The National Institute for Health and Clinical Excellence Single Technology Appraisal process: lessons from the first 4 years.

Objectives: The National Institute for Health and Clinical Excellence (NICE) Single Technology Appraisal (STA) process in the United Kingdom was established in 2005 in order to provide guidance on new technologies as close to their launch as possible. The NICE recommended timeframe for completion of an STA is 34 weeks. The purpose of this study was to map the first 95 STAs to collect information on a range of issues including timelines and appraisal decisions.

Methods: A mapping tool was devised to collect information from the NICE Web site. Data were analyzed by calculating frequencies. Simple descriptive statistics were applied where appropriate.

Results: Ninety-five STAs were included in the analysis. Almost one-third (30/95) initially identified topics did not go on to be appraised often due to licensing issues. Timelines were measured for 29 completed STAs. Eight (28%) of these were completed by 37 weeks and 20 (69%) by 42 weeks. When STAs with appeals were excluded, 31% (8/26) were completed by 37 weeks and 85% (22/26) by 42 weeks. The incremental cost-effectiveness ratios reported by manufacturers were consistently lower than those estimated by the evidence review groups. In all, 76% (38/50) of the completed STAs resulted in an approval.

Conclusions: The NICE Web site enabled access to almost all necessary information, although electronic documents were sometimes difficult to locate. One-third of the referred topics were suspended or terminated. The NICE STA process is slower than initially anticipated and this is primarily due to events outside of NICE's direct control.