Aleksandra Torbica

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.

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.

Hospital costs of central line-associated bloodstream infections and cost-effectiveness of closed vs. open infusion containers. The case of Intensive Care Units in Italy

ObjectivesThe aim was to evaluate direct health care costs of central line-associated bloodstream infections (CLABSI) and to calculate the cost-effectiveness ratio of closed fully collapsible plastic intravenous infusion containers vs. open (glass) infusion containers.MethodsA two-year, prospective case-control study was undertaken in four intensive care units in an Italian teaching hospital. Patients with CLABSI (cases) and patients without CLABSI (controls) were matched for admission departments, gender, age, and average severity of illness score. Costs were estimated according to micro-costing approach. In the cost effectiveness analysis, the cost component was assessed as the difference between production costs while effectiveness was measured by CLABSI rate (number of CLABSI per 1000 central line days) associated with the two infusion containers.ResultsA total of 43 cases of CLABSI were compared with 97 matched controls. The mean age of cases and controls was 62.1 and 66.6 years, respectively (p = 0.143); 56% of the cases and 57% of the controls were females (p = 0.922). The mean length of stay of cases and controls was 17.41 and 8.55 days, respectively (p < 0.001). Overall, the mean total costs of patients with and without CLABSI were € 18,241 and € 9,087, respectively (p < 0.001). On average, the extra cost for drugs was € 843 (p < 0.001), for supplies € 133 (p = 0.116), for lab tests € 171 (p < 0.001), and for specialist visits € 15 (p = 0.019). The mean extra cost for hospital stay (overhead) was € 7,180 (p < 0.001). The closed infusion container was a dominant strategy. It resulted in lower CLABSI rates (3.5 vs. 8.2 CLABSIs per 1000 central line days for closed vs. open infusion container) without any significant difference in total production costs. The higher acquisition cost of the closed infusion container was offset by savings incurred in other phases of production, especially waste management.ConclusionsCLABSI results in considerable and significant increase in utilization of hospital resources. Use of innovative technologies such as closed infusion containers can significantly reduce the incidence of healthcare acquired infection without posing additional burden on hospital budgets.

Funding health technologies in decentralized systems: A comparison between Italy and Spain

Although cost-containment policies in Europe are focusing increasingly on medical devices, the impact of these policies has yet to be fully investigated, particularly in cross-country settings. This paper analyses coverage, procurement, and reimbursement of three inpatient medical devices (coronary stent, knee endoprosthesis and implantable cardioverter defibrillator) in the Italian and Spanish healthcare systems. The research was carried out by reviewing published and grey literature, as well as national and regional legislation; in addition, 19 experts from hospitals and the industry were interviewed. In both countries, there has been a shift in political power from the national to the regional level. At the same time, the content of public coverage has become more explicit. A major issue in both systems is reimbursement, i.e. the rules about funding the delivery of services included in the benefit baskets. The differences in procurement and funding mechanisms create different incentives that may have an impact on the uptake and diffusion of technologies. These mechanisms, however, can only partially explain organizational and professional behaviour, as the use of technologies in both countries is mainly left to professionals who are exposed to a variety of incentives. There is limited direct and indirect guidance of national and regional authorities over the use of technologies in both countries. It is likely that the difficult search for a balance between introducing innovations, containing costs and assuring equity will require stronger regulatory action in the next future.

Validation of the Underlying Assumptions of the Quality-Adjusted Life-Years Outcome: Results from the ECHOUTCOME European Project

BackgroundQuality-adjusted life-years (QALYs) have been used since the 1980s as a standard health outcome measure for conducting cost-utility analyses, which are often inadequately labeled as ‘cost-effectiveness analyses’. This synthetic outcome, which combines the quantity of life lived with its quality expressed as a preference score, is currently recommended as reference case by some health technology assessment (HTA) agencies. While critics of the QALY approach have expressed concerns about equity and ethical issues, surprisingly, very few have tested the basic methodological assumptions supporting the QALY equation so as to establish its scientific validity.ObjectivesThe main objective of the ECHOUTCOME European project was to test the validity of the underlying assumptions of the QALY outcome and its relevance in health decision making.MethodsAn experiment has been conducted with 1,361 subjects from Belgium, France, Italy, and the UK. The subjects were asked to express their preferences regarding various hypothetical health states derived from combining different health states with time durations in order to compare observed utility values of the couples (health state, time) and calculated utility values using the QALY formula.ResultsObserved and calculated utility values of the couples (health state, time) were significantly different, confirming that preferences expressed by the respondents were not consistent with the QALY theoretical assumptions.ConclusionsThis European study contributes to establishing that the QALY multiplicative model is an invalid measure. This explains why costs/QALY estimates may vary greatly, leading to inconsistent recommendations relevant to providing access to innovative medicines and health technologies. HTA agencies should consider other more robust methodological approaches to guide reimbursement decisions.

Cost-effectiveness of a programme of screening and brief interventions for alcohol in primary care in Italy

BackgroundAs alcohol-related health problems continue to rise, the attention of policy-makers is increasingly turning to Screening and Brief Intervention (SBI) programmes. The effectiveness of such programmes in primary healthcare is well evidenced, but very few cost-effectiveness analyses have been conducted and none which specifically consider the Italian context.MethodsThe Sheffield Alcohol Policy Model has been used to model the cost-effectiveness of government pricing and public health policies in several countries including England. This study adapts the model using Italian data to evaluate a programme of screening and brief interventions in Italy. Results are reported as Incremental Cost-Effectiveness Ratios (ICERs) of SBI programmes versus a ‘do-nothing’ scenario.ResultsModel results show such programmes to be highly cost-effective, with estimated ICERs of €550/Quality Adjusted Life Year (QALY) gained for a programme of SBI at next GP registration and €590/QALY for SBI at next GP consultation. A range of sensitivity analyses suggest these results are robust under all but the most pessimistic assumptions.ConclusionsThis study provides strong support for the promotion of a policy of screening and brief interventions throughout Italy, although policy makers should be aware of the resource implications of different implementation options.

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

Assessing the value of health technologies, through health technology assessment is critically dependent on the existence of relevant and robust clinical data on the efficacy, safety and ideally, effectiveness of the technologies concerned. However, in the case of medical devices, such clinical data may not always be available, because of the different nature of the regulatory requirements in different jurisdictions. Therefore, we conducted a systematic review of the regulatory requirements in seven major jurisdictions in order to identify current challenges and to suggest possible improvements. There are differences in the requirements across jurisdictions and in the balance between pre-market and post-market controls. Several improvements are required in order to generate adequate clinical data for health technology assessment.

Diffusion and use of health technology assessment in policy making: What lessons for decentralised healthcare systems?

OBJECTIVE The Italian National Healthcare System (NHS) is one of the most decentralised systems since the devolution reform approved in 2001. HTA is spreading as an important tool for decision-making processes both at central and local levels. The aims of this study were to review the state of the health technology assessment (HTA) programmes in Italy - with a focus on regional and central initiatives - and to discuss consequences of a multi-level structure of HTA agencies in highly regionalised healthcare systems. METHODS Our method combined documentary review with interviews. We reviewed scientific literature about HTAs activities in decentralised systems, legislative and administrative documents from national as well as regional authorities. Semi-structured interviews were conducted with 18 key individuals associated with HTA both at the national and regional levels. Data on HTA programmes implemented or under development in nine regions were collected and analysed according to key principles for the improved conduct of health technology assessments for resource allocation decisions. RESULTS HTA is in the early stage of development in Italy, although with great heterogeneity across regions. The National Agency for Health Services has certainly contributed to HTA diffusion through supporting and training activities. However, the multi-level structure of HTA in Italy has not yet provided full coordination and harmonisation of practices and outcomes across the country, with a consequent exacerbate inequality of access to services and technologies. CONCLUSIONS There is probably need to rethink the multi-layer organizational framework of HTA in Italy by leveraging on current knowledge and efficient redistribution of activities across regions. We would advise for different jurisdictions playing different roles while achieving similar health outcomes for their patients, rather than jurisdictions aiming at doing exactly the same things resulting in unequal access to healthcare service provision.

Implant rates of cardiac implantable electrical devices in Europe: A systematic literature review

BACKGROUND In recent years, indications for cardiac implantable electrical devices (CIEDs) have broadened; however, budget constraints can significantly impact patient access to these life-saving health technologies. OBJECTIVE To perform a systematic literature review on the implant rates of pacemakers, cardioverter-defibrillators, and cardiac resynchronization therapy devices in Europe over the last decade to provide insight into the possible reasons for differences across regions or countries. METHODS Four electronic databases were searched to find studies describing CIED implant rates in Europe. Fifty-eight studies were included. RESULTS An overview showed a recent rise in CIED implants, with large geographic differences. The ratio between the regions with the highest and lowest implant rates within the same country ranged between 1.3 and 3.4 for pacemakers and between 1.7 and 44.0 for defibrillators. The ratio between the countries with the highest and lowest implant rates ranged between 2.3 and 87.5 for pacemakers, between 3.1 and 1548.0 for defibrillators, and between 4.1 and 221.0 for resynchronization therapy devices. Implant rate variability appears to be influenced by health care, economic, demographic, and cultural factors. CONCLUSION Publications on CIED implant rates in Europe show a wide variability within and across countries, the determinants of which are only partially investigated. Policy making should improve regarding equity of access to better care.