vitamin D3: in the prevention of osteoporosis
Authors: Zaniolo Orietta
Published: June 2016

Hypovitaminosis D is one of the principal risk factors for osteoporosis. Some studies estimated that more of 40% of Italian women over sixty are osteoporotic. Osteoporotic fracture is a significant cause of morbidity and cost. In Italy, in 2002, the global burden for hip fractures in over 65-years old patients has been estimated in more than one billion euro. Administration of vitamin D to prevent pathological fractures has a low cost-efficacy ratio, which reaches dominance compared to non-treatment in women over 70, i.e. avoided management costs of fractures exceed cost of therapy. In primary prevention, use of vitamin D3 involves some advantages with respect to partially or totally activated forms: higher safety and tolerability, lower costs and less frequent administrations. In order to prevent hypovitaminosis D, Regional Health Service of Toscana started to dispense free cholecalciferol to every person with more than 65 years (two 300.000 UI vials). The impact on the National Health Service budget, supposing all Italians over 65 would take cholecalciferol, has been estimated; annual savings resulted in more than 100.000.000 euro, only for hospitalization costs due to avoided fractures.
Resistenza all’uso degli ipoglicemizzanti orali nel trattamento del diabete tipo 2: uno studio multicentrico
Authors: Falcitelli Gianluca , Armentano Giuseppe , Pugliesi Corrado , Tatti Patrizio , Cimino Antonio
Published: June 2016

Type 2 diabetes is an important social and health care system variable due to its large diffusion, frequency of clinical complications and its health care costs. The studied population is relative to 4 italian centers distributed all over the country (Brescia, Roma, Rossano Calabro and Avola). This work has the aim to describe the Italian type 2 population according to treatment choice ruled by diabetes stage, glycemia control and HbA1c concentration. The analysis present a description of the therapeutic changes during the year of observation too, giving a complete picture of patients distribution and their treatment path through diabetes evolution in Italy.
First drug utilization data related to an anticholinergic agent recently marketed in Italy
Authors: Lucioni Carlo , Mazzi S. , Cerra C. , Lottaroli S.
Published: June 2016

A retrospective drug utilisation study was conducted, concerning a new bronchodilator (tiotropium, ATC code: R03BB04) in the first six months after its launch in Italy. The source of data was the administrative database run by a Local Health Unit located in Northern Italy. All patients (920) were selected with at least one prescription for tiotropium between September and December 2004, and data about their use of health resources (hospitalisations, class ATC R03 drugs, lab tests – only drugs and test prescribed in outpatient setting) was collected. Starting from such initial sample, further sub-samples were created (in particular to focus on patients affected by COPD – Chronic Obstructive Pulmonary Disease, for which tiotropium has got the therapeutic indication by the Italian Health Service), for the purpose of different levels of analysis. Results reported in this abstract are referred to the first level (702 patients, aged 40 years or more, still living at the end of the observation period, already with COPD in the previous year); they are expressed as average data per patient on a six-month period. Prescriptions of R03 drugs were 7.8, including 2.4 specifically for tiotropium. To such prescriptions, 348 and 103 DDDs (Defined Daily Doses) respectively corresponded; and, analogously, a cost of 487 and 205 euros. The cost for hospitalisations was 525 euros and the cost for lab tests was 28.5 euros. The other analysis levels (sub-samples with fewer patients) produced not very different outcomes. Evidence given here should prove the potential interest of such kind of studies.
Economic evaluation of the CARDS study
Authors: De Portu Simona , Menditto Enrica , Mantovani Lorenzo G.
Published: June 2016

Introduction: cardiovascular diseases (CVD) are the major component of premature mortality, generate disability and are a relevant source of cost. The growing incidence of CVD is associated with lifestyle and other modifiable risk factors. Prevention and preclinical detection of CVD reduce morbidity and mortality. Type 2 diabetes is associated with a substantially increased risk of cardiovascular disease. Objective: the aim of the study was to evaluate the health economic consequence of medical therapy with atorvastatin for primary prevention of major cardiovascular events in patients with type 2 diabetes in Italy. Materials and method: in order to reach our objective we drew clinical information from the CARDS study. This economic evaluation was carried out conducting a cost/effectiveness analysis from the perspective of National Health Service (NHS). The analysis was applied to a time horizon in conformity with the observational period adopted in the CARDS study (3.9 years). An incremental cost/effectiveness ratio (ICER) was calculated and is expressed as cost per life years gained (LYG). In order to test the robustness of the results, a one-way sensitivity analysis was performed. Results: the total cost of atorvastatin therapy over 3.9 years amounts to around 1.5 million of euros per 1,000 patients. The total cost of adding atorvastatin to standard care in people treated for primary prevention of major cardiovascular events in type 2 diabetes as those involved in the CARDS study would entail an additional cost of about 1,2 million of euros per 1,000 patients treated per 3.9 years, with an incremental cost/effectiveness ratio (ICER) equivalent to 36,566 euros per patient per LYG. Discussion: the current study is the first economic evaluation of CARDS study to the Italian situation. The results of the current study show that hypolipemic therapy with atorvastatin 10 mg in diabetic individuals is to be considered cost effective.
Tigecycline: a review of the literature
Authors: Venditti Mario , Pompeo Maria Elena , Fabi Flavia
Published: June 2016

Tigecycline is a new first-in-class glycylcycline antimicrobial agent with expanded broad-spectrum activity. It was developed to overcome the two key resistance mechanisms, efflux pumps and ribosomal protection, that limit the use of tetracycline. The spectrum of activity extends to clinically relevant susceptible and multidrug resistant bacteria, as methicillin resistant Staphylococcus aureus (MRSA), Streptococcus pneumoniae, vancomycin resistant Enterococci, Acinetobacter spp, Acinetobacter baumannii and Enterobacteriaceae, including extended-spectrum β-lactamase-producing strains (ESBLs). Tigecycline has been introduced into clinical practice as part of the effort to combat the growing problem of bacterial resistance to anti-infective therapy: tigecycline could replace some broad-spectrum agents for approved indications reducing the selective pressure provided by antibiotic administration. The expanded in vitro activity against a broad range of bacteria, including resistant pathogens, of tigecycline suggest that this novel antimicrobial agent should offer clinicians an option for the treatment of patients with serious bacterial infections.
Budget impact of rosiglitazone in type 2 diabetes
Authors: Zaniolo Orietta , Bamfi Francesco , Iannazzo Sergio
Published: June 2016

BACKGROUND: in type 2 diabetes, the maintenance of non-diabetic glycaemic levels has been shown to decrease the onset of long term complications and consequently their high management costs. In order to achieve and maintain normal blood glucose levels, lifestyle interventions are highly cost/effective, but require good compliance, strong motivation and efforts by the patients. For this reason, a majority of patients needs to start pharmacological therapy shortly after diagnosis. Rosiglitazone, an insulin-sensitising drug, is indicated for subjects with inadequate glycaemic control both as monotherapy, in those contraindicated to metformin, especially if overweight, and as combination therapy with metformin, sulphanilureas or both. OBJECTIVES: rosiglitazone offers clinical advantages over the alternatives, decreasing and/or postponing the need for insulin treatment. Its high acquisition cost may therefore be totally or partially offset by the reduction in future health care resources consumption, and by short-term practical advantages, such as the decrease in the need for blood glucose monitoring and of adverse events. Aim of this study was to investigate the impact of the use of rosiglitazone in eligible diabetic patients on the National Health System budget. METHODS: for this scope an analytic model was implemented, which pathway may be summarized as follows: a) estimate of the number type 2 diabetes patients living in Italy, grouped according to current therapeutic classes; b) estimate of the number of patients with inadequate glycaemic control for each subgroup; c) identification of patients eligible to rosiglitazone treatment; d) identification of the comparator strategy for each patient sub-group; e) comparison of costs for each couple of alternative options; f) calculation of budget impact. RESULTS: use of rosiglitazone monotherapy instead of sulphanilurea monotherapy induces a mild costs increase. Combination treatment with rosiglitazone added to metformin- or sulphanilurea- based therapies induces significant cost savings for the National Health System, related to lower resources consumption for glycaemic auto-monitoring and for hypoglycaemic events management, as compared to standard combination therapies. The hypothetical scenario in which all eligible patients are treated with rosiglitazone was estimated to induce net cost savings of about 260 millions Euro per year.
Asthma and public awareness in Italy: results from CHAOS (Chronic Airway Obstruction Survey)
Authors: Uleri Stefano , Dal Negro Roberto W.
Published: June 2016

Despite last years advances in asthma knowledge and treatment, its management and control remains a critical issue. Many surveys on general practitioners (GPs) and patients were conducted but no data, in Italy, are collected about the public awareness. The population cognition appears critic on decision maker health programs. This survey, with a face to face questionnaire, explored the perception of social relevance of asthma through the main chronic diseases and tests the disease knowledge in 1161 Italian citizens. Even if the sensibility of asthmatic (82) and their relatives (243) is superior to general population, some critical issues outcrop regarding beliefs, habits and therapy.  People not related to asthma have not cognition of social and economic burden. Asthmatic group is not confident with therapy value and possibility to measure organic damage. Educational intervention would be addressed first of all to GPs and then to patients and their relatives, while on the other hand it is important to enhance the public and decision maker sensibility to reduce the disease welfare and social cost.
Valutazione economica dello studio TNT
Authors: Mantovani Lorenzo G. , Montella Sabato , Citarella Anna , De Portu Simona
Published: June 2016

Introduction: the Treating to New Targets (TNT) study showed that intensive lipid-lowering therapy with atorvastatin 80 mg/die provides significant clinical benefit beyond that afforded by atorvastatin 10 mg/die in patients with stable coronary heart disease (CHD). Objective: our aim was to investigate the economic consequence of high dose of atorvastatin in Italian patients with stable coronary heart disease (CHD). Methods: data were derived from the Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease (TNT) study. We conducted a cost-effectiveness analysis, comparing high dose of atorvastatin (80 mg/die) versus usual-dose of atorvastatin (10 mg/die) in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of patients free from any event. We considered an observation period of 4.9 years. The costs borne after the first 12 months were discounted using an annual rate of 3%. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. Results: the cost of atorvastatin 10 mg or 80 mg therapy over the 4.9 years period amounted to approximately € 1.6 millions and € 2.5 millions per 1,000 patients respectively. The total cost of atorvastatin high dose was about € 3.7 millions, the incremental cost per patient free from event is about € 12,600. Discussion: this evaluation found that atorvastatin therapy is cost-effective. Sensitivity analysis shows that cost consequences parameters are substantially sensitive to fluctuation.
Valutazione economica dello studio PROVE-IT
Authors: Mantovani Lorenzo G. , Montella Sabato , Citarella Anna , De Portu Simona
Published: June 2016

Introduction: the PROVE-IT (“Intensive versus moderate lipid lowering with statins after acute coronary syndromes”) was a comparison of pravastatin 40 mg/die versus atorvastatin 80 mg/die in patients with an acute coronary syndrome (ACS). Aim: our aim was to investigate the economic consequence of high dose of atorvastatin vs usual-dose of pravastatin in Italian patients with a history of acute coronary syndrome. Methods: the analysis is conducted on the basis of clinical outcomes of the PROVE-IT study. We conducted a cost-effectiveness analysis, comparing high dose of atorvastatin (80 mg/die) versus usual-dose of pravastatin (40 mg/die) in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of mortality and morbidity reduction (number of deaths, life years gained and frequency of hospitalizations). We considered an observation period of 24 months. The costs borne after the first 12 months were discounted using an annual rate of 3%. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. We also conducted a threshold analysis. Results: the cost of pravastatin or atorvastatin therapy over the 2 years period amounted to approximately 1.3 millions euro and 870,000 euro per 1,000 patients respectively. Atorvastatin was more efficacious compared to pravastatin and the overall cost of care per 1,000 patients over 24 months of follow-up was estimated at 3.2 millions euro in the pravastatin and 2.5 millions euro in the atorvastatin group, resulting into a cost saving of about 700,000 euro that is 27% of total costs occurred in the pravastatin group. Discussion: this study demonstrates that high does atorvastatin treatment leads to a reduction of direct costs for the National Health System. Atorvastatin therapy is dominant since it is both less costly and more effective than pravastatin. Results of sensitivity analysis showed that atorvastatin therapy remains dominant even in the most unfavourable hypotheses.
Solifenacin in overactive bladder syndrome: pharmacoeconomic analysis
Authors: Iannazzo Sergio , Pradelli Lorenzo
Published: June 2016

The overactive bladder (OAB) syndrome can be treated with behavioural, surgical and/or pharmaceutical interventions, mainly represented by antimuscarinic drugs. Solifenacin is a new antimuscarinic with selectivity for the bladder and it demonstrated good effectiveness, safety and tolerability. Scope of the present study is to investigate the pharmacoeconomic performance of the treatment with solifenacin, when compared to tolterodine and placebo, in Italian patients with OAB. The economic evaluation is performed with a simulation model, based on a Markov chain. The time horizon of the simulation is 52 weeks, with a 1-week cycle. The model simulates the outcomes and costs of the treatment with solifenacin (5 mg/die), tolterodine ER (4 mg/die) and no treatment in a cohort representative of the Italian population with OAB (estimated in about 1,400 thousands patients). The cost analysis is conducted mainly in the perspective of the patient, since drugs for the treatment of OAB are currently not included in the Italian reimbursement list. The results show that both treatments produce significative improvements in symptoms and quality of life, with an increase in costs of about 540-640 Euro/year with solifenacin and of 680-780 Euro/year with tolterodine. In the cost-utility analysis, solifenacin dominates tolterodine since it results more effective and less costly, and its cost cost-utility ratio with respect to no treatment is in the range 7,600-18,600 Euro/QALY. In the subgroup of patients incontinent at baseline and who best respond to the therapy (responders), the increase in costs with solifenacin results of about 100-400 Euro/year and the cost-utility ratio is 600-4,200 Euro/QALY. A supplementary scenario has been elaborated to explore the consequences of a hypothetical reimbursement decision by the Italian NHS. In this scenario, the NHS cost perspective is considered and the antimuscarinic drugs are assumed to be reimbursed at a half of the current retail price only to incontinent and responder OAB patients. The overall expenditure of such a decision, which yields clear health outcomes, is estimated in about 23 millions Euro, with a cost-utility ratio of about 600-2,400 Euro/year, suggesting an efficient allocation of sanitary resources.
Cost-utility analysis of abatacept in rheumatoid arthritis in Italy
Authors: De Portu Simona , Mantovani Lorenzo Giovanni , Olivieri Ignazio
Published: June 2016

Objective: a substantial number of patients with rheumatoid arthritis (RA) have an insufficient or unsustained response to Tumor Necrosis Factor-α antagonists (anti-TNFs). The aim of the present study was to estimate the cost-utility of abatacept, a new selective T-cell co-stimulation modulator, in patients with moderately to severely active RA and an insufficient response or intolerance to anti-TNFs in the Italian setting. Methods: a probabilistic patient level simulation model was developed to estimate long-term costs and health outcomes of abatacept versus anti-TNFs (etanercept, adalimumab, infliximab) in RA patients. The model predicted patients’ HAQ (Health Assessment Questionnaire) scores over time based on the initial response to treatment (% change in HAQ score at six months). Responding patients continued treatment with a reduced rate of HAQ progression until long-term treatment failure. Health-state utilities and use of health care resources (excluding RA therapies) were assumed to depend on HAQ scores. The model used data from a Phase III clinical trial of abatacept in patients with inadequate response to anti-TNFs (Abatacept Trial in Treatment of anti-TNF Inadequate Responders [ATTAIN]) and various secondary data sources. The study was performed using the National Health Service (NHS) perspective. Cost-utility of abatacept vs other anti-TNFs was derived in terms of incremental cost per quality-adjusted life-year (QALY) gained based on a lifetime horizon with costs expressed in Euros. Single-way sensitivity analyses were performed on key parameters. Costs and health effects were discounted at 3% annually. Results: abatacept therapy was estimated to yield 1.18 additional QALYs per patient (5.02 abatacept vs 3.84 anti-TNFs) at an incremental cost of € 21,996.41 based on a 20 years time horizon. Cost per QALY gained was € 18,567.24. These results were robust to variation of key model parameters and are well within the usual cost-utility acceptance ranges. Conclusions: This study shows that in Italy, compared to anti-TNFs, abatacept therapy is cost-effective in patients with moderately to severely active RA and with an insufficient response or intolerance to anti-TNFs.
Lombardia
Authors: Cavallo Maria Caterina , Cipriani Filippo , Gerzeli Simone , Demarteau Nadia , Marocco Alessia , Bamfi Francesco
Published: June 2016

In Lombardy region 67,2% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 155 cases of cervicocarcinoma and 65 related deaths and thus results to be cost-effective (27.092 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 142 cancer cases and 61 deaths could be prevented, with a very similar cost-effectiveness ratio. In Lombardy region, the net cost for woman vaccinated is 197 € for the single cohort and 199 € for the multiple cohort.
Liguria
Authors: Cavallo Maria Caterina , Cipriani Filippo , Gerzeli Simone , Demarteau Nadia , Marocco Alessia , Bamfi Francesco
Published: June 2016

In Liguria region 66% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 22 cases of cervicocarcinoma and 9 related deaths and thus results to be cost-effective (24.584 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 23 cancer cases and 10 deaths could be prevented, with a very similar cost-effectiveness ratio. In Liguria region, the net cost for woman vaccinated is 183 € for the single cohort and 186 € for the multiple cohort.
Toscana
Authors: Cavallo Maria Caterina , Cipriani Filippo , Gerzeli Simone , Demarteau Nadia , Marocco Alessia , Bamfi Francesco
Published: June 2016

In Tuscany region 70,2% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 51 cases of cervicocarcinoma and 21 related deaths and thus results to be cost-effective (25.732€/QALY). When the vaccination programme is extended to 16-year-old girls a further 49 cancer cases and 21 deaths could be prevented, with a very similar cost-effectiveness ratio. In Tuscany region, the net cost for woman vaccinated is 169€ for the single cohort and 172€ for the multiple cohort.
Basilicata
Authors: Cavallo Maria Caterina , Cipriani Filippo , Gerzeli Simone , Demarteau Nadia , Marocco Alessia , Bamfi Francesco
Published: June 2016

In Basilicata region 57,5% of women (aged 25-64) are screened regularly, meaning every 3 years. Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 14 cases of cervicocarcinoma and 6 related deaths and thus results to be cost-effective (20.169 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 15 cancer cases and 6 deaths could be prevented, with a very similar cost-effectiveness ratio. In Basilicata region, the net cost for woman vaccinated is 185 € for the single cohort and 189 € for the multiple cohort.
Sicilia
Authors: Cavallo Maria Caterina , Cipriani Filippo , Gerzeli Simone , Demarteau Nadia , Marocco Alessia , Bamfi Francesco
Published: June 2016

In Sicily region 39,6% of women (aged 25-64) are screened regularly, meaning every 3 years.
Considering regional tariffs and vaccine acquisition cost, the vaccination of 12-year-old girls with a 90% coverage could prevent 169 cases of cervicocarcinoma and 68 related deaths and thus results to be cost-effective (15.534 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 181 cancer cases and 75 deaths could be prevented, with a very similar cost-effectiveness ratio. In Sicily region, the net cost for woman vaccinated is 171 € for the single cohort and 176 € for the multiple cohort.
Decision analytic economic paliperidone ER in relapsing schizophrenic patients in Italy
Authors: Berto Patrizia , Negrini Cristina , Ferrannini Luigi
Published: June 2016

Schizophrenia, with its typical chronic and relapsing course, is very burdensome, both clinically and economically. Its pharmacological management relies on two main drug classes: the older, or typical, antipsychotics, which are quite effective on positive symptoms, but limited by low tolerability and poor efficacy on negative symptoms, and atypical antipsychotics, which are better tolerated and effective on a wider range of psychotic symptoms. In this article, the authors briefly discuss current management options for patients with schizophrenia and highlight some unmet clinical needs in the field. After outlining the main clinical features shown by paliperidone ER, a novel antipsychotic, in its clinical development program, a decision analytic economic appraisal of its use in relapsing schizophrenic patients in Italy, as compared to the other available atypical antipsychotics, is presented. Under base-case assumption and after applying national costs and tariffs, the model predicts paliperidone ER to be associated with better clinical outcomes, expressed in terms of stable days, and lower costs; this means that paliperidone is dominant over the alternatives, according to the principles of economic evaluation of healthcare technologies. One-way sensitivity analyses conducted on structural and cost parameters indicated robustness of base-case estimates, which remain to be confirmed by “real world” national data.
Pharmacoeconomic analysis of valsartan for the treatment of chronic congestive heart failure in Italy
Authors: Iannazzo Sergio , Pradelli Lorenzo , Zaniolo Orietta
Published: June 2016

Objective: to evaluate pharmacoeconomic implications of the use of valsartan, an angiotensin II antagonist in addition to standard therapy for the treatment of chronic congestive heart failure (CHF). Methods: the study was conducted performing cost-utility and budget impact (B.I.) analyses by means of a cohort simulation based on a probabilistic Markov model and projecting 23-months follow-up results in the Val-HeFT trial study over a 10-years time horizon. The model included four states (class NYHA I, II and III and death), and had a cycle of 1 year. Two probabilistic simulations (varying first patients parameters and after model parameters) were performed using WinBUGS, a software for bayesian analysis. The distributions of patients parameters (sex, age, use of ACE inhibitors) corresponding to Val-HeFT inclusion criteria in the simulated population were derived from the Italian CHF patients population. Individual mortality was derived from general mortality by adjusting with a NYHA state-specific HR, and the probability of changing NYHA class from Val-HeFT. Costs were calculated in the perspective of the Italian NHS and account for drugs and CHF hospitalizations. Quality of life weights were obtained by elaborating published HRQoL data of CHF patients. A 3.5% annual discount rate was applied; probabilistic sensitivity analysis was performed on each parameter using original-source 95% CI, or a ±10% range where it was unavailable. Results: in the 10 years horizon, patients were estimated to live an average of 4.4 years or 3.2 QALYs, with slight increases in the valsartan group. In this group, hospitalizations are predicted to be sensitively reduced and overall costs decreased by about 500 €/pz. In subgroup analysis, valsartan loses dominance in NYHAII and ACE-using patients, for which ICURs are 17,330 and 27,000 €/QALY, respectively. B.I. analysis predicts a saving of about 172 millions €. Conclusions: valsartan in addition to standard therapy is predicted to be a cost/effective strategy for Italian patients with mild-to-severe CHF and cost-saving from the perspective of the NHS.
Budget impact of vildagliptin
Authors: Zaniolo Orietta , Sacchi Viola , Pradelli Lorenzo
Published: June 2016

Introduction: to evaluate the impact on the Italian National Health Service (NHS) budget of the recent introduction of the DPP-4 inhibitor vildagliptin in combination treatment for NIDDM patients. Methods: NIDDM patients eligible to vildagliptin treatment were identified and quantified based on approved indications and prevalence data review; adequate alternative strategies were identified; direct medical costs associated with competing strategies were calculated according to national practice and prices (drug acquisition, therapeutic monitoring, cost for managing severe adverse events – severe hypoglycemia events, fractures, new heart failure cases) and the NHS budgetary impact was estimated according to market penetration assumptions (base-case: 5% and 10% for the first and second year, respectively). Results: patients estimated eligible for vildagliptin in Italy are about 237,500: pts inadequately controlled with metformin monotherapy (166,500), pts inadequately controlled with sulfonylurea monotherapy and intolerant/contraindicated to metformin (70,200), and those inadequately controlled with thiazolidinedione monotherapy (800). Costing and comparing of the vildagliptin-based and competing strategies revealed differences in both directions, depending on patient subgroup. Assuming uniform penetration among identified patient subgroups, vildagliptin introduction is expected to raise NHS costs by 2,750,000 Euro in the first and by 5,500,000 Euro in the second year, respectively representing 1,6% and 3,2% of the estimated total management cost of this patient population. Conclusions: the introduction of vildagliptin in the treatment of Italian NIDDM patients offers a new therapeutic option for three inadequately controlled NIDDM subpopulations; the financial impact on Italian NHS expenditures depends on patient selection and can be expected not to exceed 2-3% of the currently dedicated budget in the first two years.
Daptomycin (Cubicin) in patients with complicated skin or soft-tissue infections
Authors: Sacchi Viola
Published: June 2016

Skin and soft-tissue infections (SSTIs) are commonly observed and differ in terms of site and localization, clinical characteristics, and the aetiological agent; these infections are usually caused by Staphylococcus aureus or beta-haemolytic streptococci, and are the most frequent forms of methicillin-resistant S. aureus (MRSA) infections. SSTIs are considered complicated if they involve deeper skin structures (fascia or muscle layers), require significant surgical intervention or arise in the presence of significant co-morbidity. The progressive increase of bacterial resistance, in particular for Gram-positive bacteria infections, to currently used agents is a serious and growing problem, and in particular MRSA, GISA (glycopeptides-insusceptible S. aureus), VRE and GRE (glycopeptides-resistant enterococci) are of concern. There is, therefore, a need for additional agents active against these difficult-to-treat pathogens.
Peg-interferon plus ribavirin in chronic hepatitis C: cost-efficacy and pharmacoutilization in clinical practice
Authors: Cavalletto Luisa , Bernardinello Elisabetta , Diodati Giulio , Raise Enzo , Gatta Angelo , Chemello Liliana
Published: June 2016

The current standard of care for the treatment of chronic hepatitis C virus (HCV) infection is combination therapy with Peg-interferon (IFN) alpha-2a or alpha-2b type plus ribavirin (RBV). This antiviral schedule can in fact avoid the three fold mortality rates associated to untreated cases with HCV infection, by inducing viral eradication and liver damage regression, so as to define the patients “definitively cured” from liver disease. This analysis describes the modalities of antiviral treatment in the Veneto region, in particular the therapy-schedule mainly used and compares the cost-effectiveness of treatment with the 2 available Peg-IFNs with strategies proposed as in the every day practice. Twelve on line hepatologic units, centralized by a network program on “Surveillance and Control of HCV Infection in the Veneto Region”, prospectively collected data and, of these, we evaluated 450 subjects that underwent antiviral therapy for chronic hepatitis or cirrhosis. A post hoc retrospective analysis of cases treated from January 2003 to December 2005 was performed, grouping the study population in 166 cases treated with Peg-IFN alpha-2a (Pegasys®, Roche, fixed-dose of 180 μg/weekly) and 284 that received Peg-IFN alpha-2b (Peg-Intron®, Schering-Plough, weight-adjusted-dose from 50 to 150 μg/weekly), both in combination therapy with ribavirin (Copegus®, Roche, or Rebetol®, Schering-Plough, weight-adjusted-dose of 15 mg/kg/daily). Epidemiological characteristics and cumulative rate of end-of-therapy response and Sustained Virological Response (SVR) were similar in the 2 groups, but 78% of cases treated with Peg-IFN alpha-2b and RBV received a significantly lower dose with respect to the weight-adjusted dose. This event conditioned efficacy to therapy as demonstrated in cases that received a < 1 μg/kg dose with respect to those treated with > 1 μg/kg (respectively SVR: 49% vs 66%, p < 0,01), particularly in genotype HCV-1 (SVR: 29% vs 51%, p = 0,01), known to be more resistant to IFN-therapy. The overall cost of antiviral therapy in this study population was about € 3,528,000/450 treated cases and considering the 269 that reached SVR (98 and 171, respectively by Peg-IFN alpha-2a or 2b and RBV therapy), the cost/SVR was € 15,632 and € 11,672 in the 2 groups. In conclusion, the optimization of Peg-IFN therapy, that is the use of the full dose, particularly in cases treated with a weight-adjusted Peg-IFN alpha-2b and RBV, at the standard of care dosage of 1.5 μg/kg/week and 15 mg/kg/day respectively, will allow a better efficacy, especially in genotype HCV-1 with an increase of 11% in SVR (43% to 54%) at a lower cost.
Epidemiology and costs of HPV infection: review of the evidence
Authors: Bamfi Francesco , Marocco Alessia , Capri Stefano , Sideri Mario Giovanni
Published: June 2016

HPV infection is a well-established cause of both benign and malign diseases. The HPV 16 and 18 genotypes are most commonly associated with cervical cancer whereas the HPV 6 and 11 genotypes are most commonly associated with anogenital warts. In Italy are currently approved two types of vaccine: Gardasil® is a tetravalent HPV 6, 11, 16 and 18 vaccine that prevents cervix cancer and genital warts, Cervarix® is a bivalent HPV 16 and 18 genotype vaccine that protects against cervical cancer and pre cancer forms. Aim of present study was to collect the available epidemiological data and the impact on the Italian National Health Service (NHS) budget of genital warts pathology. In Italy 40,000 genital warts cases per year could be estimated in the female population. The management cost in charge of Italian NHS for the female pathology is evaluated around 7 millions €. Comparing the available evidence NHS costs for genital wart pathology represent 3-4% of the total amount for prevention and treatment of cervix cancer.
Se former pour prévenir. Les représentants syndicaux des CHSCT face aux risques cancérogènes, mutagènes et reprotoxiques
Authors: Féliu François , Jamet Ludovic
Published: June 2016

Cet article interroge la mise en oeuvre des démarches de prévention des risques cancérogènes, mutagènes et reprotoxiques (CMR) dans la région Haute-Normandie. L’accent sera mis ici sur les enjeux de formation des représentants syndicaux pour participer de manière active à ces démarches. Il s’agit de comprendre comment les représentants syndicaux se forment aux enjeux de prévention des risques CMR et comment les connaissances qu’ils acquièrent leur permettent ensuite de développer différentes pratiques syndicales. Par la formation, les acteurs s’approprient de nouvelles compétences pour se mobiliser autour de ces questions et enclencher ensuite des dynamiques de prévention. Seulement, s’inscrire dans ces dynamiques de formation reste soumis à de multiples contingences. Les acteurs peuvent également lier de nouvelles relations avec des acteurs institutionnels (rôle de l’inspection du travail, de la Carsat, des médecins du travail, etc.), ce qui contribue, pour les représentants syndicaux notamment, à leur ouvrir de nouvelles perspectives dans les relations professionnelles qu’ils entretiennent avec les employeurs.
Restructurations financières : transformation des relations collectives de travail et montée des incertitudes
Authors: Michel Frédéric , Vandewattyne Jean
Published: June 2016

Cet article a pour point de départ une restructuration financière intervenue en 2010-2011 dans une entreprise chimique de la région de Mons-Borinage en Belgique.

Dans une première partie, les notions de restructurations économiques et financières sont appréhendées à travers un relevé de la littérature économique et managériale. Il en ressort que les restructurations financières se distinguent notamment par leur caractère offensif (conquête de nouvelles positions de marché) et leurs objectifs purement financiers (rentabilité accrue).

Le cadre national et local dans lequel est intervenu la restructuration fait ensuite l'objet d'une présentation. Cette contextualisation est en effet fondamentale pour comprendre le déroulement de la restructuration mais aussi ses enjeux et ses conséquences.

Dans une dernière partie, les auteurs s’attachent à l’analyse de la restructuration. Contrairement aux précédentes restructurations, celle de 2010-2011 ressort comme étant clairement financière. Partant de ce constat, les auteurs mettent alors en discussion certaines conséquences possibles des restructurations financières sur les relations collectives de travail et le rapport à l’emploi des travailleurs.