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Last updated: 5th May 2023
What is the news?
Today NICE has announced an final initial decision not to approve Evusheld on the NHS across the UK. This means that at this current moment in time Evusheld will not become available on the NHS in the UK.
Who are NICE and what do they do?
The role of the National Institute for Health and Care Excellence (NICE) in England is to decide if a treatment is cost-effective and therefore suitable to be used on the NHS. They do this by comparing the treatment to existing treatments, if there are any. The process involves looking at clinical trial data and information on the cost of delivering the new drug. A committee of people at NICE then makes a recommendation based on the evidence they have.
Why did NICE make this final decision?
This decision has been made largely because it is uncertain how well Evusheld works against the current variants of COVID-19. The main trial of Evusheld started back in 2020 when the variants in circulation were different from those in circulation now. The results from this trial are therefore no longer applicable and it is unlikely that Evusheld is as effective as it was originally against most of the current variants in circulation.
The NICE committee did look at results from testing Evusheld on the most recent variants of COVID-19 in the lab, but the committee felt it remains uncertain how well Evusheld works in people.
Accordingly, while the NICE committee felt that it understands the strong need for a preventative treatment in the at-risk community, they have made the final conclusion that Evusheld is not clinically effective enough to meet the criteria for recommending NHS use at this moment in time.
What is Leukaemia Care’s position and what will we do?
Leukaemia Care is disappointed with this decision from NICE not to approve Evusheld on the NHS in the UK. We understand this decision will affect many of those we support and their families.
We remain concerned particularly about the duration of time between Evusheld receiving a license from the MHRA and a decision being made by NICE. Delays to this process have meant that Evusheld is no longer as effective against current COVID-19 variants, whereas it was against the variants present when it was first licensed. This is despite Leukaemia Care and others campaigning for action from the Department of Health for several months for an update on Evusheld plans before it was announced that NICE would appraise it, time which could have been used assessing Evusheld earlier.
NICE recently announced that they will continue to review the Evusheld appraisal should any new evidence or data on its clinical effectiveness against other variants come to light. Leukaemia Care will continue to engage with this process to put forward the perspective of patients.
Leukaemia Care’s CEO, Zack Pemberton-Whitely, commented “NICE’s decision not to approve Evusheld for use in the NHS will be disappointing news for many. For some leukaemia patients and their families the pandemic is far from over and is still having a significant impact on their daily lives. As variants of COVID-19 are constantly changing, we are concerned that the NICE process is not fit for purpose for the review of COVID-19 treatments. We will continue to engage with NICE to advocate for people affected by leukaemia on this topic.”
Where can I find out more about Evusheld and how it works?
Evusheld remains available to buy privately in the UK. To read more about this and what Evusheld is please see our blog here.