Farmeconomia. Health economics and therapeutic pathways
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La farmacoutilizzazione delle statine nella pratica clinica: risultati di uno studio di popolazione condotto su database amministrativi e di medici di medicina generale
Get PDFIn 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
Valutazione farmacoeconomica dell’uso di tramadolo vs ketorolac nella gestione del dolore postoperatorio
Get PDFThis 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
Valutazione economica di Infliximab (Remicade®) vs Etanercept (Enbrel®) nel trattamento dell’artrite reumatoide
Get PDFRheumatoid arthritis is one of the most severe chronic pathologies, affecting the whole organism, with invalidating outcomes that affect the quality of life of the patients. Its prevalence is estimated to be about 0,5% in Italy, with elevated costs for the national health system (NHS) and the society, in spite of the best treatment with traditional therapies that include anti-inflammatory and disease modifying antirheumatic drugs (DMARDs). The introduction of new drugs with biological activity, mainly acting through an antagonism of tumor necrosis factor (anti-TNF), is a great advance in the management of the disease, as their use has been shown to be effective in slowing the progression of the joint damage, and sometimes in reversing it,. The present article present a cost-minimization study conducted by comparing the two anti-TNFs available in Italy, etanercept and infliximab, assuming equal efficacy and approached from the perspectives of the Italian NHS and society. Only differential costs were considered, i.e. drug acquisition, drug administration and patient monitoring costs, and the analysis comprised two treatment years, in order two account for the cost differences between the first treatment year and the following. The analysis showed that infliximab represents the more convenient alternative from both the NHS and the society points of view, mainly due to lower drug acquisition costs, which offset the higher drug administration costs: the total two year treatment costs per patient with etanercept resulted of 20.173 euro and 22.164 euro from the societal and NHS perspectives, respectively, while the same costs resulted of 13.715 euro and 14.795 euro with infliximab. These results were tested with thorough sensitive analyses, conducted by varying the principal cost and time consumption estimates, that showed that etanercept results less convenient in all the hypothesis tested
Valutazione del turn over dei farmaci antiretrovirali in particolare da IP a NNRTI
Get PDFObjective: To determine the turnover for each antiretroviral drugs present in TP’s of patients under care for HIV infection, with a special focus on PI’s and NNRTI’s. Design/Methods: We have carried out a retrospective analysis with the aim of evaluating the turnover of each drug in the 3-year period 1998-2000. Using a specifically designed software, it was possible to determine the changes in TP for each single patient. We then calculated a different weighted percentage for each drug on the basis of the time interval from the drug entry to its exclusion from the TP: the shorter the interval, the greater the assigned weight. Finally we carried out a cluster analysis in order to obtain homogeneous groups of molecules showing the same degree of therapy switches. We established that a higher average score corresponds to a higher therapy switch rate. Results: Zidovudine/Lamivudine combination, Indinavir, Lamivudine, Nerivapine and Nelfinavir are the drugs with the lowest turnover. On the other hand, Saquinavir, Didanosine, Zidavudine, and Stavudine show the highest turnover. Conclusion: The introduction of NNRTI’s with the associated switch from PI’s (Saquinavir, Nelfinavir) and the Zidavudine/Lamivudine combination enables a simplification of the treatment. This practice appeared to be a good choice in the 3-year period under consideration. The adoption of these therapeutic solutions reduce the turnover, consequently giving more stability to TP’s
Sviluppo e implementazione di un modello farmacoeconomico per valutare la costo efficacia di un ACE-inibitore nella prevenzione del rischio cardiovascolare
Get PDFCardiovascular disease (CVD) remains one of the leading causes of mortality and morbidity worldwide. Since several pharmacological approaches are available for the reduction of incidence and severity of cardiovascular events and health resources in modern managed care systems are limited, the evaluation of the clinical and economical consequences of any treatment is very valuable for decison-makers and physicians. In this article we present a flexible pharmacoeconomic model that permits the calculation of the marginal costeffectiveness of cardiovascular prevention with ramipril, a drug of the class of ACE-inhibitors. The clinical data used for the modelization are derived from the HOPE (Heart Outcomes Prevention Evaluation) study, a landmark cardiovascular prevention study that showed how the benefits of ACE-inhibition with ramipril go beyond the effects on blood pressure, while Italian epidemiological, demographic and economical data make the results appliable to the Italian population. The model, structured as a decision tree comparing the alternatives “to treat” or “not to treat” with Markow chains at the terminal nodes, calculates the marginal cost-effectiveness of the preventive treatment in terms of cost/year of live saved. The model is characterized by high flexibility, as it allows health decision-makers to set epidemiological and economical data in order to reflect the local population at high risk for developing cardiovascular diseas. The model was tested on a high risk population, formed by all acute myocardial infarction survivors in Italy, and indicated that life-long treatment of this patients would yield significant clinical benefits, with a cost/ effectiveness of 3,932 euro/year of life saved. This value is well below the standards that are considered acceptable, and offsprings from the partial offset of pharmaceutical costs caused by the reduction in the expenses for diagnosis and treatment of the cardiovascular events avoided with the preventive therapy
Profilo clinico ed economico di oxatomide
Get PDFOxatomide is an antiallergic drug with a double mechanism of action: it possesses antagonistic activity on the H1 histaminergic receptor and it inhibits the production and release of flogistic and allergic mediators by effector cells, presumably acting as a selective calcium channel blocker on these cellular types. The efficacy and safety of oxatomide have been evaluated in many studies conducted on patients affected by different clinical conditions, demonstrating remarkable flexibility. It proved to be safe and effective also in extreme ages, i.e. children under 3 months of age and elderly over 80 years. Approved indications include rhinitis, asthma, conjunctivitis, urticaria, atopic and allergic dermatitis and food allergy and intolerance. In direct comparisons, oxatomide consistently proved superior than placebo and equally or more effective than other consolidated antiallergics. The drug tolerability is good, its main side effects are drowsiness and weight gain, usually transient. Cardiac and hepatic safety data are very reassuring, as is the case for drug interaction potential. Form an economical point of view, the drug acquisition cost is acceptable, being among the lowest in its class, at equally effective doses. Overall, the efficacy in several clinical conditions, the good tolerability in most patients and the reasonable purchase cost suggest that oxatomide is characterized by excellent risk-to-benefit and cost-to-benefit ratios in the treatment of allergic pathologies
Incentivi ai farmaci generici a livello di ASL: l’osservatorio I.H.A.G.O.
Get PDFGeneric drugs are pharmaceutical products that contain an active substance whose patent-covered period expired and are marketed with the name of the molecule. The public health authorities of most EU countries agree on the importance of generic drugs in rationalising the pharmaceutical market, particularly by favouring reasonable pricing of “mature” products. In contrast with this wide consensus, the market share of generic drugs remains quite poor in Italy, despite recent regulatory incentives for the promotion of their use. The longlasting lack of specific laws - reference-price politics were introduced only in 2001- and the unusually long patent-covered period fixed by the past legislation are among the main reasons for the scarce utilisation of generics in Italy. The awareness of the importance of promoting initiatives conducted on a local (ASL), and not only national (SSN) scale conducted to the I.H.A.G.O. project, an observatory on the diffusion of generics in several local health districts. The project analyses the impact, in terms of market share, of local promoting activities (investigated by means of questionnaires) conducted during the year 2001 in 11 ASLs (local health districts), deliberately selected among the most active in terms of promotion of the use of generics. The I.H.A.G.O. observation revealed several praiseworthy promotional efforts, particularly of informative and cultural kind, conducted by some of the considered ASLs. Unfortunately, these measures seem not to have had a practical impact on the generics market in the observed districts: the market share increase was superior to the one observed on national scale only in 4 of the considered ASLs, in other 4 it was similar, and in the remaining 3 it resulted even inferior. It appears useful to plan further measures to support the diffusion of generics, maybe by motivating health operators to their prescription with the introduction of “prize/punishment” mechanisms
La misura della qualità di vita e dell’utilità in farmacoeconomia: strumenti e loro applicazioni in una rassegna di letteratura
Get PDFIn a climate of economic scarcity, decisions about the allocation of healthcare resources need to be made explicit. An economic evaluation is able to identify and quantify the relationship between an input of resources and an output, hence to appreciate the efficiency of the project. One of the recent methodological approaches that has been used increasingly in health economic evaluations is the ‘cost-utility analysis’ (CUA). CUA considers benefits in utility terms and uses a unique index to assess them. We investigated the generic measurements of health related quality of life in the economic evaluation. Different instruments for evaluating quality of life and utility were categorized and briefly introduced. Literatures published in the journal “PharmacoEconomics” in 1997-2001 regarding quality of life and utility were reviewed. We were especially interested in the application of health profile SF-36 and utility measure EQ-5D. Selected articles were further analyzed and some issues concerning the methodologies of quality of life and utility are discussed
Appropriatezza clinica ed economica: strumenti e modelli di valutazione e gestione dell’attività psichiatrica
Get PDFThe Italian health care system is experiencing a profound reform process: due to the increasing level of expenditures, new models of organizations are being experimented to increase both efficiency and efficacy of the health care delivery system. In this general framework, our group has developed a research project with clinical, statistical and economic implications. The ambitious aim of the project is to improve the allocation and management of resources assigned to Mental Health Departments, on the basis of recent experiences in the Piedmont region. The paper presents the methodology developed to implement the project “ Evaluation of Appropriateness of care and Costs of Psychiatric Disorders”. The project aims at analysing both appropriateness and efficiency of the routine care provided by the various agencies of three Mental Health Departments. We believe that a regular monitoring of both appropriateness and efficiency of care would assist in the development of rational choices for the allocation of funds and the clinical management of patients
ALPRAZOLAM: profilo farmacoeconomico nei disturbi d’ansia e da attacchi di panico
Get PDFAlprazolam is a triazolo analog of the 1,4 benzodiazepine class, widely used to treat patients with anxiety disorder, panic attacks and anxiety comorbidity with depressive disorder. Following oral administration, alprazolam is readily absorbed with peack plasma levels in 2 hours; extensive hepatic metabolism occurs and about 80% of the oral dose is excreted by kidney. The main metabolic route is hydroxylation catalyzed by cytochrome P450 3A: alpha-hydroxy alprazolam is partially active. Alprazolam possesses anxiolytic properties similar to other benzodiazepines; however, the triazolo ring confers to alprazolam a peculiar antidepressant and antipanic activity. Anxiety disorder, panic attacks with or without agoraphobia, and mixed anxiety-depressive disorder represent an heavy economic burden to National Health System (NHS) and to society. In the present work the clinical pharmacology and the therapeutic profile of alprazolam are reviewed and analysed under the pharmacoeconomic perspectives of the italian patients, General Practitioners, NHS and society