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Covid-19: Evusheld is unlikely to prevent infection with current or future variants, NICE concludes

BMJ 2023; 380 doi: https://doi.org/10.1136/bmj.p387 (Published 16 February 2023) Cite this as: BMJ 2023;380:p387
  1. Elisabeth Mahase
  1. The BMJ

The National Institute for Health and Care Excellence (NICE) has decided not to recommend Evusheld for adults who are unlikely to have an adequate immune response or cannot have the vaccine against covid-19, citing a lack of evidence that it is effective against circulating variants.1

In its draft guidance NICE said that it would not be approving Evusheld, a combination of the long acting antibodies tixagevimab and cilgavimab, as a pre-exposure prophylactic for vulnerable adults. However, it is still reviewing whether the antibody drug could be used to prevent covid-19 infection in adults at the highest risk of severe illness, including people with immunodeficiency, people who have had a solid organ transplant, and people with cancer.

The recommendation comes after the US Food and Drug Administration withdrew its emergency use authorisation for Evusheld in January. At the time it said that the treatment was unlikely to be effective against the XBB.1.5 subvariant of omicron dominating the country. The FDA had authorised the drug in late 2021 to prevent covid infection in clinically extremely vulnerable people.2

“Disappointing result”

NICE has said that the “only evidence showing any clinical benefit” for Evusheld was from a trial completed earlier in the pandemic, when different variants were circulating, and that no clinical studies showed evidence that it worked against current variants. It added that, while in vitro studies had shown “some effectiveness” against older omicron variants, studies “showed clearly that Evusheld did not work against the current common and fastest growing variants.”

It concluded that Evusheld was “unlikely to prevent infection with most of the variants circulating in the UK now and in the near future.”

NICE’s director of medicines evaluation, Helen Knight, acknowledged that the decision would be “disappointing for the many thousands” of vulnerable people who “continue to significantly modify their behaviour to avoid infection.” However, she highlighted that NICE was developing a new review process to update recommendations on the cost effectiveness of covid-19 treatments, to speed up processes if they showed promise against new variants and to provide value for money.

“NICE will be able to respond quickly if evidence emerges that Evusheld or other existing treatments are effective against a particular variant,” she said. “This would rely on us receiving timely information from partners, and we are in the process of putting agreements in place to ensure this. 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.”

New treatments needed

The UK’s medicine regulator approved Evusheld in March 2022, but the drug was never rolled out because the government found “insufficient data” on the duration of protection it provided against omicron and its subvariants. The government had said that the drug would be rolled out on the NHS if NICE ruled in its favour.3

Commenting on NICE’s decision, Lennard Lee, senior clinical research fellow at the University of Birmingham, said, “While it’s right for NICE to ensure that treatment options are based on the best possible evidence for their safety, efficacy, and cost effectiveness, it must be recognised that those who remain extremely vulnerable to covid need to be prioritised in trials akin to those early days of the pandemic to find treatments fit for them.

“Otherwise, we run the risk of consigning half a million people to continue to live in 2020, stuck in their homes, not able to see their families and friends for fear of infection with no protection.”

NICE’s guidance on Evusheld is open for consultation until 9 March.

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