title: When does NICE recommend the use of health technologies within a programme of evidence development? : a systematic review of NICE guidance.
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.
  
  
  OBJECTIVE
  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  In total, 29 final and 31 draft guidance documents included OIR/AWR recommendations up to January 2010.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.
  
  
  CONCLUSIONS
  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.
authors: Health Economics Research Group, Brunel University, Uxbridge, Middlesex, UB8 3PH, UK. louise.longworth@brunel.ac.uk
authors: Louise
authors: L
authors: Longworth
authors: Jihee
authors: J
authors: Youn
authors: Laura
authors: L
authors: Bojke
authors: Stephen
authors: S
authors: Palmer
authors: Susan
authors: S
authors: Griffin
authors: Eldon
authors: E
authors: Spackman
authors: Karl
authors: K
authors: Claxton
mesh_terms: D003362:Cost-Benefit Analysis; D003657:Decision Making; D019317:Evidence-Based Medicine / Q000458:organization & administration*; D017408:Guidelines as Topic; D006801:Humans; D012051:Reimbursement Mechanisms; D012106:Research / Q000191:economics / Q000458:organization & administration*; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000458:organization & administration*; D006113:United Kingdom