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.

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.

Resource utilization and hospital cost of HIV/AIDS care in Italy in the era of highly active antiretroviral therapy.

This study set out: (1) to describe resource utilization patterns among four groups of HIV-infected patients at different stages of the disease, and (2) to estimate the direct hospital costs of HIV/AIDS care among these patients in Italy. It is a multi-centre, prospective observational study conducted between August 1997 and July 1998. The 483 patients, enrolled in five infectious diseases departments located in different areas of Italy, were stratified into four groups according to their CD4+ lymphocyte cell count and status of AIDS Defining Illness (ADI) at enrolment. Average direct hospital costs (L = Italian Lire, 1997 exchange rate US$ 1 = 1,704 Italian Lire) were L.23,725,584 (US$ 13,923.5), L.15,208,287 (US$ 8,925.1), L.11,942,761 (US$ 7,008.7) and L.7,660,942 (US$ 4,495.9) for the four groups of patients. More than 80% of patients in the first group and about 65% of patients in the second group received highly active antiretroviral therapy (HAART). The proportion of patients receiving HAART in the third and fourth group increased from 37.1% to 56.5% and from 15.3% to 31.5%. The number of hospital days observed in this study was much lower than previously published numbers in Italy. These results may indicate a shift of costs from hospitalisation to outpatient care and ARV.

The outpatient cost of diabetes care in Italian diabetes centers.

OBJECTIVE: To provide resource utilization patterns and cost estimates of outpatient care for types I and II diabetes mellitus in Italy, based on retrospectively collected data. DESIGN: Multicenter, retrospective observational study analyzing individual costs in a sample of patients with diabetes mellitus. STUDY POPULATION: A total of 2260 patients were stratified into eight groups by type of diabetes, glycemic control, and age. SETTING: Thirty-five centers for diabetes care in Italy. RESULTS: The per-patient cost of treatment was [symbol: see text] 136.8 in two months for type I diabetes (N = 592) and [symbol: see text] 123.3 for type II diabetes (N = 1668). Pharmaceutical therapy consisting of antidiabetic drugs only accounted for only 32% to 36% of treatments cost in type I patients and between 13% and 24% in type II. Diagnostic tests accounted for 27% to 42% of treatment costs in patients with both type I and type II diabetes, day-hospital days accounted for 15% to 22% in type I, 25% to 27% in type II, and consultations accounted for 16% to 20% in type I patients and between 17% and 21% in type II diabetes. CONCLUSION: Despite limitations caused by the short period considered, and considering that in Italy the cost of diabetes has received limited attention, we believe this study presents some interesting information on the burden of diabetes in this country.

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.

The costs of childhood epilepsy in Italy: comparative findings from three health care settings.

PURPOSE: To determine the direct costs of epilepsy in a child neurology referral population, stratified by disease, duration, and severity, comparing three different health care settings [i.e., teaching or clinical research (CR) hospitals, general hospitals, and outpatient services]. METHODS: Patients were accepted if they had confirmed epilepsy and were resident in the center catchment area. Eligible subjects were grouped in the following categories: (a) newly diagnosed patients; (b) patients with epilepsy in remission; (c) patients with active non-drug-resistant epilepsy; and (d) those with drug-resistant epilepsy. Over a 12-month period, data regarding the consuming of all resources (i.e., consultations, tests, hospital admissions, drugs), were collected for each patient. Using the Italian National Health Service tariffs, the unit cost of each resource was calculated and indicated in Euros, the European currency. RESULTS: A total of 189 patients was enrolled by two teaching-CR hospitals, two general hospitals, and two outpatient services. The patients were evenly distributed across the four categories of epilepsy. The mean annual cost per person with epilepsy was 1,767 Euros. Drug-resistant epilepsy was the most expensive category (3,268 Euros) followed by newly diagnosed epilepsy (1,907 Euros), active non-drug-resistant epilepsy (1,112 Euros), and epilepsy in remission (844 Euros). Costs were generally highest in teaching-CR hospitals and lowest in outpatient services. Hospital services were the major cost in all epilepsy groups, followed by drugs. CONCLUSIONS: The cost of epilepsy in children and adolescents in Italy tends to vary significantly depending on the severity and duration of the disease Hospitals services and drugs are the major sources of costs. The setting of health care plays a significant role in the variation of the costs, even for patients in the same category of epilepsy.

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.

Ramipril prolongs life and is cost effective in chronic proteinuric nephropathies.

BACKGROUND: Our objectives were to predict the long-term cost and efficacy of the angiotensin-converting enzyme, ramipril, in patients with nondiabetic chronic nephropathies. METHODS: The time to end-stage renal disease (ESRD) was predicted by two different models based on the rate of glomerular filtration rate decline (DeltaGFR) and incidence of ESRD (events) measured during the Ramipril Efficacy in Nephropathy Trial in 117 and 166 patients, respectively, randomized to comparable blood pressure control with ramipril or conventional therapy. Direct medical costs of conservative and renal replacement therapy were estimated by a payer perspective, and cases more and less favorable to ramipril were computed by a sensitivity analysis. The study took place at the Clinical Research Center for Rare Diseases, "Aldo & Cele Daccò," Bergamo, Italy. Patients included those with chronic, nondiabetic nephropathies and persistent urinary protein excretion rate >/=3 g/24 h. Time to ESRD, survival, and direct costs of conservative and renal replacement therapy are discussed. RESULTS: Both in the DeltaGFR-based or events-based models, ramipril delayed progression to ESRD and prolonged patient survival by 1.5 to 2.2 and 1.2 to 1.4 years, respectively, and saved $16,605 to $23,894 lifetime and $2, 422 to $4203 yearly direct costs per patient. Even in the less favorable hypotheses, ramipril allowed lifetime and yearly cost savings that exceeded 10 to 11 and 20 to 40 times, respectively, the additional costs related to prolonged survival. CONCLUSIONS: In our study population, ramipril prolongs life while saving money because of its beneficial effect on the course of nondiabetic chronic nephropathies.

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.