Pharmacoutilization and costs of osteoarthritis: changes induced by the introduction of a cyclooxygenase-2 inhibitor into clinical practice.

OBJECTIVE: To establish whether the introduction of a cyclooxygenase-2 inhibitor has led to changes in pharmacoutilization in the treatment of osteoarthritis (OA) in clinical practice. METHODS: Administrative and general practice databases were cross-linked to analyse the use of non-steroidal anti-inflammatory drugs (NSAIDs) and gastroprotective agents (GPAs) before and after the introduction of rofecoxib. Costs of treatment and costs of hospitalization for gastrointestinal events were also considered. RESULTS: A total of 3090 patients were evaluated. A significant reduction in the use of GPAs in the rofecoxib group was observed, corresponding to reductions of 64 and 59.7% compared to NSAIDs among patients in incident and prevalent cases respectively. The weighted mean daily cost of therapy with rofecoxib in incident cases was 1.88 euro, 7.4% lower than that of NSAIDs (2.03), and in prevalent cases it was 1.87 euro, 28.1% higher than that of NSAIDs (1.46). Although the rate of hospitalization was similar, there was an additional daily cost per patient of 186.6 for patients being treated with NSAIDs and 21.6 euro for those being treated with rofecoxib. CONCLUSIONS: The cyclooxygenase-2 inhibitor rofecoxib determined substantial changes in the pharmacoutilization and costs of OA.

Clinical and economic outcomes of pneumonia in children: a longitudinal observational study in an Italian paediatric hospital.

RATIONALE, AIMS AND OBJECTIVES: Antibiotic prescription for acute lower respiratory infections (ALRI) in hospitalized children can have a major impact on cure and costs. We performed a longitudinal study to explore the appropriateness of prescriptions, the predictors of therapeutic patterns, and the main outcomes: readmission, length of stay (LOS) and costs. METHODS: Ninety-nine children who were inpatients of a paediatric hospital receiving antibiotic treatment for community acquired ALRI were consecutively enrolled. To calculate the costs of pneumonia treatment, we collected data on clinical presentation and resources consumption. We used multiple regression analysis to identify predictors of LOS and choice of therapy, and one-way ANOVA to evaluate cost differences among treatment groups. RESULTS: Parenteral antibiotics were administered in 64.6% of cases, whereas 35.4% received oral antibiotic therapy by itself (OAT). Switch therapy (SWT) was performed in 43.4% of cases. The most frequently prescribed antibiotic for parenteral therapy was ceftriaxone (58.3%), and for oral therapy cefprozil (58.1%). The median LOS was 3 days and the cure rate 99% (95%CI: 97-100%). SWT and OAT were significantly associated with a shorter LOS. The clinical variables were not significantly associated with SWT or OAT. The average costs per patient in the management of pneumonia were Euro 1435. SWT or OAT were associated with significant lower costs: Euro 1487 per patient (95%CI: 1395-1580) and Euro 1335 per patient (95%CI: 1233-1437), respectively. CONCLUSIONS: The hospital management of paediatric pneumonia was more influenced by the early discharge policy than by clinical variables without under-cure.

Cost-minimization analysis of simvastatin versus atorvastatin for maintenance therapy in patients with coronary or peripheral vascular disease.

BACKGROUND: Previous health economic studies have demonstrated the cost-effectiveness of simvastatin in the treatment of coronary heart disease (CHD) based on clinical results of the Scandinavian Simvastatin Survival Study. A prior analysis evaluated the "cost of getting to goal," but ignored all costs after titration. However, when evaluating the cost-effectiveness of long-term therapies, it is important to consider the maintenance costs as well. OBJECTIVE: The purpose of this study was to evaluate the maintenance costs of treatment with simvastatin versus that of treatment with another more recently available statin, atorvastatin, in a European context. METHODS: We assessed the long-term maintenance cost of simvastatin versus atorvastatin in terms of the cost of reducing low-density lipoprotein cholesterol (LDL-C) levels to the recommended goals based on a previously published clinical trial in patients with CHD. The analysis focused on the patients in the original clinical trial who were randomized to treatment with simvastatin or atorvastatin. Patients began therapy with 10 mg of simvastatin or atorvastatin; the dose of study drug was titrated every 12 weeks up to 40 mg simvastatin or 80 mg atorvastatin, with the addition of up to 8 g/d of cholestyramine until a modified European Atherosclerosis Society LDL-C goal (<2.84 mmol/L) was reached. As there was no significant difference between the 2 groups in resource utilization for adverse events, only drug costs were included. The calculated average annual maintenance cost was based on the distribution of the final daily dosing regimens and the public drug prices for each regimen. Individual country analyses were conducted using each local currency. RESULTS: There was no significant difference between groups in the percentage of patients reaching their LDL-C goal over the study period (80% for simvastatin-treated pa- tients vs 89% for atorvastatin-treated patients, P = 0.135). However, the cost of maintaining a similar percentage of patients at their appropriate LDL-C levels was significantly lower in the simvastatin group compared with the atorvastatin group in 13 of the 17 countries assessed. In the remaining 4 countries, there was a cost advantage for simvastatin, but it did not reach statistical significance. CONCLUSIONS: Across Europe there was a significant reduction in the cost of maintaining patients at their appropriate LDL-C levels with simvastatin versus atorvastatin. The results of this analysis, along with the proven clinical benefits of simvastatin, support the use of this drug as the treatment of choice in the secondary prevention of CHD.

Dermatan sulfate versus unfractionated heparin for the prevention of venous thromboembolism in patients undergoing surgery for cancer. A cost-effectiveness analysis.

BACKGROUND: In a recent clinical trial, dermatan sulfate was found to be more effective than unfractionated heparin (UFH), but equally well tolerated, for the prevention of deep vein thrombosis (DVT) after major surgery for cancer. OBJECTIVE: To perform a cost-effectiveness analysis of dermatan sulfate versus UFH in this clinical setting. DESIGN AND SETTING: This was a retrospective economic analysis using data from a randomised clinical trial, and was performed from the hospital perspective. METHODS: Clinical event rates were extrapolated from the observed venographic DVT rates, using appropriate assumptions from the scientific literature. The economic effects of switching DVT prophylaxis from UFH to dermatan sulfate and the potential lives saved were assessed by a predictive decision model. RESULTS: The per patient cost, including the burden of residual thromboembolic events and major bleeding complications, was estimated to be 154 euros (EUR) for dermatan sulfate and EUR185 for UFH (1998 values). With reference to a potential target population of 60,000 patients/year undergoing surgery for cancer in Italy, the total prophylaxis-associated cost was EUR9,258,000 for dermatan sulfate and EUR11,096,000 for UFH, whereas the potential deaths from prophylaxis failure were 204 and 392, respectively. This represented a saving of EUR1,838,000 and 188 potential lives per year with the dermatan sulfate option. The final costs and effects were mainly sensitive to variations in the rates of DVT and pulmonary embolism, and to the possible need for 1 extra day of hospitalisation because of the earlier preoperative initiation of dermatan sulfate prophylaxis. CONCLUSION: Dermatan sulfate is more cost effective than UFH for the prevention of postoperative venous thromboembolism in patients with cancer. If the hospital stay needs to be prolonged, then the dermatan sulfate option may involve a small additional cost (EUR47) per potential life saved.

Cost-effectiveness study of imipenem/cilastatin versus meropenem in intra-abdominal infections.

BACKGROUND: The efficacy of two carbapenems, imipenem/cilastatin (I/C, 1.5 g daily) versus meropenem (3 g daily) in intra-abdominal infections was assessed in a recent multicenter randomized clinical trial. The aim of this article is to perform a cost-effectiveness analysis as in real-world practice according to the findings of this clinical trial. METHODS: A decision tree was used to estimate the clinical outcomes and direct costs of treating intra-abdominal infections using the two carbapenems from the perspective of the Italian National Health Service (INHS) or a private insurance company (PIC). RESULTS: In a population of 30,000 patients with intra-abdominal infections in Italy, it was estimated that 97 potential deaths/year could be avoided if these patients were treated with I/C versus meropenem. In addition, from the perspective of INHS, the total costs of treatment were estimated as ITL 106,874 million and 134,042 million for I/C and meropenem, respectively. In favor of the PIC point of view, the total costs were estimated as ITL 110,500 million and 135,899 million for I/C and meropenem, respectively. CONCLUSION: The treatment of intra-abdominal infections with I/C is shown to be more effective (97 deaths avoided/year) and less costly than with meropenem (with a saving of ITL 27,168 and 25,399 million/year for INHS and PIC, respectively).

A comparative economic analysis of simvastatin versus atorvastatin: results of the Surrogate Marker Cost-Efficacy (SMaC) study.

Health care payers have become increasingly interested in economic analyses to guide the allocation of limited health care resources. The Surrogate Marker Cost-Efficacy (SMaC) study was undertaken to assess the economics of treatment with simvastatin versus treatment with atorvastatin in reducing low-density lipoprotein cholesterol (LDL-C) in patients in 10 European countries, based on the results of a 1-year, double-blind, parallel-group clinical trial. Participants were between 18 and 80 years of age (n = 177; median age, 57; 94 men and 83 women). Entry criteria were a baseline LDL-C value between 4.2 and 7.8 mmol/L (160 to 300 mg/dL) and a triglyceride value < or =4.5 mmol/L (400 mg/dL). Patients were randomly assigned to receive simvastatin 10 mg or atorvastatin 10 mg. At 16 weeks, any patients not reaching their appropriate LDL-C level received simvastatin 20 mg/d or atorvastatin 20 mg/d. Patients were then followed up for a total of 52 weeks. The overall euro cost analysis was based on the weighted average price of each product across all the independent pharmaceutical markets based on official euro conversion rates. Individual country analyses also were conducted in each local currency. Over the 52-week study, there were no significant differences in the percentage of patients achieving an appropriate LDL-C level (simvastatin 48%, atorvastatin 50%). In the overall euro cost analysis, the cumulative cost of atorvastatin (134 euros) was 33% more than for simvastatin (101 euros) during the first 16 weeks. After titration to 20 mg, the total cost of treatment during the 52-week study remained significantly lower in the simvastatin group than in the atorvastatin group (429 vs 538 euros; P<0.0001). In individual country analyses, therapy with simvastatin was significantly less expensive than therapy with atorvastatin in 8 of 10 countries (P = 0.001 to 0.003). In the remaining 2 countries, there was no significant difference in cost. Across the countries included in the evaluation, there was a significant reduction in the cost of getting patients to appropriate LDL-C levels with simvastatin compared with atorvastatin. These results should provide useful information for physicians and payers; however, additional long-term clinical trials are required to assess fully how treatment with atorvastatin affects patient outcomes, safety, and costs.

[Epidemiology and social/health implications of hydatidosis in Sardinia]. / Epidemiologia ed implicazioni socio-sanitarie dell'idatidosi in Sardegna.

All surgically treated cases of hydatidosis registered in Sardinia from 1969 to 1984 have been analysed. The 16-year period clearly shows that unilocular hydatid disease caused by larvae of tapeworm, Echinococcus granulosus, is endemic in Sardinia. In this region there are foci of human infection notably in the sheep rearing areas, of Nuoro and Sassari. The incidence of human hydatidosis shows a marked regional variation varying during the last survey (1982-1984) between 16.9/1000 in the province of Nuoro to 8.3/1000 in the province of Cagliari. Not all population is at equal risk e.g. 47.1/1000 is the incidence in shepherds respect to 8.9/1000 in employed in services. In Sardinia, although there are a wide variety of suitable intermediate host species, is sheep the determinant host for the perpetuation of the parasite's life cycle. The prevalence rate in cattle, pigs and goats in under 30% while the sheep incidence is extraordinarily high, over 90% are infected. The dogs showed a prevalence rate of 10-20%, the infection was more frequent in shepherd-dogs and strays. The rate of hydatidosis in man appears significantly correlated with number of dogs and sheep per inhabitants. Two factors are, at present, determinant in the dissemination of hydatidosis: the common sardinian practice of slaughtering sheep at home and the indiscriminate proliferation of dogs which mainly live as strays. The epidemiological picture and the economic consequences of hydatidosis in man and livestock, a damage of 28 billions of liras per year, strongly suggest this disease as a major public health problem in Sardinia.

[Hydatidosis in Sardinia. Co-involved parameters and hypothesis for a control campaign]. / Idatidosi in Sardegna. Parametri coinvolti ed ipotesi per una campagna di controllo.

Although hydatidosis provokes in man and livestock losses of economic significance, there has been no comprehensive study on this disease. This article is an account of Sardinia as an important area of echinococcosis-hydatidosis. The incidence and distribution of infection in the intermediate and definitive hosts are reviewed and the current status of hydatid disease is evaluated. The review is divided into main sections: (a) geographical and environmental data; (b) domestic intermediate hosts; (c) definitive host; (d) human infections. An average of 85% of the sheep are infected and about 75% of cysts are fertile, 13% of the dogs are parasitized and mainly live as strays, up to 39% of the shepherd's dogs were found to harbour the mature worm of Echinococcus granulosus. Hospital data indicate that even nowadays about 200 people are operated every year with an incidence of 11.1/100.000 inhabitants. The socio-cultural factors (seminomadism, slaughtering practice, etc.) involved in the dissemination, the economic implication of this disease, the benefits due to an eradication, the feasibility of a campaign and the organizational structure aimed at eradicating echinococcosis/hydatidosis in this area, are discussed.

Hydatidosis in Sardinia: review and recommendations.

In Sardinia, hydatidosis due to Echinococcus granulosus is endemic and constitutes a current and important problem in the economy and public health. This paper reviews the epidemiological aspects, including the geographical distribution, and the socio-cultural factors involved in the dissemination of hydatidosis. Hospital data indicate that about 200 people undergo surgery for hydatid cysts every year with an average of 8.8 deaths annually. An average of 80% of the sheep are infected, constituting a livestock loss estimated as over 20 billion liras per year. The benefits expected from a hypothetical control programme amount to approximately 32 billion liras against an investment of 17 billion liras in a control programme extending over a period of 10 years. The eradication campaign should result in a gradual reduction of infection rate from 80% to 10% in sheep, from 30% to 3-5% in dogs and in a reduction of human morbidity from 200 to 15 cases, equal to a prevalence rate of 1 per 100,000 inhabitants.

Cost-effectiveness analysis of echinococcosis-hydatidosis eradication project in Sardinia.

In this study we attempt to evaluate the convenience of a campaign to eradicate the echinococcosis in Sardinia vs a 'do-nothing' or do-very-little policy adopted at this time. The main conditions which have to be met in setting up the eradication programme are identified as follows: (a) precise knowledge of the real diffusion of the parasitosis in man and animals; (b) eradication project control (action research); (c) health education; (d) reduction of stray canine population; (e) anthelmintics distribution and permanent health control to registered dogs. In Italy, echinococcosis-hydatidosis is present in many regions but in none has reached the diffusion rate present in Sardinia where over 200 patients per year are surgically treated, with a prevalence rate of 13.32 per 100,000 inhabitants. The disease does not spare any social or age group. The economic aspects of hydatidosis involve losses due both to human and to livestock resources, evaluated in monetary or non-monetary terms, according to circumstances. As a method to evaluate the human life has been assumed the years gained related to the Potential Years of Life Lost (PYLL). Several Net Present Values (NPV) have been calculated under alternative discount rates inclusive of the Internal Rate of Return (IRR).