Evusheld is not clinically effective against Covid-19, say NICE

There is not enough evidence that Evusheld is clinically effective against Covid-19, according to draft guidance from NICE.

It was hoped that Evusheld, a neutralising monoclonal antibody combination of tixagevimab and cilgavimab, could be an effective alternative for vulnerable people who are unlikely to have an adequate immune response to Covid-19 vaccination, or who can’t be vaccinated. But NICE said that there is not enough evidence of its effectiveness against current variants and those likely to be circulating in the next six months.

NICE is now developing a new review process to update recommendations on the cost-effectiveness of Covid-19 treatments, so they can be made available more quickly if they show promise against new variants and are found to be cost-effective.

It follows a decision by the US drug regulator to withdraw its emergency use authorisation for Evusheld as a preventative treatment for Covid-19.

NICE heard from patients who are not protected following vaccination

In developing the draft guidance on Evusheld, the committee heard from, and took into account the views and experiences of patient experts who described the challenging ongoing impact of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.

The committee also heard that the only evidence showing any clinical benefit for Evusheld was from 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 rapidly evolving nature of Covid-19.

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.”

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.

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.

Many vulnerable patients put hope in Evusheld

Helen Rowntree, Chief Executive of Blood Cancer UK, said that many people with blood cancer have put a lot of hope in Evusheld offering them a way back to a more normal way of life, and they will be disappointed to hear the drug has not been deemed clinically effective for use on the NHS by the independent body NICE.

She said:  “While Evusheld still remains privately available, what the government and NHS should do today is make sure the roll-out of booster vaccines to the immunocompromised, including those with blood cancer, is vastly improved. The NHS has been less successful at vaccinating immunocompromised people than older people, and we have seen particularly low vaccination rates in those from the Pakistani, Bangladeshi, Black African and Black Caribbean communities. Post-exposure treatments have also been incredibly important for the blood cancer community, and it’s vital the NHS makes sure everyone who’s eligible has quick access to them if they develop Covid-19.

“Blood Cancer UK expects to see clear plans from the government about how to best protect immunocompromised individuals as we continue to live with Covid-19.”