bluuebunny/crossref_metadata_2025 huggingface dataset:
Incentivi ai farmaci generici a livello di ASL: l’osservatorio I.H.A.G.O.
Authors: Martina Silvia , Cornago Dante , Garattini Livio , Gruppo di studio I.H.A.G.O I.H.A.G.O
Published: June 2016

Generic drugs are pharmaceutical products that contain an active substance whose patent-covered period expired and are marketed with the name of the molecule. The public health authorities of most EU countries agree on the importance of generic drugs in rationalising the pharmaceutical market, particularly by favouring reasonable pricing of “mature” products. In contrast with this wide consensus, the market share of generic drugs remains quite poor in Italy, despite recent regulatory incentives for the promotion of their use. The longlasting lack of specific laws - reference-price politics were introduced only in 2001- and the unusually long patent-covered period fixed by the past legislation are among the main reasons for the scarce utilisation of generics in Italy. The awareness of the importance of promoting initiatives conducted on a local (ASL), and not only national (SSN) scale conducted to the I.H.A.G.O. project, an observatory on the diffusion of generics in several local health districts. The project analyses the impact, in terms of market share, of local promoting activities (investigated by means of questionnaires) conducted during the year 2001 in 11 ASLs (local health districts), deliberately selected among the most active in terms of promotion of the use of generics. The I.H.A.G.O. observation revealed several praiseworthy promotional efforts, particularly of informative and cultural kind, conducted by some of the considered ASLs. Unfortunately, these measures seem not to have had a practical impact on the generics market in the observed districts: the market share increase was superior to the one observed on national scale only in 4 of the considered ASLs, in other 4 it was similar, and in the remaining 3 it resulted even inferior. It appears useful to plan further measures to support the diffusion of generics, maybe by motivating health operators to their prescription with the introduction of “prize/punishment” mechanisms.
Lo studio FAST: FAringotonsillite STreptococcica in età pediatrica Impatto farmacoeconomico delle Linee Guida dell’American Academy of Pediatrics sulla pratica clinica di 600 pediatri italiani
Authors: Colombo G. L. , Caruggi M. , Muzio A. , Marseglia G. L.
Published: June 2016

The American Academy of Pediatrics (AAP) has recently published its new guidelines for the treatment of pediatric tonsillopharyngitis; a diagnostic test for the detection of streptococci is recommended, followed by a treatment with penicillins (10 days) or cephalosporins (5 days) in case of positivity, and by no treatment otherwise. The success of a guideline, in general, depends on its diffusion in practice and on its adaptability to different local settings. The aim of the present study (FAST) was the evaluation of the clinical and economical impact of the application of the AAP guidelines in the Italian reality. The study was conducted with the cooperation of 600 pediatricians, uniformly distributed on the Italian territory, and involved 3072 patients. The pediatricians were left free to decide whether to follow the guidelines or not. The results of the analysis indicate that only some 20% of the pediatricians adhered to the suggested protocol; the total cost (calculated in the perspective of the National Health System, with a time horizon of about 3 months) per patient, nonetheless, resulted inferior in the group treated according to the proposed protocol (50,45 • vs. 53,30 •). Furthermore, a lower incidence of complications occurred in these patients. Among the “off-protocol” behaviors, two showed particularly evident misuse of health resources: inappropriate treatment after test positivity (59,15 •/patient), and treatment after test negativity (14% of the total population). Another interesting, although not surprising, result of this study was the evidence that penicillins are as effective as cephalosporins in the short-term, but significantly inferior in terms of complications, positivity for streptococci at the control test, and complications detected at follow-up.
Analisi costo/efficacia della doxofillina vs. teofillina nella terapia dell’asma cronica reversibile dell’adulto
Authors: Eandi Mario , Berno Elisa , Pradelli Lorenzo
Published: June 2016

Doxofylline is a methyl-xanthine with bronchodilator activity which clinical efficacy in the treatment of asthma and COPD is equivalent to theophylline. Clinical trials prooved that while doxofylline is as effective as theophylline in the treatment of asthma, it is associated with lesser side effects. For our pharmacoeconomical evaluation, we employed the data of an international multi-centric study that compared the efficacy and tolerability of 12 weeks of treatment with either theophylline 250 mg tid, or doxofylline 400 mg tid, or placebo. The efficacy was evaluated with pulmonary function tests and by recording the number of asthma attacks and beta-2 agonist puffs: doxofylline 1200 mg/day and theophylline 750 mg/day resulted equally effective, but the former resulted better tolerated, as the adverse effects were lesser in number and severity. We performed a cost/effectiveness analysis in order to compare the two treatments, considering the perspective of the Italian health system (SSN) and of the Italian society. For the purposes of this analysis, the efficacy indices we considered were two: one simple, consisting in the number of avoided asthma attacks (AAA), and a more complex one, i.e. UATD (Utility Adjusted Therapy Days). For the construction of this index, we extracted the survival curve of the patients remaining in therapy; this curve showed that the cumulative number of therapy days is significantly greater in the doxofylline group, although the percentage of dropouts is similar at the end of the three months: this is due to the fact that the drop-outs in the theophylline group occur earlier after treatment start. The number of therapy days was then weighed for an utility index inversely proportional to the main daily number of avoided asthma attacks, thus obtaining the UATDs. The results of the cost/effectiveness analyses showed that doxofylline dominates theophylline treatment in asthma, as it is less expensive and more effective (in terms of AAAs and UATDs) for both considered decision-makers, i.e. Italian SSN and society. The consistency of these results was further confirmed by oneway sensitivity analyses.
Appropriatezza clinica ed economica: strumenti e modelli di valutazione e gestione dell’attività psichiatrica
Authors: Munizza Carmine , Nieddu Salvatore , Bianco Maurizio
Published: June 2016

The Italian health care system is experiencing a profound reform process: due to the increasing level of expenditures, new models of organizations are being experimented to increase both efficiency and efficacy of the health care delivery system. In this general framework, our group has developed a research project with clinical, statistical and economic implications. The ambitious aim of the project is to improve the allocation and management of resources assigned to Mental Health Departments, on the basis of recent experiences in the Piedmont region. The paper presents the methodology developed to implement the project “ Evaluation of Appropriateness of care and Costs of Psychiatric Disorders”. The project aims at analysing both appropriateness and efficiency of the routine care provided by the various agencies of three Mental Health Departments. We believe that a regular monitoring of both appropriateness and efficiency of care would assist in the development of rational choices for the allocation of funds and the clinical management of patients.
Il ruolo della SPECT in associazione a iofupane nella diagnosi della Malattia di Parkinson: i risultati di un’esperienza
Authors: Antonini Angelo , Colombo Giorgio L.
Published: June 2016

According to the latest data, in Italy 200.000 patients are affected by the Parkinson’s Disease, and the trend is bound to go up. Generally the diagnosis, crucial in this pathology, is based on the clinic observation. But the absence of typical signs or symptoms increases the possibility of diagnostic mistakes. Ioflupane (DATSCAN ®) is a new diagnostic agent indicated for detecting loss of functional dopaminergic neuron terminals in the striatum of patients with clinically uncertain Parkinsonian Syndromes. The use of Ioflupane (DATSCAN ®) in association with the single-photon emission computed tomography (SPECT) allows to improve the diagnosis. Applying systematically this diagnostic model could cause a significant reduction in hospedalization cost, with less trouble for patients and a better quality of life. Aim of this study is to show the clinical and economic consequences of the use of Ioflupane (DATSCAN â) in association with SPECT as a new standard for the diagnosis of Parkinson’s Disease, considering the perspective of the National Heath System (NHS) and a single hospital structure.
Malnutrizione associata a patologie, una problematica da risolvere
Authors: Eandi Mario , Pradelli Lorenzo , Palmo Augusta
Published: June 2016

Disease-related malnutrition, the most frequent cause of undernourishment in industrialized countries, appears to be highly prevalent among western patient populations, interesting up to 60% of the hospitalized and almost one fifth of the persons attending to the general medicine service. There are several reasons for this high prevalence, among which pathology-related causes, inadequate presentation of the meals in hospitals and institutions, and low recognition of nutritional problems by health professionals. Several studies have shown that undernourished patients have higher morbidity and mortality rates than the general population and suffer of more and more severe complications, leading to prolonged hospital stays and worse clinical outcomes. This determines a much higher Health costs, estimated in an English study as a yearly additional burden of over 7 billion £ for the National Heath Service. Nutritional interventions, such as the administration of oral supplements or enteral tube feeding, are capable to increase body mass index (BMI), that is considered the most reliable indicator of the nutritional status, muscle strength and overall psycho-physical performance, determining an improved quality of life and a reduced need for medical assistance. These functional improvements go alongside with better clinical outcomes, as shown by a reduced mortality rate, shorter hospital stays and lower incidence of complications observed after supplementation. Studies that have analyzed the economical impact of nutritional supplementation in terms of cost-benefit have shown that the cost of enteral nutritional interventions is almost negligible when compared to the associated savings in the production of the health service, mainly determined by lower hospitalization rates, shorter hospital stays, reduced costs for the treatment of complications and for the consultation of specialists. Greater awareness of the health professionals and more encouraging health policies toward nutritional interventions are required to reduce the clinical and economical impact of this unnecessarily wide-spread condition.
Analisi della persistenza e delle risorse allocate nel trattamento farmacologico dell’ipertensione arteriosa
Authors: Degli Esposti Luca , Capone Alessandro , Degli Esposti Ezio , Valpiani Giorgio , Di Martino Mirko , Baio Gianluca , Russo Pierluigi , Buda Stefano , Sturani Alessandra , Caprino Luciano
Published: June 2016

In this study, the persistence with treatment and resources allocated in antihypertensive pharmacotherapy has been evaluated. Administrative databases of the Local Health Unit of Ravenna listing patients baseline characteristics, drug prescriptions and hospital admissions were used to perform a population-based retrospective study. All new users 20 years old or over receiving a first prescription for diuretics, beta-blockers, calcium channel-blockers, ACE inhibitors or AII-Antagonists between January 1st, 1997 and December 31st, 1997 were included. A one-year follow-up for prescriptions of anti-hypertensive drugs were considered. According to duration of therapy, treated population was divided in persistent patients (continuers and switchers) and non-persistent patients. A total of 16,783 patients was included in the study of whom 64.9% were non-persistents. Persistence with treatment seems to be associated with the class of anti-hypertensive drug initially prescribed, and with patient-related factors. Patients initially prescribed for AII-Antagonists were more likely to persist than those starting on the other antihypertensive classes. Annual antihypertensive treatment cost accounted for • 1,076,053.55 of which 25.4% for non-persistent patients. An appropriate use of claims data may be considered as a powerful tool, providing detailed epidemiological and economic information concerning the antihypertensive treatment.
Il trattamento di pazienti con sepsi grave mediante drotrecogin alfa: una valutazione economica con riferimento all’Italia
Authors: Lucioni Carlo , Mazzi Silvio , Christopher Chinn
Published: June 2016

Sepsis can be defined as a spectrum of clinical conditions caused by the immune response of a host to infection or trauma and characterized by systemic inflammation and coagulation. Particularly in elderly, immunocompromised and critically ill patients, sepsis is a major cause of morbidity and mortality in intensive care units (ICUs) worldwide. In the US, sepsis is the leading cause of death in noncoronary ICU patients. Drotrecogin alfa, or recombinant human activated protein C, has antithrombotic, antiinflammatory, and profibrinolytic properties. Recently in a phase III trial (PROWESS), Drotrecogin alfa demonstrated significantly reduced mortality in severe sepsis patients at 28 days. In this trial important value factors for the assessment of costs and outcomes of severe sepsis were also considered. The purpose of the present study is to determine the economic burden of the treatment with Drotrecogin alfa, according to a cost-effectiveness analysis based on the data of the PROWESS trial. The study has been adapted to the italian health environment. As regards to the costs per surviving patient and costs per QALY (Quality Adjusted Life Year), the predicted cost-effectiveness ratio of drotrecogin alfa in severe sepsis patients is much lower than the standard values considered as acceptable in the international litterature.
Osteoporosi: la malattia e il suo costo sanitario
Authors: Zara Gianpaolo , Della Pepa Carlo , Pradelli Lorenzo , Eandi Mario
Published: June 2016

Osteoporosis is a disorder of bone re-modeling, characterized by loss of its micro-architecture and decreased bone density, which lead to fragility and high risk of fracture following moderate traumata. Osteoporosisrelated pathological fractures occur more frequently in post-menopausal women, and the WHO estimates that the risk of osteoporotic fractures in women is approximately 40% during lifetime. The prevention of these osteoporotic fractures is considered one of the primary objectives for the control of the economical health burden of modern societies. The first part of this paper briefly outlines the physio-pathological basis, the epidemiology, the diagnosis and the available treatment options for osteoporosis, with particular regard to those therapies that are able to reduce the incidence of pathological fractures, that represent the main cost factor of the disease. In the second part, we reviewed the economical evaluations published on the cost of illness and of the costefficacy of the treatments. The studies that have analyzed the cost of osteoporosis, although incompletely, highlight that the greatest expenditures are related to hospitalization and rehabilitation after hip fracture, while the cost for the pharmacological treatment is relatively low. The cost-efficacy and cost-utility analyses conducted on pharmacological treatment are quite heterogeneous, and therefore hardly comparable, beside being conducted in countries with different health systems; the obtained data are nor directly transferable to the Italian setting. However, it emerges that diphosphonates, estrogens and SERMs (selective estrogen receptor modulators) are among the drugs with more favorable cost/effectiveness ratio, but there is still an uncertainty in the detection of the appropriate patient groups, which is crucial for the clinical, economical and ethical optimization of prevention interventions.
Valutazione del turn over dei farmaci antiretrovirali in particolare da IP a NNRTI
Authors: Sabbatani Sergio , Cesari Raffaella , Pipitone Emanuela , Chiodo Francesco
Published: June 2016

Objective: To determine the turnover for each antiretroviral drugs present in TP’s of patients under care for HIV infection, with a special focus on PI’s and NNRTI’s. Design/Methods: We have carried out a retrospective analysis with the aim of evaluating the turnover of each drug in the 3-year period 1998-2000. Using a specifically designed software, it was possible to determine the changes in TP for each single patient. We then calculated a different weighted percentage for each drug on the basis of the time interval from the drug entry to its exclusion from the TP: the shorter the interval, the greater the assigned weight. Finally we carried out a cluster analysis in order to obtain homogeneous groups of molecules showing the same degree of therapy switches. We established that a higher average score corresponds to a higher therapy switch rate. Results: Zidovudine/Lamivudine combination, Indinavir, Lamivudine, Nerivapine and Nelfinavir are the drugs with the lowest turnover. On the other hand, Saquinavir, Didanosine, Zidavudine, and Stavudine show the highest turnover. Conclusion: The introduction of NNRTI’s with the associated switch from PI’s (Saquinavir, Nelfinavir) and the Zidavudine/Lamivudine combination enables a simplification of the treatment. This practice appeared to be a good choice in the 3-year period under consideration. The adoption of these therapeutic solutions reduce the turnover, consequently giving more stability to TP’s.
Gli inibitori della pompa protonica nelle patologie acido correlate: il ruolo di rabeprazolo in una strategia di cost-minimisation
Authors: Colombo Giorgio L. , Muzio Andrea
Published: June 2016

The clinical management of acid-related diseases incurs the consumption of a relevant part of the health resources in Italy, as indicated by the fact that PPIs (proton pump inhibitors) represented the first pharmacological class in terms of drug expenditures in 2002, making up 6,3% of the total. It’s therefore of primary importance to evaluate the economical consequences of their utilization, beyond the clinical outcomes. In the present article a cost-minimization analysis is performed, basing on drug consumption data and focusing on the new reference-price based criteria introduced by the Italian Ministry of Health for the reimbursement of pharmaceuticals. A model for the economical evaluation of the use of PPIs was developed, based on the assumption that all the active substances in this class share the same clinical benefit, and following a stepdown approach, in which the PPIs are administered full-dose for a month, followed by a one year maintenance period at half-dose. The model yielded the following results: rabeprazole is the most cost-saving drug of this class in the Italian setting, permitting important savings on an hypothetical 1.000 patient population, ranging from 13.000 euro, when compared to omeprazole, to 279.000 euro, if related to the most expensive substance, esomeprazole. In other terms, on the basis of the assumed equal effectiveness of the considered alternatives, the costs incurred for the treatment of 1.000 patients with esomeprazole would be sufficient to treat 1.769 patients with rabeprazole.
Costi sanitari di un programma vaccinale: analisi di minimizzazione dei costi
Authors: Colombo G. L. , Muzio A. , Giordani R.
Published: June 2016

The global cost of a vaccination program is made up by many more cost components than the acquisition expense, although the former is the first cost usually taken into consideration when comparing two or more alternatives. The present article analyses the economical impact consequent to the use of two different hexavalent vaccine formulations (Hexavac, liquid ready for injection, and Infanrix Hexa, dry, to be re-hydrated) available on the Italian market for the mandatory vaccination of newborns during their first year of life. The cost minimization analysis was conducted considering only differential costs, i.e. those costs than can differ with the use of one of the two products, and not those common to the two competing products, such as acquisition cost (33 euro in average for both), the costs for the organization, the call of the infants to be vaccinated, etc.. The differences among the considered alternatives detected by this study regard the work for the preparation and administration of the vaccines, the quantity of special waste they produce and the incidence of serious febrile reactions leading to pharmacological treatment and physician consultation (body temperature > 40°C). The liquid formulation resulted more convenient in terms of cost for nurse work (0,63 euro saved per patient), waste disposal, and adverse reactions management. The robustness of these results was confirmed by sensitivity analysis and an estimate of the global saving for the Italian health system associated with the universal utilization of the liquid formulation is furnished.
Farmacoepidemiologia e farmacoeconomia della terapia anti-ipertensiva: uno studio osservazionale della popolazione della Asl di Ravenna
Authors: Degli Esposti Luca , Capone Alessandro , Di Martino Mirko , Saragoni Stefania , Berlini Samuele , Russo Pierluigi , Degli Esposti Ezio
Published: June 2016

The aim of the paper was to perform a pharmacoepidemiological and pharmacoeconomic analysis of
antihypertensive drug treatment. An administrative database kept by the Local Health Unit of Ravenna listing patient baseline characteristics, drug prescriptions and hospital admissions was used to perform a population-based cohort study. The study included all new users of antihypertensive drugs, 20 years of age or over receiving a first prescription for diuretics, beta-blockers, calcium channel-blockers, ACE inhibitors or angiotensin II antagonists (AIIAs) between January 1st, 2000 and December 31st, 2000. All prescriptions for anti-hypertensive drugs filled during the 12-months follow-up period were considered. Patients were classified as continuers, switchers and discontinuers on the basis of their prescription dynamics. A total of 14.062 patients were included in the study of whom only 39,7% resulted persistent at 12 months. Patients initially prescribed for AIIAs were more likely to continue antihypertensive treatment than those started on other drug classes as well as those with older age, concurrent drug therapies and previous hospitalisation for cardiovascular diseases. The overall cost of the study cohort for antihypertensive drugs amounted to 1.238.752,37 euros of which 80,6% was used for persistent patients. The annual average cost for antihypertensive drugs was 171,73 euro for continuers, 205,10 euros for switchers and 28,29 euros for discontinuers. Factors associated to drug cost were age, pattern of persistence, number of prescribed drug classes, and class prescribed at enrolment. Nonpersistence with antihypertensive pharmacotherapy induced a high cost for the consumption of antihypertensive drug since discontinuers are responsible for a significant percentage of drug resources allocated on subjects exposed to therapy. A correlation between drug therapy cost and persistence with treatment is needed to evaluate the appropriateness of drug utilization and to perform cost-effectiveness analyses between alternative pharmacological agents.
Sviluppo e implementazione di un modello farmacoeconomico per valutare la costo efficacia di un ACE-inibitore nella prevenzione del rischio cardiovascolare
Authors: Iannazzo Sergio , Pradelli Lorenzo , Eandi Mario
Published: June 2016

Cardiovascular disease (CVD) remains one of the leading causes of mortality and morbidity worldwide. Since several pharmacological approaches are available for the reduction of incidence and severity of cardiovascular events and health resources in modern managed care systems are limited, the evaluation of the clinical and economical consequences of any treatment is very valuable for decison-makers and physicians. In this article we present a flexible pharmacoeconomic model that permits the calculation of the marginal costeffectiveness of cardiovascular prevention with ramipril, a drug of the class of ACE-inhibitors. The clinical data used for the modelization are derived from the HOPE (Heart Outcomes Prevention Evaluation) study, a landmark cardiovascular prevention study that showed how the benefits of ACE-inhibition with ramipril go beyond the effects on blood pressure, while Italian epidemiological, demographic and economical data make the results appliable to the Italian population. The model, structured as a decision tree comparing the alternatives “to treat” or “not to treat” with Markow chains at the terminal nodes, calculates the marginal cost-effectiveness of the preventive treatment in terms of cost/year of live saved. The model is characterized by high flexibility, as it allows health decision-makers to set epidemiological and economical data in order to reflect the local population at high risk for developing cardiovascular diseas. The model was tested on a high risk population, formed by all acute myocardial infarction survivors in Italy, and indicated that life-long treatment of this patients would yield significant clinical benefits, with a cost/ effectiveness of 3,932 euro/year of life saved. This value is well below the standards that are considered acceptable, and offsprings from the partial offset of pharmaceutical costs caused by the reduction in the expenses for diagnosis and treatment of the cardiovascular events avoided with the preventive therapy.
Profilo clinico ed economico di oxatomide
Authors: Pradelli Lorenzo , Eandi Mario
Published: June 2016

Oxatomide is an antiallergic drug with a double mechanism of action: it possesses antagonistic activity on the H1 histaminergic receptor and it inhibits the production and release of flogistic and allergic mediators by effector cells, presumably acting as a selective calcium channel blocker on these cellular types. The efficacy and safety of oxatomide have been evaluated in many studies conducted on patients affected by different clinical conditions, demonstrating remarkable flexibility. It proved to be safe and effective also in extreme ages, i.e. children under 3 months of age and elderly over 80 years. Approved indications include rhinitis, asthma, conjunctivitis, urticaria, atopic and allergic dermatitis and food allergy and intolerance. In direct comparisons, oxatomide consistently proved superior than placebo and equally or more effective than other consolidated antiallergics. The drug tolerability is good, its main side effects are drowsiness and weight gain, usually transient. Cardiac and hepatic safety data are very reassuring, as is the case for drug interaction potential. Form an economical point of view, the drug acquisition cost is acceptable, being among the lowest in its class, at equally effective doses. Overall, the efficacy in several clinical conditions, the good tolerability in most patients and the reasonable purchase cost suggest that oxatomide is characterized by excellent risk-to-benefit and cost-to-benefit ratios in the treatment of allergic pathologies.
Costo-efficacia dell’amfotericina B liposomiale nella terapia dell’aspergillosi invasiva
Authors: Eandi Mario
Published: June 2016

Invasive aspergillosis (IA) is a common and life-threatening infectious complication of immune system depression. Amphotericin B deoxycholate (AMB-d) has been considered standard therapy for IA for over 40 years, despite the fact that success rates rarely exceed 40% and adverse effects are quite common. At present two more recent pharmacological agents are available for the treatment of IA: liposomal amphotericin B (L-AMB) and voriconazole (VOR). In this article, we present a pharmaco-economical study comparing the relative costeffectiveness of 5 alternative strategies in the treatment of invasive aspergillosis, analysed from the point of view of the Italian hospital: administration of L-AMB as first line therapy, followed by no rescue treatment in case of failure (L-AMB I°); administration of L-AMB as first line therapy, followed by VOR in case of failure (LAMB I° + VOR rescue); AMB-d as first line, followed by L-AMB in case of failure (L-AMB rescue); AMB-d as first line, followed by other antifungals as needed (AMB-d I°) and VOR as first line, followed by rescue treatments in case of failure (VOR I°). The cost-effectiveness analysis was conducted using decision tree modelling techniques: efficacy data were obtained from published clinical trials; costs parameters were fitted on the Italian setting. The results indicate that two strategies, L-AMB rescue and VOR I°, are dominated, i.e. induce higher costs and lower success rates than the alternatives. The three remaining strategies are neither dominated nor dominate the others, but are associated with different clinical and economical outcomes: AMB-d I° has the lowest total cost, but also the highest cost-effectiveness ratio and the lowest overall efficacy; L-AMB I° has the best cost-effectiveness, but requires the willingness to pay 2,100 euro for each additional success; L-AMB I° + VOR rescue is the most effective treatment, but this choice is associated with incremental costs of 17,200 euro for each additional success, compared with L-AMB I°. In conclusion, our analysis indicates that for clinical, economical and ethical reasons the best option in the treatment of IA is the administration of L-AMB as first line therapy, thus limiting the use of VOR to the rescue of the patients not cured by this approach.
Neridronato nel trattamento dell’osteogenesi imperfetta: prestazioni cliniche ed economiche di un farmaco orfano
Authors: Zaniolo Orietta , Eandi Mario
Published: June 2016

Bisphosphonates (BPs) are osteoclast-mediated bone resorption inhibitors and the nature of the groups attached to the central carbon atom determines the drug potency. Neridronate is an injectable aminobisphosphonate, structurally similar to alendronate and pamidronate, authorized for the treatment of osteogenesis imperfecta (OI). This drug has often been used to treat other pathologies, as an off-label option, to increase tolerability and ameliorate compliance, partly because the management of orally administered bisphosphonates, with their gastrointestinal side effects, results complicated. In this paper pharmacokinetic, pharmacodinamic and main placebo-controlled clinical trials on OI patients are reviewed. The available scientific evidence demonstrates the neridronate efficacy to improve spine and hip bone mineral density, to lower markers of skeletal turnover and to decrease fracture incidence, compared with controls. We also report clinical trials results and data about the effect of intravenous infusions of neridronate in patients with postmenopausal osteoporosis, Paget’s disease and rheumatoid arthritis. Finally, we consider the economical impact of chronic and incapacitating pathologies, like osteogenesis imperfecta, on family’s total income and the influence of the disease on quality of life of pediatric and adult patients.
La tromboprofilassi post-chirurgica e la terapia del tromboembolismo venoso con eparine a basso peso molecolare: ruolo della bemiparina in una strategia di minimizzazione dei costi
Authors: Pradelli Lorenzo , Eandi Mario
Published: June 2016

The introduction of low molecular weight heparins (LMWHs) has opened new possibilities for the costeffective management of the thrombotic risk associated with surgical procedures, allowing prophylaxis – and sometimes even treatment of established deep vein thrombosis – on a out-patient basis. This article gives a brief overview of the pharmacological and clinical features of LMWHs, focusing on the differences with unfractionated heparin (UFH), which allow great simplification of dosing regimens and settings without disadvantages in terms of efficacy or safety. In fact, some data indicate that LMWH might be better tolerated than UFH. The overcoming of the need for hospitalization for pre- and post-surgical thromboprophylaxis has important economical implications and is leading to a different formation of health care costs in these patients. The clinical and economical consequences of the pharmacological differences between LMWHs and UFH are analyzed with a “value matrix”, a pharmacoeconomical technique for preliminary evaluations. The last section examines Italian drug acquisition costs and compares the economical values of the recommended dosing regimens of LMWHs available on the national market for the prevention and the treatment of deep vein thrombosis. Bemiparin is the most convenient LMWH for all approved indications. In the management of surgery-associated thrombotic risk, no clinically relevant differences among LMWHs have been demonstrated. Thus, bemiparin appears to be the most logical choice in a costminimization strategy.
Una valutazione economica di citrato di fentanile ad assorbimento orale (Actiq®) per la terapia del dolore in pazienti affetti da cancro
Authors: Lucioni C. , Mazzi S.
Published: June 2016

Breakthrough cancer pain is a component of chronic cancer pain that is particularly difficult to treat due to its severity and rapid onset. Effective relief of cancer pain is an integral part of comprehensive cancer care. Many cancer patients experience persistent pain that is treated with a fixed scheduled opioid regimen. But these patients can experience acute breakthrough pain, with sudden onset that occurs spontaneously or as a result of activity. To supply this occurrence is indicated an addictional prescription of opioids. The ideal preparation for managing breakthrough pain is one that is able to mirror its characteristics, i.e. rapid in onset and relatively short in duration. Oral transmucosal fentanyl (Actiq®), an innovative form of fentanyl citrate, provides a rapid onset of pain relief and it is more appropriate than morphine for treating episodes of breakthrough pain. Besides the impact on the patients’ quality of life, cancer pain involves remarkable expenditures, as direct and indirect costs, by the National Health Care System and the Society. This study presents the estimation of the costs associated with the use of oral transmucosal fentanyl (Actiq®). Aim of the study is to verify if the use of oral transmucosal fentanyl (Actiq®) can be considered as cost saving or cost effective compared with current therapy.
Analisi di costo di pemetrexed vs docetaxel nel trattamento di seconda linea del carcinoma polmonare non a piccole cellule
Authors: Ravasio Roberto
Published: June 2016

OBJECTIVES: to compare costs of pemetrexed versus docetaxel in patients with non-small cell lung cancer previously treated with chemotherapy paying special attention to the adverse events. MATERIALS AND METHODS: a cost analysis was carried out performing comparison between pemetrexed and docetaxel. Clinical data (overall survival) and resource consumption (chemotherapy drugs, G-CSF, and hospitalizations due to adverse events) were obtained from a randomized phase III trial. The economic evaluation was based on direct costs using local Italian unit costs (euro 2005). The perspective was the National Health Service’s. RESULTS: the study results showed that mean survival of pemetrexed (8,3 months; 0,69 years) was higher than mean survival of docetaxel (7,9 months; 0,66 years). The mean cost of treatment with pemetrexed was 8.684,26 euros and with docetaxel was 6.182,87 euros. This difference was nearly offset by the difference in the costs of adverse events: the mean cost of adverse events due to chemotherapy treatment with pemetrexed (493,93 euros) turned out to be lower than with docetaxel (2.394,34 euros). CONCLUSION: the present cost-analysis could be a stable ground for a further cost-utility analysis, aimed at reaching a more cost-effectiveness management of the chemotherapy-related adverse effects in patients with NSCLC.
Costi e bisogni sanitari degli anziani non autosufficienti presso le strutture residenziali: strategie e interventi per una popolazione che invecchia
Authors: Moro Marta , Salvato Chiara , Terrazzani Gianni , Serraglia Donatella , Saramin Cristina , Giusti Pietro , Chinellato Alessandro
Published: June 2016

CONTEXT: The number of elderly is constantly increasing in the western world and many of this people spend the last years of their life in a nursing home with physical and/or mental disabilities. OBJECTIVE: To estimate the Health Service resource and direct costs for Community Residential Care (CRC) disabled elderly people. METHODS: A retrospective observational study was conducted between January 2002 and December 2002 among all CRC (23 CRC and 1665 disabled residential elderly population REP) of the Local Health Authority n° 9 of Treviso. For each CRC data regarding patients, hospitalisation, clinical analysis, general practitioner and hospital medical doctor assistance, drug utilisation were collected and analysed. RESULTS: Males were 27% and female 73% with an average age 78 and 86 years old respectively. Frequency of hospitalisation, clinical analysis and drug utilisation vary widely between the CRC and an inverse correlation is observed between cost of hospitalisation and drug plus clinical analysis. The first causes of hospitalisation are pneumonia 7.2% and cardiovascular disease 4.9% both considered preventable cause of hospitalisation. Regarding the drug consumption analysis enalapril, furosemide, omeprazole are the most used molecules with a consumption of 308, 185, 166 DDD/1000 REP/die; systemic antibiotics are the more expensive drugs with a cost of 0.3 euro/REP/die. Unexpected laxatives consumption is lower than data from literature with a 17% of the total REP exposed. Finally average annually cost for a REP in CRC is 16,445 euros and beside the direct sponsor of local health authority to the CRC hospitalisations cost are the most important (899 euros) while drugs, medical assistance and sanitary material cost are similar with an annual cost of 530 euros, 492 euros, 450 euros respectively. Hypnotic and anxiolytic consumption appear to be correct with literature data with about 30% population exposed. CONCLUSION: Females are disabled about 10 years after males, many hospitalisation could be avoided with correct sanitary programs and finally and inverse correlation of drug consumption and hospitalisation is observed.
Razionalizzare la spesa ospedaliera: Day-Hospital, ADI, Hospice
Authors: Eandi Mario
Published: June 2016

In the modern age, advances in processes, technology and clinical imperatives generated an evolution of the health care organization, particularly regarding hospitals, born as generic shelter and poor house. Nowadays the availability of high technologies and the intensity of intervention on patients are the main factors to warrant the modern hospital for acute care. This evolution trend brings out the need for new models of health care, focused on people’s different request about assistance (e.g. day-hospital, day-surgery, integrated home care, hospice). The present study gives an outline of the Italian situation, which is deeply changed in the latest years. New models of heath care emerged in Italy, as it had previously in the United States and other European countries, as able to improve assistance and reduce costs: the average hospital stay decreased, while the number of day-hospital and day-surgery increased. In spite of the rise observed in the last 3-4 years, both integrated home care and hospice availability remain still limited, especially considering the high potential request of the elderly population and the oncologic patients.
Costo/efficacia della prevenzione di infezioni alle prime vie aeree mediante un estratto batterico immunostimolante aspecifico (OM-85)
Authors: Zaniolo Orietta , Pradelli Lorenzo , Eandi Mario
Published: June 2016

OBJECTIVES: To estimate the pharmacoeconomical impact of preventing recurrent upper respiratory tract infections (URTIs) with OM-85, a non-specific immunostimulating agent, in at-risk children. METHODS: Implementation of a decisional model. The evaluation of effectiveness (number of prevented URTIs/therapeutic cycle) was based on weighted average of the results of four randomized, double-blind, placebo-controlled trials identified by literature reviewing. The clinical events considered in the model were natural resolution of the infection, onset of complications (acute otitis media, sinusitis, others) and their evolution. Baseline event probabilities were derived by reviewing published data in the literature. URTI-related direct and indirect costs supported by patient, by Italian health system and by community were structured according with the principal guidelines and implemented with current Italian prices and tariffs. The cost/ effectiveness of OM-85 was calculated for five scenarios, differing in the number of therapeutic cycles, grade of patient co-payment and other secondary assumptions. Sensibility analyses were performed to evaluate the model robustness. RESULTS: Immunostimulation with one cycle of OM-85 prevented on average 1,60 URTI/patient in six months (RR = 0,515). In the basic scenario, this preventive action induced savings for 107,42 euro/patient in the perspective of the patient’s family, for 48,52 euro/patient in the perspective of Italian health system and for 231,26 in the community perspective. Sensibility analyses confirmed the robustness of basic scenario results. Threshold analyses showed that OM-85 prophylaxis is economically convenient as long as more than 7% of infections are prevented or global cost of one episode of URTI is greater than 10,00 euro. CONCLUSIONS: Non-specific immunotherapy with OM-85 induces a reduction in the incidence of URTIs in atrisk children with a concurrent saving for patient and health system.
Il federalismo in sanità: opportunità e rischi tra finanziamento, equità ed assistenza
Authors: Gianfrate Fabrizio
Published: June 2016

Federalism in Italy arised beginning ’90, pushed bipartisanly from establishment in order to contrast the succesfull poll of northern league party. Being about 80% of the regions budget for healthcare, federalism had its hard impact on it. Regions can manage autonomously their healthcare organization, adding to the State financial resources own money earning from other their services or coming from local taxes, on condition that they provide the State LEA (Essential Level of Assistance). That means a high level of responsabilization for local government for reaching a higher level of efficiency in allocation of resources and organizational models of production and erogation of healthcare, beside a better ability to catch local healthcare demand. Even if now the sharing of State financial resources are agreed between all regions and Government, it’s not clear for the future wheter each region will have to procure its own finance, introducing many problems for those southern regions unable to substain theirselves. It has still to be defined wheter and how reach regions will have to transfer part of their resources to the poor ones. That means a risk of iniquity of level in healthcare provision among regions of the same country, generating possible social conflict. Therefore federalism now has from a hand the opportunity to better tail healthcare on each local demand and, on the other hand, it risks to introduce social disparity and conflicts.
Livello di dipendenza dai Servizi Territoriali e costi relativi al trattamento della schizofrenia
Authors: D’Allio Giorgio , Rutto Fernando , Coppi Michela , Guidi Luca
Published: June 2016

The present study was designed to evaluate the level of dependence from Mental Health Care Department, in Casale Monferrato, of three groups of psychotic patients treated with olanzapine (31), risperidone (30) or typical neuroleptics (31). The observation was retrospective, lasting one year (2003-2004), and collected data relative to health care resources as specialist visits, home interventions operated by nurses or physicians, drug administration, rehabilitation, psychotherapy, hospitalizations. The data collected allowed to evidentiate substantial differences among olanzapine and risperidone treated patients, usually younger, versus typical treated patients, usually older and more chronic. In general, atypical treated patients, evidentiate a reduction of home nurse intervention in respect to typical treated patients while olanzapine shows a trend in hospitalization and specialist visits reduction versus risperidone. Total health care costs are not significantly different among the three groups but evidentiate interventions more oriented to rehabilitation in the group treated with olanzapine while risperidone treated patients needed a major number of hospitalizations. Typical treated patients requested, instead, an high number of home intervention due to their chronic conditions and cognitive imparement.
Analisi costi-efficacia di 90Y-ibritumomab tiuxetano (Zevalin®) vs. terapie attualmente disponibili nel trattamento dei pazienti affetti da Linfoma Non-Hodgkin (LNH) refrattario o recidivato
Authors: Lazzaro Carlo , Beelke Manolo
Published: June 2016

The aim of the paper is to compare Italian healthcare-related costs and effectiveness of 90Y-ibritumomab tiuxetan (Zevalin®) vs. currently available II and III line therapies (chemotherapy; radiotherapy; stem cell transplant) for relapsing or refractory Non-Hodgkin Lymphoma (NHL). A cost-effectiveness analysis was performed from Italian National Healthcare Service (INHS) perspective. Clinical, epidemiological and healthcare-related resource consumption data were collected from four independent sources: three clinical databases created in Canada, The Netherlands and United Kingdom (currently available III line therapies) and one published clinical trial (90Y-ibritumomab tiuxetan); further inpatient and outpatient healthcare-related resource consumption data were provided by a Dutch costing study. Inpatient and outpatient healthcare-related procedures were evaluated according to INHS tariffs, provided that 90Y-ibritumomab tiuxetan was administered in day-hospital setting. Whenever not included in INHS tariffs, drugs were mainly costed according to Italian National Therapeutic Formulary. Costs are expressed in euro 2005. Per patient cost for 90Y-ibritumomab tiuxetan equals 17,424.84 euro, whereas the average per patient cost for currently available II and III line therapies reaches 6,870.93 euro (95% CI: 533.67-13,208.19 euro). As far as effectiveness is concerned, 90Y-ibritumomab tiuxetan performs better than currently available II and III line therapies both in terms of average and median therapy-free survival (+ 0.34 years and + 0.38 years, respectively); both the differences reach statistical significance (p