The primary aim of this thesis is to investigate the challenges in conducting economic evaluations for medical devices with evolving evidence bases. While economic evaluations for capital projects and medicines are well established in theory and practice, the same cannot be said for novel medical devices. New medical devices are often expensive and rely on scarce evidence for efficacy and cost. This increases uncertainty surrounding their clinical and cost effectiveness. In addition, as fewer formal procedures exist for evaluating devices relative to medicines, evidence bases are weak and health technology assessment agencies are reluctant to make rapid decisions. To address these issues a continuous iterative framework developed and proposed for economic evaluations of medical devices.In this thesis, using Transcatheter Aortic Valve Implantation (TAVI) as a case study, an iterative economic evaluation, employing Bayesian techniques, is developed to investigate how the challenges associated with medical devices can be overcome to produce an efficient and informative economic evaluation. This study is the first to investigate these challenges and identify solutions while conducting an economic evaluation early in a device’s life cycle, using the proposed continuous iterative framework. The consideration of Access with Evidence Development schemes to overcome these challenges and balance access with evidence generation for expensive and novel medical devices, with evolving evidence, is another important contribution of the thesis.Transcatheter Aortic Valve Implantation (TAVI) is a novel treatment for severe Aortic Stenosis for operable and inoperable patients. The iterative economic evaluation concludes that TAVI can be considered cost effective for inoperable patients compared to medical management. There is little value in commissioning new research for continued data collection for this group. However, the continued collection of evidence via the UK TAVI registry as indicated in the National Institute of Clinical Excellence (NICE) guidelines will ensure up to date evidence is available to inform future decisions regarding TAVI in this patient group. For operable patients, the iterative model could not conclude that TAVI was cost effective compared to Aortic Valve Replacement (AVR). However, additional evidence of improved outcomes from TAVI should enhance its cost effectiveness for these patients. The Bayesian value of information analysis indicates that further information on short and long term probability, resource and quality of life parameters is most valuable and the optimal research design for collecting such information is a registry.
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Economic evaluations for health technologies with an evolving evidence base: a case study of transcatheter aortic valve implantation