GMS health technology assessment
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Today there are approximately one million people with dementia in Germany. If current demographic trends continue, this number is likely to rise substantially in the coming years. In the older population, dementia is the most frequent reason for long-term care. Because most forms of dementia cannot be cured, the aim of treatment is to delay disease progression and to maintain functioning and quality of life. ⋯ The studies conducted to date do not provide sufficient evidence of neither efficacy nor cost-effectiveness for any of the nursing interventions considered in the present HTA. However, lack of evidence does not mean lack of efficacy. Instead, more methodologically sound studies are needed. Particullary desireable are studies reflecting the framework of dementia care in Germany. This holds also for the healtheconomic evaluations of the chosen interventions.
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GMS Health Technol Assess · Jan 2008
Procedures and Criteria for the regulation of innovative non-medicinal technologies into the benefit catalogue of solidly financed health care insurances.
Because great interest in an efficient range of effective medicinal innovations and achievements has arisen, many countries have introduced procedures to regulate the adoption of innovative non-medicinal technologies into the benefit catalogue of solidly financed health care insurances. With this as a background, this report will describe procedures for the adoption of innovative non-medicinal technologies by solidly financed health care insurances in Germany, England, Australia and Switzerland. This report was commissioned by the German Agency for Health Technology Assessment at the German Institute for Medical Documentation and Information. ⋯ In principle, the starting point for improving regulations of innovative non-medicinal technologies lies in the extension of transparency, the shortening of decision-making time (especially the central decision-making processes), the further development of evaluation methods, more flexibility and increased capacity in the governing bodies' decision-making processes and also, if needed, in the creation of a single authority to act as contact for people who are interested in introducing an innovation into the benefit catalogue. More research is required, especially in the area of decentralized decision-makers and how they actually decide whether or not to introduce innovative technologies into the core care system (methods, criteria, etc.). In view of this, it would also be interesting to see how the application of innovations actually happens in practice once their adoption has been approved by the corresponding governing bodies.
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GMS Health Technol Assess · Jan 2007
The role of Homocysteine as a predictor for coronary heart disease.
There is an ongoing debate on the role of the cytotoxic aminoacid homocysteine as a causal risk factor for the development of coronary heart disease. Results from multiple case control-studies demonstrate, that there is a strong association between high plasma levels of homoysteine and prevalent coronary heart disease, independent of other classic risk factors. Furthermore, results from interventional studies point out that elevated plasma levels of homocysteine may effectively be lowered by the intake of folic acid and B vitamins. In order to use this information for the construction of a new preventive strategy against coronary heart disease, more information is needed: first, whether homocysteine actually is a causal risk factor with relevant predictive properties and, second, whether by lowering elevated homocysteine plasma concentrations cardiac morbidity can be reduced. Currently in Germany the determination of homocysteine plasma levels is reimbursed for by statutory health insurance in patients with manifest coronary heart disease and in patients at high risk for coronary heart disease but not for screening purposes in asymptomatic low risk populations. Against this background the following assessment sets out to answer four questions: Is an elevated homocysteine plasma concentration a strong, consistent and independent (of other classic risk factors) predictor for coronary heart disease?Does a therapeutic lowering of elevated homoysteine plasma levels reduce the risk of developing coronary events?What is the cost-effectiveness relationship of homocysteine testing for preventive purposes?Are there morally, socially or legally relevant aspects that should be considered when implementing a preventive strategy as outlined above? ⋯ Many currently available pieces of evidence contradict a causal role of homocysteine in the pathogenesis of coronary heart disease. Arguing with the Bradford-Hill criteria at least the criterion of time-sequence (that exposure has to happen before the outcome is measured), the criterion of a strong and consistent association and the criterion of reversibility are not fulfilled. Therefore, homocysteine may, if at all, play a role as a risk indicator but not as risk factor. Furthermore, currently available evidence does not imply that for the prevention of coronary heart disease, knowledge of homocysteine plasma levels provides any information that supersedes the information gathered from the examination of classical risk factors. So, currently for the indication of prevention, there is no evidence that homocysteine testing provides any benefit. Against this background there is also no basis for cost-effectiveness calculations. Further basic research should clarify the discrepant results of case control studies and prospective studies. Maybe there is a third parameter (confounder) associated with homocysteine metabolism as well with coronary heart disease. Further epidemiological research could elucidate the role of elevated homocysteine plasma levels as a risk indicator or prognostic indicator in patients with pre-existing coronary heart disease taking into consideration the classical risk factors.
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Major objective is the evaluation of the medical effectiveness of different therapeutical approaches and the cost effectiveness with relevance for Germany. ⋯ The spectrum of therapeutical procedures has increased for atopic dermatitis but is still not sufficient. The spectrum of established substances is much smaller compared to psoriasis, another chronic and common inflammatory skin disease. There is need for the development new substances which can be applied topically and which are aimed to treat atopic dermatitis in early childhood. Another need for new developments can be found for the treatment of severe atopic dermatitis in adults. Due to lack of health economic evaluations therapy decisions in the treatment of atopic dermatitis must take place on the basis of clinical decision criteria. The prescription of topic corticosteroids should prefer low priced drugs. Reliable statements about the cost effectiveness of the new calcineurin-inhibitors tacrolimus and pimecrolimus.
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GMS Health Technol Assess · Apr 2006
Extracorporal hemodialysis with acute or decompensated chronical hepatic failure.
Conventional diagnostic procedures and therapy of acute liver failure (ALF) and acute-on-chronic liver failure (ACLF) focus on to identify triggering events of the acute deterioration of the liver function and to avoid them. Further objectives are to prevent the development respectively the progression of secondary organ dysfunctions or organ failure. Most of the times the endocrinological function of the liver can to a wide extent be compensated, but the removal of toxins can only marginally be substituted by conventional conservative therapy. To improve this component of the liver function is the main objective of extracorporal liver support systems. The following principles of liver support systems can be differentiated: Artificial systems, bioartifical systems and extracorporal liver perfusion systems. This HTA report focuses on artificial systems (e.g. BioLogic-DT/-DTPF, MARS, Prometheus), because only these approaches currently are relevant in the German health care system. In 2004 a category "Extracorporal liver assist device" was introduced in the list of "additional payments" in the German DRG-system, which makes reimbursement for hospitals using the technology in inpatient care possible, based on an hospital's individual contract with statutory sickness funds. ⋯ The results of the detected publications do not give any evidence for a positive medical efficacy of BioLogic-DT. Concerning MARS there is some evidence for positive effects on 30d-survival, clinical parameter, and some lab tests, although the evidence is limited by the small number of studies and their methodological weakness. The currently strongly limited evidence shows a trend to an acceptable cost-effectiveness of MARS, although the results are based on only one non-randomised trial. To give valid recommendations concerning the medical efficacy as well as the cost-effectiveness of artificial liver support systems further studies are necessary.