A drug designed to protect vulnerable patients against COVID is unlikely to be effective enough, according to UK regulators.
The National Institute for Health and Care Excellence has stepped back from recommending Evusheld for vulnerable adults to protect against COVID-19.
Draft guidance, published today, says it does not recommend tixagevimab-cilgavimab, which is also called Evusheld and is made by AstraZeneca, to help prevent COVID-19 in adults who are unlikely to have an adequate immune response to vaccination, or for whom vaccination is not recommended.
It made the recommendation after finding no evidence of its clinical effectiveness against current variants and those likely to be circulating in the next six months.
Today’s draft guidance comes after last month’s decision by the FDA in the USA to withdraw its emergency use authorisation for Evusheld as a preventative treatment for COVID-19, citing insufficient evidence of effect against the dominant variants circulating in the US.
NICE’s independent appraisal committee reached the same conclusion, after considering evidence that showed Evusheld is unlikely to prevent infection with most of the variants circulating in the UK now and in the near future.
‘Timely’ information needed
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.
“NICE will be able to respond quickly if evidence emerges that Evusheld or other existing treatments are effective against a particular variant. 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.”
NICE has also announced 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 cost effective.
The committee will consider any comments received at a meeting on 4 April 2023.
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