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.
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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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