OBJECTIVES: The National Institute for Health and Care Excellence (NICE) evaluates medicines, medical devices, and diagnostics using different health technology assessment (HTA) methodologies, in four specialized programs: technology appraisal (TA), highly specialized technologies (HST), the medical technologies evaluation program (MTEP), and the diagnostics assessment program (DAP). This study explores differences between programs in terms of HTA processes and requirements, and analyzes output to date.
METHODS: Published NICE processes and guidance were reviewed on the NICE website up to April 2018 and verified by consultation with NICE technical staff. The processes and HTA requirements of each program were compared. Program output was reported for the number of technologies assessed over time and recommendations given.
RESULTS: TA assessed 770 technologies since 2000 (56% recommended; 23% optimised; 4% only in research; 15% not recommended; 2% cancer drugs fund). HST assessed 7 orphan drugs since 2015 (29% recommended; 71% optimised; 0% not recommended). MTEP assessed 35 devices since 2010 (83% recommended; 14% in research; 3% not recommended). DAP produced 29 publications since 2011, providing 84 recommendations involving 87 technologies (40% recommended; 40% only in research; 20% not recommended). Cost-effectiveness analysis using different thresholds is used for decision-making by TA, HST, and DAP, whereas MTEP assesses cost neutrality or cost-saving potential using cost consequences analysis. Published estimated timescales ranged from 25 weeks (HST without need for consultation) to 63 weeks (DAP). Patient access schemes were implemented in TA and HST, but not DAP or MTEP.
CONCLUSIONS: NICE uses a range of HTA methods to assess technologies in different programs: cost consequences analysis in place of cost-effectiveness analysis for cost-saving devices, and higher cost-effectiveness thresholds for orphan drugs and those that meet end-of-life criteria. New developments include a budget-impact test and a ”fast track” TA process for technologies that are likely to be highly cost-effective.
