Evusheld is not being recommended for immunocompromised people to protect against COVID-19 in the UK, despite a long running campaign calling for it to be made available on the NHS.
The National Institute for Health and Care Excellence (NICE) says there's no clinical evidence that it protects against existing coronavirus variants or those expected to circulate in the next 6 months.
Evusheld, also called tixagevimab-cilgavima, is a prophylactic monoclonal antibody treatment designed to protect severely immunocompromised people against COVID where vaccines aren't recommended or don't work.
These include people with immunodeficiency, people who've had a solid organ transplant, and people with certain types of cancer.
Disappointment After High-Profile Campaign
The decision is a huge disappointment to campaigners who've been trying to get Evusheld made available on the NHS for the so-called ' Forgotten 500', an estimated over half a million clinically vulnerable people living in the UK who are still having to shield as they don't have protection against COVID-19.
One of those clinicians was Dr Lennard Lee, a medical oncologist at the University of Oxford. He told Medscape News UK: "This announcement will undoubtedly feel devastating to the most vulnerable in our community. Immunocompromised patients need alternatives treatments when they do not have good protection against the virus following COVID vaccinations.
"Many have not been able to see family or to hug loved ones, facing ongoing restrictions or shielding for 3 years. They need to be listened to, prioritised, and have a much stronger central co-ordinated approach to empower us all to live with coronavirus."
"NICE had a very difficult assessment to make," said Professor Alex Richter, Director of the Clinical Immunology Service at the University of Birmingham. He acknowledged that preventative antibody treatments, such as Evusheld, had been proven to work well against previous COVID-19 variants as a treatment and as a preventative treatment. However: "There is laboratory evidence that Evusheld does not work against 85% of the COVID-19 variants currently circulating in the UK. NICE recognise that the virus is evolving faster than the evidence can be produced and their assessment process can be undertaken, so that they need to find a way of more rapidly assessing treatments for the immune vulnerable. "
Bureaucracy and Delays 'Cost Lives'
Martin Eve, is co-leader of the 'Evusheld for the UK' campaign group. He says the NICE verdict on Evusheld is disappointing but not surprising and lessons must be learned.
"Owing to government and process delays, this committee was pushed back and back while COVID continued to mutate. By the time the committee met, almost a full year after the MHRA gave marketing authorisation for Evusheld, it was no longer proven to work against the most recent variants," he told Medscape News UK.
"It is not acceptable in an ongoing pandemic for drug appraisal processes to take 11 months. We have immunocompromised people in our group who have now been totally shielding for 3 years. The virus will continue to mutate. Overly bureaucratic and slow cost appraisal processes for COVID drugs are useless and are outpaced by the virus. And it's costing patients their lives."
Kidney Care UK is also critical of the time it took NICE to make the decision.
The charity's Policy Director Fiona Loud said: "We believe that Evusheld could have helped vulnerable people over the past year by supporting them to return to normal life, as it has in over 30 countries around the world; but that opportunity was wasted due to the failure to act quickly and decisively. It is clear that the current protracted NICE process is completely inappropriate and has left a huge number of people without protection and reassurance when they needed it most. This is a painful lesson that, in the case of a rapidly mutating virus like COVID-19, time is of the essence for people who remain at greater risk."
Reducing The Risk
Helen Rowntree, Chief Executive of Blood Cancer UK, said:"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.
“There are still things people with blood cancer can do to protect themselves against COVID-19. For some people with blood cancer the COVID-19 vaccines may be less effective but can still offer some level of protection. Given people with blood cancer have a higher risk of becoming more ill from COVID-19, reducing that risk is really important and everyone with blood cancer should come forward to receive their vaccines when they’re offered them."
NICE New Review Process
The guidance by NICE follows the Department of Health’s decision last year not to back Evusheld because of a lack of evidence of its benefit against variants. Also last month the FDA in the US withdrew its emergency use authorisation for Evusheld as a COVID preventative treatment for similar reasons.
NICE’s independent appraisal committee reached the same conclusion and has issued the draft guidance for public consultation until 9 March 2023. The committee will consider any comments received at a meeting due to take place in April.
NICE said it is now developing a new review process to update recommendations for COVID treatments so they can be made available more quickly to patients if they show promise.
Director of medicines evaluation at NICE, Helen Knight said in the statement: "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.
Fiona Loud from Kidney Care UK said: "It is frustrating that it has taken until now for NICE to start developing a new rapid review process. It is vital that this is put in place without further delay," she added.