| Abstrakt: |
Introduction: Health Technology Reassessment (HTR) is emerging, as the focus of health technology assessment agencies shifts from traditional methods of technology adoption to managing technologies throughout their lifecycle. The National Institute for Health and Care Excellence (NICE) evaluates devices, digital and diagnostic technologies by producing medical technologies guidance, which could recommend for adoption, no adoption, or further research. The desire to move to a lifecycle approach in the evaluation of medical technologies is reflected in the guidance review process, which involves review of the technology every three years or upon notification of significant new evidence. The outcomes of the guidance review can be to amend, update, withdraw, or leave the guidance unchanged. Methods: Information on all technologies which have undergone guidance review since the commencement of the process was collected, including the recommendation before and after review and the basis for this recommendation. The proportion of guidances which were not changed, amended, updated, and withdrawn was calculated and the trends, including the bases for recommendation change were analyzed. Results: In total, 34 medical technology guidance reviews have been performed. During the process, 15 (44%) were amended to reflect minor changes in the economic or clinical evidence, which did not change the recommendation. Ten (29%) were not changed, while three (9%) were updated respectively. Three (9%) were withdrawn. Another three (9%) represent special cases, which entered guidance review, but were paused due to external reasons. Among the guidances that progressed to update, two out of three had a cost increase, whereas one was broadened to reflect evidence for a larger population. Conclusions: HTR is an important mechanism to improve patient care and system efficiency. In NICE's evaluation of medical technologies, changes in the recommendation stemmed from changes in the technology's (or standard care's) cost, the evidence for clinical effectiveness, or the safety profile. [ABSTRACT FROM AUTHOR] |
