The prognostic score we developed may be useful in designing clinical trials for the treatment of advanced Hodgkin's disease and in making individual therapeutic decisions, but a distinct group of patients at very high risk could not be identified on the basis of routinely documented demographic and clinical characteristics.
Indication value-based pricing (IBP) has been proposed in the United States as a tool to capture the differential value of drugs across indications or patient groups and is in the early phases of implementation. In Europe, no major country has experimented with IBP or is seriously discussing its use. We assessed how the reimbursement and pricing environment allows for IBP in seven European countries, evaluating both incentives and hurdles. In price setting countries such as France and Germany, the Health Technology Assessment and pricing process already accounts for differences of value across indications. In countries where differential value drives coverage decisions such as the United Kingdom and Sweden, IBP is likely to be used, at least partially, but not in the short-term. Italy is already achieving some form of differential value through managed entry agreements, whereas in Spain the electronic prescription system provides the infrastructure necessary for IBP but other hurdles exist.
In the last thirty years the concept of manufacturability has been applied to many different processes in numerous industries. This has resulted in the emergence of several different "Design for Manufacturing" methodologies which have in common the aim of reducing productions costs through the application of general manufacturing rules. Near net shape technologies have expanded these concepts, targeting mainly primary shaping process, such as casting or forging. The desired outcomes of manufacturability analysis for near-net-shape (NNS) processes are cost and lead/time reduction through minimization of process steps (in particular cutting and finishing operations) and raw material saving. Product quality improvement, variability reduction and component design functionality enhancement are also achievable through NNS optimization. Process parameters, product design and material selection are the changing variables in a manufacturing chain that interact in complex, non-linear ways. Consequently modeling and simulation play important roles in the investigation of alternative approaches. However defining the manufacturing capability of different processes is also a "moving target" because the various NNS technologies are constantly improving and evolving so there is challenge in accurately reflecting their requirements and capabilities. In the last decade, for example, CAD, CNC technologies and innovation in materials have impacted enormously on the development of NNS technologies. This paper reviews the different methods reported for NNS manufacturability assessment and examines how they can make an impact on cost, quality and process variability in the context of a specific production volume. The discussion identifies a lack of structured approaches, poor connection with process optimization methodologies and a lack of empirical models as gaps in the reported approaches.
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