A general model for the estimation of societal costs of lost production and informal care in Italy

We developed a general model for estimating and comparing disease- and treatment-specific lost paid/unpaid production (due to premature death and reduced ability) and informal care received (due to reduced ability) in Italy, starting from survival, demographic and Health-Related Quality of Life (HRQoL) data. Assuming the disease is not selecting a systematically different population in terms of mean wage than the general public, age- and gender-specific yearly production values are estimated combining data from the last Italian Time-Use-Survey on time dedicated to paid and unpaid (household, caring and volunteering) activities, with a) the last Italian Wage-Structure-Survey, for paid activities (Human Capital approach), and b) market prices for an equivalent service, for unpaid production (Proxy Good approach). To avoid double counting, age- and gender-specific maximum care needs are approximated with time dedicated to eating and personal care,reported in TUS. Present monetary values of future productivity and informal care are estimated applying a 3.5% annual discount rate. Lost life years due to a particular condition/treatment are estimated by comparison of its survival curve with the corresponding age- and gender-normalized survival curve of the general Italian population. The degrees of reduced productivity and need for informal care for remaining life years are estimated by comparison of condition-/treatment-specificreported HRQoL data with demographically matched Italian norms. Our results will be useful for cost-effectiveness and budget impact analyses conducted from the perspective of the Italian society and we encourage the inclusion of these costs in economic evaluations to allow decision makers to be fully informed about the costs and consequences of their decisions on healthcare interventions

Perceval Sutureless valves in isolated and concomitant AVR procedures: an economic model shows overall decrease of costs for isolated or combined operations

BACKGROUND: aortic valve replacement (AVR) the most common heart valve operation, accounts for a majority of all valve surgery performed in the elderly. The Perceval S (P) is a new aortic valve which is implanted without suturing, which causes a significant reduction in cross-clamping times (CCTs), and makes valve implantation easier and faster thanks to its collapsed profile. These features potentially allow the pool of operable patients to be expanded, even with minimally invasive surgery in isolated AVRs. AIM: to predict costs and outcomes of AVR procedures associated with this new valve in 4 European countries (Italy, France, Germany, and UK), as compared to traditional (T) valve implants, from the cost perspective of the hospital. METHOD: a probabilistic, patient-level simulation model was fully coded in WinBugs, permitting a seamless integration of parameter estimation and outcomes prediction, which was entirely based on the associated CCTs and on the surgical technique (mini-invasive [MiS] vs. full sternotomy [FS]), through published correlations. Unit cost were retrieved from official and literature sources for all countries. Besides the incorporated probabilistic sensitivity analysis, a series of deterministic sensitivity analyses was performed. RESULTS: the model predicts the use of the Perceval S valve to be associated with less complications and with savings (valve cost excluded), mainly related to a reduction in surgery costs and ICU/hospital bed days. These savings range from € 3,600 (Italy) to £ 3,900 (UK) for PFS in isolated AVRs and from about € 6,000 (Italy) to £ 6,700 (UK) for PMiS in isolated AVRs, and for PFS in concomitants. Extensive sensitivity analyses confirm the robustness of such findings.CONCLUSIONS: the results of the present analysis indicate that the hospital acquisition cost difference between the new sutureless Perceval S valve and traditional valves is offset by important savings in other cost items

Comparison between traditional and goal directed perfusion in cardiopulmonary by-pass. A differential cost analysis in US

OBJECTIVES: High oxygen delivery (DO2) during cardiopulmonary bypass (CPB) is associated with better renal outcomein cardiac surgery. Traditional perfusion (TP) techniques, targeted on body surface area and CPB temperature, achieveshigh DO2 in about 50% of the cases while a goal directed perfusion (GDP) approach can lead to more than 90% of casesachieving high DO2 with a consequent reduction in Acute Kidney Injury (AKI) rate of about 40%. Aim of this study isto perform an economic evaluation of GDP strategy with respect to TP in US. METHODS: A Discrete Event Simulationmodel was developed to compare TP and GDP strategy in patients undergoing CPB. The patient’s pathways from operationto discharging from hospital was simulated: AKI incidence, in-hospital mortality, hospital length of stay, transfusions werecorrelated to probability to achieve high DO2 target using published correlations. National perspective was adopted to calculate costs associated to each event while GDP strategy was exploited the introduction of Sorin Heartlink (HL) Card/GDPCard and Sorin Connect (electronic data management system). RESULTS: GDP strategy saved more than 3 days in hospitaland 11% of AKI episodes. The cost-saving is $3,137 (95$180, 95% CI: 113-249) is more than offset by savings in hospital stay that result the main driver in cost ($ 3,222, 95% CI:1,235-4,950). Deterministic sensitivity analysis shows that the total savings are mainly influenced by nadir haematocritduring CPB and hospital LOS/cost per day both in ICU and in ward. CONCLUSIONS: GDP seems to improve significantlythe main outcomes related to CPB surgery, when compared to TP techniques. Additional costs due to perform GDP strategyhave no impact on the total cost since completely offset by the savings in hospital cost

Comparison between traditional and goal directed perfusion in cardiopulmonary by-pass. Adaptation of a differential cost analysis

BACKGROUND: A previous patient-level discrete event simulation (DES) model was developed to perform an economic evaluation of GDP strategy with respect to TP in US. Aim of this supplement is provide results of the adaptations of the differential cost analysis to Belgium, Canada, France, Germany, Italy, and UK. METHODS: A Discrete Event Simulation model was developed to compare TP and GDP strategy in patients undergoing CPB. National perspective was adopted to calculate costs associated to each event while GDP strategy was exploited the introduction of Sorin Heartlink (HL) Card/GDP Card and Sorin Connect (electronic data management system). RESULTS: GDP reduces the total cost with respect to traditional perfusion; furthermore the cost of GDP strategy (Sorin GDPTM Monitor and Sorin ConnectTM) is completely offset by the saving in hospital stay. CONCLUSION: GDP seems to improve significantly the main outcomes related to CPB surgery, when compared to TP techniques. Additional costs due to perform GDP strategy have no impact on the total cost since completely offset by the savings in hospital cost

Prevenzione e terapia precoce del diabete mellito di tipo II: aspetti farmacoeconomici

Type II (non-insulin-dependent) diabetes is one of the most widespread chronic patologies in the developed countries and its prevalence in Italy is about 2-3% of the population. Type II diabetes is also associated with several other metabolic abnormalities such as central obesity, hypertension, and dyslipidemia, which contributes to the very high rate of cardiovascular morbidity and mortality. Therefore Type II diabetes involves a significant financial burden on the health care system. The purpose of this paper is to explain the composition of the healthcare costs of managing people with Type II diabetes and the economic repercussions due to the adoption of an aggressive strategy against the pathology. To carry out this evaluation we considered the CODE-2 (The Cost of Diabetes in Europe - Type II) Study results, the American Diabetes Association Position Statement, the Diabetes Prevention Program and the UK Prospective Diabetes Study. Evidence exists to show that introducing prevention program or an early therapy can avert or delay significantly the onset of cardiovascular morbidity in Type II diabetes patients. According to the pharmacoeconomical criteria, this very desiderable clinical goal is associated to a little increase of the health expenditures, and sometimes also to a costs saving

Topical metronidazole and clotrimazole in the treatment of vulvo-vaginal infections during pregnancy

Vulvo-vaginal infections are the most common gynaecological pathologies seen in clinical practice. While being predominantly benign, although disturbing, in non pregnant women, their presence during pregnancy has been associated with peri-natal and obstetric complications. The opportunity to prevent these adverse outcomes, especially prematurity and low birth weight, has to be cautiously balanced against the potential to induce fetal toxicity, inherently related to the continuous exchanges among maternal and fetal blood that occurs in the placenta. In this paper, a brief overview of the evidence regarding efficacy, safety and utility during pregnancy of topical clotrimazole and metronidazole, whose combined spectrum covers the great majority of the involved pathogens, is provided. These antimicrobials, especially when applied topically, are highly effective and have been used in pregnant women for many years without evidence of adverse outcomes; in conclusion it appears that they hold an adequate risk-to-benefit ratio and represent valid therapeutic options in the treatment of vulvo-vaginal infections during pregnancy

Terlipressina: profilo farmacologico clinico, terapeutico e farmacoeconomico nel trattamento delle varici esofagee

The formation and rupture of esophageal and gastric varices are severe but common complications of hepatic cirrhosis. They represent the cause underlying more than one forth of all deaths in cirrhotic patients and exact an impressive burden in terms of survival, quality of life and health care resource consumption. Therapeutic options for the control of active variceal hemorrhage comprise pharmacological agents, endoscopic techniques and surgery. Of these, the only options immediately available in the absence of highly specialized medical personnel are vasoactive drugs, namely vasopressin and derivatives and somatostatin and derivatives. Despite this clear advantage, the role of pharmacological treatment is still debated; furthermore, there’s no consensus on the drug of choice for variceal bleeding control. In this paper the main pharmacological and clinical features of terlipressin, a synthetic vasopressin analog, are outlined, as well as a frame for its pharmacoeconomical evaluation. Terlipressin is the only vasoactive drug that demonstrated survival benefits in cirrhotic patients with active variceal hemorrhage, even in those treated with endoscopic sclerotherapy, and is characterized by a favorable risk/benefit ratio. The relative cost-effectiveness of the different drugs, nevertheless, is yet to be determined by methodologically rigorous studies, partly because at the present state of the research there still are clinical and economical uncertainties to be cleared

Gli antagonisti del recettore GPIIb/IIIa: farmacologia, clinica ed economia nelle sindromi coronariche acute NSTEMI e nelle rivascolarizzazioni per via percutanea

Inhibition of platelet glycoprotein IIb/IIIa (GP IIb/IIIa) receptor prevents platelet aggregation by controlling its final common pathway, the cross-binding of fibrinogen, bridging across adjacent platelets. Three pharmacological agents capable of inhibiting GP IIb/IIIa are available for use in Italy: abciximab, eptifibatide and tirofiban. In this paper, some relevant studies on the pharmacology of GP IIb/IIIa inhibitors are summarized, as well as the main clinical trials assessing their use in the management of unstable angina (UA) and during percutaneous coronary interventions (PCI). Furthermore, the recommendations on their appropriate use in UA and PCI issued by authoritative scientific societies are presented. Finally, some of the pharmacoeconomic evidence published in the international literature is reviewed and implications in the Italian health care setting are discussed

Terapia del dolore: nuove norme e aspetti pratici per l’uso degli analgesici

Until recently, pain therapy in Italy was conducted with largely sub-optimal standards, as revealed by one of the lowest mean morphine consumption values, an important indicator of pain therapy quality according to the WHO, among industrialized countries. The recognition of such a negative situation has led to an important effort to improvement, carried out by the law-maker, institutions and health professionals. As suggested by the WHO, these efforts aimed at three main objectives: reducing the cultural barriers to appropriate opioid use through targeted education and information, easing of analgesic drug prescription and availability, and improvement of the integration among hospital-based and domiciliar pain management and care-giving. In this article, the new legal framework concerning the prescription and administration of analgesics - regulatory innovations started in February 2001 - is presented and its practical implications for health professionals are discussed. Alongside the new laws, some regulatory interventions recently adopted by the Italian Drug Agency (AIFA) are presented and discussed, as they share the proposition of simplifying pain therapy and permit the prescription of more analgesics paid for by the National Health Service. In the last years, the premises for a more rational and modern approach to pain therapy in Italy have been created, which will need to be followed by cultural, organizing and clinical practice adaptations in order to warrant effective and efficient management of algic patients

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 among the lowest in its class for many 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