Informing a decision framework for when NICE should recommend the use of health technologies only in the context of an

The decision to approve a health technology for use in the NHS requires an assessment of whether the heath that is expected to be gained from its use exceeds the health that is expected to be forgone elsewhere as other NHS activities are curtailed to accommodate the additional costs. However, any assessment of these expected health gains and costs will be uncertain, particularly if the technology is new and has not been widely used in the NHS. In these circumstances further research would be able to confirm whether or not the technology is worthwhile, leading to better decisions for future patients. There will be circumstances in which this research can be conducted while the technology is in wide spread use but in others the type of research which is needed may only be possible before the technology is approved and made available. This research intends to establish the principles of what assessments need to be made to guide the decisions about whether a technology should only be approved for use in research or when approval can be granted while additional evidence is gathered. It will also examine how these assessments should be made. For example they could be made based on a set of criteria applied to the type of information and analysis currently considered by NICE in their appraisal process or could be based on additional information and analysis that could be conducted and made available. This research will include an examination of past decisions made by NICE as well as a series of more detailed case studies. The results of this research will be presented at a series of workshop which will include representative of those who have an interest in and responsibility for different aspects of the appraisal of health technologies. These workshops will make recommendations about what assessments are needed and how they should be made.

The general issue of balancing the value of evidence about the performance of a technology and the value of access to a technology can be seen as central to a number of policy questions. Establishing the key principles of what assessments are needed, as well as how they should be made, will enable them to be addressed in an explicit and transparent manner. The aims of this research are to: i) Establish the key principles of what assessments are needed to inform an only in research (OIR) or Approval with Evidence Development (AED) recommendation. ii) Evaluate previous NICE guidance where OIR or AED recommendations were made or considered. iii) Establish what impact OIR and AED decisions may have had on subsequent research. iv) Evaluate a range of alternative options to establish the criteria, additional information and/or analysis which could be made available to help the assessment needed to inform an OIR or AED recommendation. v) Provide a series of final recommendations, with the involvement of key stakeholders, establishing both the key principles and associated criteria that might guide OIR and AED recommendations, identifying what, if any, additional information or analysis might be included in the Technology Appraisal process and how such recommendations might be more likely to be implemented through publically funded and sponsored research. To meet these aims the research is broadly structured as follows: i) development of a coherent conceptual framework to establish the key principles of what assessments need to be made and identify a set of explicit criteria (checklist of assessments) which could be applied; ii) review previous NICE guidance and develop a series of detailed case studies to evaluate a range of options for informing these assessments; iii) evaluate both the development of key principles and the range of options for informing assessments through a series of workshops involving a wide range of key stakeholders.