Katharina E. Fischer

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BACKGROUND Since 2011, when the German Pharmaceutical Market Restructuring Act (AMNOG) came into effect, newly licensed pharmaceuticals must demonstrate an added benefit over a comparator treatment to be reimbursed at a value greater than the reference price. Evidence submitted by manufacturers is assessed by the Institute for Quality and Efficiency in(More)
OBJECTIVES The comparison of fourth hurdle processes is challenging because they are heterogeneous and decision practice may deviate from formal process rules. This study applies a published framework consisting of key steps of coverage decision processes to the area of cancer prevention. METHODS A research design was developed for analysis of case(More)
BACKGROUND Decision-making in healthcare is complex. Research on coverage decision-making has focused on comparative studies for several countries, statistical analyses for single decision-makers, the decision outcome and appraisal criteria. Accounting for decision processes extends the complexity, as they are multidimensional and process elements need to(More)
OBJECTIVES The role and impact of health technology assessment (HTA) in health policy has been widely discussed. Researchers have started to analyze how decisions on coverage of new technologies are made. Although the involvement of HTA may be an indicator of a well established decision process, this hypothesis requires validation. Also, it is not known(More)
Decision-makers need to make choices to improve public health. Population-based newborn screening (NBS) is considered as one strategy to prevent adverse health outcomes and address rare disease patients' needs. The aim of this study was to describe key characteristics of decisions for funding new NBS programmes in Europe. We analysed past decisions using a(More)
BACKGROUND To achieve fair-coverage decision making, both material criteria and criteria of procedural justice have been proposed. The relationship between these is still unclear. OBJECTIVE To analyze hypotheses underlying the assumption that more assessment, transparency, and participation have a positive impact on the reasonableness of coverage(More)
The Hyper-X Program, NASA's focused hypersonic technology program jointly run by NASA Langley and Dryden, is designed to move hypersonic, air-breathing vehicle technology from the laboratory environment to the flight environment, the last stage preceding prototype development. The Hyper-X research vehicle will provide the first ever opportunity to obtain(More)
BACKGROUND Little is known on the performance of the newly introduced health benefit assessment process, AMNOG, in Germany compared to other health technology assessment agencies. OBJECTIVE We analysed whether decisions of the German Federal Joint Committee (FJC) deviate from decisions of the UK National Institute for Health and Care Excellence (NICE),(More)
The aim of this study was to analyze influences of process- and technology-related characteristics on the outcomes of coverage decisions. Using survey data on 77 decisions from 13 countries, we examined whether outcomes differ by 14 variables that describe components of decision-making processes and the technology. We analyzed the likelihood of committees(More)
To identify the influences on the diffusion of generics after patent expiry, we analyzed 65 generic entries using prescription data of a large German sickness fund between 2007 and 2012 in a sales model. According to theory, several elements are responsible for technology diffusion: (1) time reflecting the rate of adaption within the social system, (2)(More)