Ermanno Attanasio

Dermatan Sulfate versus Unfractionated Heparin for the Prevention of Venous Thromboembolism in Patients Undergoing Surgery for Cancer: A Cost-Effectiveness Analysis

AbstractBackground: 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.

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.

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).

Una prima valutazione economica dell’impiego di rofecoxib versus FANS convenzionali nell’artrosi

SummaryObjectiveRandomised clinical trials have demonstrated that rofecoxib has a better gastrointestinal tolerability profile than conventional nonsteroidal anti-inflammatory drugs (NSAIDs) in osteoarthritis, which results in a reduced utilisation of gastroprotective agents (GPA). The aim of this study was to estimate, from the national healthcare system perspective, the total drug costs in patients switched from NSAIDs plus GPAs to rofecoxib.DesignIn this longitudinal, observational study, drug prescriptions for symptomatic treatment of osteoarthritis were recorded. A decision tree was used to compare the mean daily drug cost of the following therapeutic options for ostheoarthritis: conventional NSAIDs and rofecoxib/conventional NSAIDs.SettingAzienda Unità Sanitaria Locale 110, Ravenna, Italy.Patients56,827 patients affected by osteoarthritis were monitored from January 1997 to December 1999. Of this group, we considered the first 2,935 patients who were examined by 21 General Practitioners in the period July 2000-October 2000, in order to point out changes in GPAs co-prescription after the introduction of rofecoxib in the Italian market.InterventionsAlternative treatments compared were: NSAIDs either alone or combined with GPAs (NSAIDs option), and just after the introduction of rofecoxib, NSAIDs or rofecoxib alone and NSAIDs or rofecoxib combined with GPAs (rofecoxib/NSAIDs option).Main outcome measures and results27,511 out of 56,827 patients (48.4%; IC 95%: 48.0–48.8%) treated with NSAIDs also received a GPA co-medication. In the aforementioned subgroup of 2,935 patients, 1,814 (62%) received multiple prescriptions of NSAIDs or rofecoxib. In this subgroup, rofecoxib was associated with a statistically significant reduction of GPAs utilisation of 58.8% (IC 95%: 30.7–80.1; p = 0.012) compared with what was recorded during treatment with NSAIDs. In fact, the mean daily cost per patient of the NSAIDs option was € 1.66 versus € 1.55 of the rofecoxib/NSAIDs option (6.6% lower).ConclusionsOur preliminary results suggest that the use of rofecoxib is associated with cost savings in terms of total drug costs compared with conventional NSAIDs.

Analisi costo-efficacia di due combinazioni sequenziali di trattamenti di eradicazione dell'Helicobacter pylori

SummaryObjective To compare the costs and outcomes of two different protocols of three consecutive combinations of eradication therapies in patients with Helicobacter pylori (HP)-positive dyspepsia with or without peptic ulcer disease, from the perspective of the Italian National Health System (INHS). Design An open comparative study with a one-year follow-up was performed. A decision tree was used to calculate cost-effectiveness. Setting Department of Infectious and Tropical Diseases of the University “La Sapienza”, Rome, Italy. Interventions Three different eradication therapies were tested: Amoxicilline + Metronidazole + Omeprazole [Amo]; Clarithromycin + Metronidazole + Omeprazole [Cmo]; Tetracycline + Clarithromycin + Bismuth [Tcb]. These eradication therapies were consecutively arranged in the CAT protocol (Cmo-Amo-Tcb) and in the ACT protocol (Cmo-Amo-Tcb). Patients and participants The patients enrolled in the study were 229 and distributed as follows: 104 in the ACT protocol and 125 in the CAT protocol. Main outcome measures and results The CAT protocol resulted more effective and costly than the ACT protocol after the first two eradication therapies. The incremental effectiveness was 12 and 22 eradicated patients while the incremental cost was Lit. 221,461 and Lit. 279,948 in patients with and without peptic ulcers, respectively. However, considering the entire therapeutic cycle (three eradication treatments), the total direct cost per patient with initial ulcer was Lit. 1,166,919 for CAT patients (Lit. 1,157,368 for those without ulcer) and Lit. 1,196,571 for ACT ones (Lit. 1,330,648 for those without ulcers). Conclusions The CAT protocol resulted more effective and less costly than the ACT ptotocol at the end of the full therapeutic cycle. After a year from diagnosis, the CAT protocol could produce saving to the INHS ranging from Lit. 60 to 520 billions due to lower drug consumption and lower use of diagnostic tests.

Health Technology Assessment: un altro punto di vista

ConclusioneIn conclusione, nel settore esiste una ripetizione di esperienze con scarse possibilità di recuperare le informazioni utili. Gli strumenti di valutazione appaiono ancora come fenomeni locali, scarsamente coordinati e generalizzabili, con conseguente spreco di energie. Non esiste alcuna politica che guardi all’HTA come strumento di programmazione, nel rispetto delle diverse necessità e dello sviluppo compatibile. L’iniziativa della SIHTA sarebbe veramente meritoria se riuscisse a raccogliere le esperienze fatte e le realtà esistenti in un sistema complessivo di orientamento delle decisioni circa l’opportunità, la convenienza e la sostenibilità delle innovazioni tecnologiche nella moderna medicina.[27] Altrimenti, si confonderebbe tra le tante iniziative intraprese, nate e morte senza risultati nel lungo termine, e sarebbe proprio il caso di ripetere: “nihil sub sole novi”.

Questionnaire for Trial Submission

Please return the completed questionnaire as soon as possible to the Section Editor: Susan Galandiuk, MD Department of Surgery School of Medicine University of Louisville Louisville, KY 40292, USA Tel.: +1 502 852 5442 Fax: +1 502 852 8915 or contact: S. Karger AG Attn.: Ms. Yvonne Rebmann Allschwilerstrasse 10 PO Box CH–4009 Basel Tel.: +41 61 306 13 51 Fax: +41 61 306 12 34 E-Mail: y.rebmann@karger.ch ABC K I 99 69 3