Farmeconomia. Health economics and therapeutic pathways
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    L’impatto della prematurità sulla qualità di vita del bambino

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    In the last years prematurity rates have increased, together with the survival rate among premature subjects. In addition now even infants born at 23 weeks of gestational age can survive. However, some studies demonstrate that premature children are more likely to show late disabilities and to be hospitalised during childhood. In Italy the premature childrens’ care level too often depends on the socio-economic status of the Region: central decisions about assistance until the beginning of teenage are yet to be taken. A strict monitoring of pregnancy and of risk factors predisposing to premature birth as well as a careful management of perinatal period should further improve survival and quality of life of these subjects

    The health and social costs of chronic kidney disease in Italy

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    Chronic kidney disease is growing as a global public health problem throughout the world. In Italy, CKD is becoming increasingly common with 52,777 patients treated with dialysis in 2010, about 10,000 new patients/years in dialysis from 2010.  The impact on the health care system includes € 2.1 billion/year for dialysis plus € 338 million for indirect costs. Aim of the present analysis was to explore socio-economical variables in the management of CKD, and assess direct and indirect health costs and NHS resources consumption. The overall cost for patients in dialysis is about 44,000 €/years for hemodialysis and 30,000 €/years for peritoneal dialysis with different resources consumption over the different stage disease. The possibility of reducing the progression of renal damaging and beginning of dialysis may induce a low expenditure for the Italian NHS

    Tiotropium bromide in the routine care of GOLD stage II COPD patients: a pharmaeconomic evaluation

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    Background: a secondary pre-specified analysis of the UPLIFT cohort demonstrated that the inclusion of tiotropium bromide in the routine care of GOLD stage II (moderate) chronic obstructive pulmonary disease (COPD) patients is associated with stronger improvements of survival, quality of life, and exacerbation rate than those shown in the total cohort; in this subgroup, tiotropium furthermore induces a significant reduction in the rate of FEV1 decline.Objective: to adapt the Spiriva® model, originally built to evaluate cost-effectiveness of tiotropium inclusion in the general COPD population, to GOLD II patients.Methods: the Spiriva® model is a probabilistic Markov patient-level simulation developed over a lifetime horizon to compare outcomes associated with the inclusion of tiotropium in routine care (RC) for COPD treatment with those obtained with RC alone. Patients are characterised by gender, age, height, smoking status and FEV1. Model structure and sources have been maintained unvaried, except for demographic characteristics, specific for GOLD II patients, as extrapolated from an Italian observational study, and tiotropium efficacy, based on the secondary analysis of GOLD II UPLIFT patients. As in the original model, only direct health care costs are considered.Results: patients treated with tiotropium on average (95% CI) gain 0.70 (0.00/7.23) LYs or 0.77 (0.02/4.67) QALYs compared to RC. The incremental lifetime cost is € 3,520 (-6,391/26,686), meaning that the incremental cost required to gain a QALY (incremental cost-effectiveness ratio – ICER) is equal to € 4,548. Sensitivity analysis shows that tiotropium has a 50% probability of being cost-effective for a willingness-to-pay (WTP) around 4,600 €/QALY; 100% probability is achieved with a WTP of € 9,300.Conclusions: the adoption of a strategy based on the inclusion of tiotropium from the early COPD stages represents good value for money in Italy, as the ICER estimated for GOLD II patients is well below conventional WTP thresholds, and lower than that calculated for the entire UPLIFT cohort

    Clinical and economic profile of entecavir in the treatment of chronic hepatitis b virus infection

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    HBV infection in Italy is frequently underestimated, raising the risk of important complications, such as cirrhosis and hepatocellular carcinoma, and thus increasing mortality. In infections phases requiring treatment, it’s possible to choose among the currently available drugs: interferons, nucleoside and nucleotide analogues. Entecavir is a nucleoside analogue able to maintain a high genetic barrier, and to reduce the viral load < 300 copies/ml in 67% of HBeAg-positive patients and in 90% of HBeAg-negative patients after 48-weeks treatment, improving also necroinflammatory grade and fibrosis degree. In spite of the high cost of the confection, entecavir induces a saving in health costs because of the decrease in the disease progression. If compared, through pharmacoeconomic models and analysis, to tenofovir, a nucleotide acid considered equivalent in the first-line monotherapy of HBeAg-positive patients and in the long-term treatment of HBeAg-negative patients by the current international and Italian guidelines, it seems favourable in terms of safety and consequently in terms of costs of adverse events spared. However further studies are required: in particular direct comparative studies are still lacking

    Prophylaxis against febrile neutropenia with pegfilgrastim in Italy: a budget impact analysis

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    Introduction: prophylaxis with granulocyte colony-stimulating factors (G-CSF) is indicated for reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy.
Objective: to evaluate the budgetary impact for the Italian NHS.
Design: a decision-analytic model has been developed to analyze the budget impact from the national health care system perspective. Costs include direct healthcare costs to the public payer of G-CSFs as well as their administration costs and costs of FN-related events. The comparison has been done using prophylaxis with G‑CSF (filgrastim for 11 days, pegfilgrastim, lenograstim for 11 days) and antibiotics.
Patients and participants: The population of interest for the analysis were patients with breast cancer in stage II and III and patients with non-Hodgkin’s lymphoma (NHL).
Main outcome measures and results: for all the three patients group (NHL, Breast II and III), and for all the chemotherapy regimens (CHOP 21 and R-CHOP 21 for NHL, AC-T, TAC and TC for Breast stage II and III) the budget impact analyses shows a cost reduction for the Italian NHS, as a result of an increase of the use of pegfilgrastim.
Conclusions: in Italy, a treatment strategy including pegfilgrastim as either primary or secondary prophylaxis provides value for money.

    New reimbursement criteria for lipid-lowering drugs

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    oai:journals.seedmedicalpublishers.com:article/6

    Gefitinib: a pharmacoeconomic profile of its use in patients with Non Small Cell Lung Cancer EGFR+

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    Lung cancer is the most common form of cancer with the highest incidence worldwide. The mortality rates are highest in males and second highest in females, after breast cancer. The genetic predisposition to Non Small Cell Lung Cancer (NSCLC) is still under investigation, however, studies have shown that the Epidermal Growth Factor Receptor (EGFR), a receptor tyrosine kinase is frequently over-expressed and activated to a phosphorylated state in NSCLC. The activity of EGFR in cancer cells results in the phosphorylation of downstream proteins that promote cell proliferation, invasion, metastasis, and inhibition of apoptosis. Targeting the EGFR pathway therefore constitutes a relevant strategy for cancer therapy. Gefitinib is a selective inhibitor of the EGFR tyrosine kinase and is indicated for the treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of EGFR-TK. From the pharmacoeconomic point of view gefitinib is dominant (more effective and less expensive) compared to the alternatives. In conclusion, gefitinib is a treatment option for NSCLC tumors with a high clinical and economic value in the Italian setting

    New prices for generic equivalent drugs

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    Valutazione dei processi assistenziali e del carico economico dei soggetti con ospedalizzazione incidente di infarto acuto del miocardio mediante il Data Warehouse DENALI

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    Aims: this study wants to estimate the economic burden of incident Acute Myocardial Infarction (AMI) registered in Lombardy (about 9.2 million residents). Method and results: a longitudinal study was conducted using a Data Warehouse (DENALI) that organised Healthcare Administrative databases of Lombardy related to eligibility criteria, hospital discharges (HDs), pharmaceutical and outpatient claims of citizens. All individuals with a HD for a first event of AMI during 2003 were identified and followed for 12 months. During 2003 12,049 individuals (64% males, mean age 70 +/-13 y.o.) had a HD for incident AMI. The total cost during the first year was € 163 million, corresponding to the 1% of the healthca re budget of Lombardy. The monthly cost in the first year was € 1,249 per person (77% attributable to HDs, 15% to pharmaceuticals and 8% to outpatient care). While most of the uptake of drugs used in secondary prevention was quick and happened in the first 3 months after the index event, the phenomenon of non persistence at 12 months was relevant. Conclusion: this large study on the burden of AMI shows the epidemiologic, economic and clinical impact of the disease. DENALI, with its large population followed over time, is a powerful and dynamic tool for epidemiologic and health economic research

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    Farmeconomia. Health economics and therapeutic pathways
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