‘Game-changing’ Alzheimer’s drug lecanemab gets green light in the UK but WON’T be available on the NHS

A “GAME-CHANGING” drug shown to slow the progression of Alzheimer’s has been approved in the UK.

Lecanemab , developed by pharmaceutical company Eisai, given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA).

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It means the medicine is deemed safe and effective and can now be prescribed privately in Britain for the first time.

But the National Institute of Health and Care Excellence (NICE) has advised that “the benefits are too small to justify the cost”, so it won’t be available on the NHS.

No price for the drug has been publicly announced in the UK, but it costs around £20,000 a year in the United States.

Fiona Carragher, chief policy and research officer at Alzheimer’s Society, said: “Today’s MHRA approval of the first safe and effective Alzheimer’s disease treatment, shown to slow progression, is a defining moment for people with early-stage Alzheimer’s disease in the UK and a significant step towards a more hopeful future.

“But it is disappointing that NICE has not recommended approving lecanemab for use on the NHS at this stage.”

David Thomas, head of policy at Alzheimer’s Research UK, added: “This is a bittersweet moment.

“While the drug is now available to prescribe privately, it will be cost-prohibitive for all but only the very wealthiest people.”

Lecanemab, sold under the brand name Leqembi, is a targeted antibody treatment that binds to amyloid – a protein which builds up in the brains of people living with the disease.

It is designed to help clear the build-up and slow down cognitive decline , and is given to patients via an intravenous drip fortnightly.

Lecanemab is already licensed in the United States , as well as in China , Japan , Hong Kong , South Korea and Israel .

It was, however, rejected by the European Medicines Agency (EMA) in July.

The EMA said the benefits of lecanemab did not counterbalance the risk of people suffering serious side effects, such as bleeding and swelling in the brain, and the impact of the drug on delaying cognitive decline was small.

In the UK, lecanemab is now approved to treat adults in the early stages of Alzheimer’s who have one or no copies of the APOE4 gene .

About 15 per cent of those diagnosed have two copies and are at increased risk, while people with one copy also have an increased risk.

NHS England estimates that about 70,000 patients might be eligible for the new treatment.

Prior to being given the drugs, they will need to have a baseline MRI scan and then either a PET-CT scan or lumbar puncture to confirm Alzheimer’s.

What do the experts say?

Fiona Carragher, chief policy and research officer at Alzheimer’s Society, said:

“Today’s MHRA approval of the first safe and effective Alzheimer’s disease treatment, shown to slow progression, is a defining moment for people with early-stage Alzheimer’s disease in the UK and a significant step towards a more hopeful future.

“While we welcome the MHRA approval, it is disappointing that NICE has not recommended approving lecanemab for use on the NHS at this stage.

“The news that lecanemab will be restricted to certain groups of patients will also lead to uncertainty for many people with Alzheimer’s disease and their loved ones.

“We respect the decisions regulators have made, however we know these announcements will bring a mix of emotions for those who have been waiting a long time since the promising trial results were first announced.

“The NICE recommendation reflects the urgent challenges which must be addressed regarding how we diagnose and treat people with dementia.

“A third of people affected by dementia have not received a diagnosis, and for those who have been diagnosed, it’s often not early or accurate enough for a person to be eligible for new treatments.

“A dementia diagnosis not only opens up the potential for treatment. It is also the single most effective route to the care, support and information we know is so important for everyone living with dementia and their loved ones.

“Now more than ever, Alzheimer’s Society is calling on Governments and health systems across the UK to prioritise dementia by improving early diagnosis in order to deliver ground-breaking treatments at scale.

“We know first-hand the devastation that dementia causes and would encourage anyone with dementia or concerns about potential symptoms to contact Alzheimer’s Society for support and information.”

Professor Sir Stephen Powis, NHS National Medical Director, said the NHS is still awaiting the final decision from NICE.

“Lecanemab is the first disease modifying treatment for Alzheimer’s with a market approval in the UK, and to ensure the health system is prepared for future advances in treatments, a dedicated NHS team is also looking ahead to 27 other drugs which are currently in advanced clinical trials that could be potentially approved by 2030.”

In total, around 900,000 Brits have dementia, with Alzheimer’s responsible for two in three cases. It is the UK’s top killer.

Cases are on the rise, with still no hope of a cure as current medications can only reduce symptoms .

Lecanemab has been hailed by experts as “the beginning of the end” for the disease as it has been found to slow cognitive decline by 27 per cent in sufferers.

Professor John Hardy, chairman of molecular biology of neurological disease at the UCL Institute of Neurology, described the drug as “game-changing”.

“There is no question this is the biggest advance for 30 years,” he added.

Today’s news is bittersweet for people affected by Alzheimer’s disease

Hilary Evans-Newton, Alzheimer’s Research UK,

In November 2022, when the results of trials were published, he said lecanemab was “the beginning of the end” for Alzheimer’s.

“It slows the disease by about 25 to 30 per cent so, you know, maybe if in the old days you were going to get five years before nursing home, now you might get seven years before nursing home care,” Prof Hardy added.

Alzheimer’s Research UK said the same findings were a “historic moment” for dementia research.

One of the first people to take the 'miracle' drug

She joined a trial of the medicine after a diagnosis of mild cognitive impairment (MCI) and a high risk of Alzheimer’s.

Joan, from Ohio , is still able to live independently and says her memory has improved.

She told The Sun: “I feel perfectly normal and I’m not having the issues that I was having.

“I’m totally functional and my memory is much better than it was.

“I’m very active, I drive regularly, I garden and cook, I read a number of books and I have my life back.”

Husband Larry, 77, added: “This drug is little short of a miracle, from our perspective.”

The couple have been married for 14 years since they met as widowers, and have a combined eight children and 25 grandkids.

Joan first noticed she was having memory problems in 2016 and tests confirmed she had MCI and Alzheimer’s plaques building up in her brain.

MCI is an early phase of memory loss which is worse than usual ageing but not as bad as dementia – although 10 to 15 per cent of sufferers go on to develop dementia.

Joan jumped at the chance to join the lecanemab trial at the Cleveland Clinic, which showed the drug reduced brain damage by an average of 27 per cent over 18 months.

It was the first medication fully proven to work this way and was hailed as a “game-changer” , though scientists warn it does not work for everyone and can have severe side effects.

Joan said: “I knew the Cleveland Clinic is a first class operation and when they thought they had a drug that might help – and I desperately needed help – I was going for it. I had no second thoughts.”

After the 18-month trial in 2020 and 2021, when she didn’t know if she was taking the drug or a placebo, Joan now injects herself with the real thing at home once a week.

It comes in an auto-injector similar to an epi-pen, a development since it was given by IV drip during the study.

She also has cognitive speech therapy alongside the medication.

Larry said: “When Joan was diagnosed my fears were that this would be a downward spiral.

“It used to be that when you mentioned Alzheimer’s you were looking into an abyss. Now this drug offers a great hope for the future.

“I’ve seen improvements in Joan’s short-term memory. She’s a fighter.”

According to NICE, clinical trials showed lecanemab can slow cognitive decline by four to six months, however there is little evidence on its long-term effects.

Chief executive Dr Samantha Roberts said: “This is a new and emerging field of medicine which will no doubt develop rapidly.

“However, the reality is that the benefits this first treatment provides are just too small to justify the significant cost to the NHS.

“It is an intensive treatment to give to patients involving a hospital visit every two weeks with skilled staff needed to monitor them for signs of serious side effects, plus the cost of purchasing the drug.

“Our independent committee has rigorously evaluated the available evidence, including the benefit for carers, but NICE must only recommend treatments that offer good value to the taxpayer.”

Despite today’s frustrating news, it really is a matter of when, not if, new treatments become available

Hilary Evans-Newton, Alzheimer’s Research UK,

Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said today’s announcement was “bittersweet” for people affected by the condition.

“It’s a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer’s, rather than just alleviating its symptoms,” she said.

“However, it’s clear our health system isn’t ready to embrace this new wave of Alzheimer’s drugs.

“It means that, as things stand, people in the early stages of the disease will be denied access to lecanemab through the NHS, and it will only be available to those who can pay privately. This is deeply disappointing.

“Of course, like first-generation treatments for other diseases, lecanemab has modest benefits and side effects that need careful monitoring.

“It’s not a cure, but it is a real step forward – the first new dementia medicine to be licensed in more than 20 years.

“Further negotiations between NICE, Eisai and the NHS may offer a way forward, but the heartbreaking reality is that those who could benefit from drugs like lecanemab don’t have time to wait.”

‘SEA-CHANGE’

Hilary added: “Lecanemab represents the beginning of a sea-change in how diseases like Alzheimer’s will be treated in future.

“There are now more than 160 trials underway testing over 125 experimental treatments for Alzheimer’s across the globe, including 30 in late-stage trials.

“Despite today’s frustrating news, it really is a matter of when, not if, new treatments become available.

“What people living with Alzheimer’s disease – and other forms of dementia – desperately need are new medicines that improve their lives and Alzheimer’s Research UK will work tirelessly on behalf of people affected by dementia to ensure they get them.”

A public consultation on NICE’s draft guidance will close on September 20.

Julian Beach, interim executive director for healthcare quality and access at MHRA, said: “Licensing medicines which meet acceptable standards of safety, quality and efficacy is a key priority for us.

“We’re assured that, together with the conditions of the licence approval, the appropriate regulatory standards for this medicine have been met.

“As with all medical products, we will keep its safety under close review, and with a controlled post-authorisation safety study to be undertaken, we will ensure that the benefit risk of lecanemab in clinical use is closely followed up.”

A similar drug called donanemab, which is developed by Eli Lilly, is also being assessed for approval in the UK by medicine regulators.