AstraZeneca’s Evusheld (tixagevimab and cilgavimab) has not been recommended by the National Institute for Health and Care Excellence (NICE) for the prevention of COVID-19 in vulnerable adults, the agency said.
In new draft guidance, NICE explained that there is not enough evidence of Evusheld’s effectiveness against current SARS-CoV-2 variants in the UK and those likely to be circulating in the next six months.
This reflects a decision made last month by the US Food and Drug Administration to withdraw its emergency use authorisation for Evusheld as a preventative treatment for COVID-19, with the regulator also citing insufficient evidence of the drug’s ability to protect against dominant variants in the US.
Evusheld contains two antibodies that boost protection against COVID-19 for those who are unlikely to have an adequate immune response to vaccination, or who cannot be vaccinated. This includes those who have received organ transplants or those with blood cancer.
Helen Knight, director of medicines evaluation at NICE, said: “We know that today’s decision will be disappointing for the many thousands of people who do not get the same protection from vaccination against COVID-19 as most people, and who therefore continue to significantly modify their behaviour to avoid infection.”
In developing the guidance, the agency’s independent appraisal committee noted that the only evidence demonstrating any clinical benefit for Evusheld was from a trial completed earlier in the pandemic when different variants of the COVID-19 virus were circulating.
The drug did show some effectiveness against some older Omicron variants in in vitro studies, NICE said, but the studies ‘showed clearly’ that it did not protect against the current common and fastest growing variants.
In the same statement, the agency also outlined that it is currently developing a new review process to update its recommendations on COVID-19 treatments so they can be made available to patients at a faster rate if they show promise in protecting against new variants and are found to be cost-effective.
Knight added: “The rapidly evolving nature of COVID-19 means we need to have a way of establishing the cost-effectiveness of existing medicines against current variants in an agile way.
“The ambition is that we will be able to produce updated recommendations in as little as six to eight weeks from receiving a positive signal of effectiveness.”