This is the fourth pharmaceutical Rapid Collaborative Review (PTRCR20) published by EUnetHTA. In March 2021, after an Article 5(3) review the European Medicines Agency (EMA) endorsed the use of bamlanivimab alone and bamlanivimab plus etesevimab combination for the treatment of confirmed COVID-19 in patients aged 12 years and older that do not require supplemental oxygen for COVID-19 and who are at high risk of progressing to severe COVID-19.
This EUnetHTA Rapid Collaborative Review aims to summarize the best publicly available scientific evidence on the clinical effectiveness and safety of bamlanivimab with or without etesevimab according to a PICO of interest to the national or regional requirements of the EUnetHTA partners. Evidence on effectiveness and safety comes from one published phase 2 BLAZE-1 RCT evaluating bamlanivimab 700 mg monotherapy and bamlanivimab 2800 mg plus etesevimab 2800 mg combination therapy in outpatients with recently diagnosed mild or moderate COVID-19. Unpublished results are summarized as well from phase 3 BLAZE-1 RCT related to bamlanivimab 2800 mg plus etesevimab 2800 mg arm, and bamlanivimab 700 mg and etesevimab 1400 mg arm, in high-risk patients with mild to moderate COVID-19.
For any questions regarding the Rapid Collaborative Review, please contact eunethta@zinl.nl.
Below is the documentation provided by the Rapid Collaborative authoring team (Final Rapid Collaborative Review and the responses to the factual accuracy check performed by Eli-Lilly, the prospective Market Authorisation Holder of bamlanivimab):
