CADTH Drug Implementation Advice on Tixagevimab and Cilgavimab (Evusheld

This disclaimer and any questions or matters of any nature arising from or relating to the content or use (or misuse) of this document will be governed by and interpreted in accordance with the laws of the Province of Ontario and the laws of Canada applicable therein, and all proceedings shall be subject to the exclusive jurisdiction of the courts of the Province of Ontario, Canada. [...] Based on the evidence available at the time of the review, the panel suggested prioritizing patient populations for the appropriate use of tixagevimab and cilgavimab, in the context of limited supply. [...] The clinical value of tixagevimab and cilgavimab was deliberated in the context of the ongoing public health emergency of the COVID-19 pandemic. [...] In the PROVENT trial, the combination of tixagevimab and cilgavimab was associated with a statistically significant reduction of 77% (95% CI, 46.1 to 90.0; P < 0.001) in the risk of experiencing a SARS-CoV-2–positive symptomatic illness compared with placebo; however, the number of events that occurred and were included in the analysis was low considering the overall size of the trial population. [...] In terms of populational generalizability, a total of 4% of patients included in the PROVENT trial were 75 years of age or older; this limits conclusions on the efficacy and safety of the combination of tixagevimab and cilgavimab in an elderly population, which is important given the significant mortality risk in this population.14 A total of 78% of patients presented with at least 1 of the variou.