Perspectives on the National Institute for Health and Clinical Excellence's recommendations to use health technologies only in research

Medicine and Health Policy, Management and Evaluation, University of Toronto, Keenan Research Centre of Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario M5B 1W8, Canada.
International Journal of Technology Assessment in Health Care (Impact Factor: 1.31). 08/2009; 25(3):272-80. DOI: 10.1017/S026646230999002X
Source: PubMed


The concept of using public funds to pay for healthcare interventions only when provided in the context of ongoing research is receiving increasing attention worldwide. Nevertheless, these decisions are often controversial and implementation can be problematic.
The aim of this study was to investigate the views of United Kingdom stakeholders on the current arrangements for implementing "only in research" (OIR) decisions and to investigate how improvements might be made.Methods: After an internal review of previous OIR decisions issued by the National Institute for Health and Clinical Excellence (NICE), deliberations by NICE's Citizens Council, and an international workshop convened by NICE and the United States Agency for Healthcare Research and Quality, thirteen key stakeholders and experts from academia, industry, government, and the National Health Service (NHS) were interviewed using a semistructured interview guide. Interview transcripts were subjected to a framework-based analysis using computer-assisted qualitative data analysis software.
All interviewees endorsed the use of the OIR option. There was a high degree of consensus for several suggestions regarding how the use of the OIR option might be improved. For example, there was universal agreement that a formal process should be established to prioritize research needs arising from OIR decisions and that funds for publicly funded research projects should be channeled in a manner that would better motivate healthcare providers to participate in OIR-related research.
The findings of this study suggest several potential modifications of the OIR pathway in the United Kingdom and may also be helpful to health technology assessment agencies in other countries that already use or are considering using an OIR-like option to reduce the uncertainty inherent in health technology assessment.

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    • "Guidance including PASs could be categorized as OIR/AWR providing that the guidance was conditional on the access scheme, and that the scheme contained a requirement for further research or the collection of further data. The documents containing OIR/AWR recommendations were cross-checked with a review of OIR recommendations compiled by NICE to check for potential omissions [16]. "
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    ABSTRACT: BACKGROUND: There is growing interest internationally in linking reimbursement decisions with recommendations for further research. In the UK, the National Institute for Health and Clinical Excellence (NICE) can issue guidance to approve the routine use of a health intervention, reject routine use or recommend use within a research programme. These latter recommendations have restricted use to 'only in research' (OIR) or have recommended further research alongside routine use ('approval with research' or AWR). However, it is not currently clear when such recommendations are likely to be made. OBJECTIVES: This study aims to identify NICE technology appraisals where OIR or AWR recommendations were made and to examine the key considerations that led to those decisions. METHODS: Draft and final guidance including OIR/AWR recommendations were identified. The documents were reviewed to establish the characteristics of the technology appraisal, the cost effectiveness of the technologies, the key considerations that led to the recommendations and the types of research required. RESULTS: In total, 29 final and 31 draft guidance documents included OIR/AWR recommendations up to January 2010. Overall, 86 % of final guidance included OIR recommendations. Of these, the majority were for technologies considered to be cost ineffective (83 %) and the majority of final guidance (66 %) specified the need for further evidence on relative effectiveness. The use of OIR/AWR recommendations is decreasing over time and they have rarely been used in appraisals conducted through the single technology appraisal process. CONCLUSION: NICE has used its ability to recommend technologies within research programmes, although predominantly within the multiple technology appraisal process. OIR recommendations have been most frequently issued for technologies considered cost ineffective and the most frequently cited consideration is uncertainty related to relative effectiveness. Key considerations cited for most AWR recommendations and some OIR recommendations included a need for further evidence on long-term outcomes and adverse effects of treatment.
    PharmacoEconomics 01/2013; 31(2). DOI:10.1007/s40273-012-0013-6 · 2.45 Impact Factor
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    • "A programme to support innovative and costly technologies was created in the early 2000s by the French Ministry of Health, with the aim of supervising their diffusion whilst simultaneously assessing their clinical and cost effectiveness. In the United Kingdom, a procedure for temporary reimbursement has been set up for innovative devices when used only in research for the purposes of generating clinical data and good practice guidelines [29]. "
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    ABSTRACT: Background Scientific evidence supports decision-making on the use of implantable medical devices (IMDs) in clinical practice, but IMDs are thought to be far less investigated than drugs. In the USA, studies have shown that approval process of high-risk medical devices was often based on insufficiently robust studies, suggesting that evidence prior to marketing may not be adequate. This study aimed to ascertain level of evidence available for IMDs access to reimbursement in France. Methods The objective was to examine the scientific evidence used for IMDs assessment by the French National Authority for Health. We collected all public documents summarising supportive clinical data and opinions concerning IMDs issued in 2008. An opinion qualifies the expected benefit (EB) of the IMD assessed as sufficient or insufficient, and if sufficient, the level of improvement of the expected benefit (IEB) on a scale from major (level I) to no improvement (level V). For each opinion, the study with the highest level of evidence of efficacy data, and its design were collected, or, where no studies were available, any other data sources used to establish the opinion. Results One hundred and two opinions were analysed, with 72 reporting at least one study used for assessment (70.6%). When considering the study with the highest level of evidence: 34 were clinical non-comparative studies (47.2%); 29 were clinical comparative studies of which 25 randomised controlled trials (40.3%); 5 were meta-analyses of randomised controlled trials (6.9%); and 4 were systematic literature reviews (5.6%). The opinions were significantly different according to the study design (p < 0.001). The most frequent design for insufficient EB, IEB level V and IEB level IV was a non-comparative study (10/19, 52.6%; 15/24, 62.5%; and 8/15, 53.3%; respectively). For the 30 opinions with no supporting clinical study, 16 (53.3%) were based on an expert-based process, 9 (30.0%) were based on the conclusions of a previous opinion (all concluding IEB level V), and 5 (16.7%) reported no data (concluding insufficient EB for 4 and IEB level V for 1). Conclusions This study confirmed that level of evidence of clinical evaluation of IMDs is low and needs to be improved.
    BMC Public Health 08/2012; 12(1):585. DOI:10.1186/1471-2458-12-585 · 2.26 Impact Factor
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    ABSTRACT: Liquid Crystal on Silicon (LCoS) microdisplays is a viable technology for applications in projection and near-to-eye displays. As the performance of the microdisplay is related to the image quality, the characterization and understanding of the critical factors affecting the image quality need to be studied. The overall objective of this work is to establish a quantitative understanding of the functional performance of the tiled LCoS microdisplay as a function of thermal gradients and mechanical stress. The initial design calls for a three-tile configuration. Such a device needs to be assembled to very exacting tolerances, and must be able to undergo all of the assembly, and operating conditions without significant changes in the critical parameters, namely tile gap, cell gap and/or, silicon tile warpage. The ongoing work deals with the thermomechanical performance simulation of the 3-tile LCoS microdisplay during operating conditions. The focus of this work is to maintain the critical parameters, cell and tile gap, within the prescribed tolerances. Finite element analysis has been used for this purpose and three-dimensional quarter symmetry models have been built to conduct a thorough study of the effect of operating conditions on the critical parameters. The proposed initial design was further improved by conducting parametric studies on material and dimensional parameters. Further, the sub-modeling technique has been used to conduct convergence studies that are essential in finite element analysis.
    Thermal and Thermomechanical Phenomena in Electronic Systems, 2004. ITHERM '04. The Ninth Intersociety Conference on; 07/2004
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