Resource utilization and direct costs of pediatric HIV in Italy.

This multicenter, prospective, observational study assessed the global economic impact of HIV care in a large cohort of HIV-infected children and adolescents in Italy. Three pediatric departments of reference participated on a voluntary basis. Centers were asked to enroll all their children during the period April 2010-March 2011. At enrollment, a pediatrician completed a questionnaire for each patient, including the type of service at access (outpatient consultation or day hospital), laboratory tests, instrumental examinations, specialists' consultations, antiretroviral therapy and opportunistic illness prophylaxis. Eligible patients had a confirmed diagnosis of HIV infection caused by direct vertical maternal-fetal transmission, their age ranging from 0 to 24 years. Since patients routinely have quarterly check-ups in all three centers, we adopted a three-month time horizon. Health-care services were priced using outpatient and inpatient tariffs. Drug costs were calculated by multiplying the daily dose by the public price for each active ingredient. A total of 142 patients were enrolled. More than half the patients were female and the mean age was 14 years, with no significant differences by center. There were substantial differences in health-care management among the three centers, particularly as regards the type of access. One center enrolled the majority of its patients in day-hospital and prescribed a large number of clinical tests, while children accessed another center almost exclusively through outpatient consultation. Drug therapy was the main cost component and was very similar in all three centers. The day-hospital was the second highest cost component, much higher than outpatient consultation (including examinations), leading to significant differences between total costs per center. These findings suggest that a recommendation to the Italian National Health Service would be to use more outpatient consultation for patients' access in order to increase their efficiency in treating pediatric HIV infection.

Healthcare costs of multiple myeloma: an Italian study.

Few economic evaluations are currently available on multiple myeloma (MM) and they address treatment-related rather than disease-related costs. We estimated resource utilisation and costs associated with MM in an Italian haematology department. This was a single-centre observational study which followed retrospectively for 2 years 90 patients with MM stages II-III. To investigate the association between costs and age as a prognostic factor for treatment eligibility, patients were classified in two age groups (under 65 or >65). The annual average cost per patient was very similar in the two subgroups. Drugs and hospitalisations were the largest cost components. Differences between the two age groups were significant only for drugs, hospital admissions and day hospital (DH) days. Autologous stem-cell transplantation (ASCT) accounted for more than 80% of the non-pharmacological therapy costs, being nearly double in the younger patients. Cost of elderly patients is comparable with that of younger ones who generally receive expensive procedures such as ASCT. The higher hospital costs of younger patients were counterbalanced by supportive pharmaceutical care and DH days for older patients, mainly in the group treated with new immunomodulatory agents. Further multi-centre studies on larger samples of patients are needed.

Pharmacoeconomic studies in Italy: a critical review of the literature.

To assess the state of pharmacoeconomics in Italy we reviewed all the original studies published by Italian authors in national and international journals from January 1994 to December 2003. We selected 70 articles and broadly assessed 92 economic evaluations (EEs) since some articles contained multiple analyses. We adopted common analysis criteria to allow methodological comparison of the studies. The variables investigated can be grouped into three categories: general methods, costs, and consequences. To further assess the quality of the EEs, we decided to rank them according to criteria of both clinical and economic good practice. Then, to complete our critical evaluation, we analysed whether sponsorship might have somehow affected the results. Our analysis seems to support the widespread scepticism of the Italian NHS decision-makers towards pharmacoeconomic studies, whose results seem to be biased by flawed methods and sponsors' interference with results.

Quality of vision: A consensus building initiative for a new ophthalmologic concept.

PURPOSE: Many studies have addressed the quantification of visual acuity, and the conventional method of measuring it has so far demonstrated serious limitations. Vision testing requires new methods that can more precisely express the quality of vision as perceived by the patient. METHODS: This study employed the Delphi method of consensus building. Concepts associated with quality of vision (QoV) were identified by a board of experts and proposed to participating specialists in two subsequent questionnaires. Upon receipt of the completed questionnaires, the replies were classified to determine the building blocks of a consensus. RESULTS: By analyzing the replies to the two questionnaires, the authors determined the key elements of QoV on which a consensus was found among the respondents. CONCLUSIONS: A consensus was reached on the opinion that the quantification of visual acuity by traditional means is inadequate for investigating QoV. Although visual acuity is still a basic element for testing, the experts believe that contrast sensitivity, reading speed, and microperimetry are additional parameters necessary for quantifying QoV. The use of a psychometric questionnaire on visual function could allow a better interpretation of visual impairment.

The costs of epilepsy in Italy: a prospective cost-of-illness study in referral patients with disease of different severity.

PURPOSE: [corrected] Epilepsy poses a considerable economic burden on society. However, information is insufficient on the comparative costs of different disease varieties. The purpose of this study was to compare the direct costs of epilepsy in referral patients with disease of different severity and duration. METHODS: Patients with newly diagnosed epilepsy (NDE), seizure remission (SR), occasional seizures (OS), frequent non-drug-resistant (NDR) and drug-resistant (DR) seizures, and surgical candidates (SC) from 14 epilepsy centers were the target population. All patients were followed prospectively for 12 months and all medical and paramedical contacts for diagnostic and therapeutic services were noted with details, using ad-hoc diaries and semistructured questionnaires. RESULTS: The study population comprised 525 consecutive children and adults with partial (68%), generalized (25%) and undetermined epilepsy (4%) as follows: NDE 70; SR 131; OS 108; NDR 101; DR 107; SC 8. Ambulatory visits (mean 2.8 per patient per year) were the leading service in all groups, followed by EEG recordings (1.8) and biochemical assays (1.1). At entry, the commonest drugs were carbamazepine (50%), valproate (37%), phenobarbital (21%), vigabatrin (14%) and lamotrigine (11%). New antiepileptic drugs (AED) were used increasingly with the severity of the disease. The total annual costs varied significantly across groups: 3945 Euro (SC), 2198 Euro (DR), 1626 Euro (NDR), 1002 Euro (NDE), 558 Euro (OS), 412 Euro (SR). The main item of expenditure was hospital stay (including day-hospital), followed by drug treatment and outpatient visits. The costs of outpatient services, hospital services and drugs varied significantly across groups. CONCLUSIONS: The direct costs of epilepsy vary significantly depending on the severity of the disease and the response to treatment. Hospital admissions and drugs are the commonest items of expenditure.

Economic evaluation of an educational campaign for early diagnosis of cutaneous melanoma.

Public educational campaigns for the early diagnosis of cutaneous melanoma are considered an effective approach in the prevention of this disease, since they increase the number of cases detected early and consequently lengthen patients' life expectancy. We performed an economic evaluation of such a campaign in Bergamo, Italy, in order to quantify its costs and consequences. We used cost-effectiveness analysis to compare the costs and effects of the campaign with those of the 'do nothing' option. The analysis was performed from the perspective of the Italian National Health Service [the Servizio Sanitario Nazionale (SSN)]. Accordingly, only direct costs related to publicly financed healthcare services were considered. No indirect costs or benefits were considered because they are not relevant to the SSN. Incremental analysis was used to obtain results in terms of additional costs per life-year saved (LYS). Overall LYS were quantified by comparing the survival curves for 4 subgroups of patients with different lesional thicknesses at diagnosis ( < 0.76mm, 0.76 to 1.50mm, 1.51 to 3.00mm and > 3.00mm). All costs were estimated in 1993 Italian lire (L). Overall effectiveness amounted to 233.49 LYS. Using a 5% discount rate, the value of effectiveness was 171.3 LYS. The total cost of the educational campaign (i.e. the sum of the organisational and 'induced' costs minus the costs saved) was estimated at L817 million (approximate 1993 exchange rate $US1 = L1573), and L905 million after discounting at a rate of 5%. Thus, using discounted cost and effectiveness data, the cost of the educational campaign was L5.28 million per LYS.

The cost of urinary incontinence in Italian women. A cross-sectional study. Gruppo di Studio Incontinenza.

OBJECTIVE: To offer cost estimates of urinary incontinence (UI) in the general population based on prospectively collected data. DESIGN: We analyzed individual costs in a sample of women with UI who were identified in the framework of a cross-sectional study on the prevalence of UI in women aged > 40 years. SETTING: Six areas in Italy. INTERVENTION: Home interview. PATIENTS AND PARTICIPANTS: Women were identified among the patients registered with a network of general practitioners operating in each area using computer-generated random number lists. RESULTS: A total of 2767 women were identified. Of these, 408 (14.7%) reported UI during the year before the interview and 229 underwent a detailed interview on UI-related costs. On the basis of this information, we estimated the direct costs associated with UI from the perspective of the Italian National Health Service (INHS). The lifetime cost per patient of diagnosis was 80,131 Italian lire (L) (exchange rate: $US1 = L1618). Consultations accounted for only 20% of the diagnostic cost, diagnostic tests for 36% and hospital admissions for diagnostic procedures accounted for 44%. The diagnosis cost estimate seems low, partly because several women did not request either consultations or diagnostic tests (the overall rate per patient was 0.76 for consultations and 0.39 for diagnostic tests). The only appreciable treatment cost, according to the INHS perspective, was for diapers. The annual cost per patient for diapers was L255,519. The prevalence of UI in women aged > 40 years in Italy is estimated in the study at 9.3%. Thus, combining this information with the cost estimates, the annual treatment cost of UI in Italian women aged > 40 years is L351,800 billion, considering diapers and drugs only. CONCLUSION: This study has estimated the individual cost of UI in the general population. These figures may be useful when designing economic evaluations of UI.

Economic evaluation of ACE inhibitor treatment of nephropathy in patients with insulin-dependent diabetes mellitus in Italy.

Diabetic nephropathy is one of the major complications of insulin-dependent diabetes mellitus (IDDM), with proteinuria being the main clinical manifestation of diabetic nephropathy. Most patients who develop overt proteinuria progress to end-stage renal disease (ESRD), usually within 5 to 7 years; ESRD necessitates dialysis or renal transplantation. Although a relationship between blood pressure reduction and delaying of ESRD has been assumed for a long time, only recently has a controlled randomised clinical trial shown that the treatment of diabetic nephropathy with an ACE inhibitor can significantly delay the loss of renal function and, therefore, ESRD. Consistent with the clinical trial on which this economic evaluation was based, the costs and consequences of 2 alternatives were considered: (i) patients subject to blood pressure control with only antihypertensive medication, but without an ACE inhibitor (placebo group) and (ii) patients given ACE inhibitor therapy (captopril group) with similar blood pressure control to the placebo group. This cost-effectiveness analysis was performed from the perspective of the Italian National Health Service [Servizio Sanitario Nazionale (SSN)]. Accordingly, only direct costs related to publicly funded healthcare services were included. The number of dialysis-years avoided (DYA) was the clinical end-point. A 10-year time horizon was considered for the economic evaluation. Captopril therapy was dominant, being at the same time more effective and less costly. The total cost for the captopril alternative during the 10-year period was 21,901,625 Italian lire (L; 1993 values) per patient, while total cost for the placebo alternative was L30,352,590 per patient. Compared with placebo, 20.01 DYA per 100 patients treated were estimated with captopril therapy during the trial period, equivalent to 2.4 months per patient. The robustness of this result was confirmed by sensitivity analysis: for both extremes, captopril remained dominant. This economic evaluation, requested by the Italian Ministry of Health, demonstrated savings in healthcare expenditure with the use of an ACE inhibitor in patients with proteinuria.

Costs of diabetes. A methodological analysis of the literature.

OBJECTIVE: To review studies on the costs of diabetes and its complications through a scheme designed specifically for assessing the quality of cost-of-illness (COI) studies. DESIGN AND SETTING: The methodology of COI studies in diabetes was analysed in order to assess the significance of quantitative results. The scheme adopted 7 items identified as the main points for discussing the methodological choices governing the results. We also used a checklist based on questions related to the 7 items. MAIN OUTCOME MEASURES AND RESULTS: The answers showed that many studies appear not to give technical details, so it is hard to understand the method. Methodological choices varied widely between the studies. This is probably due to the lack of consensus on the methodology of COI studies. Based on the findings of this review, we suggest also some specific points that could help produce more reliable results on the costs of diabetes. CONCLUSIONS: Clearly, a general consensus on COI studies is still remote, making the value of any comparison of results questionable.

Direct costs of schizophrenia in Italian community psychiatric services.

OBJECTIVE: To estimate resource utilisation and direct costs of treatment for patients with schizophrenia in Italian Community Mental Health Centers (CMHCs). DESIGN: Multicentre, retrospective observational study. CMHCs recruited all patients who attended a follow-up consultation during the period September to December 1998. At enrollment, psychiatrists completed a questionnaire on consumption of resources in the 2 months before recruitment. SETTING: 14 CMHCs. PERSPECTIVE: Italian National Health Service (INHS). PATIENTS: 702 patients with a diagnosis of schizophrenia or other psychotic disorders, defined according to the Diagnostic and Statistical Manual of Mental Disorders-fourth edition. These patients had been followed by the CMHCs for at least 2 years and attended a follow-up consultation either during the period September to December 1998 or on randomly selected days during this period. Patients were classified into seven groups according to their diagnosis. RESULTS: The mean direct cost of patients with schizophrenia in the 2-month observation period was 2,234,475 Italian lire [L] (1154.01 Euro; EUR); direct costs ranged from L.1,545,818 to L.2,775,658 (EUR798.35 to EUR1433.51) by prognostic group. There was wide variability for prognostic groups in the impact of most cost components on total cost. Admissions accounted for between 11.4 and 56.3% of the total cost, daycare centre days for between 11.3 and 35.5%, home visits for 7.8 to 16.4%, and day-hospital days for 5.4 to 32.8%. Antipsychotics and anxiolytics were the most prescribed drugs and also the most costly. CONCLUSION: Despite the limitations of the study related to the short period considered, we believe this study offers some interesting information on the burden of schizophrenia, a disease for which its cost has received limited attention so far in Italy.

A comparative analysis of generics markets in five European countries.

A generic medicine is a faithful copy of a mature drug--no longer under patent marketed with the chemical name of the active ingredient. This article analyses generics markets in five European countries: France, Germany Italy, The Netherlands and the U.K. The study investigate all the main issues--patent, approval to market, pricing and reimbursement, prescription and distribution--which affect the life cycle of a pharmaceutical product. The situation in the five countries varied widely. Because of European harmonization, patent legislation and approval procedures no longer affect much the development of generics. Only national legislation on patent protection approved before the EU directive came into force still plays a role. Approval differences seem to be due mainly to common practice, rather than to the regulations themselves. None of the countries have an efficient public information system on patent expiry. Generics have had more success in countries with more flexible pricing policies. Reimbursement has not yet been used widely to discriminate between generics and proprietary drugs. Financial incentives are based more on physicians' prescribing behaviour than on pharmacists. The freedom of pharmacy ownership and the consequent possibility of dispensing pharmaceuticals through different channels affects dramatically the structure of generics markets. A free market of wholesalers and retailers can enhance a comparative market, through horizontal and vertical integration all along the distribution chain. Such an environment has stimulate the success of unbranded generics by delegating strong purchasing power to distributors.

The German experience in reference pricing.

Price regulation schemes function both as a means for public authorities to contain costs, and as an economic tool to support the national pharmaceutical industry. This twofold contradictory aim of public intervention in pharmaceutical demand and supply makes such pricing schemes difficult to apply. This article concerns the reference price scheme which concerns setting a price cap for each active ingredient, or group of active ingredients considered equivalent according to some feature (e.g. therapeutic effects and chemical structure). In 1989, the reference price scheme for reimbursable drugs was introduced in Germany to reduce pharmaceutical expenditure, which had been steadily increasing in the past. The study investigates the economic effects of introducing reference prices in Germany in order to assess whether this system has been effective in containing public pharmaceutical expenditure. We conclude that the reference price scheme is an effective tool for price control, but cost containment requires further measures.

A comparative analysis of domiciliary oxygen therapy in five European countries.

This comparative study analyses the domestic market of domiciliary oxygen therapy in five European countries (Denmark, France, Germany, Italy, and the UK) according to a common checklist of subjects. Domestic legislation, prescription procedures, delivery, and the market situation concerning oxygen therapy were considered. The analysis involved (i) reviewing the literature on oxygen therapy in national and international journals, and (ii) interviewing a selected expert panel of market operators in each country (composed of at least one civil servant, one physician, one distributor, and one oxygen manufacturer). The analysis did not find any specific relationship between the health care system framework and the oxygen therapy market, except for a greater inclination towards home care in national health services. In all these countries oxygen therapy is reimbursed, but the type of supply and its diffusion differ widely. The spread of domiciliary care has undermined the traditional role of pharmacies in the oxygen distribution chain in all countries except Italy. The study did not help identify any specific country that can be considered a benchmark for oxygen therapy, each one dealing with oxygen therapy in a different way. An economic evaluation of the different supply modalities could help improve decision making by public authorities.

Is EQ-5D a valid measure of HRQoL in patients with movement disorders? A comparison with SF-36 and FIM questionnaires.

We assessed the descriptive part of the EQ-5D system in rehabilitation patients with validity severe moving disorders and compared it with the FIM and the SF-36 Health Survey in a sample of 60 patients. We analyzed the EQ-5D convergent validity and the correlations between EQ-5D scores and a clinical variables. The internal validity of the EQ-5D instrument proved good. Moreover, the EQ-5D discriminated symptom severity as scored by the FIM and the SF-36 correspondent subscales. We analyzed the sensitivity of the EQ-5D only with respect to the ability of patients to move with or without a wheelchair. Most patients considered "moving a wheelchair" as a good way of "getting about." This investigation can be considered a pilot study on the performance of the EQ-5D in a group of pathologies involving various degrees of movement disorders. The findings show possible problems of misinterpretation in the levels of the mobility dimension.

Pharmacoeconomic analysis of prescriptions in Italian pediatric general practice.

Most drugs used by children are prescribed by general pediatric practitioners (GPPs) in ambulatory settings. Prescription profiles are affected by GPPs' attitudes while the cost is related to the reimbursement modality. This study evaluated the Italian National Health Service (INHS) and family expenditures associated with prescribing practices to children younger than 12 years. Forty-two GPPs from southern Italy participated in the study. All visits recorded by GPPs during a 13-week period (February-April 1998), including telephone contacts and office and home visits were analyzed. The cost analysis of prescriptions is based on a sample of randomly selected consultations. INHS and family expenditures were evaluated according to reimbursement modalities for drug prescriptions. Total expenditure induced by all prescriptions during the study period was about 148 million Italian lire (7650 euros); 54% of this was borne by the INHS and the rest remaining by families. When corrections according to prescription modalities - following appropriate reimbursement form - were applied, only 49% of total expenditure were covered by INHS and 51% by families. Analysis of expenditures showed that drugs for symptomatic therapies (e.g., cough and cold preparations, analgesics, antipyretics) and vitamins accounted for most of the families' expenditure, while antibacterial and antiasthmatic drugs did so for the INHS. Of the ten most prescribed drugs the cost of three fell entirely on the family: paracetamol (the most commonly prescribed drug),morniflumate, and ambroxol. Therapeutic indications causing greatest expenditures for families were all the common,trivial childhood symptoms such as cough, fever, rhinitis, flu, and pharyngitis. Despite the universal coverage for pharmaceutical care more than one-half of drug therapy expenditures for children was covered directly by the parents. Prescription attitudes by GPPs remain the crucial factor for an equal cost distribution between families and the INHS.

Cost analysis of dialysis modalities in Italy.

This study analyses management and costs of dialysis in the Italian National Health Service (NHS). Information on efficacy and health-related quality of life (HRQOL) based on the existing literature also is presented. The clinical differences between the dialysis modalities seem to be related to their appropriateness to specific patient groups. Efficacy rates are similar and the only differences are in complications and HRQOL. Traditional haemodialysis (THD) can be done by Italian patients in dialysis centres or in hospital. Highflux haemodialysis (HFHD) is generally only done in hospital. Peritoneal dialysis (PD) is usually done at home. The cost analysis was performed on a sample of Italian dialysis centres and hospitals, according to the full cost method. As expected, HFHD was more expensive than THD and PD, but no marked differences emerged among the different HFHD modalities. THD modalities in dialysis centres were less costly than in hospitals. Automated PD (APD) was much more expensive (almost twice) than continuous ambulatory PD (CAPD), the cheapest method in absolute terms. This study confirms that dialysis is costly and that it is very difficult to assess the cost-effectiveness of the different approaches. Although this study has limits, it should provide sufficient analytical information to local healthcare managers for more rational allocation of financial resources to dialysis services.