bluuebunny/crossref_metadata_2025 huggingface dataset:
Mutua disponibilità, prezzi e rimborsabilità di farmaci autorizzati con procedura centralizzata europea
Authors: Cipollina Laura , Folino-Gallo Pietro , Grande Daniela , Felisi Maria Grazia , Ravera Simona , Ceci Adriana
Published: June 2016

The european pharmaceutical market doesn’t seem to be a common integrated european market as far as prices and reimbursements within different countries are concerned. Moreover, to better define such differences, little information is available because of the lack of homogeneous and updated european databases. The aim of this study is to assess mutual availability, prices and reimbursements of innovative drugs authorised by EMEA under European Centralised Procedure between 1995-2000 and marketed in five european countries (Italy, Spain, United Kingdom, France and Denmark). Our results demonstrate that the adoption of different drug-price definition models, within different Member States, is the main cause of the heterogeneity. Currently, in countries adopting a controlled drug-price system, prices are lower than prices set in countries that adopt an uncontrolled drug-price system. In this regard, Italy ranks in a middle position as products marketed in Italy generally have prices lower than in the United Kingdom and Denmark, and higher than in France and Spain. Product availability and level of drug breakthrough in the national markets seem to greatly affect the variations we noted among prices and reimbursements in different countries. Differences we observed emphasize the need of finding a common methodology at european level, in order to define the proven “therapeutic benefit” and the “therapeutic advantage” of innovative drugs, allowing a “right price” and reimbursement to the entitled.
Valutazione farmacoeconomica dell’uso di tramadolo vs ketorolac nella gestione del dolore postoperatorio
Authors: Mantovani Lorenzo G.
Published: June 2016

This article represents the first evaluation that compares the economic consequences of managing postsurgical pain with tramadol or ketorolac in the Italian setting. The economic evaluation was based on 5 clinical trials that directly compared the efficacy and tolerability of tramadol and ketorolac treatments in different settings and that contained drug consumption data. Since the review of these data confirmed that their efficacy is comparable (tramadol showed a quicker onset of the analgesic action, which was not considered for the purposes of the economic evaluation), it was chosen to conduct a cost minimization analysis. The calculations were made considering two different drug acquisition costs: the hypothetical price for the hospital, computed by discounting 50% off the retail price, and the mean price really paid by hospitals according to the IHS. The analyses showed that, when the discounted price is applied, tramadol induces costs that are similar to those induced by ketorolac in 2/3 of the cases and lower in the remaining 1/3. Considering the mean price paid by hospitals, tramadol results economically more advantageous than ketorolac in all considered settings. In conclusion, ketorolac and tramadol are two effective and tolerable drugs in the management of post-surgical pain, although they differ in the adverse event pattern and in the rapidity of their action. In the Italian setting, tramadol appears to be economically more efficient, due to lesser consumption and lower drug acquisition costs.
La farmacoutilizzazione delle statine nella pratica clinica: risultati di uno studio di popolazione condotto su database amministrativi e di medici di medicina generale
Authors: Di Martino Mirko , Capone Alessandro , Russo Pierluigi , Degli Esposti Luca , Ceccarelli Pierluigi , Buda Stefano , Degli Esposti Ezio , Caprino Luciano
Published: June 2016

In spite of findings of large-scale clinical trials which showed an overall reduction of morbidity and mortality from coronary heart disease in patients treated with 3-hydroxy-3-metylglutaryl coenzyme-A reductase inhibitors (statins), relatively little is still known about the real prevalence of treatment in general practice setting, particularly in patients with a high cardiovascular risk. The objective of this study was to investigate among patients with cardiovascular risk profile estimated according to the Framingham Heart Prediction Risk Study, the percentage of those exposed to statins, and the proportion of patients reaching total cholesterol (TC) target levels. A cross-sectional analysis was conducted on a large cohort of patients listed in the administrative databases of the Local Health Unit of Ravenna (total resident population of 356,000). In 2001, every single patient who received a prescription for a statin, and/or with a recorded plasma TC level, and/or with a hospital admission for cardiovascular reasons (identified by ICD-9 code), and/or with a clinical appraisal based on the presence of cardiovascular risk factors, was defined eligible. Sebsequently, pharmaceutical, and nosocomial databases, were cross-linked with that of 50 general practitioners in order to assess the pharmacoutilization of statins on a patient-by-patient basis. A cohort of 9,208 patients with a well documented cardiovascular risk profile were analyzed. The mean age of those patients was 57 (SD=17) years and 42% of them was male. On the basis of raised TC levels and cardiovascular risk profiles, patients for whom a statin treatment was suggested amounted to 7,233. However, the number of those who received statins was significantly lower (n = 1,343), corresponding to 18.6%. In those exposed to statins, just a small group of patients reached a level of TC below 190 mg/dl (n = 271), equivalent to 20.2%. In the group of treated who did not achieve recommended TC target levels, 31.7% (n = 340) of patients was at very high cardiovascular risk. Moreover, among all patients with high plasma TC levels (n=5,890), there was a 45.7% (n = 2,690) who did not received any lipid lowering drug even though they had a high cardiovascular risk profile. Results from large population-based administrative databases suggest a remarkable level of undertreatment among patients with cardiovascular risk factors. Furthermore, many patients did not achieve recommended TC target levels with their statin treatment. Pharmacoutilization of statins in general practice reveals the need of a more careful pursuing of therapeutic goals.
I farmaci “generici” in Italia: opportunità di ricerca e sviluppo di prodotti di qualità a prezzi competitivi
Authors: Eandi Mario , Della Pepa Carlo
Published: June 2016

Every drug whose copyright coverage has expired can be manufactured by a pharmaceutical company other than the one that developed it, giving rise to the market of the so-called generic drugs. It can be distinguished among two types of generic drugs: branded and unbranded, according to the choice of the manufacturer to assign it a fantasy name or to sell it with the name of the active principle, followed by the company’s name. In order to be accepted for marketing, every new drug has to pass the registration procedures of the Italian Ministry of Health, which are simplified for generics, as it’s sufficient to demonstrate the bioequivalence, considered a reliable proxy of therapeutic equivalence, of the new drug with the standard formulations it copies. The bioequivalence of two drugs depends on various parameters, related to the quality of the raw materials employed and the industrial processes they go through. There are several ways of assessing the equivalence between pharmaceutical products, and it is important the registration studies are conducted following strict rules, in order to guarantee the quality of generics, fundamental for achieving the trust of health operators and patients. The reason to be of generic drugs is essentially economic, as they bare no therapeutic innovation, and their introduction is mainly aimed to contain drug expenditures and to facilitate a competitive market, but to do so, they need to be widely accepted by the medical community and the population. In Italy, the market of generic drugs is very young and relatively underdeveloped if compared to what is observed in other industrialized countries such as the USA, Germany or UK, but it has a good expansion potential, as it also represents a chance for quality enhancement for the Italian pharmaceutical industry.
Moxifloxacina: profilo farmacologico, terapeutico e farmacoeconomico
Authors: Eandi Mario
Published: June 2016

Moxifloxacin is a new fluorquinolone antibiotic, recently introduced among the treatment options for upper and lower airways infections. It possesses a wide antibiotic spectrum, covering the major pathogens involved in the genesis of community acquired pneumonia (CAP), acute exacerbations of chronic bronchitis (AECB) and acute bacterial sinusitis (ABS). It acts in a concentration-dependent manner by inhibition of bacterial DNAgirase and topoisomerase IV, has a long biological half-life (about 12 hours), good oral bioavailability, excellent tissue diffusion and a better safety profile than other quinolones, because of the lack of phototoxicity and the scarsity of clinically significant drug interactions. The clinical results of moxifloxacin in CAP, AECB and ABS have been compared with those of available alternative antibiotics in several multicentric, double-blind studies, and the new fluorquinolone resulted at least as effective as the comparators, with similar tolerability profiles. These studies demonstrated a high correlation among the eradication of the pathogen and the clinical recovery of the patients. The pharmacodynamics, pharmacokinetics and clinical results of moxifloxacin render it one of the most attractive options for the empirical treatment of upper and lower airways infections, more so since its pharmacoeconomic profile appears to be very convenient. In fact, the low dosing frequency (once daily), the possibility of oral administration, the quick onset of the therapeutic action, the high clinical and microbiological success rate even with low duration cycles (5 days) and the good safety profile make the cost/efficacy ratio of moxifloxacin in the treatment of common airways infections very advantageous in comparison to those of all available treatment alternatives.
Considerazioni cliniche ed economiche nel trattamento del cancro della prostata: analisi costo-efficacia di bicalutamide vs flutamide in combinazione con LHRH
Authors: Marchetti Monia , Colombo Giorgio Lorenzo
Published: June 2016

Prostate carcinoma (PC) is the most common malign neoplasm found in men over 65 years of age. In Italy, the incidence of this cancer is around 60/100,000/year, corresponding to about 11,000 new cases each year. Patients with PC consume health resources for a cost that is 10-24% higher than that of similar populations without PC. It is estimated that in Italy, each year, there are 19,000 hospitalizations for prostate cancer in patients over 65, a figure that represents 4% of the total hospitalizations for oncological diseases. We conducted a marginal cost/effectiveness analysis of bicalutamide vs. flutamide, both administered in combination with LHRH, in patients with advanced (metastatic) PC, on the basis of a randomized trial comparing 4 strategies of total androgenic blockade (TAB). The analysis was conducted in the perspective of the SSN (National health system). The comparison revealed that drug acquisition costs are not the only determinants of the economical differences between the two therapeutical strategies. Furthermore, we demonstrated that prolonged survival of the patients does not increase the consumption of health resources, since the chronological shift of the terminal phase reduces the value of the resources dedicated to it. When conducing the cost/effectiveness analysis, the survival advantage associated to bicalutamide has been adjusted to balance the low quality of life of PC patients. The pharmacoeconomical benefit of bicalutamide resulted of 12,150 Euro/QALY, while the cost per year of life saved resulted inferior, ranging from 8.327 to 11.440 Euro. This cost/QALY value is nevertheless lower than that associated to several therapeutical strategies that are commonly accepted in developed countries (domiciliar hemodialysis, heart transplantation, breast cancer screening, etc.). Considering that 12.150 Euro/QALY is the highest estimate of the relative cost/effectiveness of bicalutamide, it appears that the combination bicalutamide + LHRH represents an economically acceptable alternative to flutamide + LHRH in advanced PC patients.
Analisi dei costi di buprenorfina vs metadone nella terapia dei soggetti con dipendenza da oppiacei
Authors: Colombo Giorgio L. , Faillace Guido , Ferdico Michele
Published: June 2016

In the last decades, methadone has virtually represented the only available option for the treatment of opioid addicts in Italy. Early in the year 2000 buprenorphine has been introduced on the market as a possible alternative to methadone. While most of the research conducted so far in our country has focused on possible differences in clinical outcomes, depending on the pharmacological differences among the two molecules, the economical aspects of the choice between the two drugs have barely been addressed. In this paper we present a pharmacoeconomical comparison between buprenorphine and methadone in the treatment of heroin dependence by the Italian health service, adopting the perspective of the Society. For this purpose, we constructed a decision analysis model comprising the possible clinical pathways a patient can go through following the inclusion in the therapeutic programs of the SerT. Two types of incremental costs have been considered in the model: direct health costs, i.e. drug acquisition and medical staff costs, and indirect cost, due to loss of working hours for the administration of the drug. The analysis was conducted with a cost-minimization approach, mandatory in the absence of reliable data on clinical differences, and with a time perspective of 12 months. Our results indicate that buprenorphine, despite its higher pharmaceutical cost, is the more convenient option for the treatment of opioid dependence in Italy, as it permits a significant saving of productivity losses. The difference in indirect costs relies on the shorter mean treatment time with buprenorphine and on the possibility of reducing dosing frequency, which allows many patients to attend health services only thrice in week, instead of the daily visits to the SerT necessary for most methadone-treated patients. The results were challenged in a series of sensibility analysis conducted on all relevant and uncertain paramenters, and in no case the option methadone resulted more convenient than buprenorphine, confirming the reliability of the results obtained in the base case scenario.
Losartan: il valore clinico ed economico
Authors: Pradelli Lorenzo , Eandi Mario
Published: June 2016

Losartan is an angiotensin II receptor antagonist (ARB) that has been proven effective and well tolerated in the treatment of hypertension and in the reduction of global cardiovascular risk, but is more expensive than many alternatives. The present paper resumes its main pharmacological and clinical features, as a basis for analyzing its economical value. Despite the universally accepted relevance of good blood pressure control, hypertension is still undertreated and poorly controlled. Among the main reasons for this, poor adherence to therapeutic regimens plays a relevant role. Losartan and ARBs have been shown to be associated with compliance rates superior to those observed with any other antihypertensive drug class, due to an adverse events incidence similar to placebo and scarcity of relevant pharmacological interactions, and can therefor improve the cost-effectiveness of hypertension treatment. Several trials have indicated that losartan determines clinical benefits that go beyond its haemodynamic effect, such as renal protection, reduced incidence of stroke and cognitive improvement. The addition of losartan to conventional hypertensive therapy in diabetic patients with nephropathy has been estimated to induce net health cost savings in different settings, a relevant result, as very few medical interventions have demonstrated such a potential. To understand the real economical value of losartan, its drug acquisition costs have to be balanced against the benefits deriving from antihypertensive effectiveness, high compliance and non-haemodynamic target organ protection.
Parnaparin: confronto con le altre eparine a basso peso molecolare
Authors: Pradelli Lorenzo , Eandi Mario
Published: June 2016

Sodium parnaparin is a low molecular weight heparin (LMWH). The introduction of this drug class has represented a medical advancement in the prevention and therapy of thromboembolic pathologies, as they maintain the same efficacy of unfractionated heparin, but with simplified dosing regimens and reduced side effects. Parnaparin has demonstrated its thromboprophylactic efficacy on both high- and moderate risk surgical patients, besides resulting effective in treating established deep vein thromboses and thrombosis-associated phlebopathies. Alongside these clinical advantages, parnaparin and other LMWHs allow outpatient or home-based therapy of a large number of subjects that should otherwise be treated in hospital, with important savings of health resources and enhanced quality of life for the patients. In Italy, parnaparin drug acquisition cost is the lowest among all LMWHs for the majority of their applications, permitting marginal savings in health costs at the same efficacy level. In summary, the use of parnaparin in thrombotic pathologies has very good efficacy and safety profiles, and has positive clinical and economical outcomes for patients, health system and society as a whole.
Levetiracetam: review clinica ed economica di un nuovo antiepilettico
Authors: Zaniolo Orietta , Eandi Mario
Published: June 2016

Uncontrolled epilepsy has a significant negative impact on patient’s quality of life, on his emotional well-being and his social functioning. Seizure places an undue economic burden on the patient and community. The increased costs are direct and indirect (e.g.,inpatient care and loss of earnings associated with time lost from work). Levetiracetam is a new antiepileptic drug used as adjuntive therapy in the treatment of refractory epilepsy. Its nonconventional mechanism of action is not completely understood, but preclinical studies suggest that its antiepileptic action.may depend on a reversible, saturable and stereoselective binding site in CNS membranes. In this paper, we review the main clinical and economic data available in the scientific literature. Levetiracetam has a favourable pharmacokinetic profile characterised by rapid and nearly complete absorption, very low potential for drug interactions and a prolonged pharmacodynamic effect that permits twice-daily dosing. Several placebo-controlled clinical trials have demonstrated that its efficacy has enabled many patients who were refractory to treatment with other antiepileptic drugs to achieve long-term seizure freedom; furthermore in levetiracetam trials the frequency of adverse events is low and withdrawal rates are comparable with those of placebo. A cost/effectiveness analysis compared direct medical costs of levetiracetam add-on therapy with maintenance of standard therapy alone within the UK National Health Service. A 1-year dose escalation decision model was set up in refractory patients who failed to respond to two or more other currently available therapies, with seizure freedom selected as the measure of effectiveness. Available pharmacoeconomic data show that the incremental cost of treating patients with levetiracetam is low when compared with the benefits of seizure freedom, at least in the UK. Furthermore, current studies suggest that this antiepileptic drug has a potential as first-line treatment for many types of epilepsy and in many different patient populations.
Impiego degli Inibitori della Pompa protonica (IPP) in Piemonte: indagine sulle abitudini prescrittive dei Medici di Medicina Generale
Authors: Ceci Adriana , Baiardi Paola , Ravera Simona , Chiò Emilia , Cristiana Pellegri , Negrini Cristina , Capitelli Giorgio , Cela Renato , Corda Giuliana , Gaia Ezio , Gozzi Sandro , Marocchino Francesco , Marrazzo Eleonora , Pizzini Andrea , Ravaglia Aldo , Saullo Franco , Tonini Marcello
Published: June 2016

Proton Pump Inhibitors (PPIs) (Omeprazole, Lansoprazole, Pantoprazole, Rabeprazole and Esomeprazole), one of the most commonly prescribed classes of medications in the primary care setting, are considered a major advance in the treatment of acid-peptic diseases. In Italy PPIs are reimbursed by National Health Service on the basis of CUF (Commissione Unica del Farmaco) 1 and 48 Notes. In 2002 and 2003 a significant increase in PPIs consumption and expenditure have been documented, showing differences between regions. The aim of this study is to investigate and monitor, at regional level, type and entity of PPIs use through a drug utilization study, evaluating prescribing behaviour and compliance of PPIs treatments with CUF Notes indications. The study has been carried out on a sample of 436 General Practitioners belonging to 22 Piemonte’s ASL (Aziende Sanitarie Locali). The data analysis shows that acid-related pathologies are significantly more common in patients with at least 50 years of age and the most frequent condition is represented by gastroesophageal reflux disease. Despite the general conditions of PPIs use by General Practitioners in terms of duration and dosage of therapy result in most cases (from 49% to 80% for duration and from 54% to 97% for dosage) compliant with what proposed by CUF Notes, in some cases the same CUF Notes indications seem to be not observed. Consequently the Piemonte Region has decided to plan a guideline on PPIs rational use. Such guideline, expected to be introduced in the regional area, may also be considered as an instrument able to lead to a more appropriate expenditure for this drug class. Moreover, in order to control PPIs expenditure, pharmacoeconomic methodologies can be applied allowing to identify the most cost - effective active substance and therapeutic scheme, overcoming CUF Notes which consider all PPIs use under the same reimbursement conditions.
Il prezzo dei farmaci orfani in Italia: il caso di Citarabina Depot (DepoCyte®) nella meningite linfomatosa
Authors: Zaniolo Orietta , Eandi Mario , Zinzani Pier Luigi
Published: June 2016

Orphan drugs definition should be related to prevalence criteria. In Europe the prevalence criterion is 5/10.000. These drugs are called “orphans” because the pharmaceutical industry has little interest under normal market conditions in developing and marketing products intended for only a small number of patients. For this reason governments have emphasized the need for economic incentives to encourage drug companies to develop and market orphan drugs. Aim of this study is the analysis of the contributing factors involved in the price definition of orphan drugs in Italy, focusing on the case of DepoCyte®, a new orphan drug recently approved by the European Medicines Agency. DepoCyte® is a slow-release formulation of cytarabine designed for intrathecal administration in the treatment of neoplastic meningitis due to metastatic cancers. It maintains cytotoxic concentrations of free cytarabine in the cerebrospinal fluid for more than 14 days following a single injection. In two randomized clinical trials DepoCyte® was compared to standard formulation of cytarabine, showing a better time to neurologic progression and survival trend in favor of DepoCyte®, associated with an improved mean change about quality of life in Karnofsky performance score. The innovative technology and the efficacy of DepoCyte® allow to frame some interesting pharmacoeconomical consequences: the results of the present work showed that DepoCyte® is more expensive but also more effective than standard formulation, and the new formulation-correlated improvement in the patients’ quality of life seems to justify the difference between the costs of the two alternatives.
Farmacoeconomia e outcomes research
Authors: Attanasio Ermanno
Published: June 2016

Pharmaceutical products are relevant for their contribution to the medicine progress and in health peoples improvement, altough this evidence goes back to the forthy years with the reduction in mortality, morbidity and hospitalisation rates. The ambivalence of drugs, both remedy and poison, needs a careful assessment of risks and benefits. Primitive estimates of health treatments evaluation occurred in the human history but the modern concept of evaluation in health care derived from cost-benefit analysis (welfare economics) and technology assessment. Then a new discipline, pharmacoeconomics and outcomes research, developed with the contribution of health economics, clinical medicine, pharmacology, statistics and epidemiology. Pharmaceutical products are also relevant because of their responsability of health expenditure growth. From 1992, in Italy, several legislative actions were made to face up the pharmaceutical expenditure. The most important one (L. 537/1993) achieved the maximum decrease of 16,8%, in 1994, and modified radically the pharmaceutical policy. Nevertheless, in the following six years the pharmaceutical expenditure grew more than 93%. New actions were made fixing the pharmaceutical expenditure to 13% of health expenditure, any excess being charged to Regions. In the new version for the current year, the excesses will be paid-back by pharmaceutical companies (60%) and Regions (40%). Furtherly, the creation of Agenzia Italiana del Farmaco increases the relevance of cost-effectiveness analyses for drugs reimbursement. However, pharmacoeconomic evaluations have still many methodological problems. Economic variables should be treated in the same manner of biomedical or epidemiological data, that is, by confidence intervals and sample sizes. There would be an “economic significance” besides to clinical and statistical ones. In this way, pharmacoeconomics and outcomes research would be able to add rationality to health care expenditure.
Analisi di minimizzazione dei costi del trattamento della leucemia cronica con fludarabina fosfato (Fludara®) e.v. e p.o.: metodologia e risultati di un’indagine empirica
Authors: Lazzaro Carlo
Published: June 2016

The aim of the paper is to compare healthcare-related costs of a 5-day course with fludarabine phosphate i.v. vs a 5-day course with oral fludarabine phosphate in Italian patients with chronic leukemia. A cost-minimization analysis was performed from both Italian National Healthcare Service (INHS) and hospital perspectives. Healthcare-related costs were collected from 2 out of a sample of 28 Ematology wards and included those of drug acquisition, drug preparation, drug administration, reception and discharge of patient before and after drug administration; hospital overheads were calculated as a percentage of the total healthcare-related costs. The reimbursement schemes for acquisition and administration of fludarabine phosphate i.v. were gathered from the whole sample of 28 Ematology wards taken into account. Costs were expressed in euros 2004. When compared to fludarabine phosphate i.v., oral fludarabine phosphate allowed savings ranging from 223,47 euros (hospital perspective) to 477,05 euros (INHS perspective) per patient. As far as hospital perspective was concerned, savings associated with oral fludarabine phosphate were due to hospital overheads (115.1%), drug preparation (19.6%), drug administration (17.3%), reception and discharge of patient before and after drug administration (2.9%), whereas costs for drug acquisition was higher for oral formulation (-54.8%). When INHS perspective was taken into account, 3 out of 28 Ematology wards (11%) were reimbursed on a drug-plus-outpatient-drug-administration-basis, whereas 25 out of 28 Ematology wards (89%) were reimbursed on a day-hospital-stay-basis. Savings associated with oral fludarabine phosphate were due to day-hospital stay (253.4%), outpatient drug administration (1.1%), whereas cost for drug acquisition were higher for oral formulation (-154.5%). Sensitivity analysis confirmed the robustness of basecase results. Savings associated with oral fludarabine phosphate may be of relevant interest for INHS policies aimed at reducing public expenditure for drugs in Italy.
Parecoxib nel trattamento del dolore post-operatorio: considerazioni farmacoeconomiche
Authors: Mathis Federica , Pradelli Lorenzo , Eandi Mario
Published: June 2016

Parecoxib sodium is the first selective COX- 2 inhibitor to be available for parenteral administration. This pharmaceutical feature, alongside its favorable efficacy and safety profile, makes the new drug particularly suitable for simple and effective management of post-surgical pain. Aim of this work is to describe the pharmacoeconomical profile of the drug in the Italian setting, focusing on the comparison with parenteral ketorolac, the most widely prescribed treatment for post-surgical pain in Italy. The first part of the article describes the most important pharmacological characteristics of parecoxib and reviews the main efficacy and safety studies that were performed on patients presenting with post-surgical pain. A similar article about parecoxib was published on “Farmeconomia e percorsi terapeutici” 2003; 4(1): 39-50. At that moment, the price to the public wasn’t yet fixed and therefore the pharmacoeconomical analysis was based on estimated price. Moreover, during this year, extra studies were published on the efficacy of parecoxib on patients with post-surgical pain. For these reasons, we intend to present here an updated version of the profile.
Terlipressina: profilo farmacologico clinico, terapeutico e farmacoeconomico nel trattamento delle varici esofagee
Authors: Pradelli Lorenzo
Published: June 2016

The formation and rupture of esophageal and gastric varices are severe but common complications of hepatic cirrhosis. They represent the cause underlying more than one forth of all deaths in cirrhotic patients and exact an impressive burden in terms of survival, quality of life and health care resource consumption. Therapeutic options for the control of active variceal hemorrhage comprise pharmacological agents, endoscopic techniques and surgery. Of these, the only options immediately available in the absence of highly specialized medical personnel are vasoactive drugs, namely vasopressin and derivatives and somatostatin and derivatives. Despite this clear advantage, the role of pharmacological treatment is still debated; furthermore, there’s no consensus on the drug of choice for variceal bleeding control. In this paper the main pharmacological and clinical features of terlipressin, a synthetic vasopressin analog, are outlined, as well as a frame for its pharmacoeconomical evaluation. Terlipressin is the only vasoactive drug that demonstrated survival benefits in cirrhotic patients with active variceal hemorrhage, even in those treated with endoscopic sclerotherapy, and is characterized by a favorable risk/benefit ratio. The relative cost-effectiveness of the different drugs, nevertheless, is yet to be determined by methodologically rigorous studies, partly because at the present state of the research there still are clinical and economical uncertainties to be cleared.
Analisi farmacoeconomica del trattamento di pazienti psicotici cronici con olanzapina, antipsicotici atipici e neurolettici tipici: uno studio regionale
Authors: Vadruccio Felice , Biricolti Giovanni , Mendolicchio Leonardo
Published: June 2016

BACKGROUND: Psychotic disorders are a ravaging and costly mental illness. Treatment of these disorders involves pharmacological and non pharmacological resources. Pharmacological therapy with antipsychotic drugs contribute strongly to relieve psychotic patients symptoms. By the end of 90’s the new atypical antipsychotic have been introduced. This kind of drugs is supposed to be more effective but also more expensive compared with the old typical neuroleptics. OBJECTIVE: To compare costs and outcomes associated with 12 months treatment of psychotic disorders using typical and atypical antipsychotics in addition to psychiatric services. Moreover to extend the same comparison among the atypical drugs currently used in the clinical practice (olanzapine, risperidone, quetiapine and clozapine). METHODS AND PATIENTS: A multicentre observational study was carried out in 131 patients affected by psychotic disorders (schizophrenia and bipolar). Data were collected with reference to patients followed by several Psychiatric Services of Regione Puglia (Italy). Patients were classified in five groups (typical neuroleptics, olanzapine, risperidone, quetiapine and clozapine) according to their main antipsychotic therapy. Treatment outcomes had been assessed during 12 months of observation considering the patients improvement in their work and social functioning. For these patients we analyzed pharmacological, non pharmacological (medical/ nurse visits, social assistance, rehabilitative sessions) and hospital interventions, choosing the perspective of the Italian Mental Health Centers for costs attribution. Moreover indirect costs (caregiver) and private assistance to the patient had been evaluated for each group of treatment. The study is based on the observation of real clinical behaviours; therefore patients are not randomised to different treatments. RESULTS: The analysis of treatment outcomes didn’t generate significant differences among the groups despite a positive trend in terms of work functioning in favor of olanzapine. The pharmacological interventionts evidentiated an economic significant advantage (p
Il trattamento dei disturbi psicotici con olanzapina, risperidone e neurolettici tipici: una valutazione comparativa di costo/efficacia in una realtà psichiatrica locale
Authors: Filippelli Egidio , Biricolti Giovanni , Scarano Cinzia , Russo Federico , Luciano Lucio
Published: June 2016

BACKGROUND: Several clinical trials demonstrated that atypical antipsychotics are more effective but also more expensive (as drug cost) compared with the typical neuroleptics by treating psychotic disorders. The present study aimed to evaluate this result using an observational approach which better reflects the real clinical practice. OBJECTIVE: To evaluate clinical effectiveness (including work and social functioning) and overall direct costs in a group of patients affected by psychotic disorders (schizophrenia and bipolar) and treated with typical and atypical (olanzapine and risperidone) antipsychotics. METHODS: With a multicentre observational design - two years long - 89 patients (in charge by Psychiatric Centers of Regione Campania - Italy) were assessed using CGI (Clinical Global Impression) and GAF (Global Assessment of Functioning) scales. Moreover economic data were collected with reference to pharmacological and non-pharmacological (hospitalization, medical/nurse visits, etc.) resources consumption. The pharmacoeconomic analysis were conducted choosing the perspective of the local Psychiatric Services for costs attribution. RESULTS: Considering the treatment outcomes, the use of the atypical drugs provided better performances with reference to the patients quality of life. The results in terms of work and social functioning indicated an advantage in the olanzapine group of patients. Overall direct costs of treatment (drugs and healthcare resources) didn’t generate significant differences among the groups of therapy despite the pharmacological cost evidentiated an economic advantage (p
I farmaci per lo scompenso cardiaco: criteri di scelta razionale e costo-efficace
Authors: Costa Francesco Vittorio , Pradelli Lorenzo
Published: June 2016

Chronic heart failure (CHF) is the final phase of many common cardiovascular diseases. Consequently, it represents a frequent clinical condition: it’s estimated that in developed countries, Italy included, its prevalence exceeds 3%. CHF is also burdensome from an economical point of view, as it absorbs more than 2% of the Italian total health care budget. The main cost driver in CHF, accounting for approximately two thirds of its total expense, is represented by hospital admissions for relapse. The most frequent reason for relapse, in turn, is inadequate treatment, intended both as low patient compliance to prescribed drug regimens and as inappropriate prescribing. Evidence-based guidelines for the optimal pharmacological treatment of CHF have been developed and are constantly updated, and it’s demonstrated that the stricter the adherence to these recommendations, the better the clinical and economic outcomes. Pharmacoeconomic studies conducted on the use of ACE-inhibitors and beta-blockers, in particular, have shown that correct therapeutic strategies can be cost-saving in CHF management, besides providing important clinical benefits. The expansion of generic drug market has brought by a reduction in pharmaceutical prices, allowing to offer the benefits of these highly effective, and cost-effective, treatments for CHF to a larger number of patients, without increasing the global pharmaceutical expense, but probably reducing the total economical burden of the disease.
Forme galeniche e qualità di vita: il caso di tramadolo
Authors: Zaniolo Orietta
Published: June 2016

Tramadol is a weak opioid analgesic used for moderate to severe pain control in acute and chronic diseases. Two new formulations of tramadol are recently admitted for marketing: once-daily (OD) controlled-release and fast-release orodispersible tablets. OD tramadol with its special lipophilic matrix permits to prolong drug effect up to 24 hours with a steady-state bioavailability comparable to that of immediate-release formulations. The efficacy and safety of this formulation of tramadol was evaluated in several trials on patients with moderate to severe chronic pain from osteoarthritis. These studies show similar effect of OD tramadol compared to standard formulation in pain control, quality of sleep, physical and mental functions, dropouts due to insufficient therapeutic effect and adverse events. Specially in the elderly and in chronic pain patients, frequency and complexity of dosing regimen remarkably affects quality of life. Furthermore, several studies show that a high number of daily administrations is one of the main factors that reduce patient compliance. For these reasons, OD tablets of tramadol seem to improve quality of life and acceptability of the therapy. Tramadol orodispersible tablets are useful for acute pain control, in the titration phase and for breakthrough pain control in chronic diseases. The manifacturing process of this formulation allows for rapid disintegration (20-30 seconds), once placed into the mouth, secondary to contact with salivary enzymes. This property facilitates its administration (in every place, without need of water), primarily for people with difficulty in swallowing tablets. Furthermore, respect to drops, it decreases the risk of misdosage. A open, randomized crossover study shows that, even although the galenics of tramadol in orodispersible and conventional fast-release capsules are different, they are bioequivalent and have similar pharmacokinetic parameters.
Analisi di costo efficacia nella terapia della BPCO
Authors: Iannazzo Sergio , Pradelli Lorenzo , Negro Roberto W. Dal , Eandi Mario
Published: June 2016

Current practice guidelines for the treatment of COPD recommend the use of combined inhaled corticosteroids and long-acting bronchodilators in severe and very severe patients (GOLD stages III and IV). OBJECTIVES: To analyze the economical and clinical impact of this recommendation, the affordability of its widespread application, as well as the relative pharmacoeconomical performance of the available options for severe and very severe COPD in Italy. METHODS: Published data on the Italian COPD population were fitted in a disease progression model based on a Markov chain representing severity stages and death. Alternative therapeutic options (salmeterol/ fluticasone - SF, formoterol/budesonide - FB, salmeterol alone - S, fluticasone alone - F and control - C) were represented as competing arms in a decision tree. Efficacy data from international trials were expressed in terms of risk reduction. Clinical parameters used were number of exacerbations and symptom-free days. Direct and indirect costs were considered and valued according to present prices and tarifs. The analyses were conducted from National Health System, societal and patient perspectives with time horizons of 1,5, and 10 years, and lifelong. RESULTS: The yearly total direct costs of treating COPD patients in Italy is estimated in approximately 7 billion Euro, with a mean cost/patient/year around 2,400 Euro. Mean survival of the cohort is 11,5 years. The C and F strategies are dominated (i.e. are associated with worse outcomes and higher costs) by all alternatives. S/F and F/B are the most effective strategies, with a slight clinical superiority of the latter, but are also marginally more expensive than S. Incremental cost/effectiveness of S/F vs. S is 679,55 Euro/avoided exacerbation and 3,31Euro/gained symptom-free day. CONCLUSIONS: The recommended use of combined inhaled corticosteroids and long-acting bronchodilators for severe and very severe COPD patients, as compared with current practice, has the potential of improving clinical outcomes without increasing health care costs.
Valutazione farmacoeconomica della prevenzione con picotamide vs acido acetilsalicilico dei pazienti diabetici con vasculopatia periferica
Authors: Iannazzo Sergio , Pradelli Lorenzo , Eandi Mario
Published: June 2016

Type 2 diabetes mellitus (DM) and peripheral arterial disease (PAD) are two very relevant cardiovascular (CV) risk factors, which can often be found concurrently in the same patient. The DAVID trial, a double-blind, randomized, aspirin(ASA)-controlled study, has demonstrated that the use of picotamide, a thromboxane A2 synthase and receptor dual inhibitor, is associated with lesser CV morbidity and mortality in this type of patients in comparison to ASA, considered the standard antiplatelet agent. In order to estimate clinical and economic impacts of picotamide in the Italian health care setting, we developed a pharmacoeconomic model based on clinical data from DAVID and national economic parameters and demographics. The base case scenario, which reflects current prices and reimbursement policy (i.e. ASA fully paid for, picotamide out-of-pocket for patients) yielded an incremental cost/effectiveness ratio (ICER) of about 8,500 euro/year of life (YOL) saved, which falls below conventionally adopted willingness to pay thresholds. This cost, however, is totally born by the patient, while the savings on health care expenditures for avoided events (and less ASA) benefit the national health service (NHS). These results may help the physician in explaining the consequences of this choice to his/her patients, facilitating a fully-informed choice. The availability of a theoretical model allowed to explore some alternative scenarios, that indicate that the ICER can be further lowered and the economical burden better distributed through policy changes. In conclusion, the pharmacoeconomic model indicated that picotamide is likely to be a cost/effective option for CV mortality and morbidity prevention in patients with concurrent type 2 DM and PAD and that the level of adoption of this strategy will depend on willingness to pay and policy priorities of the NHS and patients themselves.
Le benzodiazepine nel trattamento dell’ansia: profilo clinico e farmacoeconomico
Authors: Cascio Barbara , Zaniolo Orietta
Published: June 2016

Anxiety disorders impose a significant economic burden on healthcare system, patients and society as a whole. A patient with anxiety disorders, especially with panic disorder, shows some difficulties to work or to maintain an acceptable social functioning, and, frequently, needs more medical care than a normal subject, often due to unnecessary or inappropriate diagnostic tests. Adequate psychiatric treatment of anxiety disorders can lead to higher direct specialists costs (psychiatric drugs and visits) but this may be offset by a decrease in non-specialist care costs and in indirect costs. Benzodiazepines have been extensively used for the treatment of anxiety and related disorders since the 1960s. Although new pharmacological and psychological treatments for anxiety are available, a lot of psychiatrists continue to endorse benzodiazepines as primary or adjunctive treatment for these disturbs, especially in the early or acute phases of the illness. In Italy, benzodiazepines have been available also as generic drugs for some years. In order to be accepted for marketing, a generic drug has to demonstrate bioequivalence, considered a reliable proxy of therapeutic equivalence, with the standard formulation and its price has to be at least 20% cheaper than the originator drug. The use of generic drugs can contain drug expenditures and facilitate a competitive market. Despite that their prices are considerably higher than those of generics, branded benzodiazepines are still widely prescribed, because of prejudices and lack of information in the community of physicians and patients. In conclusion, benzodiazepines may treat anxiety disorders, mainly in early and acute phases, increasing quality of life and saving medical resources. The availability of generics allows for marginal reduction in initial investment in drug costs.
Impiego di tramadolo nelle diverse patologie dolorose
Authors: Zaniolo Orietta
Published: June 2016

Pain represents a major health problem that afflicts a significant number of patients, resulting in personal suffering, reduced productivity and substantial health care costs, specially in chronic conditions. Chronic pain, such as low back pain, osteoarthritis, neuropathic and oncologic pain, requires a global management based on clinical evaluation, defining of the adequate therapeutic strategy and assiduous cares. Generally, patients with chronic pain need two different analgesic formulation: one at fixed doses and prolonged duration of action for control of baseline pain and one fast-release drug for treatment of breakthrough pain. Main guidelines recommend use of the same active principle for both these formulations. Tramadol, a dual action analgesic agent, used for controlling moderate to severe pain control in acute and chronic diseases, is available in several different oral formulations. This is important because, apart from efficacy and tolerability, that are the most important criteria to evaluate a therapy, the choice of a formulation with an uncomplicated dosing regimen can increase compliance and, consequently, clinical results, and ameliorate patient quality of life. For the treatment of chronic pain, the appropriate analgesic dosage can be achieved through a gradual titration: this permits to minimize adverse effects and cost of therapy.With tramadol this action can be realized with 50 mg extended-release capsules, that represent the minimal effective dose. When adequate pain relief is obtained, it’s possible to reduce frequency and complexity of dosing regimen using a new once-daily tablet of tramadol. Fast-release orodispersible tramadol tablet, with its practical advantage (rapid disintegration in the mouth without need of water), can be used for the control of breakthrough and acute pain. The cost of treatment with tramadol results relatively low, also when two daily episodes of breakthrough pain are considered.