A Review of the National Institute for Health and Care Excellence (NICE) Medical Technologies Guidance over the Last 10 Years
Author(s)
Green M*1;Harper S1, Wright D2
1York Health Economics Consortium, University of York, York, UK, 2York Health Economics Consortium, University of York, York, NYK, UK
OBJECTIVES: The National Institute for Health and Care Excellence (NICE) published its first Medical Technologies Guidance (MTG) in December 2010. This research reviews and analyses the published guidance.
METHODS: All MTG published between December 2010 and June 2020 were reviewed. Data on the outcome of the guidance and rationale for this, publication date, the device and its intended use, device cost, clinical and economic evidence, and prior publication of a MedTech Innovation Briefing (MIB) were extracted. A Fisher's exact test measured statistical significance.
RESULTS: A total of 49 MTG have been published since the inception of NICE’s Medical Technologies Evaluation Programme of which 45 remain on the NICE website. The device has been recommended or partially recommended in 34 (76%) of MTGs with 9 devices (20%) recommended in research. Two devices (4%) were not recommended. A range of devices across various disease areas have been considered, with wound care or prevention products evaluated most frequently. The clinical study design on which the evidence was based varied by MTG with 23 MTG (51%) based on randomized control trial (RCT) data. There was no significant difference in likelihood of a full or partial recommendation dependent on RCT data (78.3% with RCT data and 72.7% without RCT data), but where there was RCT data and no positive recommendation the Committee noted issues with the alignment of the RCT to the NICE Scope. An economic model was submitted for all MTG. Where a MIB was published the likelihood of a positive recommendation was 50% compared with 81% without (p=0.085).
CONCLUSIONS: Devices receiving MTG are highly likely to be recommended for general use or in research. RCT data are only helpful in achieving a positive outcome where they are well aligned with the decision problem. An economic model was always required to aid decision making.
METHODS: All MTG published between December 2010 and June 2020 were reviewed. Data on the outcome of the guidance and rationale for this, publication date, the device and its intended use, device cost, clinical and economic evidence, and prior publication of a MedTech Innovation Briefing (MIB) were extracted. A Fisher's exact test measured statistical significance.
RESULTS: A total of 49 MTG have been published since the inception of NICE’s Medical Technologies Evaluation Programme of which 45 remain on the NICE website. The device has been recommended or partially recommended in 34 (76%) of MTGs with 9 devices (20%) recommended in research. Two devices (4%) were not recommended. A range of devices across various disease areas have been considered, with wound care or prevention products evaluated most frequently. The clinical study design on which the evidence was based varied by MTG with 23 MTG (51%) based on randomized control trial (RCT) data. There was no significant difference in likelihood of a full or partial recommendation dependent on RCT data (78.3% with RCT data and 72.7% without RCT data), but where there was RCT data and no positive recommendation the Committee noted issues with the alignment of the RCT to the NICE Scope. An economic model was submitted for all MTG. Where a MIB was published the likelihood of a positive recommendation was 50% compared with 81% without (p=0.085).
CONCLUSIONS: Devices receiving MTG are highly likely to be recommended for general use or in research. RCT data are only helpful in achieving a positive outcome where they are well aligned with the decision problem. An economic model was always required to aid decision making.
Conference/Value in Health Info
2020-11, ISPOR Europe 2020, Milan, Italy
Value in Health, Volume 23, Issue S2 (December 2020)
Code
MT3
Topic
Health Technology Assessment, Medical Technologies, Study Approaches
Topic Subcategory
Decision & Deliberative Processes, Literature Review & Synthesis, Medical Devices, Systems & Structure, Value Frameworks & Dossier Format
Disease
Medical Devices