Assessment of medical device features in health technology assessment: a review of NICE medical technology guidance.

Abstract

Objective: This investigation evaluates the relationships between claims of patient and health system benefit, evidence in support of those claims, and the recommendation outcomes of medical technologies assessed by the National Institute for Health and Care Excellence (NICE).

Methodology: Data on evidence, claims, and recommendation outcomes were gathered from published Medical Technologies Guidances (MTGs) on the NICE Web site between 1 December 2010 and 11 April 2023. Binary logistic regressions and descriptive data analyses were performed to investigate the correlation between claims, evidence, and recommendation outcomes.

Results: The technology was fully or partially recommended in forty-six (67.7 percent) of sixty-eight MTGs. No correlation was found between types and number of claims and type and quantity of clinical evidence. However, claims supported directly by evidence were significantly correlated (p < 0.016) with recommendation.

Conclusion: Evidence supporting claims is crucial for receiving a full or partial guidance recommendation. There is no clear pattern in what kind of or quantity of evidence leads to a recommendation, and to increase the probability of receiving a favorable recommendation, the manufacturer needs to plan early in the development phases on how to articulate and refine the claims and to substantiate claims through clinical evidence. It is therefore advisable to take advantage of the opportunity for scientific advice, which NICE offers.