Wie beeinflussen andere Gesundheitssysteme die Gesundheitsreformenentwicklung 2003 in Deutschland?

Ansätze anderer Industrieländer sind zunehmend Vorbild für gesundheitspolitische Reformen in Deutschland. Am Beispiel des Gesetzes zur Modernisierung der gesetzlichen Krankenversicherung untersucht dieser Beitrag den Einfluss anderer Gesundheitssysteme auf die deutsche Reformdebatte erstmals systematisch. Die Analyse zeigt, dass deutsche Akteure vor allem über die USA, die Schweiz, die Niederlande, Großbritannien und Frankreich diskutieren; jedoch sind ihre Sichtweisen auf gleiche Tatbestände häufig konträr. Modelle aus anderen Ländern werden in der gesundheitspolitischen Auseinandersetzung so zum einen an den deutschen Kontext angepasst, der durch Föderalismus, Selbstverwaltungsprinzip und kulturelle Werte in einem bevölkerungsreichen Land gekennzeichnet ist. Verweise auf andere Länder dienen zum anderen aber auch als machtvolles Instrument, gesundheitspolitische Interessen durchzusetzen. Ein eindrücklichsten ist dieser Prozess am Institut für Qualität und Wirtschaftlichkeit nachzuvollziehen, das ursprünglich nach dem National Institute of Clinical Excellence in England und Wales entworfen wurde, sich von diesem aber in Struktur und Funktion deutlich entfernt hat. Internationale Erfahrungen haben so weit reichend Eingang in die deutsche Debatte Eingang gefunden, dass für die deutsche Gesundheitspolitik und alle beteiligten Interessensgruppen ein zeitnahes Wissen über Ansätze anderer Gesundheitssysteme und eine kritische Bewertung von deren Erfolgen oder Misserfolgen in der Praxis unabdingbar geworden ist.Concepts form other countries are often used as role models for health policy reforms in Germany. This article's aim is to systematically analyse the impact of other health care systems on the German health policy debate. The study focuses on the latest health care reform; the Act on Modernization of Compulsory Health Insurance which came into force in 2004. German actors and stakeholders discuss mostly about the USA, Switzerland, the Netherlands, UK and France. But, often their point of view to identical matters of facts is contrarian. In this debate models form other countries are adapted to the German context, which is characterized by federalism, selfgovernance, specific cultural an ethical values and a populous country. But actors also use experiences in other countries as a powerful standard argument to support their health policy objectives and push through interests. An impressing example is the recently established German Institute of Quality and Efficiency in Health Care. This institution was initially designed after the National Institute of Clinical Excellence (NICE) in England and Wales but now differs considerably form NICE in function and configuration. International experience has extensively entered the German health policy debate. It is therefore an increasing requirement for policy makers as well as for stakeholders to acquire real-time knowledge about developments in various health care systems and to critically assess their success or failure in practice

Methods for the comparative evaluation of pharmaceuticals

Political background: As a German novelty, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IGWiG) was established in 2004 to, among other tasks, evaluate the benefit of pharmaceuticals. In this context it is of importance that patented pharmaceuticals are only excluded from the reference pricing system if they offer a therapeutic improvement. The institute is commissioned by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) or by the Ministry of Health and Social Security. The German policy objective expressed by the latest health care reform (Gesetz zur Modernisierung der Gesetzlichen Krankenversicherung, GMG) is to base decisions on a scientific assessment of pharmaceuticals in comparison to already available treatments. However, procedures and methods are still to be established. Research questions and methods: This health technology assessment (HTA) report was commissioned by the German Agency for HTA at the Institute for Medical Documentation and Information (DAHTA@DIMDI). It analysed criteria, procedures, and methods of comparative drug assessment in other EU-/OECD-countries. The research question was the following: How do national public institutions compare medicines in connection with pharmaceutical regulation, i.e. licensing, reimbursement and pricing of drugs? Institutions as well as documents concerning comparative drug evaluation (e.g. regulations, guidelines) were identified through internet, systematic literature, and hand searches. Publications were selected according to pre-defined inclusion and exclusion criteria. Documents were analysed in a qualitative matter following an analytic framework that had been developed in advance. Results were summarised narratively and presented in evidence tables. Results and discussion: Currently licensing agencies do not systematically assess a new drug's added value for patients and society. This is why many countries made post-licensing evaluation of pharmaceuticals a requirement for reimbursement or pricing decisions. Typically an explicitly designated drug review body is involved. In all eleven countries included (Austria, Australia, Canada, Switzerland, Finland, France, the Netherlands, Norway, New Zealand, Sweden, and the United Kingdom) a drug's therapeutic benefit in comparison to treatment alternatives is leading the evaluation. A medicine is classified as a therapeutic improvement if it demonstrates an improved benefit-/risk-profile compared to treatment alternatives. However, evidence of superiority to a relevant degree is requested. Health related quality of life is considered as the most appropriate criterion for a drug's added value from patients' perspective. Review bodies in Australia, New Zealand, and the United Kingdom have committed themselves to include this outcome measure whenever possible. Pharmacological or innovative characteristics (e.g. administration route, dosage regime, new acting principle) and other advantages (e.g. taste, appearance) are considered in about half of the countries. However, in most cases these aspects rank as second line criteria for a drug's added value. All countries except France and Switzerland perform a comparative pharmacoeconomic evaluation to analyse costs caused by a drug intervention in relation to its benefit (preferably by cost utility analysis). However, the question if a medicine is cost effective in relation to treatment alternatives is answered in a political and social context. A range of remarkably varying criteria are considered. Countries agree that randomised controlled head-to-head trials (head-to-head RCT) with a high degree of internal and external validity provide the most reliable and least biased evidence of a drug's relative treatment effects (as do systematic reviews and meta-analyses of these RCT). Final outcome parameters reflecting long-term treatment objectives (mortality, morbidity, quality of life) are preferred to surrogate parameters. Following the concept of community effectiveness, drug review institutions also explicitly favour RCT in a "natural" design, i.e. in daily routine and country specific care settings. The countries' requirements for pharmacoeconomic studies are similar despite some methodological inconsistencies, e.g. concerning cost calculation. Outcomes of clinical and pharmacoeconomic analyses are largely determined by the choice of comparator. Selecting an appropriate comparative treatment is therefore crucial. In theory, the best or most cost effective therapy is regarded as appropriate comparator for clinical and economic studies. Pragmatically however, institutions accept that the drug is compared to the treatment of daily routine or to the least expensive therapy. If a pharmaceutical offers several approved indications, in some countries all of them are assessed. Others only evaluate a drug's main indication. Canada is the only country which also considers a medicine's off-label use. It is well known that clinical trials and pharmacoeconomic studies directly comparing a drug with adequate competitors are lacking - in quantitative as well as in qualitative terms. This is specifically the case before or shortly after marketing authorisation. Yet there is the need to support reimbursement or pricing decisions by scientific evidence. In this situation review bodies are often forced to rely on observational studies or on other internally less valid data (including expert and consensus opinions). As a second option they use statistical approaches like indirect adjusted comparisons (in Australia and the United Kingdom) and, commonly, economic modelling. However, there is consensus that results provided by these techniques need to be verified by valid head-to-head comparisons as soon as possible.ConclusionsIn the majority of countries reimbursement and pricing decisions are based on systematic and evidence-based evaluation comparing a drug's clinical and economic characteristics to daily treatment routine. However, further evaluation criteria, requirements and specific methodological issues still lack internationally consented standards

A Vast Thin Plane of Co-rotating Dwarf Galaxies Orbiting the Andromeda Galaxy

Dwarf satellite galaxies are thought to be the remnants of the population of primordial structures that coalesced to form giant galaxies like the Milky Way. An early analysis noted that dwarf galaxies may not be isotropically distributed around our Galaxy, as several are correlated with streams of HI emission, and possibly form co-planar groups. These suspicions are supported by recent analyses, and it has been claimed that the apparently planar distribution of satellites is not predicted within standard cosmology, and cannot simply represent a memory of past coherent accretion. However, other studies dispute this conclusion. Here we report the existence (99.998% significance) of a planar sub-group of satellites in the Andromeda galaxy, comprising approximately 50% of the population. The structure is vast: at least 400 kpc in diameter, but also extremely thin, with a perpendicular scatter <14.1 kpc (99% confidence). Radial velocity measurements reveal that the satellites in this structure have the same sense of rotation about their host. This finding shows conclusively that substantial numbers of dwarf satellite galaxies share the same dynamical orbital properties and direction of angular momentum, a new insight for our understanding of the origin of these most dark matter dominated of galaxies. Intriguingly, the plane we identify is approximately aligned with the pole of the Milky Way's disk and is co-planar with the Milky Way to Andromeda position vector. The existence of such extensive coherent kinematic structures within the halos of massive galaxies is a fact that must be explained within the framework of galaxy formation and cosmology.Comment: Published in the 3rd Jan 2013 issue of Nature. 19 pages, 4 figures, 1 three-dimensional interactive figure. To view and manipulate the 3-D figure, an Adobe Reader browser plug-in is required; alternatively save to disk and view with Adobe Reade

Current international initiatives in the evidence-based assessment of pharmaceuticals: Implications for licensing and health technology assessment in Germany and Europe

International sind in den letzten Jahren mehrere Initiativen entstanden, die sich mit der Weiterentwicklung der evidenzbasierten Bewertung von Arzneimitteln nach der Marktzulassung befassen, um Entscheidungssituationen in der gesundheitspolitischen oder klinischen Praxis zu unterstützen. Der Bericht analysiert Ziele, Arbeitsweise und Ergebnisse des von der Europäischen Kommission initiierten Arzneimittelforums mit seiner Arbeitsgruppe zu Relative Effectiveness, des europäischen Netzwerks für Health Technology Assessment EUnetHTA und des nationalen Programms für Comparative Effectiveness Research in den USA. Gemeinsamkeiten und Unterschiede der drei Initiativen und mögliche Implikationen für die Zulassung und HTA von Arzneimitteln in Deutschland und Europa werden abgeleitet. Abschließend werden Themen und Fragestellungen für weitere vertiefende Forschung identifiziert. Gedruckte Version im Universitätsverlag der TU Berlin (www.univerlag.tu-berlin.de) erschienen, ISBN 3-978-7983-2298-1Over the past years several initiatives have developed internationally that address the further development of evidence-based assessments of pharmaceuticals after licensing in order to support decision making in policy and clinical practice. The report analyzes objectives, procedures, and results of the Pharmaceutical Forum initiated by the European Commission and its Working Group on Relative Effectiveness, of the European network for Health Technology Assessment EUnetHTA, and of the national US‐program for Comparative Effectiveness Research. Similarities and differences of the three initiatives are highlighted. Finally, issues and questions for further research areas are identified. Printed version published by Universitätsverlag der TU Berlin (www.univerlag.tu-berlin.de), ISBN 3-978-7983-2298-