The National Institute for Health and Care Excellence (NICE) has issued draft guidance on ‘Evusheld’ which is not recommended for vulnerable adult with high risk of severe Covid-19 on Thursday (16 February).
The draft guidance is open for public consultation until 9 March 2023. The committee will consider any comments received at a meeting currently due to take place on 4 April 2023.
It comes after last month’s 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 insufficient evidence that Evusheld is effective against the dominant variants of Covid-19 in the US.
NICE’s independent appraisal committee has reached the same conclusion having considered evidence which shows Evusheld is unlikely to prevent infection with most of the variants circulating in the UK now and in the near future.
It has also announced that it is developing a new review process to update recommendations on the cost-effectiveness of Covid-19 treatments so they can be made available more quickly to patients if they show promise against new variants and are found to be 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 6 to 8 weeks from receiving a positive signal of effectiveness.”
According to NICE, Evusheld did show some effectiveness against some older Omicron variants in the in vitro studies. However, the studies showed clearly that it did not work against the current common and fastest growing variants.