Assessment of quality of data submitted for NICE technology appraisals over two decades (13 February 2024)

Summary

The National Institute for Health and Care Excellence (NICE) pioneered the Health Technology Assessment (HTA) processes and methodologies. Technology appraisals (TAs) focus on pharmaceutical products and clinical and economic data, which are presented by the product manufacturers to the NICE appraisal committee for decision-making. Uncertainty in data reduces the chance of a positive outcome from the HTA process or requires a higher discount. This study in the BMJ Open aimed to investigate the quality of clinical data submitted by product manufacturers to NICE.

The authors found that the primary components of clinical evidence influencing NICE’s decision-making framework were of poor quality. They argue that there is a need to generate robust clinical data for premarket and postmarket introduction of medicines into clinical practice, to ensure they deliver benefits to patients.