Farmeconomia. Health economics and therapeutic pathways
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    Ipertensione arteriosa, continuum cardiovascolare e ruolo clinico dei sartanii

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    The cardiovascular and cardiorenal continuum comprises the transition from cardiovascular risk factors to endothelial dysfunction and atherosclerosis, to chronic congestive heart failure, and-stage renal disease or premature death. RAAS (renin-angiotensin-aldosterone system) is involved in all steps along this pathway. Data from clinical studies involving valsartan and other ARBs provide evidence of the reduction of risk of cardiovascular events, and end-organ damage in the heart, kidneys and brain. This paper summarizes the status on research of ARBs based on clinical trials and regulatory approval

    Valsartan: come versatilità e tollerabilità possono contribuireal contenimento della spesa sanitaria

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    The search for a more specific and complete blockade of the hypertensive effects of angiotensin and of better tolerability than ACE-inhibitors has led to the development of angiotensin II receptor blockers (ARBs). ARBs have been evaluated in several large studies in terms of efficacy and safety in reducing blood pressure, as well as for cardiovascular and renal protection. Among angiotensin II receptor blockers, valsartan and losartan have the greatest number of therapeutic indications. In light of the costs related to cardiovascular disorder valsartan represents a potential long-term health cost saving strategy. Furthermore valsartan shows one of the lowest costs for patient achieving blood pressure goals and the higher level of persistence in its class

    Estimation of economic consequences of GOLD guidelines adoption in the Italian clinical practice

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    Background: Chronic Obstructive Pulmonary Disease (COPD) affects about 4.5% of the Italian population, representing one of most burdensome public health problems. Literature data report an annual health care expenditure ranging between € 1,300 and € 4,500 per patient, of which drug costs are a limited share. In 1998 the WHO started GOLD program in order to ameliorate COPD patient management. As a part of his program, periodically updated guidelines are produced with the aim of defining an efficient diagnostic-therapeutic pathway managed by a multidisciplinary team and based on the optimization of the use of drugs and diagnostic tests and the reduction of exposure to risk factors.Objective: to estimate the economic consequences of GOLD guidelines adoption in the Italian clinical practice.Methods: a decision analytic model capable of calculating the impact on the National Health Service budget of an ameliorated adherence to GOLD guidelines (GOLD GL strategy), basing on the needed variations in health care strategies on a defined patient cohort treated with the current approach (CURRENT strategy). The simulation runs on a cohort representing Italian COPD patients over 45 years who transit through 5 Markov health states (4 GOLD stages and death), according to patient characteristics (age, gender, FEV1), with a time horizon of 3 years. Stage-specific drug consumption of the CURRENT strategy is based on data of 3,113 patients collected by three Health Local Units involved in a larger clinical audit project. The consumption of other health resources, i.e. medical visits and inpatient care, is estimated based on a multicentre observational Italian study. The GOLD GL strategy includes spirometry-based staging on the totality of the simulated patients, the development of a therapeutic strategy including the redefinition of pharmacological therapy based on guideline recommendations and experts opinion, and variation of other health resources consumption based on observational data. Costs of health care resources are calculated based on published micro-costing analysis and current prices and tariffs.Results: the model estimates an adjunctive cost of about 19 million of Euros with the GOLD GL strategy, just for the the spirometry-based restaging of about 40% of the over 1 million and 250 thousand prevalent Italian COPD patients. Furthermore, in the first year of the analysis, the redefinition of the best clinical management strategy for all patients would cost about 100 million Euros, which are to be added to the more than 320 million Euros associated with adaptation of the GOLD stage specific pharmacological therapy, consisting mainly in a higher usage of long-acting beta agonist/corticosteroid combinations, only partially offset by the lower prescription of corticosteroid alone. Based on Italian observational data, the consumption of other health care resources with the GOLD GL strategy is reduced by about 44%, reflected in an estimated cost saving of more than 850 millions of Euros. For the first analysis year, the net cost saving associated with full GOLD guideline adoption is estimated equal to 410 millions of Euros; this value decreases by 11% and 21% respectively in the second and third years.Conclusion: our model estimates that the adoption of GOLD guidelines in the Italian clinical practice is associated to an average cost saving of about 300 Euros per patient/year

    Adherence to treatment and anticoagulation control in vitamin K antagonists-treated patients: an administrative databases analysis in a large Italian population

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    Oral anticoagulant therapy is essential for the treatment and prevention of many thromboembolic disorders. The aim of the present study is to evaluate the level of anticoagulation intensity in patients treated with vitamin K antagonists (VKAs) in a clinical practice setting and to explore the relationship between anticoagulation intensity and adherence to VKA treatment. We conducted a retrospective cohort study using the administrative databases of three Italian Local Health Units. Patients were enrolled if they had filled at least one prescription for VKAs (ATC code B01AA) between January 1st, 2007 and June 30th, 2008. In the same period all determinations of the international normalised ratio (INR) were collected. The parameters evaluated were anticoagulation control and adherence to VKA treatment.The survey showed that only 47.9% and 56.3% of INR determinations, in VKA naïve and established patients respectively, were into the recommended range (2.0-3.0). Moreover, the percentage of INR determination below the recommended range was higher than the percentage of INR determination above the recommended range for both naïve and established patients. Moreover, adherence to VKA treatment was poor both in naïve and established patients and, consequently, anticoagulation control is poor. Also in patients with the highest adherence to VKA treatment, only about 60% of INR determinations were into the recommended range. Our findings evidence that the anticoagulation control in clinical practice settings is still unsatisfactory and it is necessary to evaluate interventions to increase the amount of time at which patients’ INR are within the recommended range

    Pharmacoeconomic aspects of poor adherence to treatment in multiple sclerosis management

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    Multiple sclerosis (MS) is a chronic autoimmune disease, which affects the central nervous system and is the leading cause of chronic disability in young adults. Especially in the most common form characterized by relapses and remissions (RRMS), MS is a major burden on the NHS and society at a cost of illness per year for Italy estimated at 1.5 billion euros. The DMT (Disease-Modifying Therapies) when used continuously since the diagnosis of the disease have proved effective in reducing the risk of relapses, slowing the progression of the disease, reducing the consumption of health resources, especially hospitalizations, with a significant savings on healthcare costs. High rates of adherence have been associated with DMT not only to improved clinical performance, but also to a significant reduction in costs associated with the consumption of health resources. Because some recent studies have shown that the use of IFNβ-1a IM leads to better adherence to therapy and a significant savings in hospitalizations, outpatient visits, and also on the access to the PS, it is desirable that in Italy the use of IFNβ-1a IM will become ever greater. In this way, we can assume that we can achieve a significant saving in direct health care costs that affect the NHS, as has been observed in some foreign studies in which adherence to treatment was associated with a reduction in the average annual cost per patient between 33 and 65%.

    Cost/effectiveness analysis of atorvastatin in patients with acute coronary syndromes

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    Introduction: recent clinical trials found that high-dose statin therapy, compared with conventional-dose statin therapy, reduces the risk of cardiovascular events in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). With the introduction of simvastatin and pravastatin generics and the next patent expiration of atorvastatin, projected for 2011 in Italy, it is natural to ask: what is the most cost-effective treatment for a rational use of resources?Aim: the aim of this study was to estimate the cost-effectiveness of high-dose atorvastatin versus conventional standard-dose statins based on the scenario of atovastatin price evolution.Methods: a cost-effectiveness analysis was conducted in the perspective of the Italian National Health Service over the 4.9 years time horizon. Clinical data were obtained from a pooled analyses of the 3 clinical trials that directly compared high-dose atorvastatin with conventional standard-dose statins in patients with either ACS or CAD. Hospitalizations were quantified based on the Italian National Health Service tariffs and drug costs according to the Italian National Therapeutic Formulary (2009). Assuming the cost of atorvastatin reduces in line with that observed for simvastatin when the patent expires, 3 scenarios were constructed: atorvastatin current price (scenario 1); 55% price discount (scenario 2); 65% price discount (scenario 3). Effects were measured in terms of primary composite endpoint (coronary death or any adverse cardiovascular event). All costs were discounted at 3% per annum. Sensitivity analyses were performed to assess the robustness of findings. Results: intensive therapy with atorvastatin provided a hospitalization cost saving of 245,519.36 € per 1,000 patients. Under the assumptions established for scenario 1 and scenario 2, the incremental cost-effectiveness of treatment with atorvastatin 80 mg was estimated to be 20,289.72 € and 917.05 € for patient free from event, respectively; it was cost-saving for the scenario 3. Conclusions: high-dose atorvastatin represented a cost-effective use of healthcare resources in Italy. If the cost of atorvastatin reduces by 65% when the patent expires, for every million patient with SCA or CAD stable, treated for 5 years, the high-dose atorvastatin strategy potentially yields a cost-saving of ~2,4 billion € for the NHS

    Revisiting the role of a service-Day Hospital in infectious diseases, based on the natural history of HIV infection in the era of potent antiretroviral combination therapy

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    On the ground of the analysis of health care assistance performed by an Infectious Diseases Day-Hospital outpatient service operating in a metropolitan area during a 15-year-old time, we assess the evolution of referred disorders, in order to plan eventual future remodeling of the service and structure organization and performances, based one the present and evolving epidemiology of infectious diseases

    Ankylosing spondylitis and psoriatic arthritis: clinical and economic consequences of the use of etanercept

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    Spondyloarthritis (SpA) is the name for a family of inflammatory rheumatic disease that can affect the spine and joints, ligaments and tendons. Spondyloarthritis disease include ankylosing spondylitis, reactive arthritis, psoriatic arthritis, the spondylitis associated with the inflammatory bowel diseases and the undifferentiated spondyloarthritis. The most common treatments prescribed for spondyloarthritis are nonsteroidal anti-inflammatory drugs (NSAIDs) given in combination with disease-modifying antirheumatic drugs (DMARDs). Due to a recently suggested role of the tumour necrosis factor (TNFa) in the pathogenesis of SpA, new therapies specifically blocking TNFa have been investigated. Anti-TNF medications currently available on the Italian market are etanercept, infliximab and adalimumab. The aim of the present work was to furnish a clinical and pharmaco-economical profile of etanercept in treatment of psoriatic arthritis and ankylosing spondylitis based on a review of the published literature. Economical evaluations performed in several countries indicate that total treatment costs are lower with etanercept and adalimumab as compared to infliximab, mainly because of differences in the route of administration. Etanercept appears to be cost effective for the treatment of psoriatic arthritis and ankylosing spondylitis especially considering improved health related quality of life and lower medical costs due to superior efficacy of treatment

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    Farmeconomia. Health economics and therapeutic pathways
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