Farmeconomia. Health economics and therapeutic pathways
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    Valutazione economica dello studio TNT

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    Introduction: the Treating to New Targets (TNT) study showed that intensive lipid-lowering therapy with atorvastatin 80 mg/die provides significant clinical benefit beyond that afforded by atorvastatin 10 mg/die in patients with stable coronary heart disease (CHD). Objective: our aim was to investigate the economic consequence of high dose of atorvastatin in Italian patients with stable coronary heart disease (CHD). Methods: data were derived from the Intensive Lipid Lowering with Atorvastatin in Patients with Stable Coronary Disease (TNT) study. We conducted a cost-effectiveness analysis, comparing high dose of atorvastatin (80 mg/die) versus usual-dose of atorvastatin (10 mg/die) in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of patients free from any event. We considered an observation period of 4.9 years. The costs borne after the first 12 months were discounted using an annual rate of 3%. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. Results: the cost of atorvastatin 10 mg or 80 mg therapy over the 4.9 years period amounted to approximately € 1.6 millions and € 2.5 millions per 1,000 patients respectively. The total cost of atorvastatin high dose was about € 3.7 millions, the incremental cost per patient free from event is about € 12,600. Discussion: this evaluation found that atorvastatin therapy is cost-effective. Sensitivity analysis shows that cost consequences parameters are substantially sensitive to fluctuation

    Valutazione economica dello studio MIRACL

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    Introduction: the MIRACL study (“Effects of atorvastatin on early recurrent ischemic events in acute coronary syndrome”) has evaluated the effects of atorvastatin on early recurrent ischemic events in acute coronary syndromes. It has demonstrated that, for patients with acute coronary syndrome, lipid-lowering therapy with atorvastatin (80 mg/die) reduces recurrent ischemic events in the first 16 weeks, mostly recurrent symptomatic ischemia requiring rehospitalization. Aim: the goal of this pharmacoeconomic study is to evaluate the MIRACL study in the Italian context. Methods: the analysis is based on clinical outcome data from the MIRACL study. Clinical outcomes measured in the study include: death, cardiac arrest, nonfatal myocardial infarction (MI), fatal MI, angina pectoris, stroke, congestive heart failure (CHF), and surgical or percutaneous coronary revascularizations. Economic evaluation was carried out conducting a cost/effectiveness analysis, comparing economic and clinical consequences of high doses atorvastatin (80 mg) vs placebo in patients with unstable angina or acute myocardial infarction. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of mortality and morbidity reduction (number of deaths, life years gained and frequency of hospitalizations). All direct medical costs were taken from the perspective of the Italian National Health System during a 16-week period. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. We also conducted a threshold analysis. Results: the cost of atorvastatin therapy over the 16 weeks period amounted to approximately 162,489 euro per 1,000 patients. The total cost of atorvastatin high dose was about 2.2 millions euro, the incremental cost per patient free from event is 6,601 euro. Discussion: This evaluation found that atorvastatin therapy is cost-effective. Sensitivity analysis shows that cost consequences parameters are substantially sensitive to fluctuation

    Costs and efficacy ofolanzapine and risperidone in schizophrenia

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    Introduction: schizophrenia is a serious and long lasting psychiatric disease. The new “atypical” antipsychotic drugs, introduced in the 90s, have substantially improved the effectiveness of medical treatments, compared to previous neuroleptic drugs. Nowadays they tend to be used as first choice drugs. The ddd cost of atypicals may differ by 20% and health authorities may have an incentive to deliver the less costly drug, especially if they are generic. However the various drugs show differential effectiveness rates and a rational choice should consider both cost and effectiveness.
Objective: the purpose of this analysis is to review the existing evidence on cost-effectiveness studies of olanzapine and risperidone, the two most prescribed drugs in Italy. Six published studies were identified, but attention was focused on two articles that reported consistent and methodologically sound results.
Results: most reviewed studies are cost-minimization analyses, since effectiveness indicators show no significant statistical difference between the two drugs, and are inconclusive since the results depend on the evaluation setting. However one observational retrospective study showed a significant severity reduction over 12 months for patients treated with olanzapine (-2.46 on HoNOS scale; p<0.05), compared to a smaller non significant reduction of the risperidone group (-0.57). Despite the higher drug cost, the average total cost per reduced severity score was lower for olanzapine than for risperidone patients (€ 4,554 vs. € 10,897). The only medical and related health care costs for risperidone patients were higher than total costs for olanzapine patients. Another study comparing cohorts of patients with similar starting severity showed a significant severity reduction and global functioning increase over 12 months for olanzapine but no significant increase for risperidone patients (-0.35, p<0.01 on CGI scale; +3.66, p <0.05 on GAF scale, compared respectively to -0.27, p<0.05 and +2.00 n.s.). Again average cost per reduced severity/increased functioning score was higher for risperidone than olanzapine patients (€ 4,568 vs. € 4,170 for CGI and € 2,284 vs. € 1,139 for GAF scales respectively).
Conclusion: the use of olanzapine in the treatment of schizophrenia is the most cost-effective alternative for the SSN (Italian National health service), as it minimizes the cost per score of severity reduction or functioning increase. Even if the price of risperidone were to be reduced by 50% (becoming a generic), total 12 months treatment costs would exceed those of olanzapine in its highest ddd (30 mg).

    Valutazione economica dello studio CARDS

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    Introduction: cardiovascular diseases (CVD) are the major component of premature mortality, generate disability and are a relevant source of cost. The growing incidence of CVD is associated with lifestyle and other modifiable risk factors. Prevention and preclinical detection of CVD reduce morbidity and mortality. Type 2 diabetes is associated with a substantially increased risk of cardiovascular disease. Objective: the aim of the study was to evaluate the health economic consequence of medical therapy with atorvastatin for primary prevention of major cardiovascular events in patients with type 2 diabetes in Italy. Materials and method: in order to reach our objective we drew clinical information from the CARDS study. This economic evaluation was carried out conducting a cost/effectiveness analysis from the perspective of National Health Service (NHS). The analysis was applied to a time horizon in conformity with the observational period adopted in the CARDS study (3.9 years). An incremental cost/effectiveness ratio (ICER) was calculated and is expressed as cost per life years gained (LYG). In order to test the robustness of the results, a one-way sensitivity analysis was performed. Results: the total cost of atorvastatin therapy over 3.9 years amounts to around 1.5 million of euros per 1,000 patients. The total cost of adding atorvastatin to standard care in people treated for primary prevention of major cardiovascular events in type 2 diabetes as those involved in the CARDS study would entail an additional cost of about 1,2 million of euros per 1,000 patients treated per 3.9 years, with an incremental cost/effectiveness ratio (ICER) equivalent to 36,566 euros per patient per LYG. Discussion: the current study is the first economic evaluation of CARDS study to the Italian situation. The results of the current study show that hypolipemic therapy with atorvastatin 10 mg in diabetic individuals is to be considered cost effective

    Asthma and public awareness in Italy: results from CHAOS (Chronic Airway Obstruction Survey)

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    Despite last years advances in asthma knowledge and treatment, its management and control remains a critical issue. Many surveys on general practitioners (GPs) and patients were conducted but no data, in Italy, are collected about the public awareness.
The population cognition appears critic on decision maker health programs.
This survey, with a face to face questionnaire, explored the perception of social relevance of asthma through the main chronic diseases and tests the disease knowledge in 1161 Italian citizens.
Even if the sensibility of asthmatic (82) and their relatives (243) is superior to general population, some critical issues outcrop regarding beliefs, habits and therapy. 
People not related to asthma have not cognition of social and economic burden.
Asthmatic group is not confident with therapy value and possibility to measure organic damage.
Educational intervention would be addressed first of all to GPs and then to patients and their relatives, while on the other hand it is important to enhance the public and decision maker sensibility to reduce the disease welfare and social cost.

    Valutazione economica dello studio IDEAL

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    Introduction: the IDEAL (“High-dose atorvastatin vs usual-dose simvastatin for secondary prevention after myocardial infarction”) study was carried out to compare intensive lowering of low-density lipoprotein (LDL)-cholesterol using the highest recommended dose of atorvastatin 80 mg with simvastatin 40 mg. Aim: our aim was to investigate the economic consequence of high dose of atorvastatin vs usual-dose of simvastatin in reducing major coronary events in patients with a history of acute myocardial infarction (AMI). Methods: the analysis is based on clinical outcome data from the IDEAL study. We conducted a cost-effectiveness analysis, comparing high dose of atorvastatin (80 mg/die) versus usual-dose of simvastatin (20 mg/die) in the perspective of the Italian National Health Service. We identified and quantified medical costs: drug costs according to the Italian National Therapeutic Formulary and hospitalizations were quantified based on the Italian National Health Service tariffs (2006). Effects were measured in terms of mortality and morbidity reduction (number of deaths, life years gained and frequency of hospitalizations). We considered an observation period of 4.8 years. The costs borne after the first 12 months were discounted using an annual rate of 3%. We conducted one and multi-way sensitivity analyses on unit cost and effectiveness. We also conducted a threshold analysis. Results: the cost of simvastatin or atorvastatin therapy over the 4.8 years period amounted to approximately 2.3 millions euro and 2.6 millions euro per 1,000 patients respectively. Atorvastatin was more efficacious compared to simvastatin and the overall cost of care per 1,000 patients over 4.8 years of follow-up was estimated at 4.3 millions euro in the simvastatin and 4,18 millions euro in the atorvastatin group, resulting into a cost saving of 121,518 euro that is 2.8% of total costs occurred in the simvastatin group. Discussion: this study is the first economic evaluation of IDEAL study based on the Italian context. Atorvastatin therapy is dominant since it is both less costly and more effective than simvastatin. Results of sensitivity analysis showed that atorvastatin therapy remains dominant even in the most unfavourable hypotheses

    Which future for pharmacoeconomics in Italy?

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    Budget impact of rosiglitazone in type 2 diabetes

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    BACKGROUND: in type 2 diabetes, the maintenance of non-diabetic glycaemic levels has been shown to decrease the onset of long term complications and consequently their high management costs. In order to achieve and maintain normal blood glucose levels, lifestyle interventions are highly cost/effective, but require good compliance, strong motivation and efforts by the patients. For this reason, a majority of patients needs to start pharmacological therapy shortly after diagnosis. Rosiglitazone, an insulin-sensitising drug, is indicated for subjects with inadequate glycaemic control both as monotherapy, in those contraindicated to metformin, especially if overweight, and as combination therapy with metformin, sulphanilureas or both. OBJECTIVES: rosiglitazone offers clinical advantages over the alternatives, decreasing and/or postponing the need for insulin treatment. Its high acquisition cost may therefore be totally or partially offset by the reduction in future health care resources consumption, and by short-term practical advantages, such as the decrease in the need for blood glucose monitoring and of adverse events. Aim of this study was to investigate the impact of the use of rosiglitazone in eligible diabetic patients on the National Health System budget. METHODS: for this scope an analytic model was implemented, which pathway may be summarized as follows: a) estimate of the number type 2 diabetes patients living in Italy, grouped according to current therapeutic classes; b) estimate of the number of patients with inadequate glycaemic control for each subgroup; c) identification of patients eligible to rosiglitazone treatment; d) identification of the comparator strategy for each patient sub-group; e) comparison of costs for each couple of alternative options; f) calculation of budget impact. RESULTS: use of rosiglitazone monotherapy instead of sulphanilurea monotherapy induces a mild costs increase. Combination treatment with rosiglitazone added to metformin- or sulphanilurea- based therapies induces significant cost savings for the National Health System, related to lower resources consumption for glycaemic auto-monitoring and for hypoglycaemic events management, as compared to standard combination therapies. The hypothetical scenario in which all eligible patients are treated with rosiglitazone was estimated to induce net cost savings of about 260 millions Euro per year

    Liberalization of drugs market in Italy and trends in OTC in Europe

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    Farmacoeconomia e malattie cardiovascolari

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    Farmeconomia. Health economics and therapeutic pathways
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