As NHS refuses to fund ‘wonder’ treatment… would you pay £20k for the Alzheimer’s drug that could delay your loved one needing a care home by two years?
It’s a breakthrough dementia drug that has, perhaps surprisingly, left the medical profession divided. For some doctors, lecanemab – the first Alzheimer’s treatment to be developed in more than 20 years – represents ‘the beginning of the end’ for the devastating degenerative disease that affects almost a million Britons.
For others, it’s simply false hope – a treatment that could do more harm than good. Approved by Britain’s medicine safety regulators last week, it was immediately rejected by the NHS.
The National Institute for Health and Care Excellence (NICE) spending watchdog ruled that ‘the relatively small benefits it provides to patients means it cannot be considered good value’.
Not that the drug was too expensive – after all, in recent months NICE has approved drug treatments costing in excess of £1million a dose.
But it just wasn’t worth the estimated £20,000 per year.
For some doctors, lecanemab represents ‘the beginning of the end’ for the Alzheimer’s, for others, it’s simply false hope since it was rejected by the NHS
This means that lecanemab, also known by the brand name Leqembi, will only be available privately.
Campaigners and patient groups reacted with huge disappointment — and David Thomas, of the charity Alzheimer’s Research UK, added that it meant the ‘game-changing’ drug would probably be out of reach for ‘all but the very most wealthy individuals’.
The drug, which is given twice a month, removes proteins called amyloid plaques – thought to cause cognitive decline in Alzheimer’s sufferers – from the brain.
Clinical trials also suggest it may slow the rate of deterioration among patients in the early stages of the disease by nearly a third.
Some doctors claim that taking it could delay needing a care home by as much as two years.
Given the average annual cost of care is roughly £60,000, this could make a private prescription for lecanemab a sound investment.
Meanwhile, other experts have warned of frightening side-effects, including deadly brain bleeds.
Those considering paying will understandably be wondering whether it is worth the cost.
The Mail on Sunday has spoken to some of the country’s top Alzheimer’s experts to answer these questions and more, and paint a clearer picture for patients and their loved ones.
The NHS says lecanemab isn’t worth it – but doctors are calling it a wonder drug and clinics are still offering it privately. I’m not sure what to think?
The diverging approaches of the drug safety watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) and NICE have left many confused.
The key to making sense of it, says Dr Robert Howard, professor of old-age psychology at University College London (UCL), is understanding the different criteria of each organisation.
‘The MHRA are looking to see that the benefits of the treatment exceed its risks,’ he explained. ‘And they decided that, on balance, they do.
‘But NICE has to look at how many people could benefit, as well as the value of the treatment if it was offered on the NHS.
‘They’re asking whether the improvement this treatment provides for patients is worth the expense of buying the drug, administering it and monitoring the product.
‘As the NHS only has a finite amount of money, any new treatment inevitably means that there is less funding for other NHS medicines. The decision isn’t just based on cost – it’s based on value. And NICE decided lecanemab wasn’t worth it.’
But I’ve heard that lecanemab could mean extending the time before needing nursing home care from five to seven years – surely that’s valuable?
Professor John Hardy, of UCL, honorary vice president of Alzheimer’s Research UK and the scientist who first discovered the role of amyloid in the disease, is responsible for this claim.
‘It’s an extrapolation from the 18-month and two-year data from recent clinical trials, but I believe that the drug will give you more time and reduce your nursing home costs,’ he said.
‘After 30 years, this is the first drug that has worked. It slows Alzheimer’s by an average of 25 per cent. I don’t think the NICE decision is for all time – they want more long-term data.’
Those considering going private face a tough decision, he said, adding: ‘There are similar drugs in the pipeline which may have fewer side-effects, and one doesn’t know how they may work out. But if I was in the early stage of the disease, I would take the drug.’
Others disagree. ‘Pitching it as a delay of up to seven years oversells it,’ said Professor Dennis Chan, neurologist and Alzheimer’s expert, also at UCL. ‘It’s not a wonder drug, and when I see people saying that, it makes my heart sink a little bit.
‘We don’t have enough information about how the medication works as people progress, and to package it in that way is misleading.
‘It’s the first drug found to have a clinical benefit and I don’t want to downplay that, but the risk-benefit ratio is on the edge for me.’
So what does this 25 per cent reduction in Alzheimer’s symptoms actually mean?
This figure is where the disagreement arises – it’s not quite as simple as dementia lessening by a quarter. In fact, says Dr Sebastian Walsh, public health researcher at the University of Cambridge, lecanemab’s effect is so small that doctors working on the study were unable to tell who was on the drug and who wasn’t.
‘To get this figure, the researchers checked in with patients every six months – having them take a cognitive test and chat with a doctor,’ he explained.
‘The test was roughly scored out of 144 points. On average, the group who had been given the drug declined by ten points and the placebo group declined by 13.
‘That’s where the 25 per cent number has come from – because the amount of decline over a year and a half is still quite small, any percent sounds like a lot. But this difference in decline still wasn’t considered clinically meaningful – meaning the clinicians checking in with the patients throughout the trial couldn’t pick it up.’
Dr Howard agrees: ‘It’s a difference you can measure with a scale, but you probably couldn’t see in real life.
‘If your loved one was taking lecanemab, they certainly wouldn’t get better. It would slow the deterioration, but perhaps not in a way that you’d be able to detect.’
If it’s not that effective, why have so many people claimed it’s changed their lives?
This may be because lecanemab is only given to people in the very early stages of Alzheimer’s, when they’ve just begun experiencing its cognitive impact.
‘We picture people with the condition as dependent on their carers or in wheelchairs, unable to function,’ said Dr Walsh.
‘So when people get a diagnosis, they assume that’s where they’re heading very rapidly. But that’s not how early Alzheimer’s works – and it may mean that when people have it in their heads that that’s where they’ll be in 18 months, they’re shocked when they’re not and will attribute it to the drug.’
It also may simply be the placebo effect, explained Dr Howard. ‘We can only really go by the trial to say how well the medication works,’ he added.
Are there any positives at all?
While lecanemab may not be a ‘wonder drug’, that doesn’t mean it has no benefit for Alzheimer’s patients.
Perhaps most importantly, the fact that the drug slowed the progression of the disease at all proves that targeting amyloid plaque in the brain could eventually lead to an even more effective treatment.
‘As a researcher, I’m excited because, after 30 years, this is the first drug that has worked,’ said Professor Hardy.
‘The analogy is that, from when the Wright Brothers got the first plane – which was basically a modified bicycle – off the ground in North Carolina, it only took ten years before flights were travelling between London and Paris.
‘Once someone has showed something is possible, it’s easier going forward. So, at the risk of sounding like Churchill, I do believe that this is the beginning of the end of Alzheimer’s.’
And progress seems nearer than a decade away. A similar drug, donanemab, is just months from being approved for Alzheimer’s – although it’s also unlikely that NICE will allow it on the NHS.
While showing slightly better results than lecanemab, donanemab also has a higher risk of side-effects.
But the drug’s trial process revealed two things, explained Dr Walsh. Unlike lecanemab, the trial split patients who were given donanemab into two further groups – those with more plaque build-up and those with less.
Those with less build-up – in an earlier stage of the disease – did better. Dr Walsh added: ‘It showed that if you take this drug before your disease has progressed, you have some sort of increased benefit, which would suggest it’s actually addressing the cause of Alzheimer’s rather than just treating its symptoms.
‘So by extension, it may mean that if we can get people at an early stage of the disease, we may be able to halt its progress more effectively in the future.
‘Both the lecanemab and donanemab trials also signalled that the drugs helped to lower neurodegeneration – stopping brain cells from deteriorating.
‘This is further indication that these drugs are affecting the underlying progression of the disease, not just causing small cognitive change – which is good news for similar Alzheimer’s medications in development.’
There are other options for treating Alzheimer’s – although there is no cure. ‘If people want to slow the progress of early dementia and don’t want the infusion, the best is look at their lifestyle,’ said Professor Chan.
OK, I feel like I understand the facts and figures. But would I even be eligible?
Before being given lecanemab, patients will need an extensive screening process – checking their amyloid levels, neurological health and genetic profile.
The drug has only been proven to benefit people at an early stage of the disease – before a significant amyloid build-up in the brain.
But many won’t have even received an Alzheimer’s diagnosis at this point – particularly as the NHS screening system has a serious bottleneck.
MHRA approval also only extends to patients without certain genetic characteristics.
Those with two copies of the hereditary APOE4 gene variant are not eligible because it raises their risk of side-effects. This is significant because having two copies of this gene also greatly raises the risk of developing Alzheimer’s. Those with vascular dementia, as well as those with two other types of the disease called Lewy body dementia and frontotemporal dementia, cannot take lecanemab either.
Patients seeking it privately, therefore, will need to be in the right spot in terms of disease progression, genetic profile and general neurological health – as medications such as blood thinners can dramatically increase the likelihood of side-effects.
Remind me, what are these side-effects that worry experts?
Around one in ten participants in the clinical trial had swelling in the brain after taking the drug, and one in six had small brain bleeds, which in rare cases led to life-threatening symptoms. Three patients out of 1,800 died of these suspected side-effects.
‘With some people there are complications called Aria – amyloid-related imaging abnormalities,’ explained Professor Hardy.
‘This is when the medication causes an inflammation of the blood vessels in the brain. Usually it has no symptoms and is caught on scans before it eventually goes away. But occasionally it can cause a brain haemorrhage.’
Professor Chan says that if a patient came to him desperate to take the drug – and eligible for it – he would encourage them to look for a private provider as long as they had a full understanding of potential side-effects. ‘It all comes down to an individual’s perception of risk and what they’re willing to take,’ he explained.
‘I’d advise them to make sure they have a contingency plan sorted out with whichever clinic they go to.
‘You don’t want to wake up on a Sunday with a terrible headache that might indicate a brain bleed or swelling and get your private clinic’s out-of-office message when you call.’
If the drug provides a slight improvement, surely that’s better than nothing?
There are other options for treating Alzheimer’s – although there is no cure. ‘If people want to slow the progress of early dementia and don’t want the infusion, the best is look at their lifestyle,’ said Professor Chan.
‘Don’t smoke or drink too much alcohol, eat well and stay socially and physically active. We’ve known these things can help lower the risk and effects of dementia for years – and they’re free.
‘It costs nothing to see friends and family, but it has a significant impact on one’s quality of life.’
It’s also important to remember that most people eligible for lecanemab are still relatively young and early on within the progression of their disease.
Professor Chan added: ‘Every person wants to kick the proverbial can down the road. But I would advise anyone interested in the drug to speak with a specialist who will give an unbiased opinion and explain the benefits and risks.’
One private clinic in London said more than 100 people had been in contact about lecanemab in the week after it was approved.
Dr Emer MacSweeney, consultant radiologist at Re:Cognition Health, said prospective patients ranged from the ages of 55 to 90.
‘Many getting in touch still only have quite mild symptoms,’ she explained. ‘But with this new drug being announced they’re suddenly thinking that there’s something they can do to be proactive. For a lot, their first thought is not the cost, but will they be suitable for it?’
However, the cost of getting lecanemab privately is likely to be out of reach for many. Dr MacSweeney estimates with all extra testing and monitoring, the annual price tag could be around £60,000. Sue Noakes, 65, from Crawley, West Sussex, hopes to receive disease-modifying medication by being accepted on a clinical trial. The retired therapeutic counsellor, right, began having Alzheimer’s symptoms in her mid-50s.
Now, she finds it hard to spell and can no longer help neighbours with computer issues as she once did. ‘If we had the money, I would certainly look to get lecanemab,’ she said.
Alzheimer’s charities want the Government to widen access to diagnosis and treatment. The Alzheimer’s Society said: ‘This is urgently needed…to give everyone living with dementia the certainty, care and support so many currently miss out on.’
