Social/economic costs and health-related quality of life in patients with juvenile idiopathic arthritis in Europe.

OBJECTIVE: The aim of this study was to determine the economic burden from a societal perspective and the health-related quality of life (HRQOL) of patients with juvenile idiopathic arthritis (JIA) in Europe. METHODS: We conducted a cross-sectional study of patients with JIA from Germany, Italy, Spain, France, the United Kingdom, Bulgaria, and Sweden. Data on demographic characteristics, healthcare resource utilization, informal care, labor productivity losses, and HRQOL were collected from the questionnaires completed by patients or their caregivers. HRQOL was measured with the EuroQol 5-domain (EQ-5D-5L) questionnaire. RESULTS: A total of 162 patients (67 Germany, 34 Sweden, 33 Italy, 23 United Kingdom, 4 France, and 1 Bulgaria) completed the questionnaire. Excluding Bulgarian results, due to small sample size, country-specific annual health care costs ranged from €18,913 to €36,396 (reference year: 2012). Estimated direct healthcare costs ranged from €11,068 to €22,138; direct non-healthcare costs ranged from €7837 to €14,155 and labor productivity losses ranged from €0 to €8715. Costs are also shown to differ between children and adults. The mean EQ-5D index score for JIA patients was estimated at between 0.44 and 0.88, and the mean EQ-5D visual analogue scale score was estimated at between 62 and 79. CONCLUSIONS: JIA patients incur considerable societal costs and experience substantial deterioration in HRQOL in some countries. Compared with previous studies, our results show a remarkable increase in annual healthcare costs for JIA patients. Reasons for the increase are the inclusion of non-professional caregiver costs, a wider use of biologics, and longer hospital stays.

The costs of pharmacological treatment for major depression. The Italian Prospective Multicentre Observational Incidence-Based Study.

OBJECTIVE: To describe the pharmacological treatment for major depression under the conditions of routine Italian public mental health facilities, assess its costs, and study its main predictors according to a societal perspective. DESIGN: This was a prospective multicentre observational study designed to evaluate the economics of treatment of major depression using a specifically designed 65-item questionnaire. Data on drug consumption were collected in a section of the questionnaire and are presented here. PATIENTS AND PARTICIPANTS: 60 mental health facilities were selected and 556 patients were enrolled and followed up for 15 months. RESULTS: Pharmacological treatment appears to be the most common treatment for major depression. 98% of patients were prescribed an antidepressant. Selective serotonin reuptake inhibitors (SSRIs) were the most prescribed antidepressants. Patients treated with SSRIs suffered from less severe depression than those treated with tricyclic antidepressants. Benzodiazepines were prescribed for 84% of patients enrolled. The total drug cost was 1,120,000 Italian lire ($US707) per patient (1995 values). Less than 20% of this cost was borne by the Italian National Health Service, as the majority of drugs used were not reimbursed. CONCLUSIONS: The costs of the most widespread approach to treating major depression (pharmacological treatment) are not currently covered by the Italian National Health Service. Prescribing of drugs seems to diverge from the standards of treatment indicated by the Italian Drug Committee.

Mental health care in Italy: organisational structure, routine clinical activity and costs of a community psychiatric service in Lombardy region.

The Magenta Community Mental Health Centre (CMHC) is the public agency responsible for providing adult psychiatric care to about 85,000 adult residents. In 1995, it had 1,145 clients and incurred costs of Euro 1.9 millions. Average cost per patient and per adult resident were Euro 1,661 and Euro 22.2, respectively. These values mask large variation across diagnosis: while patients with schizophrenia and related disorders had an average cost of Euro 3,771, those with neurotic and related disorders had an average cost of Euro 439. Patients with schizophrenia and related disorders (28% of the patients) absorbed about 60% of total costs and made extensive use of several types of services (hospital, outpatient, domiciliary, social and rehabilitative care). Since integrating different types of services is the key element of Italian psychiatric care, the new fee-for-service system adopted by the NHS to fund providers does not appear appropriate, particularly for schizophrenic patients.

Health care costs of therapy-refractory schizophrenic patients treated with clozapine: a study in a community psychiatric service in Italy.

This study evaluates the utilization of clozapine in the treatment of therapy-refractory schizophrenia in terms both of patterns of care and of health care costs in a community psychiatric service in Italy. Data covering the year prior to commencing clozapine and the year following the initiation of the therapy were collected. Clinical outcome was assessed by means of the Clinical Global Impression (CGI) and Global Assessment of Functioning (GAF) scales. Cost analysis followed a two-step procedure: (i) to record all health care services provided to patients and (ii) to assign a monetary value to each service. Three of the 15 patients enrolled in the study dropped out before the end of the 12-month period of therapy. Considering the 12 patients on clozapine treatment for at least 1 year, clinical improvements are associated with a substantial modification of the pattern of care. While patients in the pre-clozapine period were mainly managed in hospital settings, patients on clozapine were prevalently placed in the community and participated in intensive rehabilitative programmes. The higher costs of drug therapy and community services in the post-clozapine period were more than offset by the lower costs of acute hospital care.

Clarifying the scope of Italian NHS coverage. Is it feasible? Is it desirable?

The reduction in National Health Service (NHS) expenditure as a share of total health care expenditure, the fragmentation of the NHS into 21 regional systems and the implementation of a 'quasi-market' on the provider side of the system has pressed the government to define and specify, in detail, the set of services that are to be guaranteed by the public sector. To understand whether rationing can be more rational and explicit in the Italian NHS, the following are analysed: (i) the new positive list of drugs, as a major example of limiting and making more rational NHS pharmaceutical coverage; (ii) the Di Bella case, as an example of the difficulties of rational policy-making on sensitive issues; (iii) what Italian people think about health care rationing and priority setting (using the 1998 Eurobarometer Survey);( iv) the criteria defining the set of 'essential services' to be guaranteed to all Italian citizens, which are contained in the recently released National Health Plan. The 'revolution' that has taken place in the pharmaceutical sector shows it is feasible to limit, in an explicit and rational way, the extent of NHS coverage. However, the re-classification of the positive list should be regarded as an exceptional event in the history of Italian social policy. The 'Di Bella' case, on the contrary, shows that limiting NHS coverage can be very unpopular, and that the Italian cultural and social context can be unfavourable for the implementation of hard choices. Public attitude toward rationing seems to confirm that Italians are not familiar with rationing issues. Thus, it is very difficult to predict whether the national government will really go ahead with the implementation of a 'list of essential services' and whether this attempt will be successful. Rationing and priority setting should be discussed in the context of a general debate concerning the future of the Italian NHS.

Pitfalls in the economic evaluation of thrombolysis in myocardial infarction. The impact of national differences in the cost of thrombolytics and of differences in the efficacy across patient subgroups.

BACKGROUND: The economic evaluation of the results of the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Artery (GUSTO) trial found that recombinant tissue plasminogen activator is more cost-effective than streptokinase for the treatment of acute myocardial infarction. AIM: We evaluated the impact on a cost effectiveness analysis, of the differences in the cost of thrombolytics among countries and of differences in efficacy across patient subgroups. METHODS: We considered the crude costs of streptokinase and recombinant tissue plasminogen activator in Germany, Italy, the United Kingdom, and the United States of America, and the 30-day mortality found in the GUSTO trial. We calculated the incremental costs for each life saved when streptokinase is substituted by recombinant tissue plasminogen activator. We also calculated the incremental costs for each life saved for two protocols implying a selective use of streptokinase and recombinant tissue plasminogen activator (age-selective protocol: recombinant tissue plasminogen activator in patients < or = 75 years, streptokinase in older patients; site-selective protocol: recombinant tissue plasminogen activator in anterior acute myocardial infarction, streptokinase in non-anterior acute myocardial infarction). RESULTS: The incremental costs for each life saved when streptokinase is substituted by recombinant tissue plasminogen activator in all GUSTO patients vary greatly among countries: the incremental costs for each life saved are 31%, 45%, and 97% higher in Germany, Italy, and the United States of America compared to the United Kingdom. The use of a site-selective protocol implies a halved cost-effectiveness ratio compared to the use of recombinant tissue plasminogen activator in all cases of acute myocardial infarction. CONCLUSIONS: (1) The cost-efficacy of recombinant tissue plasminogen activator vs streptokinase in acute myocardial infarction varies greatly among countries due to differences in the cost of drugs. (2) A selective use of thrombolytics for some sites of infarction is more cost-effective than the exclusive use of recombinant tissue plasminogen activator.

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 sector's 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.

[Economy and management: what doctors think. A national survey]. / Economia e Management: cosa ne pensano i medici. Una indagine nazionale.

INTRODUCTION: As managerial issues are a crucial component of the recent health care reform (Dec Leg.vo 502/92), it is urgent to collect information on physicians' knowledge, attitudes and interests on management and economics. Aim of the national survey presented here is to make a contribution in this area. METHODS: A survey based on 18 items questionnaires with closed-ended questions sent to 1,720 physicians (general practitioners, neurologists and psychiatrists). RESULTS: Response rate was 42%. Only 13% of respondents stated that the Reform will not affect physicians' work. More than 50% of our sample thought that economic and management skills may contribute to the improvement of the NHS. Younger physicians and senior consultants are more aware of the role of management in their profession, while GPs tend to be sceptical. DISCUSSION: Economic and management issues are no longer ignored by physicians. There is the opportunity to develop further training programs for physicians aimed at improving their managerial skills.

[Evaluation of the cost-effectiveness of thrombolytic therapy in acute myocardial infarct using tissue plasminogen activator or streptokinase:the Italian perspective]. / Valutazione costi-efficacia della terapia trombolitica nell'infarto miocardico acuto con attivatore tissutale del plasminogeno o con streptochinasi: la realtà italiana.

UNLABELLED: The GUSTO trial demonstrated that tPA is more effective than streptokinase in the therapy for acute myocardial infarction (AMI). Although tPA is much more expensive than streptokinase some recent analyses have demonstrated that the use of this drug is also cost-effective. However, the cost of the two drugs is different in Italy and USA. Moreover, the difference of the efficacy of the two drugs varies greatly among subgroups of patients with AMI. The aim of this study was to assess the cost-effectiveness of the exclusive use of tPA and streptokinase in the general population and in subgroups of patients divided according to age and site of AMI, using the costs of the drugs in Italy (streptokinase 100,600 and tPA 1,524,300 Italian Liras (ItL)/treatment). METHODS: The results of the GUSTO trial (30 day-mortality) obtained in the general population and subgroups (< or = 75 years and > 75 years; anterior AMI and non-anterior AMI) were applied to patients enrolled in the GISSI-2 trial. The number of lives saved and the incremental costs for each life saved were calculated for the use of tPA in respect to the use of streptokinase. Results are referred to the treatment of 1000 patients. RESULTS: In the general population, in respect to the use of streptokinase, the use of tPA would save 10 lives at an incremental cost of 142.370 millions ItL/life saved. The use of tPA in patients aged < or = 75 years would save 11 patients at the incremental cost of 129.427 millions ItL/life saved, while the use of tPA in patients aged > 75 years would save 13 patients at the incremental cost of 109.515 millions ItL/life saved. In anterior AMI, tPA can save 19 patients at the additional cost of 74.932 millions ItL/life saved, while in non-anterior AMI it can save 6 patients at the additional cost of 237.238 millions ItL/life saved. A subgroup analysis demonstrated that 9 lives can be saved with the use of tPA in anterior AMI and streptokinase in non-anterior AMI at the cost of 49.038 millions ItL/life saved, in respect to the exclusive use of streptokinase. CONCLUSIONS: 1. The cost-effectiveness ratio of tPA in the general population with AMI is comparable to that of other expensive therapies (< 150 millions ItL/life saved). 2. However, a strategy implying a selective use of the two drugs is far more cost-effective (< 50 millions ItL/life saved).

[Costs of psychiatric services: a study performed at a public mental center in the Lombardy Region, Italy]. / I costi delle prestazioni in psichiatria: un'analisi condotta in un Centro Psico-Sociale (CPS) pubblico in Lombardia.

OBJECTIVE: The implementation of a simple methodology to estimate full costs of services provided by a public mental health centre. SETTING: CPS (NHS Mental Centre) Ussl 35, Magenta, Lombardy Region. METHOD: To estimate full costs of 16 types of service we followed a two step procedure. The first step was to estimate all costs attributable to the CPS. In the second one, we allocated this estimate to each type of service provided. We attributed to the CPS the following cost items: personnel, utilities (telephone, electricity, water, heating and cleaning), land & building, transports (for services provided outside the clinic) and a share of general cost of the USSL to which the CPS belongs. Full cost of each service was then calculated on the base of the yearly number of services provided and the time spent by each health professional. RESULTS: In 1995, the CPS provided 14,562 services. Total costs amounted to L 1,356 million, and more than three quarters of this amount was attributable to the personnel working at the CPS. Unit costs ranged from L 5,300 (drug administration) to L 442,400 (family therapy involving two professionals for 90 minutes) The unit cost of psychiatric visits, psychologist consultations and nurse domiciliary visits were L 105,300, L 106,600 and L 78,000, respectively. CONCLUSIONS: This approach requires accessible data and is relatively simple to manage. Some refinements are required, especially to improve the methodology for the determination and the allocation of overheads. However, we are convinced that this cost accounting procedure provides acceptable estimates of the services provided by the CPS. These estimates suggest that charges to be used to fund NHS providers may be too low, especially if fee-for-service will be the main funding source.

The economic and social burden of Alzheimer disease on families in the Lombardy region of Italy.

The purpose of this study was to measure resource consumption associated with the provision of nonmedical care to noninstitutionalized patients with Alzheimer disease (AD) residing in the Lombardy Region of Italy. A questionnaire was mailed to 1,501 caregivers who sought advice from the "Federation Alzheimer Italia" in 1995. On the basis of 616 returned questionnaires, the authors estimated that a patient with AD requires 18 hours per week of paid nonmedical services and 45 hours per week of personal care provided by a primary caregiver. Primary caregivers are more likely to be women, spouses, and retired. Almost 7 of 10 patients are supported by at least a second caregiver. Annual expenditure for nonmedical cost per patient with AD is estimated to be L 13,388,000 (U.S. $8,218). Using the replacement cost approach, the authors estimated the economic cost of informal (unpaid) care to be L 72,877,000 (U.S. $44,736). Despite some limitations in the design of the survey, this first Italian study on primary data highlights the impressive economic burden of AD on families. It also shows that AD puts many Italian families at great financial risk. Adequate and timely funding arrangements should be urgently found to make resources available to future generations of patients.

Economic evaluation of HIV testing among intravenous drug users. An analytic framework and its application to Italy.

We performed an economic evaluation of HIV testing among intravenous drug users (IVDUs) in Italy using the analytical framework of cost-effectiveness analysis. A semi-Markov model was developed to calculate costs and life expectancy of a cohort of IVDUs with and without an annual HIV testing program. We also investigated the incremental cost-effectiveness of a hypothetical early treatment to prolong the life expectancy of HIV-infected asymptomatic subjects by 1 year. The testing program is cost saving in the low prevalence scenario (0.05), and costs L 14,000,000 (US $8,400) and L 55,800,000 (US $33,500) per year of life saved in areas of medium (0.3) and high (0.6) prevalence, respectively. The incremental cost-effectiveness of the hypothetical early treatment may compare favorably with other health care interventions. The program may be considered a cost-effective procedure in low and medium prevalence areas. Where prevalence is high, more evidence about the magnitude of the behavior change is needed. In these areas, the availability of an effective early treatment may become the economic rationale for implementing such a program.