bluuebunny/crossref_metadata_2025 huggingface dataset:
Pharmacoeconomic evaluation of influenza vaccination programs in elderly in Italy
Authors: Iannazzo Sergio , Sacchi Viola
Published: June 2016

Background: influenza infection is an important cause of morbidity and mortality in the elderly population, especially in the presence of underlying disease. Vaccination has proven effective in the reduction of influenza-like illness (ILI) cases and influenza-related hospitalizations, drug consumption, primary care consultations and death. The aim of this study is to assess the economic impact in Italy of different prophylactic strategies (vaccination with a standard vaccine, with the innovative MF59® adjuvated vaccine and no vaccination) comparing their costs and outcomes in the elderly population. Methods: a pharmacoeconomic simulation model to estimate costs and consequences of influenza with the three intervention strategies has been developed. Health economics and demographic data are taken from specific Italian sources, and vaccine effectiveness data are taken from published literature. Direct sanitary costs are considered according to current prices and tariffes. Results: it was estimated that 9,800,000 of the about 12,000,000 people with at least 65 years currently resident in Italy can be considered at high risk for influenza complications because of underlying chronic diseases. Absence of vaccination could lead to more than 2 millions of ILI cases, and 30,000 related deaths. The reduction of cases attainable with the implementation of a vaccination program would lead to an estimated 1.5 million cases with a standard vaccine, and to 1.3 million with a strategy based on the MF59® adjuvated vaccine. The standard vaccination strategy could produce a moderate total cost increase of about € 45,000,000 (+4.3%), whereas the use of the adjuvated vaccine would lead to an estimated saving of about € 80,000,000 (-7.9%), both compared to the null option. Cost savings are mainly related to hospital admissions avoided with the use of vaccines. Incremental cost-effectiveness ratio (ICER) of the standard vaccine versus no vaccination strategy is of € 85.68 for each ILI episode avoided, and of € 4,411.42 for death avoided. The strategy based on the MF59® adjuvated vaccine dominates the other two options. Conclusions: vaccination with the MF59® adjuvated vaccine (Fluad®) results more effective and cost saving when compared with the standard vaccination or the no vaccination, thus representing the strategy of choice for the elderly population. Moreover, the standard vaccine proved to be largely cost effective with respect to the null option.
Prophylaxis against febrile neutropenia with pegfilgrastim in Italy: a budget impact analysis
Authors: Rosti Giovanni , Lebboroni Maria , Cerchiari Ario , Katz Pablo
Published: June 2016

Introduction: prophylaxis with granulocyte colony-stimulating factors (G-CSF) is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy. Objective: to evaluate the budgetary impact for the Italian NHS. Design: a decision-analytic model has been developed to analyze the budget impact from the national health care system perspective. Costs include direct healthcare costs to the public payer of G-CSFs as well as their administration costs and costs of FN-related events. The comparison has been done using prophylaxis with G‑CSF (filgrastim for 11 days, pegfilgrastim, lenograstim for 11 days) and antibiotics. Patients and participants: The population of interest for the analysis were patients with breast cancer in stage II and III and patients with non-Hodgkin’s lymphoma (NHL). Main outcome measures and results: for all the three patients group (NHL, Breast II and III), and for all the chemotherapy regimens (CHOP 21 and R-CHOP 21 for NHL, AC-T, TAC and TC for Breast stage II and III) the budget impact analyses shows a cost reduction for the Italian NHS, as a result of an increase of the use of pegfilgrastim. Conclusions: in Italy, a treatment strategy including pegfilgrastim as either primary or secondary prophylaxis provides value for money.
Access to pharmaceutical products in six European countries – analysis of different pharmaceutical distribution systems
Authors: Walter Evelyn , Dragosits Aline , Said Monira
Published: June 2016

OBJECTIVES: The aim of the study was to draw a comprehensive picture of the pharmaceutical wholesale sector, outlining its socio-economic importance compared to different distribution systems such as short-line wholesaling, direct sales from manufacturers, Reduced Wholesale Arrangements (RWA) and Direct to Pharmacy (DTP) arrangements. Its role is considered from an economic, effectiveness and, most importantly, a public health viewpoint with qualitative and quantitative methods, focusing on France, Germany, Italy, the Netherlands, Spain and the UK.METHODS: First, data has been sourced from annual GIRP and IMS-Health statistics; second, a systematic literature research verified the empirical findings; third, an online-questionnaire was directed to pharmacies. Further data have been sourced from a questionnaire, addressing GIRP-full-member associations and wholesale companies (return rate 86%).RESULTS: On a weighted average, pharmaceutical full-line wholesalers in the observed countries alone pre-finance € 10.2 bn over a period of 41 days the entire medicine-market and secure the cash-flow of the social-insurers (Germany: € 2.60 bn for 38 days; Italy: € 2.27 bn for 68 days; the UK: € 1.48 bn for 36 days; France: € 1.28 bn for 22 days; Spain: € 969.76 m for 27 days; the Netherlands: € 399.09 m for 30 days on average). On average, pharmaceutical full-line wholesalers are bundling products of 18.28 manufacturers per delivery. The process costs would increase by € 164,922.43 to € 171,510.06 per year, if there were no pharmaceutical full-line wholesalers. These additional costs would have to be paid by manufacturers, pharmacies and finally by patients. Regarding the satisfaction with different distribution models, the results of the online-questionnaire show that pharmacists in the observed countries are very satisfied with the distribution through their pharmaceutical full-line wholesalers.CONCLUSIONS: The study showed that pharmaceutical full-line wholesalers have an important and unique position in the pharmaceutical supply chain. Special functions like the pre-financing of the entire medicinal product market, or the guarantee of the continuous supply of all medicinal products verify these findings.
Clinical and economic impact of aliskiren in uncontrolled hypertensive patients
Authors: Degli Esposti Ezio , Tomic Radovan
Published: June 2016

BACKGROUND: the majority of hypertensive patients do not achieve adequate blood pressure (BP) control and thus remain at risk of cardio-cerebrovascular events. Aliskiren, a novel antihypertensive drug acting as direct renin inhibitor, was authorized in Italy for the treatment of hypertension in patients who remain uncontrolled and at risk despite the use of at least two antihypertensive drugs. It was subject to an AIFA web-based monitoring registry. Results of the registry show a decrease of 20.8/9.2 mmHg in systolic/diastolic BP, within 6 months, when aliskiren is added to current therapy.OBJECTIVE: to evaluate the clinical and economic impact of such BP reduction in terms of avoidable cardio-cerebrovascular events.METHODS: an Excel-based Markov model compared aliskiren plus current antihypertensive treatment to current antihypertensive treatment alone over a 5-year horizon. Patients’ baseline characteristics and BP-reduction were taken from the AIFA registry and literature. Using Wilson and Anderson risk equations, the model simulated patient’s transitions from Pre-Event to Post-Event and Death, calculating the number of those who experience an event. Unit costs were assigned to treatments, events and follow-up. Sensitivity analyses considered: efficacy variability and societal costs of events.RESULTS: 2.47% of patients treated with aliskiren added-on to their antihypertensive therapy were expected to avoid an event. As observed in the AIFA registry, 19.8% of patients remained treated only with aliskiren whereas others reduced the number of antihypertensive treatments, leading to a 38.6% reduction of monthly concomitant antihypertensive treatment cost. Considering events and follow-up cost reduction, the per-patient annual incremental cost of aliskiren is calculated at € 187 and generates 0.042 QALYs over 5 years. The ICER was € 22,062 per QALY (€ 16,845 to € 30,771 for an efficacy range of ± 25%). Considering societal costs ICER was € 20,094 per QALY.Conclusions: AIFA registry real-world data confirmed aliskiren’s efficacy in uncontrolled hypertensive patients. Together with reaching their BP goals, patients consumed less medication from other antihypertensive drug classes and are expected to avoid cardio-cerebrovascular events. The ICER remained within acceptable thresholds, confirming that aliskiren represents a good investment in terms of health benefit.
Cost of illness of community-acquired pneumonia. Review of the literature and possible strategies in the Serbian health care setting
Authors: Jakovljevic Mihajlo , Cupurdija Vojislav , Lazic Zorica
Published: June 2016

Community-acquired pneumonia (CAP) represents a potentially severe illness with high incidence and significant economic impact. The estimated incidence varies from 1.6 to 13.4 cases/1000 inhabitants per year. Its burden of disease is attributed to high morbidity, mortality and serious health care utilization and expenditure throughout the world. The identification of determinants of high treatment costs could help in defining strategies for their reduction and more efficient use of the existing resources. In this article, a review of the existing literature about CAP cost-of-illness is provided, together with some considerations about possible strategies to decrease CAP costs in the Serbian health care setting. Available reports from cost-of-illness trials of CAP are relatively scarce. Most of them highlight the high costs generated by treatment protocols, with important differences between inpatients and outpatients. The inpatient cases of CAP varies from 18 to 60%. The therapy represents 10 to 15% of the overall costs of CAP. The costs of CAP treatment among inpatients are 7.9 times higher than those in outpatients. In case of complications and prolonged length of stay, this difference could even be 17 to 51 times higher. Frequent hospital admissions could be avoided, which would reduce the costs of CAP treatment. An important precondition for successful cost containment would be higher adherence to clinical guidelines, particularly reflected through Pneumonia Severity Index-a (PSI) application. Thus, it would be possible to significantly reduce the length of stay in hospital, in majority of patients, without jeopardizing their health or influencing the clinical course of illness.
Fluvoxamina: profilo farmacoeconomico
Authors: Eandi Mario
Published: June 2016

In this study we mean to outline a brief pharmacoeconomic review of fluvoxamine, considering only its antidepressant use. Essential objective is to highlight all the variables of cost effectiveness, tolerance and safety that can lead some types of differential costs. This study analyses the epidemiology and the economic burden of depression and a pharmacoeconomic profile of fluvoxamine, with its characteristics of effectiveness, tolerance, safety and handiness. The pharmacoeconomic evaluation is conducted according to the cost minimization analysis (CMA), considering fluvoxamine, Selective Serotonine Reuptake Inhibitors (SSRI) and antidepressant tricycic as native treatments. Fluvoxamine differs from the others SSRI far the purchase cost and it’s more convenient than the antidepressant tricycic treatment, especially for long term therapy. Economic benefits can be distributed in a balanced way between the Italian national healthcare system (NACS), the society and the patients.
Gli studi di “cost of illness” in Italia: una review della letteratura
Authors: Bracco Andrea
Published: June 2016

The cost of illness studies (COI) attempt to measure the economic burden of a specific pathology. A standardised protocol identifies three components in the COI studies: direct costs, indirect costs and intangible costs.Aim of this paper is to review the status of COI studies in Italy, searching Medline, the New York City University database, the IES database and the S.A.V.E. database according to these keywords: “Cost of Illness Italy” and “Italian Cost Analysis”. The research detected 24 studies, but only 17 complete studies has been included in this review. For being reliable, the study had to present detailed informations about: - kind of approach (bottom-up or top-down); - annual average cost for single patient and single pathology; - pathology incidence or prevalence; - methods for calculating direct and indirect costs. The studies in this review examine the following pathologies: Alzheimer’s disease, diabetic foot, schizophrenia, type 2 diabetes, epilepsy, measles, dyspepsia, hypertension, asthma, varicella, osteoporosis, benign prostatic hyperplasia, urinary incontinence, hepatitis A and hepatitis B.
ALPRAZOLAM: profilo farmacoeconomico nei disturbi d’ansia e da attacchi di panico
Authors: Eandi Mario
Published: June 2016

Alprazolam is a triazolo analog of the 1,4 benzodiazepine class, widely used to treat patients with anxiety disorder, panic attacks and anxiety comorbidity with depressive disorder. Following oral administration, alprazolam is readily absorbed with peack plasma levels in 2 hours; extensive hepatic metabolism occurs and about 80% of the oral dose is excreted by kidney. The main metabolic route is hydroxylation catalyzed by cytochrome P450 3A: alpha-hydroxy alprazolam is partially active. Alprazolam possesses anxiolytic properties similar to other benzodiazepines; however, the triazolo ring confers to alprazolam a peculiar antidepressant and antipanic activity. Anxiety disorder, panic attacks with or without agoraphobia, and mixed anxiety-depressive disorder represent an heavy economic burden to National Health System (NHS) and to society. In the present work the clinical pharmacology and the therapeutic profile of alprazolam are reviewed and analysed under the pharmacoeconomic perspectives of the italian patients, General Practitioners, NHS and society.
Unita di consumo dei farmaci e valutazioni farmacoeconomiche: uso e misuso di DDD e PDD
Authors: Eandi Mario
Published: June 2016

In pharmacoeconomical evaluations the quantification of drug utilization has to be done on the basis of measurement units that allow comparisons among series of longitudinal and transversal data. The most common techniques used for the analysis and the comparison of drug utilization patterns are based either on the Defined Daily Dose (DDD), a unit system proposed by WHO’s Drug Utilization Research Group, or on the Prescribed Daily Dose (PDD), a statistical parameter obtained from the analysis of drug prescriptions. This article illustrates the meaning of the main indicators of drug consumption that can be build with these techniques, underlining their utility and limitations. The DDD is the conventionally established theoretical mean daily dose of a drug, referred to a way of administration and to its main indication. It is, therefore, a mere technical measurement unit that cannot be interpreted as mean prescribed or consumed dose, and even less as recommended dose. The PDD, on the contrary, is not a measurement unit but a statistical mean value, that expresses the central tendency of the prescription variability in a defined setting. Starting from Italian data on the consumption of wide-spread antibiotics, the use and interpretation of various indicators based on the DDDs and PDDs are discussed. The parameters derived with the DDD technique are suitable for monitoring drug utilization and pharmaceutical expenditure. The PDD method is more direct, indicates the mean quantities actually prescribed and permits the estimation of the total dose consumed per therapeutic cycle and of other clinically relevant parameters, but requires the acquisition of more data than the other technique does. It is also important to remark the fact that both methods can’t be directly used for economical evaluations trying to assess the efficiency of resource allocation, as they are not correlated to the clinical outcomes of the therapy.
Storia naturale dell’infiammazione allergica
Authors: Tosca Maria Angela , Ciprandi Giorgio
Published: June 2016

Allergic pathologies are the most common immunologic diseases and their prevalence and severity show a constantly increasing trend in industrialized countries. The present article presents some recent epidemiological data, the natural development of the allergic inflammation and its pathophysiology, focusing on the recent concept of a “minimal persistent inflammation”, with particular regard to its long term treatment with antiallergic drugs. In fact, according to the most recent interpretations, allergy has to be considered as a complex phenomenon, characterized by a inflammatory response to allergenic stimuli. The complicated interrelation between cells, cytokines and affected structures is described. Very often allergic diseases of the upper airways are associated with and complicate asthma, and data that support the benefits of treating these diseases as a whole are presented. Long-term treatment of allergies with antiflogistic/antiallergic molecules is capable of reducing tissutal damage, besides improving the quality of life of the patient and lowering the frequency of acute episodes. The chronic treatment with antiallergic drugs appears to be favorable also from a pharmacoeconomical point of view, as it is associated with a reduction of overall pharmaceutical expenses and of lost working/school days, as well as determining an improved quality of life for the patient and its relatives, particularly in pediatric age. The management of the allergic patient has always to be approached with an integrated multidisciplinary attitude, in which the efforts tend to the identification of all concurrent diseases, because the optimal treatment may be achieved only with the recognition and the resolution of all underlying diseases.
Evoluzione storica della farmacoutilizzazione degli anti-ipertensivi in Italia (1988-1998)
Authors: Bologna Enrico , Russo Pierluigi , Licata Sabrina , Civalleri Liliana , Caprino Luciano
Published: June 2016

The aim of this study was to perform an historical evaluation of pharmacoutilization of main antihypertensive drug classes in Italy between 1988 and 1998. There were analysed numbers of packs and costs for diuretics, beta-blockers, central and peripheral antihypertensive drugs (CPAD), calcium-channel blockers (CCB), angiotensin-converting enzyme (ACE) inhibitors and angiotensin-II (AII) receptor antagonists. The amount of defined-daily-doses (DDDs) per preparation was calculated by dividing the annual number of packs by respective DDD value. The number of DDDs was grouped according to the second level of the anatomic-therapeutic-chemical (ATC) classification. The amount of annual expenditures for each ATC level was converted to current monetary values. To calculate the annual cost per DDD, the expenditure was divided by respective number of DDDs. From 1988 to 1998, total number of DDDs of antihypertensive drugs grew from 193.657.092 to 396.140.967 with an increase of 105%, while the expenditure grew from 40.886.385 to 126.102.362, with an increase of 208%. Comparing data of 1990 and 1998, the DDDs of antihypertensive drugs increased of about 79%, the expenditure for these drugs increased of about 115%, while the global pharmaceutical expenditure increased only of 34%. Taking each drug class separately, CCB and ACE-inhibitors are the classes with the higher number of DDDs and the higher expenditure; while alpha-receptor blockers, ACE-inhibitors and AII- antagonists are the classes with the higher cost per DDD. In conclusion this study describes a substantial modification of pharmacoutilization of antihypertensive drugs in Italy along a ten-years span. The agreement between utilization trends and indications of international treatment guidelines, as well as the economic impact on drugs expenditure have been discussed.
Valutazione economica di Infliximab (Remicade®) vs Etanercept (Enbrel®) nel trattamento dell’artrite reumatoide
Authors: Colombo G. L. , Muzio A. , Longhi A.
Published: June 2016

Rheumatoid arthritis is one of the most severe chronic pathologies, affecting the whole organism, with invalidating outcomes that affect the quality of life of the patients. Its prevalence is estimated to be about 0,5% in Italy, with elevated costs for the national health system (NHS) and the society, in spite of the best treatment with traditional therapies that include anti-inflammatory and disease modifying antirheumatic drugs (DMARDs). The introduction of new drugs with biological activity, mainly acting through an antagonism of tumor necrosis factor (anti-TNF), is a great advance in the management of the disease, as their use has been shown to be effective in slowing the progression of the joint damage, and sometimes in reversing it,. The present article present a cost-minimization study conducted by comparing the two anti-TNFs available in Italy, etanercept and infliximab, assuming equal efficacy and approached from the perspectives of the Italian NHS and society. Only differential costs were considered, i.e. drug acquisition, drug administration and patient monitoring costs, and the analysis comprised two treatment years, in order two account for the cost differences between the first treatment year and the following. The analysis showed that infliximab represents the more convenient alternative from both the NHS and the society points of view, mainly due to lower drug acquisition costs, which offset the higher drug administration costs: the total two year treatment costs per patient with etanercept resulted of 20.173 euro and 22.164 euro from the societal and NHS perspectives, respectively, while the same costs resulted of 13.715 euro and 14.795 euro with infliximab. These results were tested with thorough sensitive analyses, conducted by varying the principal cost and time consumption estimates, that showed that etanercept results less convenient in all the hypothesis tested.
Impatto del centro diurno sui costi di assistenza di pazienti affetti da alzheimer probabile, un.esperienza della asl di Città di Castello
Authors: Trequattrini A. , Guidi L. , Cestini R. , Mezzetti M. , Ciappi F.
Published: June 2016

Objective of the present work is to evaluate the economic impact caused by the attendance of the Local Health Care Unit Diurnal Center (DC) by Alzheimer disease patients. 21 Alzheimer patients were observed prospectively during 8 months: 2 months before DC attendance (period 1), 4 months during DC attendance (period 2) and finally 2 months after DC discharge (period 3). Data collected were analyzed and average resources consumption was translated into monetary costs according to the Local Health Care Unit point of view and family burden. Our analysis showed a significant cost reduction during DC attendance in respect to period 1 and 3, both on Local Health Care Unit and family sides. During period 2 (DC attendance) patients showed a significant clinical improvement too, as demonstrated by MMSE (Mini Mental State Examination), ADL (Activity of Daily Leaving), IADL (Instrumental Activity of Daily Leaving) scales. Finally our work demonstrates that the DC is a valid and economically advantageous support for the health care assistance of Alzheimer patients on SSN side and that it is able to reduce the burden of continuous care giving for families.
Analisi costo/efficacia di sevelamer nel trattamento dell’iperfosforemia del paziente in dialisi
Authors: Eandi Mario , Giotta Nicola , Barbone Gaia Santagostino
Published: June 2016

Dialysis-associated hyperphosphatemia has been treated with chelating calcium salts, in particular with calcium carbonate. A new option for the management of this problem is represented by sevelamer, a chelating agent which contains no calcium and no metals. Sevelamer and calcium carbonate are more or less equally effective and tolerated. The prolonged use of sevelamer instead of calcium carbonate, nevertheless, reduces calcemia and C-reactive protein levels, with a consequent reduction in myocardial infarction, angina pectoris and other peripheral vasculopathies. The limit to the wide-spread use of sevelamer is in its very high acquisition cost, as compared to the alternative. In this article, a semi-markovian pharmacoeconomical model for the comparison of clinical and economical outcomes of sevelamer and calcium carbonate is presented. The analysis is conducted in the perspective of the Italian health system (SSN). Clinical data are derived from published studies and integrated with expert panel estimates, cost data are relative to the Italian setting. The incremental cost-effectiveness analysis indicated that sevelamer is more costly, but also more costeffective: a one month gain in survival costs the SSN additional 2710 Euro, a value inferior to the conventionally accepted willingness-to-pay of industrialised countries. The majority of this excess cost is derived from the gain in survival, and consequent increase in dialysis costs. Thus, the choice of using sevelamer instead of calcium carbonate is even more justified from an ethical point of view. Sensibility analyses confirmed the robustness of the basic scenario results.
Parnaparin: confronto con le altre eparine a basso peso molecolare
Authors: Pradelli Lorenzo
Published: June 2016

Sodium parnaparin is a low molecular weight heparin (LMWH). The introduction of this drug class has represented a medical advancement in the prevention and therapy of thromboembolic pathologies, as they maintain the same efficacy of unfractionated heparin, but with simplified dosing regimens and reduced side effects. Parnaparin has demonstrated its thromboprophylactic efficacy on both high- and moderate risk surgical patients, besides resulting effective in treating established deep vein thromboses and thrombosis-associated phlebopathies. Alongside these clinical advantages, parnaparin and other LMWHs allow outpatient or home-based therapy of a large number of subjects that should otherwise be treated in hospital, with important savings of health resources and enhanced quality of life for the patients. In Italy, parnaparin drug acquisition cost is among the lowest in its class for many applications, permitting marginal savings in health costs at the same efficacy level. In summary, the use of parnaparin in thrombotic pathologies has very good efficacy and safety profiles, and has positive clinical and economical outcomes for patients, health system and society as a whole.
L’impatto farmacoeconomico del trattamento della schizofrenia con antipsicotici tipici ed atipici: l’esperienza di un DSM della Regione Sicilia
Authors: Federico Tommaso , Astuto Carmelo , Bongiorno Giuseppe , Majorana Domenico , Biricolti Giovanni , Zerbo Salvatore
Published: June 2016

Il presente lavoro è stato realizzato con il patrocinio del Dipartimento Ispettorato Regionale Sanitario dell.Assessorato per la Sanità della Regione Sicilia, nella persona del Dirigente Generale Dott. Saverio Ciriminna BACKGROUND: The comparatively high acquisition costs of the new antipsychotic drugs have induced the mental health community to look closely at their potential benefits. OBJECTIVE: To compare the clinical and economic outcomes associated with olanzapine, risperidone and typical neuroleptics treatment for schizophrenia. METHODS:Amulticenter, observational, two-years long, retrospective and prospective study was conducted with 229 psychotic patients (in charge by psychiatric Centers of Regione Sicilia - Italy). Clinical outcomes were assessed using changes in CGI (Clinical Global Impression) and PANSS (Positive and Negative Syndrome Scale) scores. The economic data collection included pharmacological and non-pharmacological resources consumption (hospitalizations, medical/nurse visits, etc.). The economic evaluation was conducted in the perspective of the Local Psychiatric Services. RESULTS: The results in terms of clinical performance indicated an advantage (statistically significant) in the olanzapine group of patients. The pharmacological costs were significantly lower (p0,05). Treatment with olanzapine was associated with a lower non-pharmacological resources consumption and showed a general reduction (p
Cost-effectiveness analysis of paclitaxel + carboplatin vs. alternative combinations in the treatment of non-small cell lung cancer
Authors: Eandi Mario
Published: June 2016

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and its medical and economical burden represents a serious matter in Europe and Usa, due to its high mortality rates and drug costs. Lung cancer is responsible for about 30% of cancer death in men and women; in Europe only about 8 per cent of people with lung cancer survive for 5 years. At present combination chemotherapy based on cisplatin or carboplatin associated with paclitaxel, vinorelbine or gemcitabine is the state of the art for the treatment in patients with stage IIIb or IV NSCLC. Aim of this study was to compare the cost-effectiveness of paclitaxel/carboplatin (PCb), gemcitabine/cisplatin (GC) and vinorelbine/cisplatin (VC) in the perspective of the Italian National Health Service. Therefore we perfomed a semi-Markov decision model mainly based on clinical results from the Italian Lung Cancer Project. The model included differential direct medical costs registered for two years from starting chemotherapy, using tariffs valid for 2005. Benefits was measured by years of life saved (YOLs). The model also allowed to estimate only costs accrued over the period of time, performing a cost-minimisation analysis. According to cost-effectiveness analysis, VC is dominated because it’s more costly and less effective than GC. On the contrary, combination chemotherapy with GC is more inexpensive but less effective than paclitaxel/carboplatin (PCb): in this case we compared the incremental cost-effectiveness ratio (ICER) with a maximum acceptable willingness-to-pay (WTP) value. In the base scenario the ICER of PCb over GC treatment is 52,326 euro/ YOLs, which is definitely lower than the maximum acceptable WTP value. Sensitivity analyses confirmed the robustness of the results from cost-effectiveness analysis in the base scenario.
The health-economic models: practical aspects and management of uncertainty
Authors: Iannazzo Sergio
Published: June 2016

Analytic models are a powerful instrument to develop pharmacoeconomic analyses and their importance is growing as they are being increasingly used to make predictions of the consequences of a particular intervention. It is possible to group the most commonly used techniques in three families: decision trees, Markov chains and probabilistic simulation models. Only the last ones take into account a wide range of uncertainties and have the capability to make probabilistic predictions. Discrete-state, discrete-time Markov models are the most used technique, but have some limits due to their structural rigidity that can make appropriate representation of clinical reality difficult. First-order simulation of Markov models produces deterministic results and can be conveniently implemented in a matrix algebra formal framework. In order to take decision based on models prediction deterministic results are not sufficient and it is widely recognized the need to handle uncertainty in its various forms. The task could be accomplished with traditional (deterministic) and/or probabilistic sensitivity analysis. Both analyses provide complementary information on how the parameters and assumptions uncertainty spreads trough the model and are recommended by ISPOR (International Society for Pharmacoeconomics and Outcomes Research) modelling guidelines.
Pharmacoeconomic analysis of long term use of darbepoetin-α in treating chronic nephropathy-induced anemia in dialysed patients
Authors: Giotta Nicola , Biamino Ercole , Eandi Mario
Published: June 2016

The main aim of this retrospective study was to perform a pharmacoeconomic analysis of long term use of darbepoetin-α (DARB) after switch from erythropoietin-ß (EPO-ß) in treating chronic nephropathy-induced anemia in dialysed patients. Secondary objective was the assessment of the actual EPO-ß-to-DARB dose conversion factor. We extracted data of 78 patients who have been treated with EPO-ß for at least 6 months and then switched to DARB from the database of the dialysis center of the Asti (Piedmont, Italy) hospital. From these, we selected 47 patients (23 males and 24 females) who completed a 120-weeks follow-up treatment with DARB. All patients were treated with a dose adjustment schedule to keep haemoglobin levels in the range 11-12g/dl. Pre-switch EPO-ß administration was thrice a week, while DARB was administered once a week, both via intravenous. Initial DARB dose has been calculated on the basis of the theoretical 200:1 conversion factor. Actual cumulative EPO and DARB consumption was recorded for all patients. Drug costs were valued according to purchasing prices for the Italian National Health System (October 2006). In the 24 pre-switch weeks the average cost (±SD) per patient for EPO-ß was € 2,309.86 (±1,434.78). In the 120 weeks of follow-up the average cost (±SD) per patient for DARB/24 weeks ranged from a minimum of € 1,487.09 (±1,125.51) to a maximum of € 2,125.73 (±1,546.85).  The switch of 47 patients to DARB produced an overall net saving for the dialysis centre estimated in 119,540.72 Euro/120 weeks, under the hypothesis that EPO-ß semester costs remain constant: the conversion from EPO-ß to DARB has the potential to maintain long term good haemoglobin control and induces significant savings for the National Health System. However the dosage should be adjusted on an individual basis in order to avoid excessive fluctuation of Hb concentrations. The actual conversion factor resulted on average higher than theoretical factor settling to 240-280:1.
Lazio
Authors: Cavallo Maria Caterina , Cipriani Filippo , Gerzeli Simone , Demarteau Nadia , Marocco Alessia , Bamfi Francesco
Published: June 2016

In Lazio region 57,3% 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 104 cases of cervicocarcinoma and 43 related deaths and thus results to be cost-effective (23.669 €/QALY). When the vaccination programme is extended to 16-year-old girls a further 105 cancer cases and 45 deaths could be prevented, with a very similar cost-effectiveness ratio. In Lazio region, the net cost for woman vaccinated is 202 € for the single cohort and 205 € for the multiple cohort.
L’art comme expérience et la pragmatique du spectateur, entre performance et philosophie
Authors: Wiame Aline
Published: June 2016

En prenant pour point de départ les thèses développées par Jacques Rancière dans Le spectateur émancipé, cet article se demande à quelles conditions la philosophie pourrait jouer un rôle constructif dans l’étude de l’engagement du spectateur. L’article propose de se tourner vers la philosophie pragmatique de John Dewey telle qu’elle est exposée dans L’art comme expérience : pensée comme transformation des énergies corporelles, l’expérience esthétique définie par Dewey est somatique, rythmique et relationnelle, permettant le dépassement des oppositions acteur/spectateur, activité/passivité. La théorie esthétique tout entière de Dewey fait une large part à l’expérience du spectateur en tant qu’elle est créative. En explorant les influences qu’a eues L’art comme expérience sur le développement des arts américains et dans l’esthétique pragmatique selon Richard Shusterman, l’article met en évidence la part performative constitutive de l’expérience esthétique. En concevant le spectateur comme partie prenante d’une performance, le pragmatisme pousse à revisiter du même mouvement le rôle et la fonction de la philosophie : aux prises avec la question de l’engagement du spectateur, la philosophie peut alors être envisagée dans ses propres dimensions performatives, selon une approche telle que celle du réseau de chercheurs récemment créé « Performance Philosophy ».
L’expérience immersive et les intermittences de l’attention
Authors: Cyr Catherine
Published: June 2016

Depuis quelques années, au Québec comme en Europe, plusieurs artistes s’attachent à mettre en scène des parcours théâtraux où le spectateur se déplace dans l’espace, de façon plus ou moins structurée. Alors que quelques-uns privilégient une certaine restriction de la mobilité physique et proposent une avancée strictement balisée, d’autres préfèrent laisser le spectateur déambuler sans contrainte dans un lieu aux frontières mouvantes, indéterminées. Cet engagement physique du spectateur dans un espace qu’il sillonne de ses pas et partage avec des acteurs (présents ou virtuels), induit des modalités particulières de réception. À travers des exemples tirés des pièces Résonances, de Carole Nadeau, et Himmelweg, de Geneviève L. Blais, et par le biais d’une réflexion portant sur le rapport à l’espace, à l’environnement sonore et aux acteurs (projetés et présents), le présent article s’attache à questionner la relation ambiguë à la représentation développée par le spectateur plongé dans un dispositif scénique où il perçoit sa propre activité, et où persiste, aiguë, sa conscience de soi. Catherine Cyr s’intéresse en particulier aux moments « blancs » ou interstitiels qui émaillent son parcours ambulatoire. Des moments de pure présence à soi qui, lorsque par intermittence disparaissent les images ou s’éteignent les voix, abolissent le rapport à l’Autre et viennent suspendre l’attention à la représentation.
Pourquoi délibérer ? Du potentiel épistémique à la justification publique
Authors: Daoust1 Marc-Kevin
Published: June 2016

Cet article a deux objectifs. Le premier est de montrer pourquoi l’argument instrumental en faveur de la démocratie est insuffisant pour justifier la délibération politique. Si notre but est l’optimisation du potentiel épistémique d’un régime politique, et que des approches agrégatives et inférentielles (sans délibération) atteignent cet objectif, alors nous ne pouvons plus justifier la délibération sur cette base. Ce problème peut être contourné en reprenant une distinction de Daniel Andler. Pour ce dernier, le groupe délibératif se distingue du groupe agrégatif parce qu’il permet aux agents, par une occasion éducative informelle, de se responsabiliser. La délibération présente donc un potentiel épistémique supérieur, mais qui ne se limite pas à identifier la meilleure réponse dans un temps donné. Le second objectif de l’article est de montrer comme l’argument d’Andler fait le pont entre, d’une part, les théories de la justification publique et, d’autre part, les théories de la démocratie épistémique.
Dimethyl Fumarate
Authors: Phillips J. Theodore , Agrella Stephanie , Fox Robert J.
Published: June 2016

Background: Delayed-release dimethyl fumarate (DMF; also known as gastroresistant DMF) is indicated for the treatment of relapsing multiple sclerosis. Flushing and gastrointestinal (GI) adverse events (AEs) are common within the first few months of starting DMF therapy. Although most symptoms are mild or moderate in severity, transient, and infrequently result in treatment discontinuation, they nevertheless present a challenge for patients to adhere to therapy and achieve an optimal treatment response.

Methods: This review discusses management strategies for the prophylaxis and treatment of common DMF-associated AEs based on clinical trial evidence and real-world experience in clinical practice settings.

Results: Before starting DMF therapy, patients should receive counseling on the importance of treatment adherence and the likely occurrence and severity of flushing and GI AEs (nausea, vomiting, diarrhea, and abdominal pain). Management strategies, such as administering DMF with food, using a slower-dose titration schedule, applying temporary dose reductions, and using symptomatic therapies, provide clinicians with several approaches to address DMF tolerability. In particular, DMF coadministration with certain foods (eg, sausage, peanut butter) may prevent or reduce the severity of GI AEs. Taking aspirin 325 mg/day 30 minutes before administering DMF in the first month of therapy can reduce the incidence and severity of flushing without negatively affecting GI-related events.

Conclusions: Through continual patient education and support and management of treatment-related flushing and GI AEs, clinicians can help patients adhere to and persist with DMF therapy, thus maximizing treatment benefit.
Investigation of isotopic signals in the unsaturated zone with the use of direct push technology and azaeotropic distillation
Authors: Kallioras Andreas , Piepenbrink M. , Khan A. , Reshid M. , Rausch R. , Dietrich P. , Schuth C.
Published: June 2016

This paper contributes to the investigation of the unsaturated zone, through the application of combined field and lab techniques. The results show that direct push methods, which are considered ideal for multilevel sampling of undisturbed soil in the unsaturated zone, proved to be effective also for the consequent extraction of the pore water for further isotopic determination. This ultimate goal can be achieved thank to the application of azaetropic distillation, which has the least isotopic fractionation effects on groundwater samples.
Geochemical evolution of groundwater in carbonate aquifers of southern Latium region, central Italy
Authors: Sappa Giuseppe , Ergul Sibel , Ferranti Flavia
Published: June 2016

Spring and well water samples, from carbonate aquifers of Latium region, have been characterized to determine the hydrochemical processes governing the evolution of the groundwater. Most of the spring samples, issuing from Lepini, Ausoni and Aurunci Mts., are characterized as alkaline earth HCO3 waters, however, some samples show a composition of Cl--SO4 -- alkaline earth waters. Groundwater samples from Pontina Plain shows three different hydrochemical facies: alkaline earth HCO3 type, Cl-- SO4 -- alkaline earth type and Cl--SO4 -- alkaline type waters. Geochemical modeling and saturation index computation of the sampled waters show an interaction with calcareous and calcareous-dolomitic lithologies. Most of the springs and wells was kinetically saturated with respect to calcite and dolomite, and all the samples were below the equilibrium state with gypsum. This indicates that the groundwater has capacity to dissolve the gypsum along the flow paths. The electrical conductivity and Cl- concentrations of the sampled waters show a positive trend with the decrease in the distance from the coast, highlighting seawater intrusion in the coastal area. According to hydrochemistry results and geochemical modeling, the dominant factors in controlling the hydrochemical characteristics of groundwater are: (i) water rock interaction with calcareous and calcareous-dolomitic lithologies; (ii) seawater intrusion in the coastal area; (iii) dissolution and/or precipitation of carbonate and (i.e. dolomite and calcite) evaporate minerals (gypsum) determined by saturation indexes; (iv) mineral weathering process; (the high Mg/Ca ratio due to the weathering of Mg-rich dolomite).
Pozzi, protezione ambientale, salute pubblica
Authors: Cempini Nicola
Published: June 2016

-
The UN System for Environmental-Economic Accounts for Water (SEEA-W) and groundwater management: the experience of the Arno River Basin Authority within the PAWA project
Authors: Mazzanti Bernardo , Bonamini Isabella , Checcucci Gaia , Fiumi Lucia , Consumi Francesco , Bartalesi Stefano , Montini Giovanni
Published: June 2016

The Pilot Arno Water Accounts (PAWA) project was recently funded under the Call “Preparatory Action on Development of Prevention Activities to Halt Desertification in Europe” of the Directorate- General for the Environment of the European Commission to promote preventive actions to manage water scarcity and drought phenomena and to meet one of the main goals under European environmental legislation: the effective and sustainable management of water resources. The partners involved in the implementation of the PAWA project (ISPRA, Arno River Basin Authority, SEMIDE/EMWIS) will carry out a pilot initiative in the Arno River Basin, an area severely affected by water scarcity and droughts phenomena and characterized by water withdrawals and land use changes. In the area a large experience about water balance application was already performed, for example in the context of the Water Framework Directive Common Implementation Strategy. Moving from this knowledge, the objective of the project is the definition of water accounting processing based on the UN System of Environmental Economic Accounts for Water, with the final goal to optimize a list of effective measures to face water scarcity phenomena. By the end of project (March 2015) the PAWA partnership aims at preparing physical water stock accounts, using the best available data resulting from field measurements or models, on a monthly step for the period 1999–201. The quality of each dataset will be assessed; tables, maps and graphs will be produced as outputs of the projects in cooperation with local stakeholders and players of the water sector. Furthermore, water accounts will be used to assess the potential impact of various measures related to water resource efficient exploitation in the most vulnerable sub-basins; their tolerability will be tested during workshops with stakeholders. Finally, water efficiency targets for potential future integration into Arno River Basin Management Plan will be identified.
Effetti del trasferimento di pressione negli acquiferi confinati
Authors: La Vigna Francesco
Published: June 2016

-
Heat exchange modeling in a multilayered karst aquifer affected by seawater intrusion
Authors: Vettorello Luca , Pedron Roberto , Sottani Andrea , Chieco Michele
Published: June 2016

A Feflow thermohaline model has been implemented in order to study borehole heat exchangers (BHEs) activity in a coastal aquifer in the South of Italy (Province of Lecce, Puglia Region). The modeled closed-loop system consists of two double u-pipe heat exchangers, installed in 200 meters deep boreholes. The main purpose of numerical modeling was to forecast thermal plume extension in groundwater after a long period of heat exchange, calculating temperature trends in observation points during a 10 years transport simulation. The complex geological structure, including calcarenites, fractured limestones and a deep karst aquifer, has been translated into a multilayered model, with a depth-related parameter distribution, assigning different values of hydraulic, thermal and chemical properties to each layer. In particular saltwater concentration has been taken into account, considering the influence of seawater intrusion on the heat transport density-dependent model. Parameters assignment was based on experimental datasets collected during initial field investigations, including thermal characterization of soil samples and GRTs, together with historical hydrogeological and hydrochemical measures and previous groundwater surveys. After model structure configuration and aquifers parameterization, a sensitivity analysis on porosity and heat dispersivity has been conducted, to evaluate their influence on thermal transport phenomena with a multiple scenarios approach, considering in particular the uncertainty related to secondary porosity in karst systems. Feflow simulation represented the first step in environmental compatibility evaluation for the BHE plant, waiting for the necessary model calibration with groundwater temperature monitoring trends.
Sogno di norma…di fine estate
Authors: Guareschi Claudio
Published: June 2016

-