Diabetes--prevalence and cost of illness in Germany: a study evaluating data from the statutory health insurance in Germany.

OBJECTIVE: This population-based study assesses the prevalence and cost of illness as a result of diabetes mellitus in Germany by retrospectively analysing routine health insurance data. Prevalence and costs were analysed from statutory health insurance (GKV) and societal perspectives. RESEARCH DESIGN AND METHODS: The analysis comprises data of all insured persons of six large sickness funds. The insured with diabetes were identified via ICD-9 diagnosis and Anatomical Therapeutic Chemical Classification System (ATC) code for regular medication prescriptions. Costs for inpatient stay, medication and sickness benefits were taken from claims data. Costs for rehabilitation, premature death and early retirement were calculated using the human capital approach and data from national statistics. RESULTS: Overall diabetes prevalence in this age and sex standardized census of six large sickness funds was 6.45%. The cost of illness for sickness funds including hospital cost, medication and sickness benefits, and excluding ambulatory doctor care, were Euro 3.69bn . The total cost of diabetes from a societal perspective was calculated at Euro 5.71bn for the year 1999. CONCLUSION: In accordance with the results of recent studies using routinely collected health insurance data, our study suggests that the prevalence of diabetes mellitus has increased steadily in the past years. The prevalence in our population of 14.7 million insured was 6.45%. Total costs of diabetes mellitus amounted to Euro 5.71bn.

Asthma: prevalence and cost of illness.

The purpose of this study was to estimate the prevalence and cost of illness of asthma in Germany by retrospectively analysing routine health insurance data. This analysis investigated claims data from all insured persons of six large sickness funds. Insurants with asthma were identified via the International Classification of Diseases (ninth revision) diagnosis and the Anatomical Therapeutic Chemical Classification System Code for regular medication prescriptions. Costs for hospital care, medication and sick benefit were taken from claims data. Costs for rehabilitation, premature death and early retirement were estimated using the human capital approach and data from national statistics. Prevalence of asthma in the German statutory health insurance was 6.34%. Total costs for asthma, including direct and indirect costs, were calculated at euro 2.74 billion during 1999. The prevalence of asthma in the German statutory health insurance has previously been estimated to be 4-6%. The results of this large study show the prevalence of asthma in the German social insurance system to be approximately 6%. The study also indicates that there is room for substantial savings in the German social insurance system, with indirect costs amounting to 74.8% of total costs and payment of sick benefits through the sickness funds amounting to 58.3% of indirect costs. These costs may be reduced with better asthma control in patients.

Weight reduction by sibutramine in obese subjects in primary care medicine: the SAT Study.

BACKGROUND: Sibutramine is a selective serotonin and noradrenaline reuptake inhibitor that is known to reduce body weight. The efficacy of this drug in primary care medicine is currently unknown. OBJECTIVE: To study, in a primary healthcare setting, the effect of a standardized non-pharmacological treatment program and 15 mg sibutramine or placebo on long-term weight reduction in obese subjects with a body mass index >or= 30 and < 40 kg/m(2). DESIGN: A multicentre, double-blind, placebo-controlled, randomized, parallel group comparison over 54 weeks of continuous therapy. SETTING: 33 general practitioners in Germany. SUBJECTS: 389 obese patients were recruited of whom 362 were randomized. MEASUREMENTS: Primary measure was weight reduction at week 54; others included reduction in BMI, waist circumference, waist-hip ratio, blood pressure and blood lipids. RESULTS: 348 obese subjects were analyzed using an intention-to-treat analysis. Mean weight loss in the sibutramine (S) group was 8.1 +/- 8.2 kg vs. 5.1 +/- 6.5 kg in the placebo (P) group (p < 0.001; Intent-to-treat analysis). More subjects lost more than 5 % and 10 % of initial weight with sibutramine than with placebo (5 %, S: 62.6 %, P: 41.4 %, p < 0.001; 10 %, S: 40.8, P: 19.0 %, p < 0.001). Weight loss was accompanied by an improvement in the lipid profile, in particular, an increase in HDL-cholesterol and a decrease in fasting triglycerides. In both groups, systolic and diastolic blood pressure decreased in those with moderate hypertension and remained unchanged in those with normal blood pressure at baseline. There was a modest increase in heart rate in S (1.9 beats/min) vs. P (- 0.9 beats/min) (p < 0.05). CONCLUSIONS: Under primary care conditions, sibutramine 15 mg daily proved to be a safe and effective drug for additional weight loss in obese subjects undergoing a comprehensive weight reduction program.

Effectiveness of the glycoprotein IIb/IIIa antagonist abciximab during percutaneous coronary interventions (PCI) in clinical practice at a single high-volume center.

OBJECTIVE: Randomized controlled trials (RCTs) showed that the glycoprotein (GP) IIb/IIIa antagonist abciximab is able to reduce ischemic complications during percutaneous transluminal coronary interventions (PCIs). Its effectiveness in daily clinical practice in unselected patients remains to be determined. DESIGN, SETTING AND PATIENTS: From 7/1997 until 12/2000, 3310 PCIs were performed at the Heart Center Ludwigshafen. Out of them, 1076 (32.5%) patients were nonrandomly treated with a GP IIb/ IIa antagonist. Patients who were treated with abciximab were matched with patients not treated with abciximab. The matching procedure resulted in 590 pairs of patients. RESULTS: Patients treated with abciximab were more likely to have a history of former PCI (13.7% versus 8.8%, p=0.008) or coronary artery bypass surgery (19.2% versus 12.8%, p=0.003). There were no differences in concomitant diseases, left ventricular function, number of vessels diseased or target vessel. However, patients treated with abciximab had a higher rate of more complex stenosis (> or =B2; 94.4% versus 80.7%, p<0.001) and a longer x-ray exposition (median 486 s versus 422 s, p<0.001). Treatment with abciximab was associated with a significantly lower incidence of the combined endpoint of death, reinfarction or stroke during the hospital stay (2.4% versus 4.4%, p=0.039). This was confirmed after adjustment for confounding parameters (p=0.034). There was no increase in the rate of severe bleeding in the abciximab group (p=0.347). After one year the rates for the combined endpoint were 8.5% in the control group and 6.2% in the abciximab group (univariate analysis, p=0.134; multivariate analysis, p=0.143). CONCLUSION: Treatment with abciximab during PCI in daily clinical practice at a high volume center in patients with a high rate of acute coronary syndromes seems to be as effective as shown in RCTs.

[Cost-effectiveness of coronary heart disease prevention]. / Kosten-Effektivität der KHK-Prävention.

Most experts agree that prevention of coronary heart disease (CHD) should be enforced. However doubt remains about how extensively pharmacological treatment should be applied. In the presence of strong financial constraints both issues emphasize the importance of health economic analyses in this area. This article describes important principles in health economics. As the effect of preventive measures can only be recognized after a considerable time lag, a long-term perspective has to be chosen. A suitable parameter are the costs per life year saved, which can be compared between otherwise completely different procedures. The assessment of different therapies depends strongly on parameters such as relative risk reduction, discount rate and costs for prevention. However it was shown that prevention with statins and anti-hypertensive therapy can be cost-effective, as the mortality reduction and hence the increase in life expectancy can be considerable. Further research is necessary, e.g., to investigate possible reductions of other vascular diseases, to acquire more knowledge about long-term cost-consequences.

[Coronary intervention and occupational rehabilitation--a prospective, randomized intervention study]. / Koronarintervention und berufliche Reintegration--Eine prospektive, randomisierte Interventionsstudie (KIRL).

Coronary catheter revascularisation is less costly than bypass surgery due to lower direct (medical) and indirect costs (loss of work). Many studies show that the time patients stay out of work following coronary intervention is much longer than necessary. This leads to a considerable increase of indirect costs, which can far exceed the medical costs of the treatment. This prospective randomised study was done to determine whether specific information to patient and family doctor results in an earlier return to work. After catheter revascularisation 100 working patients (mean age 52.4 years) were randomised either to the intervention group (information to patient and family doctor) or to the control group (no specific information about return to work). Four months later 81 patients had returned to their previous jobs (mean sick leave 18.9 +/- 24.8 days) while 19 were still out of work. In the control group, the rate was 79% and the mean sick leave was 16.4 +/- 22.0 days (median 7); in the intervention group 83% had returned to work after a mean of 21.5 +/- 27.4 days (median 10). There was no significant difference between the two groups, neither according to the rate of returned workers nor to the duration of sick leave. In the subgroup of patients with a private insurance (23% of all) 96% started to work again (mean sick leave 5.7 +/- 5.1 days median 3.5), while the rate was 77% in the group of panel patients (mean sick leave 23.7 +/- 27.4 days, median 11). The difference in sick leave between these two groups was highly significant (p = 0.0003). Specific information to the patient and family doctor has no effect on the time patients stay out of work following catheter revascularisation. It seems that the observed delay depends on social and psychological factors that cannot be influenced directly.

[Cost effectiveness of lipid lowering therapy]. / Kosteneffektivität der lipidsenkenden Therapie.

BACKGROUND: Due to increasing pressure to save money in the health care sector economical evaluations become more and more important. The following article deals with cost-effectiveness analyses regarding lipid-lowering therapy. Results are discussed in the light of methodological issues. COMPARISON OF EFFECTIVENESS: The choice of life years gained as effectiveness parameter facilitates the comparison of different therapies. Non-pharmacological therapies were able to achieve a reduction of risk factors, but a mortality reduction has not been proven so far. COST-EFFECTIVENESS OF STATINS: Own analyses from the perspective of the social insurance demonstrate that statins are cost-effective in secondary prevention of coronary heart disease (CHD). This confirms results from the viewpoint of the statutory health insurance under additional consideration of interaction between the various sectors of the social insurance in Germany. In primary prevention the cost-effectiveness is strongly related to the initial CHD risk. For which risk groups the therapy with statins is both effective and efficient depends on the underlying assumptions. Overall accepted threshold values for cost-effective therapies could be reached at a yearly risk of coronary heart disease of about 1.5%. CONCLUSION: The results should be considered by decision makers in the evaluation of statin therapy.

[Stent implantation as initial coronary interventional therapy? A theoretical model on clinical and economical consequences of in-stent restenosis]. / Die Stentimplantation als initiale koronarinterventionelle Therapie? Ein theoretisches Modell zur klinischen und ökonomischen Konsequenz der In-Stent-Restenose.

The reduction of acute complications and late restenosis compared to conventional PTCA has led to a rapid increase in stent implantation as initial treatment for coronary stenosis. As a result, in-stent restenosis has become an important clinical and economical problem, especially the diffuse form, which is much more likely to reappear. In order to compare the consequences of initial stenting and initial angioplasty, we developed an analytic model, considering the differences between diffuse and focal in-stent restenosis. The simulation based on the optimized therapeutic proceeding following an elective 1-vessel revascularization of a 60-year-old patient, dealing with probabilities for acute complications and late restenosis taken from the literature and in-hospital costs obtained from 200 elective interventions. In the stent group 71.0% of patients were free of any target lesion-related event, compared to 60.2% in the PTCA group. Catheter reintervention was necessary for 32.1% of the patients initially treated with angioplasty and for 17.6% of the initially stented patients, whereas 7.7% of the stent patients had to undergo elective bypass surgery as final treatment compared to 2.8% in the PTCA arm. Long-term medical costs for initial stenting (6,237 Euros) were 14% higher than for conventional PTCA (5,345 Euros). Taking also into consideration the indirect costs (loss of productivity) for a collective with an employment rate of 50%, the difference between stent implantation (9,067 Euros) and angioplasty (8,581 Euros) is smaller. Initial treatment of coronary stenosis by stent implantation decreases the rate of repeat revascularization compared to initial PTCA, but there is a greater likelihood that elective bypass surgery will become necessary. This difference in following treatment is related to the occurrence of diffuse in-stent restenosis. When calculating the long-term costs stenting still appeared to be more expensive than PTCAA because the savings in following costs can not compensate for the higher primary in-hospital costs. An empirical study which collects cost data in different hospitals as well as in the outpatient setting over 1 year is necessary to confirm this preliminary result.

[Coronary disease and social security. A simulation model on cost analysis]. / Die koronare Herzkrankheit und die Sozialversicherung. Ein Simulationsmodell zur Kostenanalyse.

A Monte Carlo simulation model is presented which allows an assessment of the costs for coronary heart disease (CHD) (from a social security perspective) to be made over a time interval of 10 years. The difference between a CHD population and a normal population is calculated whereby the CHD population corresponds in terms of age and gender distribution to a German population with existing hypercholesteremia. The data were generated from the results of the German Cardiovascular Prevention Trial (DHP), a population was determined which represents the age group of the 45- to 65-year-old German population. Both direct as well as indirect costs were taken into account. The model simulates 2 submodels: 1. CHD is already present in the observed population. 2. A proportion of the observed cases of hypercholesteremia develop CHD over a time interval of 10 years, whereby normal distribution of the events is assumed. From the social security perspective, the cumulative costs of CHD for the observed age group who already have CHD amount to approximately 59 billion DM in 10 years (see Table 4). On the assumption that CHD develops during the course of these 10 years and that the population does not already present with CHD at the start of the simulation model, the costs are calculated to be about 41 billion DM (see Table 3). Numerous sensitivity analyses were carried out which showed that the assumption of the direct costs per case/year were highly sensitive (see Figure 1). The special advantage of the model is the perspective chosen, since social security is considered as a whole and interactions between individual branches of social security become transparent.

[Cost-benefit analysis of an evidence-based secondary prevention of coronary heart diseases by statins. An analysis for Germany from a social security perspective]. / Kosten-Nutzen-Analyse einer evidenzbasierten Sekundärprävention koronarer Herzkrankheiten durch Statine. Eine Analyse für Deutschland aus Perspektive der Sozialversicherung.

BACKGROUND: Lowering of the cholesterol level is of central importance in the prevention of coronary heart disease. Although the clinical benefits of treatment with statins have been shown in numerous studies, economic considerations are also being taken increasingly into account for the decision process about health care benefits. With this background, a cost-benefit analysis was carried out for statin treatment. METHODS: Based on a cost analysis for coronary heart disease carried out by the authors from a social security standpoint, the net prevention costs for secondary prevention in Germany were assessed. The ICD-9 codes 410-414 were assigned to coronary heart disease. In addition to the direct costs of treatment for coronary heart disease, loss of premiums for social security, savings on old age pensions, related pension claims and wage compensations over a time period of 10 years were also quantified in the cost analysis. Furthermore, prevention through medication for the 45- to 64-year-old coronary heart disease patients was considered. Costs for prevention were assessed on the basis of the mean dosages of all medications on the market according to the Rote Liste (German Formulary). A risk reduction of 30% was assumed and numerous univariate sensitivity analyses were carried out. RESULTS: Depending on which parameters were varied, there were pronounced differences in the results. The most favourable cost-benefit relation was achieved for the preventive measures in 400,000 patients with net prevention costs of 1.08 billion DM (2.16 billion DM for 800,000 patients) for a duration of medical preventive care of 5 years. The highest net prevention costs of 3.47 billion DM for 400,000 coronary heart disease patients (or 6.93 billion DM for 800,000 patients) resulted when maximum prices for statins were assumed. In the setting taken as base analysis, approximately 25% of the prevention costs are accounted for by cost saving through prevention. DISCUSSION: The transfer of clinical study results into clinical practice is associated with uncertainties which necessitate comprehensive sensitivity analyses. The costs of coronary heart disease were shown to be highly sensitive to the cost-benefit relationship. Although from an overall social security perspective, the direct costs of treatment and the loss of premiums were balanced by reduced expenditure (pension savings), coronary heart disease does lead to a financial burden on the social security. CONCLUSION: This financial burden is decreased by prevention of coronary heart disease. Part of the costs of statin therapy can be covered in every situation by cost savings through the avoidance of coronary heart disease. Even complex simulation models, that uses realistic assumptions, could only determine the costs of an evidence-based secondary prevention of coronary heart disease unprecisely, because the worst case and the best case vary with the factor 7.