Farmeconomia. Health economics and therapeutic pathways
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Pharmacoeconomic evaluation of cefaclor in the pharyngo-tonsillitis and acute otitis in children
No full textPharyngotonsillitis (FT) and acute otitis media (OMA) are among the most frequent infectious diseases of the childhood and exact a heavy toll on the Italian national health service (INHS), families and society as a whole. In case of established or suspected bacterial origin, current treatment guidelines for FT recommend 5-10 days of oral antibiotics, chosen among available penicillins, cephalosporins, or macrolides. More controversial appears the systematical use of an antibiotic for OMAs, but prevalent expert opinion suggests use of the same agents. In this paper, an economical appraisal of five of the most prescribed oral antibiotics for these indications in Italy (cefaclor, amoxicyllin, amoxicyllin/clavulanate, clarithromycin and azithromycin) is provided. The evaluation was conducted through the development and implementation of two distinct models, constructed to reflect national treatment patterns of these infections. Clinical and economical data were obtained from several sources: literature review, including published meta-analyses, consultation of an expert panel and, most importantly, from the results of a specific questionnaire-based survey completed by 136 pediatricians, based throughout Italy. The models were run to conduct both cost-effectiveness and cost-minimization analyses, that consistently indicated cefaclor and amoxicyllin to be substantially equivalent in terms of total costs to the INHS and the Italian society, but significantly more convenient than amoxicyllin/clavulanate, claritrhomycin or azithromycin. Extensive probabilistic sensitivity analyses confirmed the robustness of this conclusion
Health care costs of comorbidities in patients with HIV infection in Italy. An estimate using a Delphi panel
No full textIn HIV affected patients, co-morbidities (also termed opportunistic infections or AIDS-defining events) characterise the disease progression, resulting from deteriorating immunologic status. They are the commonest cause of morbidity and mortality among such patients and may account for a major share of the overall health cost of HIV. Given the paucity of published data about co-morbidities costs in Italy, an estimation was targeted and then reached using a Delphi panel. A questionnaire, the same for each of the 22 co-morbidities considered, was designed where type and quantity of resources used (which and how many lab tests, hospital admissions, drugs) were to be reported concerning three steps (diagnosis, acute treatment, follow-up within one year) in each comorbidity. Six experts, belonging to as many infectious diseases centres located all over Italy, were involved to independently complete the questionnaires. Information about resources in physical terms, collected from the first round of the panel, was converted into monetary terms, aggregated (a cost for each co-morbidity was estimated averaging the corresponding six costs deriving from the centres), and sent back to the experts. Each expert received also the costs per co-morbidity data as resulting from the others’ answers (though in anonymous form) and was invited to confirm or revise the answers he had previously given. The same processing was then performed when information was available from the second round. A substantial convergence among the final data from the different experts came into evidence. According to this Delphi panel results, the overall average cost for a HIV co-morbidity in Italy is 8,967 euros; the most expensive co-morbidity is CMV retinitis (27,946 euros) and the cheapest is herpes simplex (2,057 euros)
Cost-effectiveness analysis of darbepoetin after switch from epoetin-beta in patients on hemodialysis: an Italian single-center retrospective study
No full textDarbepoetin (DARB), a human erythropoietin with improved pharmacological parameters (longer half life and a dose-response relationship independent from the route of administration) is a new treatment option for chronic nephropathy-induced anemia that in many Italian dialysis centers is substituting older erythropoietins, mainly due to greater ease of use. At current prices and at the theoretical and recommended 200:1 dose conversion factor, DARB pharmaceutical cost ranges from –9% to +17% of EPO cost. In this monocentric study, real drug consumption and related actual costs of a pre-switch semester with EPO were analysed and compared to the first two post-switch semesters with DARB therapy. Furthermore, erythropoetic response was recorded and related to drug exposition levels, in order to establish a real life EPO:DARB dose conversion factor. In this experience, the conversion factor was estimated in at least 250-280:1, depending on the method adopted for the estimation. The initial dose, chosen on the basis of the recommended conversion factor, induced an excessive erythropoietic response, which was generally followed by a dose reduction and successive titration to target desired Hb levels, generating the spiraliform dose-response curve associated with delayed feed-back mechanisms. The pharmacoeconomical analysis, conducted in the perspective of the public health service, indicated that the choice of substituting DARB for EPO in the treatment of chronic kidney failure-associated anemia is univocally convenient, the former being less costly and more effective
Olanzapine versus typical neuroleptics for schizophrenia: evaluation of social and economic costs
No full textAn important number of publications is reporting results from health outcomes studies comparing atypical antipsychotics (AA) with typical neuroleptics (TN) over 1 year of observation. Our study has prolonged the period observation of the economical and social outcomes to 4 years: 31 patients with schizophrenia were observed retrospectively during two years of TN treatment and then followed during 2 more years of olanzapine treatment after naturalistic switch. The results show a general reduction of health care interventions (territory and hospital) during the olanzapine treatment period. Global costs during olanzapine treatment were lower than during TN treatment (10506 euros with TN vs 6193 euros with olanzapine over 2 years). The social outcome, measured through the registration of the number of working days in the two periods of the study (retrospective with TN and prospective with olanzapine), was better during olanzapine treatment, probably due to increased patient compliance to the rehabilitative activities offered by the Department of Mental Health. In our experience, olanzapine appeared to dominate TN treatment, as its higher acquisition costs were offset by the reduction of territorial and nosocomial health care interventions over two years of observation, and associated with higher involvement in rehabilitative and social activities
Tigecycline: a review of the literature
No full textTigecycline is a new first-in-class glycylcycline antimicrobial agent with expanded broad-spectrum activity. It was developed to overcome the two key resistance mechanisms, efflux pumps and ribosomal protection, that limit the use of tetracycline. The spectrum of activity extends to clinically relevant susceptible and multidrug resistant bacteria, as methicillin resistant Staphylococcus aureus (MRSA), Streptococcus pneumoniae, vancomycin resistant Enterococci, Acinetobacter spp, Acinetobacter baumannii and Enterobacteriaceae, including extended-spectrum β-lactamase-producing strains (ESBLs). Tigecycline has been introduced into clinical practice as part of the effort to combat the growing problem of bacterial resistance to anti-infective therapy: tigecycline could replace some broad-spectrum agents for approved indications reducing the selective pressure provided by antibiotic administration. The expanded in vitro activity against a broad range of bacteria, including resistant pathogens, of tigecycline suggest that this novel antimicrobial agent should offer clinicians an option for the treatment of patients with serious bacterial infections
The clinical and economic value of lovastatin in the primary prevention of cardiovascular disease
No full textHMGCoA-inhibitors (statins) lower plasma cholesterol through interference with the rate-limiting enzyme in the endogenous synthesis process. Since their introduction in the early 90’s, the clinical attitude towards cardiovascular (cv) risk reduction has evolved from the attention to single risk factors to a more comprehensive global risk evaluation, and thus the indications of statins have broadened from the secondary prevention in hypercholesterolemic patients to include primary prevention in mildly and moderately hypercholesterolemic, or even normocholesterolemic patients, provided their global cv risk is considered high (typically, an estimated major cv event probability greater than 20%). Italian drug utilization data show that a small proportion of patients who could benefit from statins do actually receive them, contributing to the persistence of the clinical and economical burden of cv disease, the leading cause of mortality; since statins have proved effective, and cost-effective, in cv prevention, a more widespread use appears desirable, but requires high investments in pharmaceutical costs. This article defines a clinical profile of lovastatin, a statin with a solid efficacy and safety record only recently introduced into the Italian market despite it has been the first to become clinically available abroad. Among available statin formulations appropriate for target cholesterol reductions up to 30%, which apply to a significant proportion of statin therapy candidates, lovastatin 20 mg is marketed at the lowest price. Although the individual response to the different statins is highly unpredictable, determining a mandatory empirical molecule- and dose-finding strategy on the single patient, from the societal point of view the choice to start with lower cost molecules, among options that on average are equally-effective, may limit initial drug investment and dampen the impact of resource waste secondary to treatment interruptions and switches
Pharmacoeconomic profile of vitamin D3: in the prevention of osteoporosis
No full textHypovitaminosis D is one of the principal risk factors for osteoporosis. Some studies estimated that more of 40% of Italian women over sixty are osteoporotic. Osteoporotic fracture is a significant cause of morbidity and cost. In Italy, in 2002, the global burden for hip fractures in over 65-years old patients has been estimated in more than one billion euro. Administration of vitamin D to prevent pathological fractures has a low cost-efficacy ratio, which reaches dominance compared to non-treatment in women over 70, i.e. avoided management costs of fractures exceed cost of therapy. In primary prevention, use of vitamin D3 involves some advantages with respect to partially or totally activated forms: higher safety and tolerability, lower costs and less frequent administrations. In order to prevent hypovitaminosis D, Regional Health Service of Toscana started to dispense free cholecalciferol to every person with more than 65 years (two 300.000 UI vials). The impact on the National Health Service budget, supposing all Italians over 65 would take cholecalciferol, has been estimated; annual savings resulted in more than 100.000.000 euro, only for hospitalization costs due to avoided fractures
Bayesian statistic methods and theri application in probabilistic simulation models
No full textSignificant advances in the management of hypercholesterolemia have been made possible by the development of statins, 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors. More recently, statins have demonstrated benefit in primary and secondary prevention of cardiovascular disease also in patients without hypercholesterolemia. Therefore statins help to reduce the impact of cardiovascular disease on morbility, mortality and social costs. Statins inhibit HMG-CoA reductase competitively, reduce LDL levels more than other cholesterol-lowering drugs, and lower triglyceride levels in hypertriglyceridemic patients. Prescribing statins as first line therapy in management of hypercholesterolemia as a part of a more comprehensive prevention program of cardiovascular disease is widely recommended by international guidelines (e.g. National Cholesterol Education Program - NCEP - Adult Treatment Panel - ATP- III reports). Currently in Italy there are five available statins: atorvastatin, fluvastatin, pravastatin, rosuvastatin and simvastatin; each of them presents some differences in physical and chemical characteristics (solubility), pharmacokinetics (absorption, proteic binding, metabolism and excretion) and pharmacodinamics (pleiotropic effects). Compared to other statins, fluvastatin extended-release (RP) 80 mg provides an equal efficacy in lowering total cholesterol and low-density lipoprotein cholesterol (LDL-C), with an important action on triglyceride (TG) levels and superior increases in HDL-C levels, reducing the incidence of major adverse cardiac events (MACE). Aim of this study is to outline an updated therapeutic and pharmacoeconomic profile of fluvastatin, particularly regarding extended-release (RP) 80 mg formulation
Economic and clinical value of levofloxacin
No full textLevofloxacin is a newer fluoroquinolone, with broad spectrum of antibacterial activity and good tolerability. This drug has a pharmacokinetic and pharmacodynamic profile that allows a once-a-day administration and offers the potential for intravenous-to-oral switch therapy. Due to these characteristics, the principal guidelines recommend it, as an option for the empirical therapy of patients with mild or more severe community acquired pneumonia (CAP), acute exacerbation of chronic bronchitis (AECB), complicated urinary tract infection (cUTI) and skin and soft tissue infection (SSTI). These pathologies are common causes of morbidity and mortality and place a large burden on medical and economic resources, specially if hospitalization is required. The implementation of a critical pathway, based on levofloxacin use and on a risk prediction rule to establish the need for hospitalization, has the potential to decrease healthcare resource consumption without impairment of clinical outcomes, with respect to conventional management. The possibility of switch therapy allows to reduce length of hospital stay, with a saving in both direct and indirect costs, and an increase in patient satisfaction. In summary, when used according to appropriateness criteria and for approved indications, levofloxacin offers favorable economic features for the healthcare provider, whilst guaranteeing a positive impact on patient functioning and quality of life