OBJECTIVES:

Medical Technology Guidance (MTGs) plays crucial role in adoption of medical technologies by providing recommendations to the National Institute for Health and Care Excellence (NICE) on use in the National Health Service (NHS). We evaluated the trends and data gaps raised by External Assessment Centre (EAC), limiting the acceptance of medical technologies.

METHODS:

All MTGs published from inception to December 2022, from the NICE electronic database, were screened for technologies class (treatment or diagnostic), recommendation decisions, disease specialties, and gaps in clinical and economic evidence. The NICE Committee’s decisions for each assessment were recorded and the need of real-world data (RWD) in the MTGs was also analyzed.

RESULTS:

A total of 64 MTGs were reviewed with respect to treatment (52) and diagnostics (12). Approximately, 40% of the MTGs were recommended for use; remaining 60% were either recommended with restricted use or not recommended. The MTGs were primarily pertaining to urology (9) followed by cardiology (8), gastroenterology (7), neurology (6) and infections (6). Randomized Controlled Trials data was available for 16 MTGs and cost-effectiveness data was available for 19 MTGs. Insufficient clinical evidence was highlighted in 50% of MTGs in treatment category while one-third in diagnostics. Similarly, uncertainties in economic evidence were observed in 70-75% of technologies overall. In the EAC analysis, clinical evidence in 14 MTGs was augmented with the inclusion of new studies, and economic models were revised for 45 MTGs resulting in recommendation of 15 MTGs by NICE. In MTGs with restricted recommendation (39%), EAC has encouraged the collection of RWD to support decision making.

CONCLUSIONS:

Considerable data gaps have restricted the acceptance of medical technologies. RWD along with robust economic evidence is required for informed decision making.