bluuebunny/crossref_metadata_2025 huggingface dataset:
Farmacoeconomia dei COXIB nella patologia osteoarticolare: revisione della letteratura
Authors: Russo Pierluigi , Degli Esposti Luca , Capone Alessandro , Degli Esposti Ezio , Caprino Luciano
Published: June 2016

A new class of anti-inflammatory agents, the selective inhibitors of cyclooxygenase-2 (COXIBs), has been recently introduced into the market for the treatment of osteoarthritis and reumatoid arthritis. Randomized and controlled clinical trials showed a similar efficacy and a better tolerability profile of COXIBs compared with conventional non-steroidal anti-inflammatory drugs (NSAIDs). The aim of this study was to perform a scientific literature review relating to the economic impact produced by COXIBs’ introduction. The research of references included the following databases: MEDLINE, EMBASE and the NHS (Economic Evaluation Database) of the York University. A total of 67 in extenso pubblications have been extracted. Of these 13 papers having the specific objective to evaluate the economic implications of COXIBs in comparison to conventional NSAIDs was analysed. In ten cases (77%), cost-effectiveness analyses were performed. The European context was considered in eight cases (62%), while that of North America and Asia were investigated in four and one case, respectively. The analysis of costs took always into account direct costs of the management of arthritis exclusively (drugs, and resources associated with the treatment of gastrointestinal side effects). Indirect and intangible costs were never considered. The results of this review highlight that the higher tollerability profile of COXIBs may generate a cost-saving. This cost-saving seems to be basically due to the reduced frequency of gastroprotective agents coprescription and also to a lesser appearance of severe gastrointestinal side effects compared with conventional NSAIDs. Besides the disease management improving, the cost-saving associated with COXIBs can completely or partially offset the net increase of expense induced by their higher price of purchase.
Durata e costo delle visite in medicina generale: il progetto DYSCO
Authors: Garattini Livio , Castelnuovo Emanuela , Lanzeni Davide , Viscarra Cecilia , Gruppo di studio DYSCO VISITE DYSCO VISITE
Published: June 2016

In Italy, general practitioners (GPs) operating within the National Health Service (NHS) are paid according to the number of patients followed, without relation to the number of visits performed. This means that, from a theoretical point of view, the marginal cost of an adjunctive medical examination equals to zero. Since this view is clearly little realistic, in this paper we expose a methodological approach to estimate the real cost of a GP visit, starting from data collected in the DYSCO study, a national survey on the medical costs of dystimia in Italy. 46 GPs were asked to record the number and duration of ambulatory and domiciliar visits, along with the time spent in administrative tasks, during 4 weeks, each randomly chosen within a season (spring, summer, autumn, winter). In order to assign a monetary value to each visit, the total fee reimbursed by the NHS to a GP was divided by the total time spent on work, and then again by the number of visits conducted during this time. The calculations performed revealed that the mean duration of a ambulatory visit amounts to about 10 minutes, while a domiciliar visit (including travelling time) lasts almost the double. An interesting result was that summer visits have significantly longer duration than the mean, and consequently cost more. The mean cost of a GP’s ambulatory visit resulted about 12 Euro; a domiciliar visit costs almost 23 Euro. The times and costs calculated in this study are consistent with other calculations performed by other authors in Europe and Italy, confirming the appropriateness of the employed methodology.
Fluoxetina: profilo terapeutico e farmacoeconomico di un prodotto generico
Authors: Della Pepa Carlo , Eandi Mario
Published: June 2016

Fluoxetine has been the first antidepressive agent of the class of selective serotonine reuptake inhibitors (SSRI) to be introduced in therapy, back in 1987. The availability of SSRIs has meant a great advance in the treatment of major depression and other neuro-psychiatric pathologies. In this paper we review the scientific and clinical research on fluoxetine that has been published in the last six years, as the prior work has been extensively examined in a review conducted on the tenth anniversary of its introduction on the market. The review focuses on cost minimization strategies that can be conducted following the introduction of low cost generic fluoxetine.
Farmaci antipertensivi a confronto: costi e benefici per il paziente e la collettività
Authors: Costa Francesco Vittorio
Published: June 2016

Pharmacoeconomic analysis of antihypertensive treatment should be performed following a correct methodological evaluation and considering with accuracy both costs and benefits of different therapeutic options. Costs evaluation is frequently performed simply examining the retail price of drugs which represents only a part (usually no more than 50%) of cumulative costs of therapy. Controlled clinical trials are the main source of information about benefits of therapy, but probably, in many cases, they underestimate the benefits of treatment and are unable to differentiate the effects of different drugs because of a too short follow-up. Benefits should be calculated not only in terms of saved lives or prevented events, but also in terms of prevention-regression of target organ damage and of quality of life of patients. If analysis are performed correctly, more recent drugs, like ATII antagonists, even if they have a higher retail price, become highly costeffective thanks to their protective activity against events, and to unbeatable levels of compliance and persistence which are associated with treatment with these drugs. Comparison between old (cheaper) and newer (more expensive) drugs, and recommendations to start therapy with the cheaper drugs, are a nonsense since to achieve goal blood pressure combinations of more drugs are always necessary. Treatment of hypertension, if extended to all patients and performed aggressively, must be considered not only a life-saving, but also a money-saving tool.
Mesalazina: profilo farmacologico, terapeutico e farmacoeconomico
Authors: Eandi Mario , Ferrero Laura
Published: June 2016

The term inflammatory bowel diseases (IBD) refers to two distinct clinical entities: Crohn.s disease and ulcerative cholitis, two chronic and non-specific disorders of unknown origin. Although quite uncommon and usually not life-threatening, IBDs have a strong economical impact, as they tend to affect patients in high productivity ages and require long and demanding therapies, medical and sometimes surgical. The pharmacological approaches to IBD treatment include aminosalicylates, corticosteroids and immunosuppressive agents. Aminosalicylic acids are the most widely used agents for maintaining remission and for the cure of mild-tomoderate forms of IBDs. This paper outlines the main pharmacological and clinical properties of one of these drugs, mesalamine (mesalazine). Mesalamine is the active moiety of sulfasalazine, an effective but not always tolerated agent. Mesalamine is available in several pharmaceutical forms, to be administered either by the oral or by the rectal route. As the therapeutic action of aminosalicylates is ascribed to their topical action on the inflamed intestine, while the adverse effects are believed to be caused by the systemically adsorbed (mainly in the first tract of the small bowel) fraction, slow-release formulations are usually preferred. From an economical point of view, mesalamine appears to have a moderate acquisition cost, widely offset by the savings induced on direct sanitary and, most importantly, indirect costs of IBDs. In particular, the availability of a generic drug with advanced colon-delivery technology provides the physician with the opportunity to treat patients with the best available technology at a reasonable price.
Costi ed effetti di Risperidone Long Acting (RLA) rispetto ad antipsicotici atipici nel trattamento dei soggetti schizofrenici in Italia
Authors: Mantovani Lorenzo G. , Berto Patrizia , Ausilio Anna D. , Heeg Bart
Published: June 2016

Objective: to estimate the costs and effects of long-acting risperidone (LAR) in the treatment of schizophrenic patients in Italy, as compared to conventional and oral atypical antipsychotics. Methods: a discrete event model was used. The model simulates patients. history for every single therapeutic alternative and selects incident events, on the basis of pre-defined probability distribution-powered, randomized repetitions. The model operates on two types of parameters: patient characteristics and time-dependent variables. Patient characteristics (age, sex, illness profile and severity, probability of incurring in an adverse event and potential dangerousness) remain fixed during the 5 simulated years. Time-dependent variables are subject to changes and include outpatient visits, severity of psychotic episodes, symptom-scores, compliance, incidence of adverse effects, site of treatment and dangerousness. Three treatments have been selected: scenario 1 begins with LAR, switches to olanzapine and then to clozapine; scenario 2 starts with olanzapine, switches to oral risperidone and ends with clozapine. Direct medical costs have been computed on the basis of psychiatric visits, drug costs and costs of the institution in which the patient is treated (hospital, rehabilitation clinic, etc.) Outcome measures were number of psychotic episodes in 5 years, total time spent during these episodes and cumulative score of positive and negative symptoms at 5 years. Information on alternatives, transition probabilities, model structure and health resources utilization were derived from the literature and from a panel of experts. Results: it has been estimated that LAR is economically dominant (more effective at lower cost) respect to oral atypical antipsychotics, being able to prevent 0.87 psychotic episodes per patient, with a net cost saving of 4,773 euro per patient. Sub-group analysis indicate that LAR is always more effective than the considered alternatives and, in general, also less costly than oral atypical antipsychotics. Sensitivity analyses confirmed the robustness of the model to several variations of key parameters. Conclusions: LAR therapy dominates oral atypical antipsychotics.
Analisi Costo Minimizzazione delle preparazioni di Interferon Beta per il trattamento della Sclerosi Multipla
Authors: Macchia Francesco , Russo Pierluigi , Caprino Luciano
Published: June 2016

The multiple sclerosis (MS) is a neurologic disease that is characterized by a progressive demielinization of the white matter of the central nervous system. In the lasts decades, several therapies have been introduced after randomized, double-blind, placebo controlled trials. These trials supported the efficacy of Interferon-beta (INF- b) in reducing relapsing frequency and slowing the progressive disability, mainly in cases affected by relapsing- remitting MS course. In Italy four different preparations of INF-b are available for MS treatment having different INF-b types (i.e., INF-b1a e INF-b1b), different administration schemes, different INF-b doses and ways of administration. Recently, the biological activity of these preparations have been compared using the same assay system against the same INF-b standard. The aim of this study was to carry out a cost-minimization analysis, on the MS treatments in Italy comparing of the available preparations in terms of cost per microgram standardized by the level of biological activity. The economic evaluation has been conducted adopting the hospital perspective. Health resources have been valued considering euro currency during 2004. According to registered treatment protocol, the results showed that the micrograms per week of INF-b standardized by the level of biological activity ranged from 30mg of Avonex® to 132mg of Rebif44®. Under the same levels of biological activity, Rebif44® resulted the INF-b preparation with the lower cost per micrograms (1.95 euro), followed by Rebif®22 and Betaferon® that had a similar cost (2.90 e 2.97 respectively). Avonex® resulted the INF-b preparation with the highest cost per micrograms (6,37 euro), about three times higher than that of the preparation with the lowest cost.
Profilo terapeutico e farmacoeconomico di linezolid
Authors: Eandi Mario
Published: June 2016

The incidence of nosocomial infections from Gram-positive pathogens has been increasing in the last two decades, alongside the development of antibiotic resistance in many bacteria. Glycopeptidic drugs are the most widely used options for these patients, but some bacterial strains with low sensibility to vancomycin and teicoplanin are starting to emerge, warranting careful monitoring and control of nosocomial and also community- acquired infections. This paper outlines a clinical, therapeutic and economic profile of linezolid, the first drug of the only new antibiotic class developed in the last thirty years. In clinical trials, linezolid has demonstrated very promising efficacy and safety in the treatment of antibiotic-resistant infections, in particular those caused by methicillin-resistant staphylococci (MRSA), obtaining greater or equal clinical and microbiological success rates than the standard options. Linezolid, as most newer drugs, has higher acquisition costs than the alternatives, but also bears interesting features that may modify the formation of infection treatment costs. In particluar, linezolid is very well absorbed after oral administration, allowing the planning of sequential iv/os strategies that have the potential to reduce health care costs and to improve the quality of life of the patients by shortening the length of hospitalization. Economic evaluations have demonstrated that this advantage is not merely theoretical, but that it can be achieved in real practice. In particular, linezolid has been shown to be more cost-effective than teicoplanin and vancomycin in the treatment of hospitalized, MRSA-related nosocomial pneumonia and severe infections.
I diuretici dell’ansa nella terapia di mantenimento del paziente con scompenso cardiaco
Authors: Cecchi Franco
Published: June 2016

Diuretics are still a cornerstone of acute heart failure. Their role in chronic heart failure has recently been reconsidered, as Ace-inhibitors and Beta-blockers have been shown to be highly effective in reducing cardiovascular morbidity and mortality in patients with heart failure. Loop diuretics and aldosterone antagonists, however, are still used in chronic heart failure, at the lowest dose needed in order to mantain haemodynamic balance. The use of effective loop diuretics with longer half-lives and constant bioavailability may be beneficial, resulting in fewer hospital readmissions, both for congestive heart failure and all cardiovascular events, in improved quality of life and in health costs reduction.
Tramadolo: profilo farmacologico, terapeutico e farmacoeconomico
Authors: Serpe Loredana , Pradelli Lorenzo , Eandi Mario
Published: June 2016

Tramadol is an effective central analgesic with a dual mechanism of action: antagonism on mu-opioid receptors and inhibition of serotonin and norepinephrine reuptake. In this paper a pharmacological, clinical and economical profile of its use in pain management is provided. Tramadol has proven effective in the treatment of moderate and severe pain associated with acute and chronic conditions of different ethiology, at oral or parenteral doses of about 50-100 mg every 4-6 hours. The maximal daily dose should not exceed 400 mg, less in case of liver or kidney dysfunction. Tramadol has low potential for physical or psychological dependence; the minimal likelihood of provoking typical opioid adverse events represents an advantage over other morphine-like agents. From a pharmacoeconomical point of view, tramadol prescription appears to be efficient: the comparisons conducted in the management of post-surgical pain have shown tramadol to be more convenient than the studied alternatives. Overall, tramadol appears to be a safe and effective drug for the management of pain and it is one of the most relevant week opioids to be used in the second step of the pain management latter proposed by the WHO. The recent introduction of generic tramadol permits to choose among more products and allows to obtain savings on the cost of managing acute and chronic painful conditions.
Implicazioni cliniche ed economiche di tramadolo SR
Authors: Pradelli Lorenzo , Eandi Mario
Published: June 2016

Tramadol is one of the preferred weak opioid agonists in the management of chronic pain, due to a good efficacy and safety profile, to a particularly low interference with cardiovascular and respiratory functions and a low dependence and abuse potential. The successful use of tramadol, nevertheless, is often limited by low patient compliance, a consequence of gastrointestinal side effects (mainly nausea and vomiting) and frequent dosing regimens, among other reasons. In this paper, clinical studies conducted on slow-release formulations of tramadol and other strategies for compliance improvement in various pain conditions are reviewed. From the examined literature, it appears that the strategy with the best compliance is the use of slow release (SR) formulations, which simplify dosing regimens and tend to have a somewhat better tolerability, and a slow dose escalation, which improves tolerability. The advantages of SR formulations have to be weighed against the superior acquisition cost and the slower onset of analgesia. A frame for the evaluation of the clinical and economical advantages and disadvantages of SR versus immediate release formulations of tramadol is also proposed.
Farmacoeconomia ed etica: cure sostenibili e rispetto della persona
Authors: Spagnolo Antonio G. , Minacori Roberta
Published: June 2016

The scarcity of economic resources today is a fundamental problem in public healthcare. The importance of making well-founded choices for optimal resources allocation concerns also pharmacological treatments and is justified also on ethical grounds, besides the economic, political and/or medical considerations. In fact, a better management, also in economic sense, of the patient and sickness involves the possibility of offering an efficient treatment to all the sick, or at least to as many of them as possible. However, these considerations should always be subordinated to the ethical centrality of the patient, to the protection of his life, his health and his personal dignity, to the extent that life and health are priceless. The goal of ethics in pharmacoeconomics can be summarised in respect for the person, which must remain the end and reference of every therapeutic choice as well as every healthcare policy. The indispensable instruments for the realisation of the above objectives are, amongst others, those already highlighted but which demand further explanation: a) a suitable standard background/training and a multidisciplinary approach for optimising the evaluation procedures and increasing accuracy and verifiableness of the data; b) measures to contrast and disclose the conflict of interest for more transparency and credibility; c) a coherent evaluation of the ethical quality and humanness of the pharmacoeconomic analysis which requires a correct consideration of quality of life and a real respect for persons.
Rifaximina nel trattamento della malattia diverticolare: potenziale terapeutico ed economico
Authors: Zaniolo Orietta , Eandi Mario
Published: June 2016

Antibiotics are commonly used to treat major inflammatory complications of diverticular disease, but apparently there is no rationale for the use of antibiotic therapy in uncomplicated disease, where an inflammatory component is by definition excluded. Some observations suggest a possible role of gut microflora in determining some symptoms related to diverticular disease: bacterial overgrowth, amplifying gas production and bacterial degradation of fibres, could determine bloating, pain and high fecal density. Therefore a beneficial antibiotic action on diverticular disease symptoms can be hypothesized. In this paper pharmacokinetic, pharmacodinamic and therapeutic potential of an intestinal antibiotic, rifaximin, are reviewed. Rifaximin is a rifamycin derivative which acts by inhibiting bacterial ribonucleic acid (RNA) synthesis. It is virtually unabsorbed after oral administration and in vitro data indicate it to possess a broad spectrum of action; bacterial resistance during exposure to rifaximin has been reported but its clinical importance remains to be fully defined. The results of placebo-controlled clinical trials show that cyclic administration of rifaximin is more effective in reducing symptoms and in preventing complications than fibre supplementation alone; the drug appears to be well tolerated and safe. We consider the clinical implications and economical impact of diverticulosis on the Italian National Health System and the patient, with a particular attention on the cost of hospitalization, surgery and global management of diverticulitis and other common disease complications. The hypothetic savings correlated to the reduction of complications incidence, attainable with rifaximin use have been calculated and the comparison between the different acquisition costs of the drug frequently used to treat the diverticular disease is provided. Finally we reviewed some quality of life trials in which the psychological and sociological influence of the disease symptoms and treatments on the patient are assessed.
Il costo di una neutropenia febbrile
Authors: Lucioni C. , Crippa L. , Leoncini O. , Martinelli G. , Mazzi S. , Santoro A.
Published: June 2016

Febrile neutropenia (FN) is one of the most common and severe complications of chemotherapy, particularly when used for the treatment of hematological malignancies and bone marrow transplantation. Estimating its cost for the National Health service (NHS) is difficult, in that the cost of FN is included in the overall reimbursement, which is based on the main DRG declared at discharge. Aim of the present survey, conducted on the patient population treated in two oncology centers in Milan in the years 2001- 2002, was to evaluate the most frequent DRGs associated with neutropenia, with the objective to estimate the mean cost per patient hospitalized with FN. As expected, oncology patients with NF are spread through a wide range of DRGs, but the mean cost per patient resulted comparable in the two considered hospitals ( ~ 9500 euro), as well as the overall distribution among DRGs. The single most frequent DRG was 398 (diseases of reticuloendothelial and immune systems, with complications) which appears to be appropriate, being the closest to the clinical definition of FN available.
L’uso appropriato di antibiotici iniettivi a domicilio: criteri epidemiologici, clinici e farmacoeconomici
Authors: Eandi Mario , Serra Roberto
Published: June 2016

Outpatient parenteral antibiotic therapy (OPAT) has become an increasingly used therapeutic modality during the last 20 years. Reasons for this rapid growth include OPAT’s many patient benefits as well as the development of new technologies and well-documented cost savings. Recently the Italian Drug Agency (AIFA) has revised the list of drug’s limitations and indications; particularly two notes about OPAT (n. 55- n.56) have been modified. These new notes can assume at least a double significance: if on the one hand they try to put a check on the overuse and misuse of OPAT, steering physicians towards a better utilization of parenteral antibiotics, on the other they allow to prescribe OPAT also in case of non-ordinary infections, promoting development of more structured OPAT programmes. Prescribing physicians should be aware of a number of aspects of OPAT which distinguish it from other forms of therapy: multiple factors must be taken into account, including the probable infecting organism, the pharmacodynamic and pharmacokinetic properties of candidate drugs, the capabilities of patients who will receive OPAT and of their caregivers. The Infectious Diseases Society of America (IDSA) Guidelines have been elaborated to help physicians thorough assessment of OPAT suitability, even if they need to be adapted to many variables in each treatment setting. Aim of the present study is to re-consider the main microbiologic, clinical and pharmacoeconomic criteria supporting the prescription of an outpatient parenteral antibiotic therapy after the publication of the new AIFA notes.
La valutazione economica del trattamento farmacologico con antipsicotici nella schizofrenia: una revisione sistematica della letteratura
Authors: Ravasio R.
Published: June 2016

Schizophrenia is a chronic, severe, and disabling brain disease. Approximately 1 percent of the population develops schizophrenia during their lifetime. Available treatments can relieve many symptoms, but most people with schizophrenia continue to suffer some symptoms throughout their lives; it has been estimated that no more than one in five individuals recovers completely. The introduction of second-generation antipsychotics, also defined as atypicals, has increased the therapeutic options available for individuals with schizophrenia. Potential benefits of these agents include a more favourable profile in terms of positive and negative symptoms, less adverse effects and better cognitive functioning than first-generation antipsychotics. It is uncertain whether atypical antipsychotic agents, as prescribed in ordinary practice, are a cost-effective alternative to conventional agents. This study examined the financial and clinical implications of using atypical antipsychotics in the treatment of schizophrenia, considering both related costs and consequences. To elaborate the paper, we reviewed 8 economical studies regarding the comparison between atypical and typical antipsychotics, published in the years 1998-2004. In 5 studies atypical antipsychotics were cost-saving compared to typical, in 2 studies they were cost-neutral and in one study they resulted cost-effective. Consequently typical antipsychotics were cost-saving just in one study.
Interruzione del trattamento nei pazienti con schizofrenia che ricevono olanzapina o aripiprazolo: metanalisi degli studi clinici controllati
Authors: Santarlasci Benedetta , Biricolti Giovanni , Orsi Cecilia
Published: June 2016

BACKGROUND: In schizophrenia the drop-out rate can be used as proxy of effectiveness. The drop-out evaluation is also important considering the relevant economic impact for NHS of an antipsychotic therapy discontinuation in terms of patient hospitalization and other related healthcare resources consumption. OBJECTIVE: To analyze the differences in the rates of drop-out from clinical trials between olanzapine and aripiprazole. METHODS: Literature search was based on MEDLINE, on Iowa-IDIS and Drugdex databases (1966-Dec 2004). Analysis included 12 randomized controlled trials (3.778 patients), 8 for olanzapine (2.559 patients) and 4 for aripiprazole (1.219 patients). RCT inclusion criteria were: a) Patients affected by schizophrenia; b) Randomized assignment to olanzapine or aripiprazole treatment group; c) Number of patients included in the treatment group higher than 100; d) Drop-out frequency evaluation between 4th and 26th weeks of follow-up. RESULTS: The rate of treatment discontinuation was greater for aripiprazole than for olanzapine (42,2% vs. 31,6% respectively). The comparison between drop-out percentages is statistically significant (p
Terapia del dolore: nuove norme e aspetti pratici per l’uso degli analgesici
Authors: Pradelli Lorenzo
Published: June 2016

Until recently, pain therapy in Italy was conducted with largely sub-optimal standards, as revealed by one of the lowest mean morphine consumption values, an important indicator of pain therapy quality according to the WHO, among industrialized countries. The recognition of such a negative situation has led to an important effort to improvement, carried out by the law-maker, institutions and health professionals. As suggested by the WHO, these efforts aimed at three main objectives: reducing the cultural barriers to appropriate opioid use through targeted education and information, easing of analgesic drug prescription and availability, and improvement of the integration among hospital-based and domiciliar pain management and care-giving. In this article, the new legal framework concerning the prescription and administration of analgesics - regulatory innovations started in February 2001 - is presented and its practical implications for health professionals are discussed. Alongside the new laws, some regulatory interventions recently adopted by the Italian Drug Agency (AIFA) are presented and discussed, as they share the proposition of simplifying pain therapy and permit the prescription of more analgesics paid for by the National Health Service. In the last years, the premises for a more rational and modern approach to pain therapy in Italy have been created, which will need to be followed by cultural, organizing and clinical practice adaptations in order to warrant effective and efficient management of algic patients.
Influenza del trattamento della schizofrenia con neurolettici tipici o olanzapina sui costi sanitari e sugli outcomes lavorativi
Authors: Barioglio Angelomarco , Guidi Luca , Mariani Giorgio
Published: June 2016

The aim of the present study was to evaluate the global treatment cost of schizophrenia with olanzapine or typical neuroleptics, according to Local Health Care Unit point of view. This analysis was performed through naturalistic observation of a cohort of schizophrenic patients referring to Ascoli Piceno ASL Department of Mental Health during 4 years (2001-2004). During year 2003, investigators have identified a cohort of patients who were undergoing treatment switch from typical neuroleptics to olanzapine. These patients, after the switch, are observed prospectively for the next 2 years and retrospectively for the last 2 years of treament. This method allow us to collect data about 4 years of treatment: 2 years of typical neuroleptic treatment followed by 2 years of olanzapine treatment. The present work is presenting the analysis of the first 3 years of observation. The results of our analysis are demonstrating that olanzapine treatment, through a better patient-physician alliance and with rehabilitative activities, allow lower total medical costs for the treatment of schizophrenia than typical neuroleptics. The higher acquisition cost of olanzapine versus typical neuroleptics was compensated by less hospitalizations and territorial medical interventions. During olanzapine treatment patients followed more rehabilitative activities (+71,26%, p
Sulodexide: implicazioni cliniche ed economiche
Authors: Zaniolo Orietta , Eandi Mario
Published: June 2016

Sulodexide is a highly purified glycosaminoglycan approved for leg ulcers treatment. It contains two principal components: heparan sulfate, a fast-moving heparin fraction, (80%) and dermatan sulfate (20%). Sulodexide is available as an oral agent and as an injectable preparation. Its pharmacological action is obtained by dose-dependent coagulation factors inhibition: dermatan sulfate upgrades the physiological action of a selective thrombin inhibitor, heparin cofactor II, and heparan sulfate depresses activated factor X, via an increase of antithrombin III action. The antithrombotic action is enhanced by platelet aggregation inhibition and by the activation of the fibrinolytic system. This paper summarizes the results of some of the main trials that evaluated sulodexide in the treatment of peripheral occlusive arterial disease and venous leg ulcers; a trial on prevention of recurrent deep venous thrombosis with sulodexide is also reviewed. We analyzed data about the clinical and economical impact of chronic venous insufficiency with a particular attention to the cost of medication, hospitalization and management of leg ulcers. The hypothetical savings correlated to the reduction of leg ulcers incidence and healing time attainable with sulodexide have been estimated. A comparison between the different acquisition costs of the drugs frequently used to treat leg ulcers is also provided. Finally we reviewed some quality of life trials in which the psychological and sociological influence of the disease and its treatments on the patient are assessed.
L’analisi delle decisioni negli studi di farmacoeconomia
Authors: Bacchieri Antonella , Attanasio Ermanno
Published: June 2016

This paper is a review of the decision tree methodology. This is a very useful technique in complex decision making, when the consequences of the decisions are distant in time and the information upon which we can rely is uncertain. Decision trees are the basic structure underlying most applications of decision analysis in medicine. However, in this review we only cover their application to the pharmaco-economic field. The main steps of this decision analysis are explained. Thereafter, a case study from the literature is used as an example, i.e. an application of the decision tree analysis to a study aimed at comparing two different drugs in the treatment of gastro-esophageal reflux. The main focus of our paper is on the statistical aspects, which include the definition and quantification of the outcome variables, the definition and quantification of the probabilities of occurrence of the uncertain events considered in the decision tree, and the sensitivity analysis. The knowledge of the basic laws of the probability theory is mandatory for assigning correct values to the parameters of the decision tree (outcomes and probabilities). Finally, the sensitivity analysis is an important part of the work to be performed in the last stage of the decision analysis in order to measure the degree of robustness of the results when varying the assumptions.
Profilo farmacologico clinico e farmacoeconomico di un gel oftalmico a base di carbomero 974P e PVA (Siccafluid®) nella terapia della cheratocongiuntivite secca
Authors: Pradelli Lorenzo , Vacchini Letizia
Published: June 2016

BACKGROUND: The dry eye sindrome refers to a group of disorders of the tear film due to reduced tear production or excessive tear evaporation that is associated with symptoms of ocular discomfort and may cause disease of the ocular surface. Dry eye syndrome varies in severity, duration and etiology. The cornerstone of dry eye syndrome therapies includes the intraocular gel or ophthalmic solutions instillation, reaching correct artificial lubrication. Molecules that can produce a stable lubricating film are the carbomers. METHODS: In the first step of our work we reviewed the data from literature reporting about carbomers’ characteristics in respect to other lacrimal substitutes. Then, a pharmacoeconomical analysis has been performed on ophtalmic gels derived from carbomers 974P and PVA. RESULTS: Dry eye sindrome, if not adequately treated, determines a deterioration of the patient’s quality of life, other than high secondary costs. CONCLUSION: The high therapeutical index of carbomers 974P and PVA-based gels, in addition to the their limited cost (totally free for Sjögren patients in Italy), suggests that this product is characterized by one of the best benefits-to-costs ratios in the treatment of dry eye sindrome.
Pregabalin versus gabapentin nel trattamento dei pazienti con neuropatia periferica: adattamento di un modello internazionale per la valutazione di costo/efficacia e costo/utilità alla realtà nazionale
Authors: Marchettini Paolo , Da Deppo Lisa , Pradelli Lorenzo
Published: June 2016

OBJECTIVE: To compare the economic impact of treating neuropathic pain with pregabalin versus gabapentin. DESIGN: A cost effectiveness analysis comparing costs and effects of pregabalin 375 mg/die versus gabapentin 1800 mg/die in the perspective of the Italian National Healthcare Service was developed. The cost effectiveness analysis is examined alternatively in terms of the incremental cost per additional day with no or mild pain, and the incremental cost per quality-adjusted life-year (QALY) gained. Effects were derived from a pregabalin randomised clinical study 1008-155 and gabapentin 645-210 and 945-211 studies. Effects are expressed as reduction score of the VAS pain scale. Pharmacological costs were quantified according to the Italian market price of the drugs; healthcare procedure and hospitalisation costs were quantified on the basis of the National Tariff. Other healthcare services consumption data were derived from a Delphi Panel. To estimate the impact of pregabalin and gabapentin on daily pain experience in patients with neuropatic pain a Markov model is used. The dynamic simulation focuses on a hypothetical cohort of 1000 patients and simulates their daily pain experience over 12 weeks, to estimate clinical and economic outcomes for the group as a whole. MAIN OUTCOME MEASURES AND RESULTS: The cost-effectiveness ratio for the use of pregabalin is less than 1 euro per additional day with no or mild pain and 468 euros per QALY. The sensitivity analysis conducted to examine the effects of decreasing gabapentin dose to 1200 mg/die showes the consistency of the model results. CONCLUSIONS AND RESULTS: Although pregabalin pure costs are higher than gabapentin costs, the analyses prove pregabalin to be more effective with a small additional cost per day with no or mild pain.
Prevenzione e terapia precoce del diabete mellito di tipo II: aspetti farmacoeconomici
Authors: Pradelli Lorenzo
Published: June 2016

Type II (non-insulin-dependent) diabetes is one of the most widespread chronic patologies in the developed countries and its prevalence in Italy is about 2-3% of the population. Type II diabetes is also associated with several other metabolic abnormalities such as central obesity, hypertension, and dyslipidemia, which contributes to the very high rate of cardiovascular morbidity and mortality. Therefore Type II diabetes involves a significant financial burden on the health care system. The purpose of this paper is to explain the composition of the healthcare costs of managing people with Type II diabetes and the economic repercussions due to the adoption of an aggressive strategy against the pathology. To carry out this evaluation we considered the CODE-2 (The Cost of Diabetes in Europe - Type II) Study results, the American Diabetes Association Position Statement, the Diabetes Prevention Program and the UK Prospective Diabetes Study. Evidence exists to show that introducing prevention program or an early therapy can avert or delay significantly the onset of cardiovascular morbidity in Type II diabetes patients. According to the pharmacoeconomical criteria, this very desiderable clinical goal is associated to a little increase of the health expenditures, and sometimes also to a costs saving.
Adefovir dipivoxil nella terapia dell’epatite B cronica: profilo farmacologico clinico ed economico
Authors: Pradelli Lorenzo , Eandi Mario
Published: June 2016

Despite the fact that an effective vaccine against hepatitis B virus (HBV) has been available for over 30 years, the worldwide prevalence of this infection is still very high. Until recently, there were only two effective therapeutic options for chronic hepatitis B (CHB), interferon and lamivudine, but both are considered suboptimal therapies, for different reasons. Adefovir dipivoxil (ADV) is the oral prodrug of adefovir, an acyclic nucleotide analogue that demonstrated virological and clinical effectiveness against HBV in experimental and real world settings. In this paper the main pharmacological and clinical evidence of ADV in CHB is reviewed. Health care economics data on the direct costs of CHB in different countries are presented and potential economical consequences of its introduction in Italy are discussed.
Valutazione clinica e metabolica dell’impiego dell’insulina Lispro in pazienti con diabete mellito scompensato
Authors: Uneddu Antonio , Paolini Tito Antonio
Published: June 2016

The aim of the present work is to report preliminary results about the administration of an insulin analogue, LisPro, to treat diabetic chetoacidosis. This new procedure, in respect to insulin continuous infusion, allow significant cost reduction in terms of medical and nurses time dedicated to the patient and hospitalization length. In our experience, LisPro treatment compared to the standard of care, has allowed hospital time reduction of 2,1 days per patient. This can be translated in cost saving of about 700,00 euro per case. These preliminary data, replicating the results coming from published international experiences, have to be confirmed in our country through the implementation of more representative studies
Pharmacoeconomic evaluation of cefaclor in the pharyngo-tonsillitis and acute otitis in children
Authors: Eandi Mario , Lo Giudice Milena
Published: June 2016

Pharyngotonsillitis (FT) and acute otitis media (OMA) are among the most frequent infectious diseases of the childhood and exact a heavy toll on the Italian national health service (INHS), families and society as a whole. In case of established or suspected bacterial origin, current treatment guidelines for FT recommend 5-10 days of oral antibiotics, chosen among available penicillins, cephalosporins, or macrolides. More controversial appears the systematical use of an antibiotic for OMAs, but prevalent expert opinion suggests use of the same agents. In this paper, an economical appraisal of five of the most prescribed oral antibiotics for these indications in Italy (cefaclor, amoxicyllin, amoxicyllin/clavulanate, clarithromycin and azithromycin) is provided. The evaluation was conducted through the development and implementation of two distinct models, constructed to reflect national treatment patterns of these infections. Clinical and economical data were obtained from several sources: literature review, including published meta-analyses, consultation of an expert panel and, most importantly, from the results of a specific questionnaire-based survey completed by 136 pediatricians, based throughout Italy. The models were run to conduct both cost-effectiveness and cost-minimization analyses, that consistently indicated cefaclor and amoxicyllin to be substantially equivalent in terms of total costs to the INHS and the Italian society, but significantly more convenient than amoxicyllin/clavulanate, claritrhomycin or azithromycin. Extensive probabilistic sensitivity analyses confirmed the robustness of this conclusion.
Taxane therapy in the adjuvant treatment of breast cancer in Italy: economic evaluation
Authors: Ravera Simona , Mantovani Lorenzo G.
Published: June 2016

Breast cancer (BC) is one of the leading cause of death in developed Countries and every year more than a million new cases are diagnosed worldwide. In Italy the prevalence of BC was estimated to be 1,070 per 100,000 at 31 December 1992. Nevertheless, despite the increase in incidence, mortality rate for BC are decreased in the last decades probably due to several factors such as implementation of screening programs, early diagnosis and new adjuvant therapies. Important types of adjuvant chemotherapy include anthracyclines and taxanes and these treatments continue to be evaluated to determine optimal combinations and dosing regimens. The efficacy of paclitaxel and docetaxel in adjuvant setting for the treatment of early BC has been assessed in different trials where the two taxanes showed a significant increase in both Disease Free Survival (DFS) and Overall Survival (OS) in comparison with nontaxane therapy. In particular results from one of the last studies comparing paclitaxel and docetaxel show equivalent efficacy for both drugs. At the light of the recent findings, the objective of this work is to perform a cost minimization analysis of paclitaxel vs docetaxel in the adjuvant setting for treatment of early BC in Italy. The analysis was conducted from the National Health Service’s point of view, assuming equivalent efficacy in terms of DFS and OS for both taxanes. Costs were evaluated on the basis of therapeutic schemes used in the analyzed trials. Results show that paclitaxel, administered every 3 weeks for 4 cycles after doxorubicin and cyclophosphamide, represents the less costly therapy. This is a conservative costs estimate based on data from literature that does not take into account possible additional costs associated to the treatment of febrile neutropenia (FN) as adverse event related to chemotherapy. Since, on the basis of scientific literature data, FN seems to be more related with docetaxel than with paclitaxel administration, it is likely that in clinical practice the Growth–Colony Stimulating Factor is often prescribed as a preventive therapy when Docetaxel is administred, giving rise to treatment costs.
Telithromycin (Ketek®)in lower respiratory tract infections: economic aspects
Authors: Lazzaro Carlo
Published: June 2016

The aim of the paper is to compare Italian healthcare-related costs and effectiveness of 7- and 5- day course with telitromicin (Ketek®) 800 mg od vs. 10-day clarithromycin 500 mg bid in patients with Community-acquired pneumonia (CAP) and Acute exacerbations of chronic bronchitis (AECB), respectively. Clinical as well as healthcare-related resource consumption data were collected from two Medline indexed articles reporting results of three international trials. Since differences in effectiveness among the compared antibiotic courses did not reach statistical significance, two cost-minimization analyses were performed from Italian National Healthcare Service (INHS) perspective. CAP and AECB-related hospitalizations were evaluated according to INHS DRGs tariffs, whereas drugs were costed according to Italian National Therapeutic Formulary. Costs are expressed in euros 2005. When compared to 10-day clarithromycin 500 mg bid, savings related to 7-day telitromicin 800 mg od approach 102,10 euros per CAP patient (IC 95: -177,89 euros − -26,31 euros; p
Pharmacoeconomic analysis of biological treatments for psoriatic arthritis
Authors: Eandi Mario , Salvarani Carlo
Published: June 2016

Psoriatic arthritis is an inflammatory and possibly destructive form of arthritis; left untreated, psoriatic arthritis can be a progressively disabling disease. The arthritic manifestations often include debilitating disease of the hands and feet, as well as painful inflammation of the tendon insertions and arthritis of the spine. The most common treatments prescribed for the psoriatic arthritis are nonsteroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, corticosteroids and disease-modifying antirheumatic drugs (DMARDs). Due to a recently suggested role of the tumour necrosis factor (TNFα) in the pathogenesis of psoriatic arthritis, new therapies specifically blocking TNFα have been investigated. Aim of the present study is to compare cost/effectiveness (CEA) and cost/utility (CUA) ratios of anti-TNF medications currently available on the Italian market: etanercept, infliximab and adalimumab. The evaluation was conducted through the development of a single Markov model. Clinical data were obtained from three Phase III trials attesting the clinical efficacy of the biological therapies. Both cost/effectiveness and cost/utility analysis were implemented through the deterministic evaluation and the probabilistic evaluation, in order to assess the convenience for the Italian National Healthcare Service. Adalimumab appears to be cost effective for the treatment of psoriatic arthritis, especially considering the incremental cost/effectiveness ratio (ICER) and the incremental cost/utility ratio (ICUR); the results suggest that ICER and ICUR values of adalimumab over etanercept is definitely lower than the maximum acceptable willingness-to-pay value. Moreover, compared with infliximab, adalimumab is less costly and more effective.