Empirical data on the varicella situation in Germany for vaccination decisions.

As epidemiological data concerning varicella in Germany were not available, a retrospective study was conducted to investigate the impact of the disease, focusing also on economic aspects. A representative German-wide sample of 1334 unvaccinated varicella cases was obtained in 1999 from randomly selected paediatric (P) and general, as well as internal, mainly adult (A), practices. Following representative weighting, the median age was 5 years, with 90% of cases aged < 12 years. The highest incidence was in children aged 5-6 years. Varicella-related complications occurred in 5.7% of patients, and accounted for 0.1 hospital days/case on average. Certificates of sick leave were issued for 1.3 sick days/case, with 0.6 days paid by health insurance funds to parents caring for their sick child, and 0.7 days paid by the employer. With an annual incidence of 760,000 diagnosed cases in Germany for the year 1999, this amounts to an annual cost of c.150 million Euro, with c. 50 million Euro paid by the statutory health insurance system. It was concluded that universal varicella vaccination in Germany would provide essential clinical improvements for patients and prevent hospital admissions. In addition, significant economic benefits can be expected, mainly because of the high level of indirect health costs in Germany.

The cost-effectiveness of routine childhood varicella vaccination in Germany.

This study explores the economic value of a routine varicella vaccination program for Germany. An age-structured decision analytic model was used to assess the benefits, costs and cost-effectiveness of an immunization program for a period of 30 years. Three interventions were compared with no vaccination: universal vaccination of around 15 months old healthy children, vaccination of susceptible adolescents (11-12 years of age), and the combined strategy. The analysis was conducted from both the societal perspective and the payers', i.e. sickness funds, perspective. Input data were mainly derived from a retrospective survey (analyzed were 1334 patient records) and from a seroprevalence study (n = 4602 sera). Using a coverage rate of 85% and a vaccine efficacy rate of 86% routine children vaccination could prevent around 611,000 varicella cases and over 4700 major complications per year. Average yearly cost savings for the society are 51.3 million Euro. The benefit-cost ratio (BCR) is 4.12. From the third-party payer's perspective, the BCR is 1.75 which is a consequence of significant reimbursement of parent's lost earnings by German sickness funds. The adolescent vaccination strategy has a favorable BCR ratio of 8.44 from the societal perspective, but clearly inferior medical effects. The combined vaccination strategy showed similar results as the children strategy. Routine childhood varicella vaccination appears to be a highly efficient strategy to reduce the burden of varicella and results in significant savings for both the society and the payers.

[Economical analyses in interventional radiology]. / Okonomische Analysen in der Interventionellen Radiologie.

Considerations about the relation between benefit and expenses are also gaining increasing importance in interventional radiology. This review aims at providing a survey about the published data concerning economical analyses of some of the more frequently employed interventions in radiology excluding neuroradiological and coronary interventions. Because of the relative scarcity of literature in this field, all identified articles (n = 46) were included without selection for methodological quality. For a number of radiological interventions the cost-effectiveness has already been demonstrated, e. g., PTA of femoropopliteal and iliac artery stenoses, stenting of renal artery stenoses, placement of vena-cava filters, as well as metal stents in malignant biliary and esophageal obstructions. Conflicting data exist for the treatment of abdominal aortic aneurysms. So far, no analysis could be found that directly compares bypass surgery versus PTA + stent in iliac arteries.

Economic outcomes analysis of stenting versus percutaneous transluminal coronary angioplasty for patients with coronary artery disease in Japan.

The purpose of this study was to compare the clinical outcomes and costs of coronary stenting with conventional percutaneous transluminal coronary angioplasty (PTCA) in patients with coronary artery disease (CAD) in Japan. The increasing use of stent implantation in CAD has raised economic concerns for healthcare decision makers. This decision analysis model, which applies to the Japanese healthcare system and uses recent clinical and economic data, demonstrates coronary stenting to be superior to PTCA, both in terms of effectiveness and cost. Although the procedural costs for the stenting group are substantially higher than for PTCA (1,233,412 yen versus 709,295 yen, respectively; p<0.001), the difference in cost between the two procedures (524,117 yen) is already reduced to 299,408 yen by the time of hospital discharge due to procedural complications and associated bail-out treatments avoided during the in-hospital period. The initial incremental cost of stenting is more than recouped by the end of year one, mainly because of savings realized due to avoided repeat revascularization procedures. The cost neutrality (or small cost saving) is maintained over subsequent years. Thus, coronary artery stenting leads to better results as well as cost neutrality after one, two and three years. This highly desirable outcome implies that stenting rather than PTCA alone should be the treatment of choice and dominant strategy in Japan from the viewpoint of both the patient and the healthcare system.

Evaluation of the potential clinical and economic effects of bodyweight stabilisation with acarbose in patients with type 2 diabetes mellitus. A decision-analytical approach.

Bodyweight is an acknowledged independent risk factor for coronary heart disease (CHD). The present model analysis was undertaken to investigate the clinical and economic impact of bodyweight gain in patients with type 2 (non-insulin-dependent) diabetes mellitus and its effects on the development of CHD. Based on a retrospective re-evaluation of data from the Diabetes Intervention Study (DIS), patients with type 2 diabetes mellitus and stable bodyweight (group A) had a significantly lower rate of combined CHD events (30.3%) than patients showing a bodyweight gain (group B; 38.2%) over 10 years. Prevention of bodyweight gain, therefore, appears to be a meaningful strategy in the management of diabetes mellitus. In addition to this clinical advantage, prevention of CHD will also result in economic savings associated with avoided treatment of coronary events. Based on the clinical outcomes from the DIS, the calculated per-patient net savings for a patient with type 2 diabetes mellitus and stable bodyweight amounted to 1085 deutschmarks (DM) when compared with a patient experiencing a bodyweight increase. In a further step, the above situation was projected to current type 2 diabetes mellitus practice. Oral first-line treatment of type 2 diabetes mellitus is usually initiated with glibenclamide (glyburide), which is known to increase bodyweight (reflecting group B). The novel alpha-glucosidase inhibitor acarbose, in contrast, appears to be as effective as glibenclamide, but has the advantage of being bodyweight-neutral (reflecting group A). From the clinical viewpoint, acarbose can thus be considered an alternative to glibenclamide. From the viewpoint of drug costs, monotherapy with acarbose is 4 times as expensive as glibenclamide in Germany, resulting in per-patient incremental costs of DM3527 for acarbose over 10 years. Balanced against the potential 10-year cost saving of DM1085 resulting from the potential of acarbose to prevent CHD, around one-third of the incremental cost of acarbose may be recouped by this single effect. However, further possible benefits of acarbose, including the avoidance of hypoglycaemia and the deferral of costly insulin therapy, may improve the economic value of this novel antidiabetic agent. Given the indirect approach of this evaluation and its many limitations, the above findings need critical appraisal, and comparative trials are urgently required to substantiate our preliminary results.

Economic evaluation of ribosomal immunotherapy in patients with chronic ear, nose and throat and respiratory tract infections: results for Italy.

OBJECTIVE: This study analyses the economic value of ribosomal immunotherapy in patients with chronic ear, nose and throat (ENT) infections and respiratory tract infections (RTI) as compared with patients not receiving prophylaxis. Specifically, the objective was to determine whether the incremental costs of ribosomal immunotherapy could be offset by healthcare savings through a reduction in recurrent episodes of acute infection. DESIGN AND SETTING: The study was conducted from the payer perspective in the Italian healthcare setting. A 6-month time-frame was used in the decision analysis model, and costs reflect 1995 values. The model incorporated international clinical trial data and Italian resource use data for adult patients with chronic sinusitis and bronchitis and children with recurrent ENT infections. MAIN OUTCOME MEASURES AND RESULTS: The findings indicate that ribosomal immunotherapy is capable of generating net direct cost savings over 6 months ranging between 280 000 and 1 100 000 Italian lire (L) per patient (L1700 approximately $US1) depending on the type of chronic disease studied (otitis media or rhinopharyngitis in children, sinusitis or bronchitis in adults). Threshold incremental efficacy of immunoprophylaxis required to achieve cost equivalence compared with no prophylaxis ranged between 2 and 20%, depending on the indication and the magnitude of treatment cost associated with an acute infectious episode (low/best/high estimate) considered. In view of the incremental efficacy rates observed in clinical trials ranging between 40 and 65% for patients with ribosomal immunoprophylaxis, prevention of recurrent ENT infections and RTI appears to be an economically meaningful therapeutic strategy, even when assuming that efficacy rates achievable in real clinical practice may be lower than those reported in clinical trials. CONCLUSION: On the basis of these findings for Italy, physicians should give increased attention to ribosomal immunoprophylaxis of chronic respiratory diseases in children and adults.

New Perspectives on the Cost-Effectiveness of Palmaz-Schatzª Coronary Stenting, Balloon Angioplasty, and Coronary Artery Bypass Surgery Ñ A Decision Model Analysis.

We developed an outcomes model to compare both the clinical effects and cost-effectiveness of the following strategies for treating patients with single (SVD) and multi-vessel (MVD) coronary artery disease: coronary stent implantation (CSI), balloon angioplasty (PTCA), and coronary artery bypass surgery (CABG). These analyses have been carried out in five European countries: France, Germany, Italy, The Netherlands, and Spain, accounting for approximately 75% of revascularization procedures performed in Europe. This paper describes the methodology, details the model, discusses input data, and reports on clinical outcomes. Country-specific data and findings are reported in five ÒsatelliteÓ papers to this communication. The clinical outcomes predicted in our model are different from those of earlier studies in that we have found stenting to be clinically more superior to PTCA in terms of improving event-free survival than previously reported in SVD (89% vs. 75% at 1 year; 82% vs. 68% at 3 years). This is due to the clinical input data and expert estimates used, which consider the most recent advances in stent technology: heparin-coated stents, high-pressure post-stent dilatation, the replacement of anticoagulation with antiplatelet therapy, and a shortened length of hospital stay due to reduced complications. In MVD, CABG is the superior treatment strategy, with a predicted event-free survival of 90% at 3-years. MVD stenting is predicted to markedly improve patient outcomes as compared to PTCA, and is not far behind CABG (76% at 3 years).

Cost-Effectiveness of Palmaz-Schatzª Stenting for Patients with Coronary Artery Disease in France.

The increasing use of stent implantation in coronary artery disease raises economic concerns for health care decision-makers. This model analysis, which applies to the French health care system and uses the latest clinical and economic data, demonstrates coronary stent implantation (CSI) in single-vessel disease (SVD) to be clinically and economically superior to conventional balloon angioplasty (PTCA). Although the procedural cost for CSI remains higher than for PTCA (FF 19,500 vs. FF 12,400), this cost difference in the cath lab is decreased to approximately FF 4,800 during the in-hospital period due to avoided procedural complications and associated bail-out treatments. By the end of year one, the incremental cost of CSI is virtually recouped through savings in revascularization procedures (cost difference FF 150), and the result is maintained over subsequent years. this favorable cost outcome, combined with a higher rate of event-free patients, also improves the cost-effectiveness of CSI which has a 29.4%, 30.5% and 32.2% lower cost per event-free survivor than PTCA at the 1Ð, 2Ð and 3Ðyear follow-ups, respectively. In multi-vessel disease, CSI also appears to be a cost-effective alternative to CABG.

Cost-Effectiveness of Palmaz-Schatzª Stenting in Patients with Coronary Artery Disease in Germany.

The increasing use of stent implantation in coronary artery disease raises economic concerns for health care decision-makers. This model analysis, applying to the German health care system and using the latest clinical and economic data, demonstrates coronary stent implantation (CSI) in single-vessel disease (SVD) to be superior to conventional balloon angioplasty (PTCA). Although the procedural cost for CSI remains higher than for PTCA (DM 6,776 vs. DM 5,117), this cost difference in the cath lab is decreased to approximately DM 800 during the in-hospital period due to avoided procedural complications and associated bail-out treatments. By the end of year one, the incremental cost of CSI is more than recouped through savings in revascularization procedures, and the result is maintained over subsequent years. This favorable cost outcome, combined with a higher rate of event-free patients, also improves the cost-effectiveness of CSI, which has a 34.6%, 35.4%, and 36.8% lower cost per event-free survivor than PTCA at the 1-, 2-, and 3-year follow-ups, respectively. In multi-vessel disease, CSI also appears to be a cost-effective alternative to CABG.

Cost-Effectiveness of Palmaz-Schatzª Stenting for Patients with Coronary Artery Disease in Italy.

The increasing use of stent implantation in coronary artery disease raises economic concerns for health care decision-makers. This model analysis, which applies to the Italian health care system and uses the latest clinical and economic data, demonstrates coronary stent implantation (CSI) in single-vessel disease (SVD) to be clinically and economically superior to conventional balloon angioplasty (PTCA). Although the procedural cost for CSI remains higher than for PTCA (Lit. 7.5 million vs. Lit. 4.9 million), this cost difference in the cath lab is decreased to approximately Lit. 1.7 million during the in-hospital period due to avoided procedural complications and associated bail-out treatments. By the end of year one, the incremental cost of CSI is totally recouped through savings in revascularization procedures, and the result is maintained over subsequent years. This favorable cost outcome, combined with a higher rate of event-free patients, also improves the cost-effectiveness of CSI, which has a 30.2%, 31.2%, and 32.9% lower cost per event-free survivor than PTCA at the 1-, 2-, and 3-year follow-ups, respectively. In multi-vessel disease, CSI also appears to be a cost-effective alternative to CABG.

Cost-Effectiveness of Palmaz-Schatzª Stenting in Patients with Coronary Artery Disease in The Netherlands.

The increasing use of stent implantation in coronary artery disease raises economic concerns for health care decision-makers. This model analysis, applying to the Dutch health care system and using the latest clinical and economic data, demonstrates coronary stent implantation (CSI) in single-vessel disease (SVD) to be clinically and economically superior to conventional balloon angioplasty (PTCA). Although the procedural cost for CSI remains over NLG 3,300 higher than for PTCA (NLG 8,871 vs. NLG 5,510), this cost difference in the cath lab is decreased to approximately NLG 2,200 during the in-hospital period due to avoided procedural complications and associated bail-out treatments. By the end of year one, the incremental cost of CSI is virtually recouped (by over 90%) through savings in revascularization procedures, and this result is maintained over subsequent years. Combined with a higher rate of event-free patients, this virtual cost-equality improves the cost-effectiveness of CSI, which has a 27.8%, 29.4%, and 31.5% lower cost per event-free survivor than PTCA at the 1-, 2-, and 3-year follow-ups, respectively. In multi-vessel disease, CSI also appears to be a cost-effective alternative to CABG.

Cost-Effectiveness of Palmaz-Schatzª Stenting for Patients with Coronary Artery Disease in Spain.

The increasing use of stent implantation in coronary artery disease raises economic concerns for health care decision-makers. This model analysis, applying to the Spanish health care system and using the latest clinical and economic data, demonstrates coronary stent implantation (CSI) in single-vessel disease (SVD) to be clinically and economically superior to conventional balloon angioplasty (PTCA). Although the procedural cost for CSI remains higher than for PTCA (Ptas. 677,000 vs. Ptas. 436,000), this cost difference in the cath lab is decreased to approximately Ptas. 150,000 during the in-hospital period due to avoided procedural complications and associated bail-out treatments. By the end of year one, the incremental cost of CSI is more than recouped through savings in revascularization procedures, and this result is maintained over subsequent years. Combined with a higher rate of event-free patients, this cost-savings clearly improves the cost-effectiveness of CSI, which has a 31.1%, 32.0%, and 33.6% lower cost per event-free survivor than PTCA at the one-, two-, and three-year follow-ups, respectively. In multi-vessel disease, CSI also appears to be a cost-effective alternative to PTCA and perhaps CABG.

Results of a Meta-Analysis of Trapidil, a PDGF Inhibitor Ñ A Sufficient Reason for a Second Look to the Pharmacological Approach to Restenosis.

Restenosis in 30%Ð40% of patients remains the major limitation to the long-term success of balloon angioplasty (PTCA) in patients with coronary artery disease. So far, only coronary stent implantation has established its role as an effective strategy to prevent restenosis after PTCA. In contrast to numerous pharmacological strategies that all have failed to demonstrate a convincing reduction in the rate of restenosis, trapidil, a PDGF inhibitor, has shown promising and conclusive results in animal models as well as in three human trials published between 1992 and 1994. Although the results of the human trials showed trapidil to be capable of reducing restenosis after PTCA by 40%Ð53% compared to control patients, the compound is not well known and little used in interventional cardiology. Possible explanations for this situation may include trapidilÕs non-availability in the United States and most European countries, the small number of trapidil trials and treated patients, as well as a probable perception of the medical community that a pharmacological approach to restenosis prevention is unlikely to work. Additionally, clinical expert behavior has often shown not to be synchronized with accumulating evidence of efficacy. The results of this meta-analysis, however, demonstrate trapidilÕs efficacy. The rate of per-patient restenosis in the trapidil group was more than halved as compared to controls (odds ratio 0.44, 95% confidence interval 0.29Ð0.66). Tolerability with trapidil was good, and the rare adverse events observed included gastric intolerance, thrombocytopenia, headache, and increased serum AST and ALT levels which were transient or subsided with cessation of treatment.

Economic evaluation of immunoprophylaxis in children with recurrent ear, nose and throat infections.

This study compares the costs of immunoprophylaxis versus no immunoprophylaxis in children with recurrent ear, nose and throat (ENT) infections (otitis media and rhinopharyngitis) using ribosomal immunotherapy ('Ribomunyl'). The per-patient cost of ribosomal immunotherapy (FF297) is offset by direct savings garnered through the prevention of many acute infectious episodes. The net 6-month per-patient savings associated with immunoprophylaxis range from FF272 to FF1704, depending on the indication and the type of treatment-cost estimate. Saved healthcare resources include physician consultations and visits, laboratory tests, medicotechnical services (audiometric tests) and antibiotic therapy. Sensitivity analysis of efficacy and treatment-cost estimates enabled threshold ranges of incremental efficacy to be identified. Cost-equivalence between the 2 treatment options was found to exist when the incremental efficacy of immunoprophylaxis lay between 7.4 and 17.5% (recurrent otitis media), and between 8.9 and 26.1% (recurrent rhinopharyngitis). Thus, even when clearly lower incremental efficacy rates than those reported in controlled clinical trials (approximately 40 to 60%) are assumed, ribosomal immunotherapy can still be expected to be cost effective. An analysis of the perspectives of the various payers in the French healthcare system demonstrated that net savings occurred for all payers involved. However, social security insurance would gain most from an immunoprophylaxis programme. Based on the evidence presented here for France, physicians and payers should give increased attention to this treatment option.

[Cost-benefit analysis of malaria prophylaxis with mefloquine in travelers to Kenya]. / Kosten-Nutzen-Analyse der Malariaprophylaxe bei Keniareisenden mit Mefloquin.

With an increasing movement towards cost saving in the health sector, preventive medicine must also be judged according to its economic viability. The fact that prevention can autofinance itself is suggested by the results of a cost/benefit analysis of chemoprophylaxis of Falciparum malaria with Mefloquin among travellers in Kenya. Out of the whole group of travellers analysed by means of an interview-based test (Malpro-Study), the costs in the case of both Switzerland and the Federal German Republic were lower for those people who had undergone Mefloquin-prophylaxis than for those who had not. In this way the prophylaxis not only compensates the required outlay but also results in an overall benefit in macroeconomic terms. Therefore economically based opposition to the prophylaxis of malaria with Mefloquin for short stays in high-risk countries is not justified.