NICE has not recommended Evusheld for vulnerable adults in England with COVID-19 due to a lack of evidence of its effectiveness.
Evusheld is used to help prevent COVID-19 infection in adults and is made up of two active substances tixagevimab and cilgavimab. It has been recommended specifically for adults with weakened immune systems.
The National Institute of Health and Care Excellence (NICE) has issued draft guidance for public consultation, which does not recommend Evusheld for preventing COVID-19 in adults who are unlikely to have an adequate immune response to COVID-19 vaccination or who cannot be vaccinated.
Insufficient evidence for the use of Evusheld
This new draft guidance follows a previous decision by the US drug regulator to withdraw its emergency use authorisation for Evusheld as a preventative treatment for COVID-19, which said there was a lack of evidence that the drug is effective against dominant variants of COVID-19 in the US.
NICE’s independent appraisal committee reached the same conclusion once they considered evidence which highlighted Evusheld is unlikely to prevent infection with most of the variants circulating in the UK and in the future.
NICE is now developing a new review process to update recommendations on the cost-effectiveness of COVID-19 treatments allowing them to be made available more quickly to patients if they show promise against new variants and are cost-effective.
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.
“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. That is why we are developing a process to monitor real-world data and re-evaluate the medicines as needed against that data in a faster way than we currently do for other drugs. 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.”
Finding new medications for treating COVID-19 is a priority
The committee heard the personal views and experiences of patient experts who described the challenging ongoing impact of COVID-19 on their lives and the lives of others with a high risk of severe infection who are not protected following vaccination.
They also heard that the only evidence showing any clinical benefit for Evusheld was a trial completed earlier in the pandemic when different variants of the COVID-19 virus were circulating. None of the clinical evidence studies included evidence against current variants because of the changing nature of the infection.
Treatments like Evusheld are not as effective against COVID-19 mutations, and the committee used data from in vitro studies to come to their conclusion. Whilst the COVID-19 treatment did show some effectiveness against older Omicron variants, it did not work against the current common and fastest-growing strains.