Calls grow for health chiefs to give anti-Covid drug Evusheld green light and protect vulnerable

The father unable to hug his teenage daughter. The retired nurse too scared to walk down the street to the shops. The 25-year-old transplant patient whose friends no longer call because he hasn’t left the house in nearly three years, and the 70-year-old former teacher who has had no visitors since the beginning of the pandemic.

These are just a few of the heartbreaking stories of the Britons with serious health conditions that mean they are still in self-isolation, shielding from Covid-19, while life for the rest of us has long been fairly normal. Whereas the vast majority of people are well protected from the virus by vaccines, roughly 500,000 people in the UK are believed to have not responded to them.

This is because they have weakened immune systems due to blood cancer, or because they take powerful drugs to stop their body rejecting an organ transplant. They are known as immunocompromised and, cruelly, they are the same people who are most at risk from Covid.

There is a drug that would provide them with the protection they desperately need. It is called Evusheld and it’s already available in 32 countries, including the US, France and Israel. But the UK Government refuses to fund it.

As reported by this newspaper, Evusheld was approved by UK health regulators in March, yet Ministers and civil servants responsible for allotting NHS cash claim it is still unclear whether the drug is effective.

This is despite a multitude of countries reaching the opposite conclusion. Data from these nations show the striking impact of the drug. Studies show that after taking Evusheld, patients were drastically less likely to catch Covid or become severely ill if they did.

One patient desperate to get Evusheld is Imogen Dempsey (pictured), 43, from Colchester. The risk analyst suffers a condition that means she has not responded to vaccines

Hopes were raised in July when Government officials hinted the drug could soon be made available on the NHS.

But in August these were dashed when the Government concluded it would not fund access to Evusheld this winter. Instead it would leave the decision to the NHS spending watchdog, the National Institute for Health and Care Excellence (NICE), to make the call at a committee that will not meet until spring.

This will come far too late for many. Make no mistake, Covid still poses a huge threat to these people. Blood cancer patients alone have accounted for one in 20 of all Covid deaths since March.

In the belief that we must free the most vulnerable from living in the shadow of this threat, the MoS today launches a campaign to give people access to the drug that will provide them with the protection they need – something that experts believe should have happened months ago.

Last week it was revealed that Evusheld would be available in the UK only to patients who are willing to pay for it. The drug, which has to be taken every six months, costs upwards of £1,000 a dose – making it financially out of reach to many.

Throwing his weight behind our campaign, former Health Secretary Lord Lansley said: ‘More than 30 countries are offering Evusheld, but the UK has failed to do the same.

‘It is a sad state of affairs. With a hard winter approaching for the NHS, the Government must purchase stocks of this drug.’

One patient desperate to get Evusheld is Imogen Dempsey, 43, from Colchester. The risk analyst suffers a condition that means she has not responded to vaccines.

One American patient who has received Evusheld is Marcia Boyce (right), 67. Pictured with husband Ken

‘My blood tests show I have no protection against Covid,’ the mother-of-one says.

‘I had my latest booster earlier this month, but my GP says it won’t have made much difference.

‘I live a very narrow life. I haven’t met friends or family indoors since the beginning of the pandemic, and I am working from home permanently.’

She says her illness has also changed her 12-year-old daughter’s life. ‘Jessica wears a mask to school still to protect me,’ Imogen says. ‘There are so many basic mother-and-daughter activities I can’t do, like taking her swimming.

‘As a single mother, my biggest fear is ending up in hospital or dying with Covid. What would happen to my daughter? I need Evusheld so I can have my life back.’

So why are health chiefs adamant that Evusheld should not be offered to immunocompromised Britons?

The treatment is a combination of two medicines – tixagevimab and cilgavimab – given by injection. The drugs work by attaching to the Covid virus and inhibiting its ability to bind with healthy cells and infect the body.

Early studies showed Evusheld, created by British Covid vaccine manufacturer AstraZeneca, could reduce the risk of Covid infection by 80 per cent in immunocompromised people for six months. For those unlucky enough to catch the virus, the risk of death was halved.

Those trials pitted Evusheld against the original strain of Covid, which is no longer in circulation having been superseded by other variants. Health chiefs argued that more data was needed to prove it was still effective against the Omicron variant and its sub-variants, which now account for the majority of cases.

Based on these worries, European and US health officials decided to double the dose.

Last week it was revealed that Evusheld would be available in the UK only to patients who are willing to pay for it

Meanwhile, scientists in many countries initiated observational studies of patients who had received Evusheld, to see how the drug held up against the Omicron sub-variants. Data from the US, Israel and France all concluded that it was still highly effective. A University of Colorado study found the drug reduced the risk of infection by nearly 66 per cent, and cut the risk of death in patients who were infected by 64 per cent.

But this data was not enough for UK mandarins. In September, the Department of Health and Social Care (DHSC) published a letter from then Health Secretary Steve Barclay outlining the reasoning behind the decision to deny access to Evusheld.

According to Barclay, DHSC experts had analysed these studies and found ‘inherent limitations’.

These limitations included the fact that observational studies didn’t use enough patients to be sure of Evusheld’s effect and that some had received other drugs.

But scientists involved have hit back. ‘The UK Government used our study as evidence that more trials were needed, but that’s the opposite of what we reported,’ says Professor Adit Ginde, an emergency medicine expert at the University of Colorado. ‘We found that Evusheld is a life-saving drug for this population.’

Other experts echoed his concern. ‘This is a very bad decision by the British Government,’ says Dr Yann Nguyen, a clinical medicine expert at the University of Paris who ran an observational study involving more than 1,000 Evusheld patients.

Ministers MUST do the right thing and fund Evusheld

By Lord Lansley, former Health Secretary

Few people will fail to remember those difficult early months of the Covid pandemic – the sense of trepidation and how life, for us all, changed beyond recognition.

And then came hope: the vaccines freed us from lockdown and have been instrumental in allowing us to live with this virus.

For some, however, a return to normality is still out of reach.

Due to very serious health problems, there are hundreds of thousands of Britons who the jabs can’t help. And this is why Evusheld is so important.

Earlier this year, data began to come through that showed the treatment could give this most vulnerable group their freedom back. It cuts the risk of catching Covid by 80 per cent and the risk of hospitalisation or death by 50 per cent.

Andrew Lansley (above) was Secretary of State for Health from 2010 to 2012

At that point, along with doctors and charities, I began to talk to Ministers about when we would make it available on the NHS. I did not expect it to happen overnight, but while patients in France, America and dozens of other countries are now benefiting from it, we’ve lagged behind. We are failing those who need our help the most.

I have become disappointed by officials who are, in my view, being over-cautious. They worry the drug may not be effective against Covid variants. Yet the real-world evidence is clear. Countries that have rolled out Evusheld have reported no problems.

Not a single doctor I have spoken to believes that there is any merit to further delay or deliberation – in fact, quite the opposite.

In saying too few patients have been studied in trials, health chiefs are setting the bar far higher for Evusheld than they did for the vaccines.

Yes, we have moved beyond a pandemic phase where the Government is willing to do whatever it takes and pay whatever is required, but denying patients Evusheld, when we know it could save lives, makes little sense.

With a hard winter approaching for the NHS, the Government must purchase stocks of this drug – at least for those most severely in need. Its maker AstraZeneca has supply available. Now it is up to the Government to do the right thing.

• Andrew Lansley was Secretary of State for Health from 2010 to 2012

‘It’s nonsense to say there isn’t enough evidence to use Evusheld. And to argue that more clinical trials are needed, when the threat of Covid is so great to these patients, is unethical.’

There are worries that certain Covid variants that have appeared in recent months could render Evusheld ineffective. Particularly worrying are the BA.4.6 and BQ.1 variants, which Evusheld appears to offer little protection against.

But scientists say this is a risk that exists in the rollout of all anti-virus medicines – including vaccines. ‘Covid mutates so fast that you will never have up-to-date clinical evidence that your drug is 100 per cent effective against it. We saw that with the Covid jabs,’ says Dr Nguyen.

‘But that didn’t stop us using the vaccines. Of course we should follow variants closely, but we know that Evusheld is helping people.’

Experts who have been prescribing Evusheld privately for the past nine months have seen the benefit.

‘Many patients were shielding for over two years, and now they have the added protection which gives them the confidence to return to something resembling a normal life,’ says Dr Nguyen.

‘It’s not a complete solution. They need to keep getting their vaccines and many still wear masks, but if there’s a drug that can protect your patients, you have a responsibility to give it to them.’

Prof Ginde says: ‘Evusheld has allowed this population to do things that normal people take for granted, such as go out in public and see family and friends.’

More than 500,000 doses of Evusheld have now been administered in the US. It is deemed so crucial for the safety and wellbeing of immunocompromised Americans the US government has provided it for free – significant in a country where a ride in an ambulance can cost thousands of pounds.

One American patient who has received Evusheld is Marcia Boyce, 67. The mother-of-three, who owns a car repair shop in Chicago, has blood cancer. Tests showed that even after Marcia’s third Covid jab, her body had produced very few immune cells capable of combating the virus.

‘I was so scared during the first two years of the pandemic,’ she says. ‘I saw how high the mortality rate was for people like myself, so I barely went outside.’

But last December, Marcia was able to get Evusheld.

In June she underwent another blood test and doctors were shocked to find that, in that time, she had contracted Covid. ‘I didn’t realise,’ she says. ‘This is a virus I was likely to end up in the hospital with if I caught it, but I didn’t even have any sniffles.

‘There can’t be any other explanation than Evusheld.’

She says she’s now living her life as she did before the pandemic. ‘I’m not wearing a mask any more and I recently took a trip to New York City. It was the first time I’d flown anywhere for two years. My life is back to normal.’

Last week, AstraZeneca said it would allow patients to access Evusheld privately in the UK.

The decision came after the company had failed yet again to convince the Government that the drug was effective.

A spokesman for AstraZeneca also told The Mail on Sunday: ‘We’ve had lots of requests from clinically vulnerable patients. We understand how hard this has been for Britons still forced to shield, and this was the only option to make this drug available this winter in the UK.’

Patients who can get a referral from their NHS clinician proving they are immunocompromised can pay for Evusheld.

The first dose will cost £1,000, but will rise to £1,600 afterwards.

Studies show immunocompromised patients need a dose every six months.

AstraZeneca says it is possible that patients could get Evusheld at an NHS hospital if it has a private ward.

‘It is still unclear how this is going to work,’ says Dr Lennard Lee, a cancer expert at Oxford University. ‘NHS doctors cannot prescribe a drug that has to be paid for privately, and patients are still in the dark on where they should go to get it.’

He adds: ‘This is deeply upsetting. I have already heard from patients who say they cannot afford Evusheld.’

Charities also condemned the Government’s lack of action.

‘It should be making Evusheld available for everyone, and its refusal to do so means that a potentially lifesaving treatment is only available to those who can afford this,’ says Gemma Peters, chief executive of Blood Cancer UK.

The drug, which has to be taken every six months, costs upwards of £1,000 a dose – making it financially out of reach to many

‘What does it say about us as a country that we are trailing behind the rest of the world when it comes to offering compassion to those who are most vulnerable?’

Imogen Dempsey says she will pay for Evusheld. ‘I’m lucky that I can afford it. I’ve been waiting for this moment for so long.

‘When I finally get Evusheld, the first thing I’m going to do is take my daughter swimming. Then I’m going to go out for a steak dinner with my partner.

‘These are everyday things to normal people, but for me they are a world away right now.

‘There are many out there who don’t have the money to pay thousands of pounds every six months.

‘We are supposed to have a National Health Service in this country, so it is beyond understanding why we are being forced to pay to get our lives back.’

A DHSC spokesman said: ‘Following a review of the available data, our clinical experts advise there is insufficient data on the duration of protection offered by Evusheld in relation to the Omicron variant, and in line with that advice the Government will not be procuring doses at this time.

‘We are keeping the evidence under close review and NICE has begun its appraisal of Evusheld.

‘If it considers the treatment to be clinically and cost-effective, it will be made available on the NHS in the usual way.

‘To increase the evidence base upon which Evusheld can be assessed, we are urgently exploring commissioning a clinical trial.’