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Biomedical subjects

L Garattini

Publications and source records attributed to L Garattini.

13 recordsLinked to original sources

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.

Commerce↗

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.

Adult↗

A model for calculating costs of hospital wards: an Italian experience.

Until recently Italian hospitals had no cost accounting or activity data collection systems, being formally required only to do financial book-keeping. The cost analysis method presented here might be used to set up detailed and complete hospital cost accounting, which would permit a better understanding of patterns of resource distribution among departments, better opportunities for cost saving and cost control for hospital managers and health authorities. The study first identified a framework within which to assess the annual cost related to a hospital ward, then calculated the mean bed day cost for each speciality. Cost data were collected over one year in 1996 from manually compiled records, at one local hospital in Northern Italy. Costs were estimated following a step-down allocation method. Wards requiring a major amount of resources per day of stay are intensive cardio-coronary unit (US$650.689), and ophthalmology (US$483.322). The less expensive ward is general medicine (US$148.645). The cost analysis method presented in this study might be used to set a detailed and complete hospital cost database, which is a necessary tool for hospital managers to realise cost control and cost recovery.

Accounting↗

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.

Cost of Illness↗

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.

Analgesics, Non-Narcotic↗

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.

Adult↗

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.

Cost-Benefit Analysis↗