Giovanni Fattore

The costs of multiple sclerosis: a cross-sectional, multicenter cost-of-illness study in Italy

Objectives To estimate the socio-economic impact of multiple sclerosis (MS) in Italy. Methods Outpatients with MS were enrolled at 44 centres across Italy. Socio-demographic, clinical and resource utilization data were collected using a validated questionnaire. Each patient completed a weekly diary of expenses due to MS over a three-month period. Direct health care costs and indirect costs (lack of productivity for the patient and for caregivers) were assessed for the whole population and were compared among five groups, categorised by disease severity (EDSS score). An analysis of variance was carried out on socio-demographic variables. Results For the total population of 566 patients, the mean direct cost over three months was ITL 2,134,000, the mean indirect cost was ITL 7,775,000. Costs were significantly higher for male patients (p < 0.05) and showed a significant increase with increasing age (p < 0.0005), disease duration (p < 0.0005) and disease severity (p < 0.0005). Costs for patients in a progressive phase were significantly higher (p < 0.0005). There were no significant geographical differences among the regions of Italy. Conclusions This study confirms that MS represents a high economic burden, with indirect costs greatly exceeding direct costs. Unpaid caregivers remain the culturally accepted mode of care for MS patients in Italy and this study illustrates the impact of their loss of earnings. As costs increase with disease progression, these findings suggest that treatment efforts should focus on patients in the early stages of MS, in order to slow down disease progression.

Proposta di linee guida per la valutazione economica degli interventi sanitari in Italia

SummaryThis document presents the results of the Italian Health Economics Association (AIES) working group established to suggest guidelines on how to conduct economic evaluation studies of health programs. The document conceptualises such studies as part of health technology assessment carried out to provide guidance to the Italian National Health Service (INHS). The document aims to make available to public institutions, regulatory agencies and organizations operating in the health field a valid and feasible tool to make decisions more rational and more productive in terms of health gains. Overall, evidence-based medicine (EBM) is gaining ground and clinical decisions are increasingly taken on the basis of adequate scientific knowledge. The document suggests to extend the EBM approach to economic analysis and details how to do it in practice. The guidelines adopt the approach of the reference case which sets precise rules about major methodological decisions. Such an approach eases comparisons of results across studies and thus contributes to use them consistently in decision making. The reference case identifies the cost-effectiveness analysis, and in particular the incremental cost per Quality-Adjusted Life-Year (QALY), as the method to be used in the reference case in economic evaluations. The guidelines intend to stimulate the discussion among main actors and stakeholders who want to contribute to the development of rational governing tools for the INHS.

The new pharmaceutical policy in Italy

Pressed by an impressive series of corruption scandals and by a change of attitude towards cost-containment, the Italian pharmaceutical sectors regulatory environment was radically changed in 1994. Regulatory power was concentrated on a national technical body (CUF) and a new set of measures was taken, including a nationwide drug expenditure budget, a redefinition of both the positive list and the cost-sharing rules, and new price-setting models. As a result, in the period 1993-1996, nominal expenditures decreased by about L 1600 billion (ECU 83.6 billion at 1997 exchange rate), that is from 13.3% to 11.0% of current National Health Service (NHS) expenditure. While in the 1980s Italy was one of the most generous countries in funding pharmaceuticals, it is now one of the most parsimonious. Although the overall pharmaceutical market shrank in 1994 and 1995, a substantial part of NHS drug-bill savings resulted from cost-shifting from the public sector to patients, mainly because physicians have not aligned their prescribing behaviour to the new positive list. The new Italian approach to containing pharmaceutical costs has been certainly effective, at least in the short run. However, new relevant issues are emerging regarding the fall of NHS pharmaceutical coverage, the centralised nature of the Italian pharmaceutical policy and the gap between scientific based policies and actual prescribing behaviours.

Definitions and Typologies in Public Administration Research: The Case of Decentralization

Abstract The field of public administration knows many concepts. By focusing on one such concept, this research shows how definitions can be deceptive, and how typologies unable to capture all dimensions of a concept can blind policy makers and researchers. We concentrate our attention on decentralization. This has been a core concept in the field of public administration for decades. Definitions and typologies of decentralization have flourished. The present study gives an overview. We categorize definitions and analyse their different emphases. Typologies serve to order and compare items, but have themselves become prone to disorder. We provide a meta-analysis of typologies, exposing the wide variety of policy dimensions. Even after aggregation, typologies ignore—and definitions explicitly exclude—certain aspects of decentralization. One such issue is “silent decentralization.” It is characterized by absence of explicit decentralization reform, and thus distinguishes itself mainly by its potential origins: network changes, initiative shifts, policy emphasis developments, or resource availability alterations. Highlighting this particular aspect might well proof useful for other concepts in the field as well.

Palm oil and blood lipid–related markers of cardiovascular disease: a systematic review and meta-analysis of dietary intervention trials

BACKGROUND Palm oil (PO) may be an unhealthy fat because of its high saturated fatty acid content. OBJECTIVE The objective was to assess the effect of substituting PO for other primary dietary fats on blood lipid-related markers of coronary heart disease (CHD) and cardiovascular disease (CVD). DESIGN We performed a systematic review and meta-analysis of dietary intervention trials. Studies were eligible if they included original data comparing PO-rich diets with other fat-rich diets and analyzed at least one of the following CHD/CVD biomarkers: total cholesterol (TC), low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, TC/HDL cholesterol, LDL cholesterol/HDL cholesterol, triacylglycerols, apolipoprotein A-I and B, very-low-density lipoprotein cholesterol, and lipoprotein(a). RESULTS Fifty-one studies were included. Intervention times ranged from 2 to 16 wk, and different fat substitutions ranged from 4% to 43%. Comparison of PO diets with diets rich in stearic acid, monounsaturated fatty acids (MUFAs), and polyunsaturated fatty acids (PUFAs) showed significantly higher TC, LDL cholesterol, apolipoprotein B, HDL cholesterol, and apolipoprotein A-I, whereas most of the same biomarkers were significantly lower when compared with diets rich in myristic/lauric acid. Comparison of PO-rich diets with diets rich in trans fatty acids showed significantly higher concentrations of HDL cholesterol and apolipoprotein A-I and significantly lower apolipoprotein B, triacylglycerols, and TC/HDL cholesterol. Stratified and meta-regression analyses showed that the higher concentrations of TC and LDL cholesterol, when PO was substituted for MUFAs and PUFAs, were not significant in young people and in subjects with diets with a lower percentage of energy from fat. CONCLUSIONS Both favorable and unfavorable changes in CHD/CVD risk markers occurred when PO was substituted for the primary dietary fats, whereas only favorable changes occurred when PO was substituted for trans fatty acids. Additional studies are needed to provide guidance for policymaking.

The social and economic burden of stroke survivors in Italy: a prospective, incidence-based, multi-centre cost of illness study

BackgroundThe aim of this study was to estimate the one-year societal costs due to a stroke event in Italy and to investigate variables associated with costs in different phases following hospital admission.MethodsThe patients were enrolled in 44 hospitals across the country and data on socio-demographic, clinical variables and resource consumption were prospectively surveyed for 411 stroke survivors at admission, discharge and 3, 6 and 12 months post the event. We adopted a micro-costing procedure to identify cost generating components and the attribution of appropriate unit costs for three cost categories: direct healthcare, direct non-healthcare (including informal care costs) and productivity losses. The relation between costs of stroke management and socio-demographic and clinical characteristics as well as disability levels was evaluated in a series of bivariate analyses using non parametric tests (Mann Whitney and Kruskal-Wallis). Multiple linear regression analyses were performed to determine predictors of costs incurred by stroke patients during the acute phase and follow-up of 1 year.ResultsOn average, one-year healthcare and societal costs amounted to €11,747 and € 19,953 per stroke survivor, respectively. The major cost component of societal costs was informal care accounting for € 6,656 (33.4% of total), followed by the initial hospitalisation, (€ 5,573; 27.9% of total), rehabilitation during follow up (€ 4,112; 20.6 %), readmissions (€ 439) and specialist and general practioner visits (€ 326). Mean drug costs per patient over the follow-up period was about € 50 per month. Costs associated to the provision of paid and informal care followed different pattern and were persistent over time (ranging from € 639 to € 597 per month in the first and the second part of the year, respectively). Clinical variables (presence of diabetes mellitus and hemorrhagic stroke) were significant predictors of total healthcare costs while functional outcomes (Barthel Index and Modified Ranking Scale scores) were significantly associated with both healthcare and societal costs at one year.ConclusionsThe significant role of informal care in stroke management and different distribution of costs over time suggest that appropriate planning should look at both incident and prevalent stroke cases to forecast health infrastructure needs and more importantly, to assure that stroke patients have adequate “social” support.

The “Essential Levels of Care” in Italy: when being explicit serves the devolution of powers

The definition of an explicit health benefit package in Italy has gained importance because of devolution of powers from the national level to the regions. The set of services to be guaranteed by the public sector are defined at national level, while regions are accountable for their provision. This contribution discusses the entitlements and the decision criteria adopted by Italian policy-making bodies. Entitlements to services are clearly defined for few sectors (mainly outpatient specialist care); for hospital care the benefit catalogue is vague. The definition of the health benefit package in Italy is an essential element of the relationship between the central government and the regions. It is argued that adequate monitoring systems and accountability procedures are still needed to make the essential levels of care an effective pivotal element of the Italian National Health Service.

Health care performance comparison using a disease-based approach: The EuroHOPE project

This article describes the methodological challenges associated with disease-based international comparison of health system performance and how they have been addressed in the EuroHOPE (European Health Care Outcomes, Performance and Efficiency) project. The project uses linkable patient-level data available from national sources of Finland, Hungary, Italy, The Netherlands, Norway, Scotland and Sweden. The data allow measuring the outcome and the use of resources in uniformly-defined patient groups using standardized risk adjustment procedures in the participating countries. The project concentrates on five important disease groups: acute myocardial infarction (AMI), ischemic stroke, hip fracture, breast cancer and very low birth weight and preterm infants (VLBWI). The essentials of data gathering, the definition of the episode of care, the developed indicators concerning baseline statistics, treatment process, cost and outcomes are described. The preliminary results indicate that the disease-based approach is attractive for international performance analyses, because it produces various measures not only at country level but also at regional and hospital level across countries. The possibility of linking hospital discharge register to other databases and the availability of comprehensive register data will determine whether the approach can be expanded to other diseases and countries.

Delphi approach to select rare diseases for a European representative survey. The BURQOL-RD study

OBJECTIVES The BURQOL-RD project is intended to develop a disease based model capable of quantifying the socio-economic burden and health-related quality of life for patients with rare diseases (RDs) and their caregivers in Europe. We described the methodology used to select a set of 10 RDs to be approached in a pilot study. METHODS BURQOL-RD project includes 23 partners from 8 European countries: Spain, UK, France, Germany, Sweden, Italy, Hungary and Bulgaria. A two-round Delphi panels in combination with Carroll diagram was used to generate consensus in the selection of the 10 RDs among the project participants. RESULTS The two Delphi rounds yielded a prioritised list, to which the Carroll diagram was applied, taking into account three determinants: prevalence, availability of effective treatment and need for carer. The final set of RD to be studied was obtained: cystic fibrosis, Prader-Willi syndrome, haemophilia, duchenne muscular dystrophy, epidermolysis bullosa, fragile X syndrome, scleroderma, mucopolysaccharidosis, juvenile idiopathic arthritis and histiocytosis. CONCLUSIONS This methodology permitted the generation of an equilibrated set of RDs for the pilot study of BURQOL-RD project. The model will be suitable for application in a wide range of RDs.

Cost and reimbursement of cataract surgery in Europe: a cross-country comparison

The number of cataract extractions has increased substantially over time. At present, cataract surgery is estimated to be the most common single procedure performed in the developed world. The present study compares the costs of a cataract intervention across nine European countries. To enhance comparability, data were collected using a common template based on a case vignette. Adequate data for analysis were collected from 41 providers and were used to evaluate variation across countries and providers. Ordinary least squares and a multilevel model were used to investigate cost variation. Mean total costs per cataract intervention varied considerably from country to country, ranging from 318 euros in Hungary to 1087 euros in Italy. Variations of a similar magnitude were detected for personnel costs and overheads. However, variations in the cost of the lens were more modest. Overall, our results confirm expectations about the causes of cost variations across EU member states, indicating that these variations may be attributable to the quantity of resources used in performing the operation, the price of resources, and the type of setting in which the operation is performed. The study highlights how accounting practices and available cost data differ across Europe. It also shows the feasibility of collecting data on the basis of vignettes using common cost templates. Studies following this approach will gain importance if cross-country comparisons are to be used to promote European benchmarking exercises.