Farmeconomia. Health economics and therapeutic pathways
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Analisi costo/efficacia di sevelamer nel trattamento dell’iperfosforemia del paziente in dialisi
Dialysis-associated hyperphosphatemia has been treated with chelating calcium salts, in particular with calcium carbonate. A new option for the management of this problem is represented by sevelamer, a chelating agent which contains no calcium and no metals. Sevelamer and calcium carbonate are more or less equally effective and tolerated. The prolonged use of sevelamer instead of calcium carbonate, nevertheless, reduces calcemia and C-reactive protein levels, with a consequent reduction in myocardial infarction, angina pectoris and other peripheral vasculopathies. The limit to the wide-spread use of sevelamer is in its very high acquisition cost, as compared to the alternative. In this article, a semi-markovian pharmacoeconomical model for the comparison of clinical and economical outcomes of sevelamer and calcium carbonate is presented. The analysis is conducted in the perspective of the Italian health system (SSN). Clinical data are derived from published studies and integrated with expert panel estimates, cost data are relative to the Italian setting. The incremental cost-effectiveness analysis indicated that sevelamer is more costly, but also more costeffective: a one month gain in survival costs the SSN additional 2710 Euro, a value inferior to the conventionally accepted willingness-to-pay of industrialised countries. The majority of this excess cost is derived from the gain in survival, and consequent increase in dialysis costs. Thus, the choice of using sevelamer instead of calcium carbonate is even more justified from an ethical point of view. Sensibility analyses confirmed the robustness of the basic scenario results
Losartan: il valore clinico ed economico
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
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
Parecoxib nel trattamento del dolore post-operatorio: considerazioni farmacoeconomiche
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
La tromboprofilassi post-chirurgica e la terapia del tromboembolismo venoso con eparine a basso peso molecolare: ruolo della bemiparina in una strategia di minimizzazione dei costi
The introduction of low molecular weight heparins (LMWHs) has opened new possibilities for the costeffective management of the thrombotic risk associated with surgical procedures, allowing prophylaxis – and sometimes even treatment of established deep vein thrombosis – on a out-patient basis. This article gives a brief overview of the pharmacological and clinical features of LMWHs, focusing on the differences with unfractionated heparin (UFH), which allow great simplification of dosing regimens and settings without disadvantages in terms of efficacy or safety. In fact, some data indicate that LMWH might be better tolerated than UFH. The overcoming of the need for hospitalization for pre- and post-surgical thromboprophylaxis has important economical implications and is leading to a different formation of health care costs in these patients. The clinical and economical consequences of the pharmacological differences between LMWHs and UFH are analyzed with a “value matrix”, a pharmacoeconomical technique for preliminary evaluations. The last section examines Italian drug acquisition costs and compares the economical values of the recommended dosing regimens of LMWHs available on the national market for the prevention and the treatment of deep vein thrombosis. Bemiparin is the most convenient LMWH for all approved indications. In the management of surgery-associated thrombotic risk, no clinically relevant differences among LMWHs have been demonstrated. Thus, bemiparin appears to be the most logical choice in a costminimization strategy
Farmacoeconomia e outcomes research
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
I diuretici dell’ansa nella terapia di mantenimento del paziente con scompenso cardiaco
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
Neridronato nel trattamento dell’osteogenesi imperfetta: prestazioni cliniche ed economiche di un farmaco orfano
Bisphosphonates (BPs) are osteoclast-mediated bone resorption inhibitors and the nature of the groups attached to the central carbon atom determines the drug potency. Neridronate is an injectable aminobisphosphonate, structurally similar to alendronate and pamidronate, authorized for the treatment of osteogenesis imperfecta (OI). This drug has often been used to treat other pathologies, as an off-label option, to increase tolerability and ameliorate compliance, partly because the management of orally administered bisphosphonates, with their gastrointestinal side effects, results complicated. In this paper pharmacokinetic, pharmacodinamic and main placebo-controlled clinical trials on OI patients are reviewed. The available scientific evidence demonstrates the neridronate efficacy to improve spine and hip bone mineral density, to lower markers of skeletal turnover and to decrease fracture incidence, compared with controls. We also report clinical trials results and data about the effect of intravenous infusions of neridronate in patients with postmenopausal osteoporosis, Paget’s disease and rheumatoid arthritis. Finally, we consider the economical impact of chronic and incapacitating pathologies, like osteogenesis imperfecta, on family’s total income and the influence of the disease on quality of life of pediatric and adult patients
Profilo terapeutico e farmacoeconomico di linezolid
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
Impatto del centro diurno sui costi di assistenza di pazienti affetti da alzheimer probabile, un.esperienza della asl di Città di Castello
Objective of the present work is to evaluate the economic impact caused by the attendance of the Local Health Care Unit Diurnal Center (DC) by Alzheimer disease patients. 21 Alzheimer patients were observed prospectively during 8 months: 2 months before DC attendance (period 1), 4 months during DC attendance (period 2) and finally 2 months after DC discharge (period 3). Data collected were analyzed and average resources consumption was translated into monetary costs according to the Local Health Care Unit point of view and family burden. Our analysis showed a significant cost reduction during DC attendance in respect to period 1 and 3, both on Local Health Care Unit and family sides. During period 2 (DC attendance) patients showed a significant clinical improvement too, as demonstrated by MMSE (Mini Mental State Examination), ADL (Activity of Daily Leaving), IADL (Instrumental Activity of Daily Leaving) scales. Finally our work demonstrates that the DC is a valid and economically advantageous support for the health care assistance of Alzheimer patients on SSN side and that it is able to reduce the burden of continuous care giving for families