Publication Digest: Real-world evidence in health technology assessment of high-risk medical devices: Fit for purpose?

MTRC shares the most relevant and impactful publications in the field of market access and HEOR for medical technologies in Europe through its Publications Digest. In a recent publication, Klein et al. evaluated the use of real-world evidence (RWE) by HTA agencies in Europe for assessing the cost-effectiveness of high-risk medical devices. In total, 25 HTA reports using RWE data were reviewed. Authors offered a critical review of the use of RWE in these reports and provided recommendations for improvement.

Authors reported: “25 HTA reports were included that incorporated 28 observational studies of comparative effectiveness.

Half of the studies (46%) took important confounding and/or effect modifying variables into account in the design and/or analyses. The most common way of including confounders and/or effect modifiers was through multivariable regression analysis. Other methods, such as propensity score matching, were rarely employed. Furthermore, meaningful analyses to test key assumptions were largely omitted.

Resulting recommendations from HTA agencies on MDs is therefore (partially) based on evidence which is riddled with uncertainty.”

Access the full-text article here.