Managed competition in health care in the Netherlands and Germany: Theoretical foundation, empirical findings and policy conclusions

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Economic evaluation of the artificial liver support system MARS in patients with acute-on-chronic liver failure

BACKGROUND: Acute-on-chronic liver failure (ACLF) is a life threatening acute decompensation of a pre-existing chronic liver disease. The artificial liver support system MARS is a new emerging therapeutic option possible to be implemented in routine care of these patients. The medical efficacy of MARS has been demonstrated in first clinical studies, but economic aspects have so far not been investigated. Objective of this study was to estimate the cost-effectiveness of MARS. METHODS: In a clinical cohort trial with a prospective follow-up of 3 years 33 ACLF-patients treated with MARS were compared to 46 controls. Survival, health-related quality of life as well as direct medical costs for in- and outpatient treatment from a health care system perspective were determined. Based on the differences in outcome and indirect costs the cost-effectiveness of MARS expressed as incremental costs per life year gained and incremental costs per QALY gained was estimated. RESULTS: The average initial intervention costs for MARS were 14600 EUR per patient treated. Direct medical costs over 3 years follow up were overall 40000 EUR per patient treated with MARS respectively 12700 EUR in controls. The 3 year survival rate after MARS was 52% compared to 17% in controls. Kaplan-Meier analysis of cumulated survival probability showed a highly significant difference in favour of MARS. Incremental costs per life-year gained were 31400 EUR; incremental costs per QALY gained were 47200 EUR. CONCLUSION: The results after 3 years follow-up of the first economic evaluation study of MARS based on empirical patient data are presented. Although high initial treatment costs for MARS occur the significantly better survival seen in this study led to reasonable costs per live year gained. Further randomized controlled trials investigating the medical efficacy and the cost-effectiveness are recommended

Modelling costs and outcomes of newborn hearing screening: The economic part of a German health technology assessment project

The prevalence of newborn hearing disorders is 1-3 per 1000. Crucial for later outcome are correct diagnosis and effective treatment in the first year of life. With BERA and TEOAE low-risk techniques for early detection are available. Universal screening is recommended but not realised in most European health care systems. Objective of the study was to examine the scientific evidence of newborn hearing screening, thus to compare cost-effectiveness of different programmes, differentiated by type of strategy (risk screening, universal screening, no screening). Methods: In an interdisciplinary health technology assessment project all relevant studies on newborn hearing screening were identified and data on medical outcome, costs and cost-effectiveness extracted. A Markov model was designed to calculate cost-effectiveness ratios. Results: Economic data were extracted from 20 relevant publications. In the model total costs for screening of 100.000 newborns with a time horizon of ten years were calculated: 2.0 Mio . for universal screening (U), 1.0 Mio. for risk screening (R) and 0.6 Mio. for no screening (N). The costs per child detected: 13,395 (U) respectively 6,715 (R) and 4,125 (N). Conclusions: A remarkable small number of economic publications mainly of low methodo-logical quality was found. In our own model we found reasonable cost-effectiveness ratios also for universal screening. Considering the outcome advantages of higher numbers of cases detected a universal newborn hearing screening is recommended. --

Wertigkeit der Augeninnendruckmessung mittels Non-contract Tonometrie durch Augenoptiker in Deutschland: Eine Kosten-Wirksamkeits-Analyse

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Gesundheitsökonomische und epidemiologische Aspekte von Hirnleistungsstörungen im Alter

Vor dem Hintergrund der dynamischen Entwicklung des Bedarfs an Gesundheitsleistungen und der Zunahme älterer Bevölkerungsanteile birgt die Versorgung von Patienten mit Hirnleistungsstörungen im Alter eine wachsende medizinische, soziale und gesundheitspolitische Herausforderung. Diese Gruppe von Erkrankungen stellt eine der häufigsten Ursachen für Pflegebedürftigkeit dar und gehört zu den wichtigsten Kostenfaktoren in Gesundheitssystemen westlicher Industrieländer. Es wird ein Überblick über epidemiologische und gesundheitsökonomische Aspekte von Hirnleistungsstörungen im Alter in Deutschland, wie auch im internationalen Vergleich gegeben. Die Prävalenz bei über 65jährigen wird in Deutschland auf rund 8% geschätzt mit einer jährlichen Inzidenz von knapp 2%. Die jährlichen Kosten für die medizinische und pflegerische Betreuung liegen bei rund 30.000 – pro Betroffenen. Es lassen sich damit für Deutschland jährliche Krankheitskosten von insgesamt rund 35 Mrd. – kalkulieren. In den nächsten Jahrzehnten ist von einer Zunahme der Häufigkeit von Hirnleistungsstörungen im Alter auszugehen und die damit verbundenen volkswirtschaftlichen Belastungen dürfen nicht unterschätzt werden. --

Hausarztmodelle in der GKV: Effekte und Perspektiven vor dem Hintergrund nationaler und internationaler Erfahrungen

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Orchiectomy versus medical therapy with LH-RH analogues for the treatment of advanced prostatic carcinoma

Background: In Germany prostatic cancer is the most frequent cancer in men. The therapy of advanced prostatic cancer has changed significantly from the sub capsulate and / or total orchiectomy to the medical LH-RH analogues therapy during the last ten years, which has considerable effects on results and on costs. Both treatment procedures are based on a slowing down regulation of the growth of the hormone sensitive, neoplastic prostatic cells by the withdrawal of testosterone, which is clinically accompanied by a slowed tumor progression. Objectives: This health technology assessment depicts and evaluates international data of medical effectiveness and efficiency of orchiectomy and medical therapy with LH-RH-analogues in patients with advanced prostate cancer. Methods: A systematic, diversified literature analysis in the common medical, economic and HTA data bases and further media was conducted. Results: Five identified, randomized and controlled studies concerning the application of LH-RH analogues showed the same medical effectiveness of orchiectomy and treatment with LH-RH analogues. Four different studies regarding the quality of life revealed no significant difference between the treatment with LH-RH analogues and the therapy with orchiectomy. Dealing with health economic aspects seven cost-minimizing studies and one cost effectiveness study could be identified. All cost-minimizing studies show methodological restrictions. In general all studies draw the conclusion that the treatment of advanced prostatic cancer with orchiectomy is the most cost effective method, if one assumes a remaining life expectancy of more than one year. Conclusions: According to available studies, there is clear evidence for the equivalent effectiveness of LH-RH analogues and orchiectomy. Until now the studies - due to immense methodological restrictions - could not supply sufficient scientific evidence concerning the aspects of quality of life. In cases of a remaining life expectancy of more than one year, the orchiectomy is the more cost-effective alternative of therapy

Health Technology Assessment zur medizinischen Wirksamkeit und Kosten-Effektivität der Phototherapeutischen Keratektomiemit dem Excimerlaser bei rezidivierenden Erosionen, Hornhautdystrophien, Hornhautdegenerationen und oberflächlichen Hornhautnarben

Hintergrund und Fragestellung: Die phototherapeutische Keratektomie mit dem Excimer-Laser (PTK) wird bei rezidivierenden Hornhauterosionen, oberflächlichen Hornhautdystrophien, zentralen Hornhautdegenerationen, oberflächlichen Hornhautnarben und -irregularitäten mittlerweile weit verbreitet als Therapie eingesetzt. Beim Großteil der Indikationen gibt es nach Ausschöpfung konservativer Maßnahmen, abgesehen von der Hornhautstichelung bei rezidivierenden Erosionen und der Keratoplastik bei Hornhautdystrophien und Hornhautnarben, keine therapeutischen Alternativen. Bisher wurde die PTK bei diesen Indikationen noch nicht in den Leistungskatalog der GKV aufgenommen. Der vorliegende HTA-Bericht sollte die wissenschaftliche Evidenz zusammentragen, inwiefern der medizinischen Nutzen, die medizinischen Notwendigkeit und die Wirtschaftlichkeit der PTK bei den genannten Indikationen nachgewiesen werden können. --

Economic analysis based on multinational studies: methods for adapting findings to national contexts

Background: Health economic parameters are increasingly considered as variables in health care decisions, but decision makers are interested in country-specific evaluations. However, a large number of studies are performed in foreign countries or in a multinational setting, which limits the transferability to a single nation’s context. Objective: The present analysis summarises several of the most common international methods for generating health economic analyses based on clinical studies from different settings. Methods: A narrative literature review was performed to identify potential reasons for limited transferability of health economic evaluation results from one country to another. Based on these results, we searched the methodological literature for analytic approaches to handle the restrictions. Additionally we describe the possibility of transferring foreign economic study results to the country of interest by matching trial data with routine data of national databases. Results: The main factors for limited transferability of health economic findings were found in country-specific differences in resource consumption and the resulting costs. These differences are affected by a number of influencing cofactors (demography, epidemiology and individual patient’s factors) and the overall health care system structures (e.g. payment systems, health provider incentives). However, despite the limitations country-specific health economic assessments could be realised using the pooled/ split analyses approach, some statistical approaches and modelling approaches. Conclusion: A variety of methods for identifying and adjusting country-specific differences in costs, effects and cost-effectiveness was established during the past decades. Multinational studies will continue to play a crucial role in the evaluation of cost-effectiveness at national levels. It seems likely that the growing interest in multinational studies will lead to continued developments in adaptation methods

Extracorporal hemodialysis with acute or decompensated chronical hepatic failure

Background: 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. Objectives: To report the present evidence and future research need on medical efficacy and economic effectiveness of extracorporal liver support devices for treatment of patients with ALF or ACLF based on published literature data. Are artificial liver support systems efficient and effective in the treatment of ALF or ACLF? Methods: An extensive, systematic literature search in medical, economic, and HTA literature data bases was performed. Relevant data were extracted and synthesised. Results: Relevant controlled trials were detected for BioLogic-DT and MARS. No randomised controlled trial on Prometheus was found. None of the included studies on BioLogic-DT showed advantages of the technology compared with standard conventional therapy concerning survival, clinical scores or clinical surrogate parameter like laboratory tests of liver function. Some studies reported complications and side effects of BioLogic-DT. All studies were methodologically insufficient. Concerning the use of MARS overall five studies - three of them randomised - were identified. Two studies reported a significant higher 30d-survival after MARS compared to controls, one study showed a non-significant trend to a better survival probability after one year. The studies showed statistically significant advantages in severity of hepatic encephalopathy, routine lab tests and hemodynamic parameter of the MARS group. None of the studies reported relevant complications or side effects. Although the methodological quality of the studies is seen as slightly better than in the studies on BioLogic-DT, there are methodological limitations: The largest sample size of the randomised trials was twelve patients per group and the study population was highly selected. Because of the methodological limitations the results can hardly be generalised. Only two economic publications presenting analyses of MARS could be de-tected. One publication shows major methodological mistakes which make a further interpretation of the results impossible. The other publication presents an incremental cost-effectiveness of MARS of 29,719 EUR per life year gained after one year from a payer's perspective (German statutory sickness fund, neglecting the intervention costs because of lacking reimbursement at this time), respectively 79,075 EUR per life year gained from a societal perspective. Including health related quality of life aspects the incremental costs per QALY (Quality adjusted life years) gained were calculated to be 44,784 EUR from a payer's perspective respectively 119,162 EUR from a societal perspective. The authors state that prolonging the time horizon of the calculations would improve cost-effectiveness ratios. The limitations of the study design also limit the scientific evidence of the results. Conclusion: 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