Abstract
Many countries undertaking health technology assessments (HTAs) to inform decisions on the reimbursement of technologies focus solely on the analysis of pharmaceuticals [1, 2]. In the UK, the responsibility for undertaking HTAs falls mainly to the National Institute for Health and Care Excellence (NICE). NICE is an independent organisation whose role is to provide guidance on health technologies and clinical practice for the National Health Service (NHS) in England and Wales [3], and it is regarded as a world leader in the HTA field. In contrast to HTA bodies in most other countries, NICE has been given a wider remit to assess the full range of technologies (i.e. not just pharmaceuticals) [4]. There are difficulties present when assessing non-pharmaceutical health technologies, which can reduce the applicability of methods routinely used in the assessment of pharmaceuticals. Nevertheless, it is important not to undertake HTAs only on those technologies where the assessment process is straightforward, otherwise the allocation of resources between the different types of technology may be distorted by an imbalance in the information supporting decisions [2]. In order to overcome the aforementioned difficulties and ensure that the assessments of all forms of health technology are useful in decision-making, NICE has developed four appraisal programmes that are each overseen by a separate committee (technology appraisals, medical technologies, diagnostics and public health). At this point a distinction needs to be made between two sections of the NICE decision process: assessment and appraisal. An assessment is the review and analysis of data and other evidence, whereas appraisal is the a priori consideration of the evidence on benefits and costs of different courses of action in order to distinguish which is superior. The assessment of technologies is undertaken by the NICE technical team and an independent review group, with the manufacturer of the technology also having a major role. The evidence generated from this process is then passed onto one of the NICE committees, who have to make a decision regarding the suitability of the technology for the NHS, the appraisal section of the process. There are four NICE committees, each of which is responsible for one of the four programmes discussed previously. The newest of them is the Medical Technologies Advisory Committee (MTAC). The MTAC assesses a specific subset of health technologies, which can loosely be defined as medical devices. A full description of the technologies that are assessed by the MTAC can be found in the Medical Technologies Evaluation Programme (MTEP) methods guide [5], referred to as ‘MTEP guidance’ in the remainder of this paper. This methods guide stipulates the methodology that manufacturers must follow when undertaking economic evaluations of medical devices that are to be assessed by the MTAC. NICE aims for consistency across its four committees. However, a comparison of the methodology outlined in the MTEP guidance with those used by the other NICE decision-making committees shows some significant differences. The possible W. Green (&) York Health Economics Consortium, University of York, Market Square, Heslington, York YO10 5NH, UK e-mail: william.green@york.ac.uk
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