Farmeconomia. Health economics and therapeutic pathways
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    Durata e costo delle visite in medicina generale: il progetto DYSCO

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    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

    Farmaci antipertensivi a confronto: costi e benefici per il paziente e la collettività

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    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

    Fluoxetina: profilo terapeutico e farmacoeconomico di un prodotto generico

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    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

    Evoluzione storica della farmacoutilizzazione degli anti-ipertensivi in Italia (1988-1998)

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

    Considerazioni cliniche ed economiche nel trattamento del cancro della prostata: analisi costo-efficacia di bicalutamide vs flutamide in combinazione con LHRH

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    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

    Farmacoepidemiologia e farmacoeconomia della terapia anti-ipertensiva: uno studio osservazionale della popolazione della Asl di Ravenna

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

    Parecoxib nel trattamento del dolore postoperatorio: considerazioni farmacoeconomiche

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

    I farmaci “generici” in Italia: opportunità di ricerca e sviluppo di prodotti di qualità a prezzi competitivi

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    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

    Costi sanitari di un programma vaccinale: analisi di minimizzazione dei costi

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

    Trattamento con etanercept dei soggetti con artrite reumatoide in Italia: considerazioni economiche

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

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    Farmeconomia. Health economics and therapeutic pathways
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