bluuebunny/crossref_metadata_2025 huggingface dataset:
Pharmacoeconomic evaluation of the costs incurred by the ASP Messina for home therapy with liquid oxygen
Authors: Coppolino Salvatore
Published: June 2016

Chronic obstructive pulmonary disease (COPD) is a very frequent disease in all industrialized countries. The cost for the community includes cost for hospitalisations, doctor visits, home care, rehabilitation, loss of working days, etc. From a therapeutical point of view, an effective progression of therapy and patients survival can be obtained only by stopping smoking and by following a long term oxygen therapy. The aim of this retrospective study is to evaluate costs of liquid oxygen therapy performed at home. Obtained results are very encouraging because a part from being cheap they also provide a better evaluation of the prescribed therapy which can also be extended to gaseous oxygen.
Clinical and pharmacoeconomic profile of lanthanum carbonate treatment of hyperphosphataemia in chronic renal dialysis patients
Authors: Eandi Mario
Published: June 2016

Hyperphosphatemia is recognized as a principal mineral disorder in chronic kidney disease (CKD) that leads to the development of secondary hyperparathyroidism. Approximately 70% of patients with end-stage renal disease (ESRD) and dialysis have hyperphosphataemia, which is associated with renal osteodystrophy, metastatic calcification and increased mortality and morbidity. Despite dietary restriction and dialysis, most patients will require a phosphate-binding agent to treat this condition.Lanthanum carbonate is an new, potent, selective, no-resin, non-calcium phosphate binder that retains high affinity for phosphate over a wide pH range, does not bind bile acids or contribute to metabolic acidosis. Taken with food, it is well tolerated. It is poorly absorbed and does not require functioning kidneys to be removed from the body. There is no evidence from current studies that it accumulates to biologically significant levels in tissues. Lanthanum carbonate has been shown in clinical studies of up to 6 years to be an effective, well-tolerated phosphate binder. Lanthanum carbonate controls hyperphosphataemia without increasing calcium intake above guideline targets and has the potential to reduce pill burden and increase patient compliance compared with other phosphate binders. Reported adverse effects are mainly gastrointestinal, and do not differ from those of calcium carbonate. The new phosphate binders, lanthanum carbonate and sevelamer, have increased the possibilities for serum phosphate control, at the expenses of significant increases in costs. The cost-effectiveness of lanthanum carbonate has been assessed by three different studies. A recent analysis, conducted on the perspective of the UK NHS, shows it is cost-effective to follow current treatment guidelines and treat all patients who are not adequately maintained on calcium carbonate (serum phosphorus above 5.6 mg/dl) with second-line lanthanum carbonate. This is particularly the case for patients with serum phosphorus above 6.6 mg/dl. A retrospective analysis, performed on IHCSI data base (USA), and a prospective study conducted in Spain show that lanthanum carbonate is cost-effective as compared with sevelamer, requiring less number of tablets, a fact that might improve adherence, and that probably explains better results with lower costs.
Tiotropium in COPD: clinical outcomes and economic evidence
Authors: Zaniolo Orietta , Sacchi Viola , Dal Negro Roberto W.
Published: June 2016

Tiotropium bromide is a once-daily anticholinergic bronchodilator with duration of action of at least 24 hours. In clinical trials, tiotropium has been compared with placebo, ipratropium or salmeterol, the most frequently used long-acting β2 agonist. When compared with ipratropium or placebo in COPD management, tiotropium resulted associated with FEV1, dyspnoea and health-related quality of life (QoL) improvement, along with reduced exacerbation and hospitalisation rates. In comparison to salmeterol, it proved to be superior in terms of lung function improvement and exacerbation risk reduction. Recently, the randomised, double-blind trial UPLIFT showed that 4 years of therapy with tiotropium were associated with improvements in lung function, QoL, and exacerbations, and with an effective reduction of mortality compared with control group in 5,993 patients with moderate to very-severe COPD. These encouraging clinical effects are to be traded against the pharmaceutical cost increase induced by the inclusion of tiotropium in routine care. However, published work indicates that this pharmaceutical cost increase may be totally or partially offset by the reduction in costs needed for exacerbations management and hospitalisations. Depending on the setting analysed, tiotropium is estimated to dominate ipratropium and salmeterol or to be associated with an incremental cost of less than € 2,500 per exacerbation avoided. An Italian model based on UPLIFT data shows that therapy including tiotropium induces an incremental cost of € 6,700 for year of life and of € 7,916 for Quality-adjusted Life Year gained, with respect to routine care alone. These values are much lower than commonly accepted thresholds and than cost/effectiveness results estimated for other long-acting bronchodilators. In conclusion, available evidence suggests that tiotropium may prove an appropriate therapeutic option with a largely affordable cost.
Economic evaluation of the use of saxagliptin in the treatment of type 2 diabetes in Italy
Authors: Cristiani Marco , Citarella Anna , Belisari Andrea , Didoni Guido , Mantovani Lorenzo Giovanni , Montella Sabato
Published: June 2016

In this study we compare the cost-effectiveness of saxagliptin (Onglyza®) in combination with metformin to that of either sulphonylurea (SU) plus metformin or a thiazolidinedione  (TZD) plus metformin, in type 2 diabetes mellitus patients who are not well-controlled on metformin alone. By using decision-analytic modeling, long-term costs and health outcomes associated with the investigated treatment strategies are estimated. This is achieved by modeling the risk of experiencing diabetes-related events (e.g. myocardial infarction) or side-effects such as hypoglycemia and weight gain. The risk of these events  depends on baseline characteristics as well as risk factors (which can be altered by the treatment strategies). Ultimately, costs (NHS perspective) and quality-adjusted life years (QALYs) for each treatment strategy are based on the occurrence of these events. Based on these estimates incremental cost-effectiveness ratios (cost per QALYs) are calculated. In the analysis comparing saxagliptin + metformin with SU + metformin in 1,000 patients in a 40 years time horizon, the total QALY gain with saxagliptin + metformin is 111. The incremental cost with saxagliptin + metformin is € 1,300,000, resulting in a total cost per QALY gained with saxagliptin + metformin of € 11,800 in the base case scenario. Similarly, the comparison with TZD + metformin resulted in a total  QALY gain with saxagliptin + metformin of 127, with an incremental cost of € 144,000, resulting in a total cost per QALY gained with saxagliptin + metformin of € 1,100 in the base case scenario. The results are mainly driven by differences in hypoglycemias (associated with a utility decrement and a monetary cost) and weight gain (which is associated with a utility decrement and also increases the risk for diabetes-related events). Saxagliptin + metformin is associated with small difference in macrovascular events such as myocardial infarction, congestive heart failure compared to SU or TZD plus metformin strategies, probably due to the difference of action on net weight. Since the treatment cost is higher with saxagliptin + metformin, total costs are also higher for the Onglyza®-based strategy although the higher drug cost is partially offset by the lower rate of macrovascular costs and reduced cost of severe hypoglycemias. The present analysis suggests that saxagliptin, when added to metformin, is a cost-effective treatment alternative for type 2 diabetes mellitus patients in Italy who are not well-controlled on metformin alone. Both compared to SU + metformin and TZD + metformin, the cost-effectiveness results of saxagliptin + metformin are robust to various assumptions concerning input variables. Hence, the favorable safety profile for saxagliptin, with a risk of hypoglycemia and impact on weight similar to placebo, makes it possible to increase the utility for patients since it is not reducing risk of diabetes-related events per se.
Pharmacoeconomic comparison of ziprasidone with other atypical oral antipsychotic agents in schizophrenia
Authors: Fagiolini Andrea , Matone Alice , Gaz Claudio , Panunzi Simona , De Gaetano Andrea
Published: June 2016

Objective: to comparatively investigate – by means of computer simulations – the economic cost and clinical outcomes of five atypical oral antipsychotic agents (ziprasidone, olanzapina, risperidone, paliperidone and aripiprazolo).Methods: a cyclical stochastic model representing patient evolution, taking into account main adverse reactions (akathisia, weight gain and extra-pyramidal ARs), drug efficacy on psychosis stabilization and probability of relapse, was developed. Ten different scenarios were compared, each starting with one of the considered antipsychotics, prescribed either at home or in a hospital setting. Switching to another medication was allowed until no untried drugs were available, in which case clozapine treatment or admission to a Psychiatric Therapeutic Rehabilitation Center were irreversibly assigned. Model inputs were probabilities of ARs, probabilities of stabilization and probabilities of destabilization (assumed equal for all); as well as costs attributable to drugs, hospitalization, outpatient care and costs adverse reactions in terms of concomitant medications. Sources for the inputs were the trials reported in the most recent literature (from the year 2000), selected based on the homogeneity of the observational period and antipsychotic dosage used.Results: in each scenario, the hospitalization cost represented the highest component of the overall cost (approximately 67%). Assuming equal drug effectiveness, ziprasidone fared better than all other considered competitors, showing the lowest average annual costs per patient (and also the lowest average annual hospitalization costs) as well as the largest numbers of controlled months without adverse reactions, independently of the initial setting. Conclusions: the most important determinant of total cost appears to be hospitalization, whose cost is about 600% higher than the medications cost. Medication effectiveness and tolerability remain however of utmost importance for the patients well being and reduction of hospitalization rate.
Tiotropium bromide in the routine care of GOLD stage II COPD patients: a pharmaeconomic evaluation
Authors: Zaniolo Orietta , Carsi Michela , Iannazzo Sergio
Published: June 2016

Background: a secondary pre-specified analysis of the UPLIFT cohort demonstrated that the inclusion of tiotropium bromide in the routine care of GOLD stage II (moderate) chronic obstructive pulmonary disease (COPD) patients is associated with stronger improvements of survival, quality of life, and exacerbation rate than those shown in the total cohort; in this subgroup, tiotropium furthermore induces a significant reduction in the rate of FEV1 decline.Objective: to adapt the Spiriva® model, originally built to evaluate cost-effectiveness of tiotropium inclusion in the general COPD population, to GOLD II patients.Methods: the Spiriva® model is a probabilistic Markov patient-level simulation developed over a lifetime horizon to compare outcomes associated with the inclusion of tiotropium in routine care (RC) for COPD treatment with those obtained with RC alone. Patients are characterised by gender, age, height, smoking status and FEV1. Model structure and sources have been maintained unvaried, except for demographic characteristics, specific for GOLD II patients, as extrapolated from an Italian observational study, and tiotropium efficacy, based on the secondary analysis of GOLD II UPLIFT patients. As in the original model, only direct health care costs are considered.Results: patients treated with tiotropium on average (95% CI) gain 0.70 (0.00/7.23) LYs or 0.77 (0.02/4.67) QALYs compared to RC. The incremental lifetime cost is € 3,520 (-6,391/26,686), meaning that the incremental cost required to gain a QALY (incremental cost-effectiveness ratio – ICER) is equal to € 4,548. Sensitivity analysis shows that tiotropium has a 50% probability of being cost-effective for a willingness-to-pay (WTP) around 4,600 €/QALY; 100% probability is achieved with a WTP of € 9,300.Conclusions: the adoption of a strategy based on the inclusion of tiotropium from the early COPD stages represents good value for money in Italy, as the ICER estimated for GOLD II patients is well below conventional WTP thresholds, and lower than that calculated for the entire UPLIFT cohort.
Valutazioni economiche di atorvastatina in prevenzione secondaria: un aggiornamento
Authors: De Portu Simona , Montella Sabato , Cortesi Paolo , Menditto Enrica , Cammarota Simona , Citarella Anna , Mantovani Lorenzo G.
Published: June 2016

Introduction: cardiovascular diseases are the most common reason of mortality and morbidity in the world, despite therapeutic interventions have improved patients’ prognosis in the last decades. Aggressive lipid lowering treatment with atorvastatin has demonstrated to be effective in preventing the occurrence of new cardiovascular events requiring hospitalizations, in patients previously affected by coronary syndromes. However, the increasing costs of managing cardiovascular diseases impose a careful analysis of the economic benefits of these therapies. Objective: to assess the economic sustainability of using atorvastatin for the secondary prevention of cardiovascular events. Material and Methods: we derived clinical information from five randomized, multicenter trials (AVERT, IDEAL, MIRACL, PROVE-IT, TNT) evaluating efficacy and tolerability of high dosage treatment with atorvastatin over control groups in different patient populations and for different follow up periods. A costeffectiveness analysis in the perspective of the NHS has been performed, under the hypothesis of the imminent price reduction of atorvastatin, due to the loss of exclusivity. Results: in trials AVERT, MIRACL, PROVE IT, the treatment with atorvastatin has demonstrated to reduce both cardiovascular events and overall healthcare direct costs, compared to the respective control groups. In trials IDEAL and TNT, the therapy with atorvastatin has resulted to be cost effective, with incremental cost-effectiveness ratio respectively of € 6,310 for avoided event (vs simvastatin 10 mg) and € 9,058 for CV disease free patient (vs atorvastatin 10 mg). Discussion: the present study represents an update of previous cost-effectiveness analyses, which have previously evaluated the economic consequences of using atorvastatin for the secondary prevention of cardiovascular events. The present analysis has proved the economic benefits deriving from the usage of atorvastatin, which is a dominant alternative in the AVERT, MIRACL and PROVE-IT clinical settings, and a cost effective
option in the IDEAL and TNT study populations.
Palivizumab e virus respiratorio sinciziale: una panoramica
Authors: Manzoni Paolo
Published: June 2016

Respiratory Syncytial Virus (RSV) is a very frequent cause of respiratory infections in the first two years of life. Symptoms of­ten are mild to moderate, but in some high-risk categories of infants, particularly prematures and children with bronchopulmonary dysplasia or congenital heart disease, RSV can cause severe lower respiratory tract infections with need of hospitalisation, and, sometimes, even death. No effective treatment is available, and specific vaccines, despite several attempts during the last decades, do not exist. Palivizumab is a humanised monoclonal antibody targeting specific viral mechanisms controlling infection. If administered intramuscularly monthly during the RSV season as prophylaxis to high risk patients < 2 years of age, this antibody effectively reduces hospitalisation rates and severity of RSV infection. Based on the data from the two main phase III trials conducted so far, palivizumab prophylaxis results in 45% to 55% reduction of hospitalisation rate, with a very satisfactory profile of tolerability as most commonly reported adverse events where transient and mild irritability, diar­rhoea or fever.
L’impatto della prematurità sulla qualità di vita del bambino
Authors: Eandi Mario , Manzoni Paolo
Published: June 2016

In the last years prematurity rates have increased, together with the survival rate among premature subjects. In addition now even infants born at 23 weeks of gestational age can survive. However, some studies demonstrate that premature children are more likely to show late disabilities and to be hospitalised during childhood. In Italy the premature childrens’ care level too often depends on the socio-economic status of the Region: central decisions about assistance until the beginning of teenage are yet to be taken. A strict monitoring of pregnancy and of risk factors predisposing to premature birth as well as a careful management of perinatal period should further improve survival and quality of life of these subjects.
Abruzzo
Authors: Gasparini Roberto , Panatto Donatella , Dirodi Bruna , Prato Rosa , Amunni Gianni , Turello Valter , Sudano Luigi , Cristoforoni Paolo , Boccalini Sara , Bonanni Paolo
Published: June 2016

In Abruzzo region 71% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 16 cases of cervicocarcinoma and 7 related deaths more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (10,393 €/QALY).
Molise
Authors: Gasparini Roberto , Panatto Donatella , Dirodi Bruna , Prato Rosa , Amunni Gianni , Turello Valter , Sudano Luigi , Cristoforoni Paolo , Boccalini Sara , Bonanni Paolo
Published: June 2016

In Molise region 75% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 3 cases of cervicocarcinoma and 1 related death more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (10,517 €/QALY).
Puglia
Authors: Gasparini Roberto , Panatto Donatella , Dirodi Bruna , Prato Rosa , Amunni Gianni , Turello Valter , Sudano Luigi , Cristoforoni Paolo , Boccalini Sara , Bonanni Paolo
Published: June 2016

In Puglia region 58% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 70 cases of cervicocarcinoma and 31 related deaths more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (9,935 €/QALY).
Toscana
Authors: Gasparini Roberto , Panatto Donatella , Dirodi Bruna , Prato Rosa , Amunni Gianni , Turello Valter , Sudano Luigi , Cristoforoni Paolo , Boccalini Sara , Bonanni Paolo
Published: June 2016

In Toscana region 83% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 27 cases of cervicocarcinoma and 12 related deaths more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (11,466 €/QALY).
Umbria
Authors: Gasparini Roberto , Panatto Donatella , Dirodi Bruna , Prato Rosa , Amunni Gianni , Turello Valter , Sudano Luigi , Cristoforoni Paolo , Boccalini Sara , Bonanni Paolo
Published: June 2016

In Umbria region 85% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 6 cases of cervicocarcinoma and 3 related deaths more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (11,615 €/QALY).
Veneto
Authors: Gasparini Roberto , Panatto Donatella , Dirodi Bruna , Prato Rosa , Amunni Gianni , Turello Valter , Sudano Luigi , Cristoforoni Paolo , Boccalini Sara , Bonanni Paolo
Published: June 2016

In Veneto region 85% of women (aged 24-64) are screened regularly, meaning every 3 years. The analysis on cross-protective activity exercised by bivalent and quadrivalent vaccines shows that the bivalent vaccine could prevent more pre-cancerous lesions and cases of cervicocarcinoma than quadrivalent, and that the latter could prevent genital warts that are not prevented by bivalent. The major number of cases avoided by the bivalent make it possible to fully offset the cost savings related to warts associated with the quadrivalent vaccine. Furthermore, a cost-effectiveness analysis shows that, considering regional tariffs, the multiple cohort (12-year-old + 25-year-old women) vaccination strategy with a 90% coverage could prevent 35 cases of cervicocarcinoma and 16 related deaths more than the vaccination of only 12-year-old girls, and thus proves to be cost-effective (11,962 €/QALY).
Budget impact analysis resulting from the use of dabigatran etexilate in preventing stroke in patients with non-valvular atrial fibrillation in Italy
Authors: Mennini Francesco , Russo Sergio , Marcellusi Andrea
Published: June 2016

Background: atrial fibrillation (AF) is the most common form of alteration in cardiac rhythm and associated with more severe episodes of stroke. Treatment with oral anticoagulants vitamin K antagonists (VKA) such as warfarin, is nowadays the therapy of choice for stroke prevention in patients with AF, but dabigatran etexilate (DE) 150 mg twice daily was more clinically effective than warfarin in reducing the risk of stroke or systemic embolism, ischaemic stroke and vascular mortality whereas DE 110 mg twice daily was non-inferior to warfarin.Aim: to assess the affordability of the use of DE for the Italian NHS, in patients with non-valvular AF (NVAF) through a budget impact analysis (BIA).Methods: the BIA in a timeframe of 5 years was divided into 3 scenarios (1: current management of patients with NVAF; 2: all patients with NVAF treated with VKA; 3: all patients with NVAF treated with DE). The population considered is the one with indication for anticoagulation. Analysis is from the NHS perspective: therefore, indirect costs are excluded.Results: the underuse of oral anticoagulation, associated with the difficulty in keeping the patients treated with VKA within an acceptable therapeutic range, results in an enormous social and human cost, represented by a total of more than 63,000 strokes cumulated in the 5-year period considered. The cumulative cost for the scenario 1 over the 5-year period is over € 2.3 billion. In the scenario 2 the number of strokes avoided per year increases by -5,219 compared to no treatment (-2,368 compared to scenario 1), although the number of events remains high (about 10,000 events/year). In the 5-year observation period the scenario 2 would result in a reduction in the total number of strokes (-12,323 events vs. scenario 1), and savings for the NHS of around 95 million Euros compared to scenario 1. In the Scenario 3 there is a reduction of more than 38,600 of the total cumulative number of strokes vs. the scenario 1 and over 26,200 vs. scenario 2, and savings for the NHS at the fifth year of observation of circa 174 million Euros vs. scenario 1 and 123 million Euros vs. scenario 2.Conclusion: DE in Italy is economically sustainable, as it allows savings for the NHS in the management of patients with NVAF from the second year vs. no treatment and vs. treatment with VKA
Assessment of the innovative quality of agomelatine through the Innovation Assessment Algorithm
Authors: Civalleri Liliana , Licata Sabrina
Published: June 2016

Aim: the aim of this study was to assess the innovative quality of a medicine based on agomelatine, authorized by the European Commission through a centralized procedure on 19th February 2009 and distributed in Italy under the brands Valdoxan® and Thymanax®.Methodology: the degree of innovation of agomelatine was determined through the Innovation Assessment Algorithm (IAA), which considers the innovative quality of a medicine as a combination of multiple properties. The algorithm may be represented as a decision tree, with each branch corresponding to a property connected with innovation and having a fixed numerical value. The sum of these values establishes the degree of innovation of the medicine. The IAA is articulated in two phases: the first assesses the efficacy of the drug based on the clinical trials presented in support of the registration application (IAA-efficacy); the second reconsiders the degree of innovation on the basis of the efficacy and safety data resulting from clinical practice once the drug has been placed on the market (IAA-effectiveness).Results and conclusions: the score obtained for agomelatine was 592.73 in the efficacy phase and 291.3 in the effectiveness phase. The total score for the two phases was 884, which is equivalent to a good degree of innovation for the molecule
Perceval Sutureless valves in isolated and concomitant AVR procedures: an economic model shows overall decrease of costs for isolated or combined operations
Authors: Pradelli Lorenzo , Zaniolo Orietta
Published: June 2016

BACKGROUND: aortic valve replacement (AVR) the most common heart valve operation, accounts for a majority of all valve surgery performed in the elderly. The Perceval S (P) is a new aortic valve which is implanted without suturing, which causes a significant reduction in cross-clamping times (CCTs), and makes valve implantation easier and faster thanks to its collapsed profile. These features potentially allow the pool of operable patients to be expanded, even with minimally invasive surgery in isolated AVRs. AIM: to predict costs and outcomes of AVR procedures associated with this new valve in 4 European countries (Italy, France, Germany, and UK), as compared to traditional (T) valve implants, from the cost perspective of the hospital. METHOD: a probabilistic, patient-level simulation model was fully coded in WinBugs, permitting a seamless integration of parameter estimation and outcomes prediction, which was entirely based on the associated CCTs and on the surgical technique (mini-invasive [MiS] vs. full sternotomy [FS]), through published correlations. Unit cost were retrieved from official and literature sources for all countries. Besides the incorporated probabilistic sensitivity analysis, a series of deterministic sensitivity analyses was performed. RESULTS: the model predicts the use of the Perceval S valve to be associated with less complications and with savings (valve cost excluded), mainly related to a reduction in surgery costs and ICU/hospital bed days. These savings range from € 3,600 (Italy) to £ 3,900 (UK) for PFS in isolated AVRs and from about € 6,000 (Italy) to £ 6,700 (UK) for PMiS in isolated AVRs, and for PFS in concomitants. Extensive sensitivity analyses confirm the robustness of such findings.CONCLUSIONS: the results of the present analysis indicate that the hospital acquisition cost difference between the new sutureless Perceval S valve and traditional valves is offset by important savings in other cost items.
I costi di struttura dei servizi neurologici in Italia
Authors: Roggeri Daniela , Garattini Livio
Published: June 2016

The present study aimed to evaluate the mean unit cost of neurological services, broken down by type of output: hospital day of stay, day hospital day and outpatient consultation. The analysis concerned five neurological services (four hospital wards and one clinic), located in the North and Centre of Italy, selected among the 16 participants of the EPICOS (Epilepsy Costs) project. The most important result of this study was to estimate a baseline unit cost which can be used for assessing the total cost of a neurological disease. The study was conducted according to the full cost method. However, drugs and examinations were not included in this analysis, assuming that these costs are tightly related to the specific neurological pathology considered. Personnel was the most relevant component of total cost, accounting for 76% for outpatient services, 66% for admissions and 54% for day hospital. The estimated unit cost was L.395,000 for a hospital day of stay, L.527,000 for a day hospital day, and L.89,000 for an outpatient consultation.
È possibile coniugare risparmio e miglioramento nelle aziende USL?
Authors: Sabbatani Sergio
Published: June 2016

The present study aimed to evaluate if it’s possible to reduce the costs for the anti-infective medicine in a ward for the infectious disease. Analytic accounts data, related to the cost for three kind of drugs (antibiotic, antimicrobic and antriretroviral) will be presented. The analytic account is referred to the Bologna USL Firm (Presidi ospedalieri Bellaria and Maggiore) and to the Hospital Unit for the infectious disease (Ospedale Maggiore) in the year 1999. The Hospital Unit for the infectious disease consists of two ward for day of stay (32 beds), one day hospital for 10 beds and one divisional outpatients’ clinic. In 1999 there were 650 hospitalized (and discharged) patients and 783 day hospital patients. The overall cost for the Bologna USL Firm was L. 11.068.023.000, accounting L. 7.253.846.000 (65.5%) for the antiretroviral drug, L. 1.958.115.000 (17%) for the antibiotic drug and L. 1.856.062.000 (16.8%) for the antimicrobic drug and other antinfective medicine. The expenditure for the Hospital Unit for the infectious disease was L. 7.543.851.000, accounting L. 7.008.163.000 (92.9%) for the antiretroviral drug, L. 256.167.000 (3.4%) for the antibiotic drug and L. 279.521.000 (3.7%) for the antimicrobic drug and other antinfective medicine.
I costi della sepsi in Italia
Authors: Lucioni C. , Currado I. , Langer M. , Mazzi S.
Published: June 2016

The aim of this study is to evaluate additional hospitalisation costs and intangible costs (mortality) in patients with sepsis (intended as severe sepsis or sepsis shock) in Italy. The evaluation is based on clinical data from the Italian Sepsis Study, a prospective, multicentre study conducted in 99 Intensive Care Units (ICUs)located across Italy. Each ICU enrolled the first two (or three) patients admitted each month, during the year April 1993 to March 1994. In particular, data collected included the Average Length Of Stay (ALOS) in ICU and later in the regular ward, and the mortality within four weeks and in hospital. Out of the 2,946 patients enrolled, 2,641 never developed sepsis and were considered as the control group (comparability was confirmed based on gender, age, and comorbidity). The additional (respective to the control group) ALOSs of the patients with sepsis were valued in monetary terms using per diem full costs, inflated to 2000: 1,033.43 Euro for l day in ICU (published data) and 299.54 Euro for l day in the regular ward (estimated data based on published materials). Statistical significance was tested with Student t test. The hospitalisation cost of a patient with sepsis (21,571.88 Euro) is significantly higher (+86%) than that patient without sepsis (11,590.84 Euro), due to a longer (+ 163%) stay in the expensive ICU, not balanced by shorter stay in the regular ward. Also intangible costs are significantly higher: the risk for an ICU patient with sepsis to die in hospital is 3 times higher than that of an ICU patient without sepsis. In particular, those patients developing sepsis after admission are more costly and with a higher mortality risk.
Valutazione dei costi di trattamento dei disturbi psicotici con olanzapina, risperidone e neurolettici tipici di un DSM italiano
Authors: Rossi I. , Guidi L.
Published: June 2016

Objective of the present retrospective analysis was to evaluate resources consumption for psychotic patients treatment with olanzapine (OLZ), risperidone (RIS) or typical neuroleptics (NL) during year 2000 in the Dipartimento di Salute Mentale (DSM) of Ravenna. The screening of total number of psychotic patients followed in the Ravenna DSM during year 2000 generated 26 cases treated with OLZ, 22 treated with RIS and 17 treated with NL that were respecting criteria of equivalence for age and illness severity. For these patients we analyzed pharmacological, non pharmacological (medical visits, nurse visits, social assistance, rehabilitative sessions) and hospital interventions during the year of observation, choosing the point of view of the DSM for costs attribution. The analysis of pharmacological interventions evidentiated a major usage of associated neuroleptics in the RIS and NL groups in respect to OLZ (p
Automedicazione: una risorsa economica da valorizzare
Authors: Lucioni Carlo , Zappaterra Luca
Published: June 2016

At the beginning of this new millennium, when the request for health care exceeds overall economic growth, resorting to self-medication allows to free up healthcare resources and it has a positive outcome for public health care systems and also for the individual. Self-medication is defined as the application of prescription-free medicines (OTC) to consumers in order to cure minor ailments. Aim of this study is to present the social and economic value of self-medication, comparing the Italian situation with other national situations inside European Union, especially France, U.K. and Germany. In Italy the OTC market is still late and the present study examines the different explanations, considering the trade-off between OTC products and health public spending, the geographical distribution and the possible savings for the for public health care system.
Farmaci orfani e malattie rare: la situazione in Italia
Authors: Martina S. , Denti C. , Daina E. , Garattini L.
Published: June 2016

Aim of this study is to check the Italian market of the orphan drugs in connection with rare diseases. Data for the research have been found on the Food and Drug Administration Database, the Centro di Ricerche Cliniche per le Malattie Rare “Aldo e Cele Daccò” Database and L’informatore farmaceutico. This study also compared the Italian market with the American market, that counts the greater number of designated orphan drugs and commercial authorizations in the world. In Italy only 24 orphan drugs have been authorized by the Ministry of Health and the present work analyzes their definition under the economic profile, how many diseases and what kind of pathologies they can treat, the number of products on the market and if they are refundable or not.
Efficienza tecnologica e produttiva delle strutture trasfusionali in Italia
Authors: Cornago Dante , Garattini Livio
Published: June 2016

In all the developed countries the methods of blood collection and production are relevant subjects for the pharmacoeconomics studies, because of their health and economic implications related to the health policies in this area. The “blood market” rappresents an area where the sanitary items, the economic items and also the ethic items must be broached at the same time; therefore it can be considered emblematic. By this situation arises Progetto CO.R.SA. (COsti Raccolta SAngue), a project for estimating productivity and cost for a representive sample of italian trasfusional structure (ST). The study is supported by Società Italiana di Medicina Trasfusionale e Immunoematologia (SIMTI). In Italy there are about 380 ST, but only 30 ST resulted suitable for the study. The analysis investigates six rates concerning: a) wastes; b) technological efficiency; c) personnel productivity. The present work describes only the informations on ST organization and production, delaying the results about costs to a specific further report.
Utilità e costo/efficacia del dinoprostone in ostetricia
Authors: Eandi Mario , Pradelli Lorenzo , Benedetto Chiara
Published: June 2016

Pregnancy-related hypertension, intrauterine growth retardation, post-maturity and unfavorable local conditions are among the most frequent indications for labor induction. There are two competing strategies for the induction of labor in term pregnancies: formal induction with artificial rupture of the membranes and/or intravenous oxytocin on one side, and cervical ripening and induction with exogenous prostaglandins on the other. The use of prostaglandins in obstetrics relies on two pharmacological properties: the capacity of inducing the biochemical changes in the connective tissue of the cervix that lead to its maturation and the stimulation of the uterine smooth musculature. While the latter property is shared with oxytocin, the former offers great clinical advantages, in particular in those women that present an indication for labor induction but whose cervix, normally assessed with the use of the Bishop score, does not show “ripeness”, i.e. does not permit vaginal delivery. Since the acquisition cost of the prostaglandins is quite high, but the clinical benefit appears evident, several studies have analyzed the overall economical impact of their use, both as pre-induction cervical ripening agents and as induction drugs. When compared to a strategy of expectant management in term pregnancies without cervical ripeness, exogenous prostaglandin administration has proven to be more cost-effective and better accepted by the patients. Prostaglandins have also proven to be more cost-effective than oxytocin and/or amniotomy in women with an indication to labor induction and unripe cervix, due to the reduced number of induction failures and cesarean sections required with this strategy. The economical analyses that have compared oxytocin and prostaglandins in women with ripe cervices deliver more ambiguous data, but it appears that their cost-effectiveness is comparable. Furthermore, none of the reviewed studies has considered intangible costs, but it is a wide-spread opinion that induction with prostaglandins results in a more “natural” and less painful labor.
La misura della qualità di vita e dell’utilità in farmacoeconomia: strumenti e loro applicazioni in una rassegna di letteratura
Authors: Chan Ya-Ting
Published: June 2016

In a climate of economic scarcity, decisions about the allocation of healthcare resources need to be made explicit. An economic evaluation is able to identify and quantify the relationship between an input of resources and an output, hence to appreciate the efficiency of the project. One of the recent methodological approaches that has been used increasingly in health economic evaluations is the ‘cost-utility analysis’ (CUA). CUA considers benefits in utility terms and uses a unique index to assess them. We investigated the generic measurements of health related quality of life in the economic evaluation. Different instruments for evaluating quality of life and utility were categorized and briefly introduced. Literatures published in the journal “PharmacoEconomics” in 1997-2001 regarding quality of life and utility were reviewed. We were especially interested in the application of health profile SF-36 and utility measure EQ-5D. Selected articles were further analyzed and some issues concerning the methodologies of quality of life and utility are discussed.
Parecoxib nel trattamento del dolore postoperatorio: considerazioni farmacoeconomiche
Authors: Pradelli Lorenzo , Eandi Mario
Published: June 2016

Parecoxib sodium is the first selective COX- 2 inhibitor to be available for parenteral administration. This pharmaceutical feature, alongside its favorable efficacy and safety profile, makes the new drug particularly suitable for simple and effective management of post-surgical pain. The first part of the present article describes the most important pharmacological characteristics of parecoxib and reviews the main efficacy and safety studies that were performed on patients presenting with post-surgical pain. Starting from these clinical data, the second part outlines the pharmacoeconomical profile of the drug in the Italian setting, focusing on the comparison with parenteral ketorolac, the most widely prescribed treatment for post-surgical pain in Italy. The available scientific evidence suggests that the introduction of parecoxib in the arsenal of available options for the management of this kind of patients in Italy may have a positive clinical and economical impact, despite of the higher drug acquisition price. In particular, the better tolerability shown by parecoxib in the comparison with non-selective NSAIDs would permit a reduction in the costs for the prevention and the cure of drugrelated adverse events and reduce the need for patient monitoring. Furthermore, the improved safety and the longer duration of the analgesic action could allow the management of more minor surgery patients in daysurgery units, with great economical advantages for the hospital and the health system and improved quality of life for the patients.
Trattamento con etanercept dei soggetti con artrite reumatoide in Italia: considerazioni economiche
Authors: Mantovani Lorenzo G.
Published: June 2016

Rheumatoid arthritis is a chronic inflammatory disease affecting the joints and leading to work disability in half of the patients; its prevalence in Italy is estimated to be around 0,5%. The understanding of the pathophysiology of the disease has lead to the development of biotechnologically-derived drugs, among which anti-TNF-a agents. At the present moment, two of these drugs are available in Italy: etanercept and infliximab. The aim of the present work was to furnish a pharmaco-economical comparison among the two anti- TNF-a agents in Italy. The efficacy of antirheumatic therapies is usually measured in terms of percentage of responders, defined as those patients whose symptoms improve of at least 20, 50 or 70% (ACR20, ACR50, ACR70). A review of the published literature revealed that, according to these accepted parameters, etanercept results superior when infliximab is administered at standard doses, while it is at least as effective as infliximab when the latter is at the highest doses. Although drug acquisition costs are comparable for the two drugs at the suggested regimens, economical evaluations performed in several countries indicate that total treatment costs are lower with etanercept as compared to infliximab, mainly because of differences in the route of administration (subcutaneous vs. slow IV infusion), need for patient monitoring and co-administration of methotrexate with infliximab and days at work gained. Thus, from this preliminary analysis it appears that etanercept dominates infliximab, i.e. it provides better results at a lower cost, but this result needs to be tested and confirmed by prospective economical evaluations.
Il costo medio per tipologia di prestazione nei centri trasfusionali
Authors: Martina Silvia , Cornago Dante , Garattini Livio , Castelnuovo Emanuela
Published: June 2016

In Italy the collection, validation and separation of blood and its derivatives for transfusional interventions are carried out by some 380 transfusional centers (TCs), mainly located within greater health care structures. The aim of the CORSA (Costi Raccolta Sangue) study was to furnish an estimate of the mean cost of the main transfusional services on a sample of the Italian TCs. Of the centers contacted, only 13,3% were able to deliver the unit costs necessary to perform the full-cost, fully-allocated analysis conducted. Of the three services examined (apheresis of plasma and platelets, whole blood collection), the selective collection of thrombocytes resulted the most expensive, as opposed to whole blood collection. The mean cost of a erythrocyte, plasma and platelet unit resulted of 17,7, 21,6 and 89,8 •, respectively, although the variation among centers was substantial. To main conclusions can be drawn by the CORSA study. First, the very low percentage of TCs able to provide the necessary data for a complete economical analysis highlights an important delay in the modernizing process of health care management, started in 1992 with the aim to ameliorate resource allocation. Second, the study was not able to establish a relationship between production volume and production cost, indicating the absence of scale economy features in transfusional processes.