- NICE recognises that a new faster process is required for potential future therapies after ruling that Evusheld (tixagevimab-cilgavimab) should not be made available to vulnerable patients.
- The All Party Parliamentary Group on Vulnerable Groups to Pandemics (VGP) says a new fast-track process for future Covid-19 treatments is urgently needed and it is unacceptable that the Government has continued to leave 500,000 people vulnerable to Covid-19.
- MPs and Peers from all parties are also urging the Government to appoint a Minister with special responsibility for vulnerable groups and the #Forgotten500k families who still live at severe risk of Covid-19.
NICE has today published draft guidance recommending against the provision of Evusheld for vulnerable adults “because there is no evidence of its clinical effectiveness against current variants and those likely to be circulating in the next 6 months.”
The NICE guidance has provoked a mixed response from the cross-party parliamentarians in the All Party Parliamentary Group on Vulnerable Groups to Pandemics (VGP). Part of the campaign group (#Forgotten500k), the MPs, and Peers argue that NICE has been far too slow and goes against a growing body of international medical evidence. It continues to leave a vulnerable group without protection or without any plan for treatment options to protect them as the rest of the population go back to their normal lives.
Evusheld was approved by the MHRA in March 2022, and has been available for over a year, but patients were denied access on the NHS at the height of its effectiveness. This raises questions about how the entire NICE process on making treatments available.
The NICE announcement it will develop “a new review process to update recommendations on the cost-effectiveness of COVID-19 treatments” has been welcomed, but significantly this will not apply to Evusheld 2, which is currently undergoing trials. That means vulnerable people are still more than a year away from potential treatment on the NHS.
The APPG for VGP is urging the Government to now give specific responsibility for the clinically vulnerable to a Minister in the health team to urgently address these issues and establish a rapid pathway to providing new treatments once they have MHRA authorisation.
Policies to protect and support this community need oversight and accountability at the highest level, and the system that prevents treatments being made available quickly needs to be clarified. The Government should ensure that the voices of the vulnerable are heard, their lives are valued, and that they receive equality of healthcare provision.
Bob Blackman MP, Co-Chair of the APPG said: “The Government have disenfranchised a whole group of vulnerable people and put them outside of NHS provision for protection against Covid-19. I am disappointed that this has not yet been rectified for situations of serious national health crises. Addressing this disparity and inequality of protective provision is long overdue.
“Our constituents have been vocal in raising this issue with us, their representatives. The effects of the threat of infection and its consequences are serious for them and also for their families. We need a minister steering through proper policies to acknowledge these failings and make sure a plan is in place.”
Lord Mendelsohn, Co-Chair of the APPG said: “The terrible toll of Covid-19 on the immunocompromised and immunosuppressed is a tragic indictment of this Government’s failures. There remains a vulnerable group of half a million people who cannot ‘live with’ Covid but do live with the fear of its extreme consequences for them.
“These families have been subjected to one bad decision after the other which has caused real harm including loss of life and loss of quality of life, as well as significant economic impact. We need urgent answers on how this group can be protected from the life threatening effects of Covid-19. Taking ministerial responsibility for vulnerable groups will show that the Government has learnt its lesson and will take the protection of this group seriously.”
Dr Lennard Lee, Clinical Advisor to the APPG said: “Currently the UK is at odds with over 32 other countries who have approved vaccine alternatives, like long active antibodies, which could transform the lives of the most vulnerable in our community.
“This NICE guidance is perhaps not unexpected but is nevertheless extremely disappointing for patients and their families. The process has taken far too long and has been far more complicated than for other Covid-19 treatment. Yet more delays will inevitably cause more harm.”
Evusheld, developed by UK-headquartered AstraZeneca, was approved in March 2022 by the UK Medicines and Healthcare products Regulatory Agency. It is currently available in 32 other countries including the US, Israel and France.
The #Forgotten500k campaign calls for more action for the immunosuppressed. It launched in summer last year to allow this group to be seen, to build connections and to be heard through their personal stories, and follow scientific development. The goal is to ensure immunocompromised people are no longer forgotten. The campaign is backed by patient group ‘Evusheld for the UK’, a large number of charities and the APPG on Vulnerable Groups to Pandemics.
Members of the APPG from all parties have raised the issue regularly in Parliament since Evusheld was approved by the MHRA. An inquiry by the APPG into the forgotten 500,000 immunocompromised patients is ongoing and a report is due to be published at the beginning of March.
1. Around 500,000 immunocompromised people across the United Kingdom are at higher risk from the Covid-19 virus because their weakened immune systems make them less likely to respond well to vaccines. Many are still shielding, still in isolation, still unable to work, see friends or hug loved ones.
2. Please see https://getevusheld.uk/500k/ for more information.
3. For media enquiries and interviews, please contact:
Tracey Allen, Secretariat to the APPG: allentj(at)parliament.uk
Lennard Lee, DPhil (Oxon), MRCP (UK), BmBCh (Oxon), MA (Cantab): lennard.lee(at)oncology.ox.ac.uk
4. Previous #Forgotten500k campaign materials, created pro bono by The&Partnership and mSix&Partners, can be accessed here: