Alzheimer's drug Lecanemab rejected despite proven benefits

Millions of people's hopes for an Alzheimer's treatment revolution have been shattered after the medicines watchdog declared a breakthrough drug too costly for NHS use. Lecanemab, the world's first medication proven to slow the disease's progression , demonstrated a 27 percent reduction in cognitive decline over 18 months in trials.

The Medicines and Healthcare Products Regulatory Agency (MHRA), which determines the safety of medications, approved it this morning .

However, within minutes, the National Institute for Health and Care Excellence stated it would not endorse its use on the NHS as the benefits are "too small to justify the costs".

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This decision implies that millions of patients will be denied the drug in the future, while those who can afford it can obtain it privately. David Thomas, head of policy at Alzheimer's Research UK, said the drug would likely be unaffordable for "all but the very most wealthy of individuals".

He further commented: "We believe that if there's a licensed drug that is safe and effective, judged by the regulator, then that needs to be available to NHS patients, and not just whose with the ability to pay."

Hilary Evans-Newton, the charity's chief executive, described the decision as "deeply disappointing", adding: "Today's news is bittersweet for people affected by Alzheimer's disease."

Ms Evans-Newton hailed it as "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."

But she cautioned: "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."

Despite this, she described lecanemab as "a real step forward" since it is the first new dementia medicine to be licensed in over 20 years.

Ms Evans-Newton 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."

Alzheimer's Society expressed its disappointment, stating it will create "uncertainty and confusion" for those seeking treatment.

The charity's chief policy and research officer, Fiona Carragher, said: "Whilst we welcome the MHRA approval, it is disappointing that NICE has not approved and recommended lecanemab for use on the NHS at this stage."

"These are challenging, complex decisions informed by the current expert evidence and by experts in the field, and it's a very rapidly emerging field."

"But this news that lecanemab is not going to be approved does lead to uncertainty and probably confusion for the nearly one million people out there with dementia, and their loved ones."

Dr Samantha Roberts, chief executive of NICE, 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."

Experts hailed lecanemab as "game-changing" and a "transformation in outlook" for people with early stage disease when trial results were released in late 2022.

The drug's future was cast into uncertainty after the European Medicines Agency turned it down due to rare but grave side effects like brain swelling.

There's debate among experts about the actual benefits of the treatment, which are believed to slow disease progression by five months - a difference some argue may not be noticeable even to professionals.

After extensive review of the evidence, the MHRA has given the green light to the medication for early-stage Alzheimer's patients with one or no APOE4 gene copies.

About 15 percent of Alzheimer's patients carry two copies of the APOE4 gene, which heightens the risk of the condition.

Julian Beach, MHRA interim executive director of healthcare quality and access, commented: "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."

The drug, an immunotherapy, attacks amyloid, which forms plaques around neurons in Alzheimer's patients' brains.

The treatment works by using an antibody that attaches to small clusters of amyloid, prompting the body's immune system to target and eliminate them.

While experts have described the benefits of lecanemab as "modest", they believe it could mark the start of a new era of similar treatments that will improve over time.

Lecanemab was approved in the US earlier this year, with an annual cost of around £30,000 per patient, although the NHS typically negotiates a confidential discount.

Other countries that have approved the treatment include Japan, China, South Korea, Hong Kong, and Israel.

Larry Woelk, 77, has been taking lecanemab since joining a clinical trial in 2020 and has seen a slowing of his memory problems.

He and his wife Rita first noticed memory issues in 2016, and he was diagnosed with mild cognitive impairment, a precursor to dementia, following an MRI scan in 2018.

Larry receives the treatment via an intravenous infusion every two weeks at The Memory Assessment and Research Centre in Southampton. He said: "When I first went on the trial my memory was getting worse and worse. Not quickly, but I could tell."

"But since taking lecanemab I feel that the progression of my symptoms has plateaued. My memory assessments have been unchanged since I started on lecanemab."

Rita shared: "We believe the drug has been beneficial to Larry. There has been some decline, but it has been gradual and subtle. He is still able to live a full life. He is able to drive, go out on bike rides and socialise."

Throughout the trial, Larry was unaware if he was being given lecanemab or a placebo.

After the study concluded, it was disclosed that he had indeed been on the drug and continued into an extension of the trial.

The couple, residing in East Hampshire, both come from families with a history of dementia; Alzheimer's took the lives of Larry's mother and aunt while Rita's sister currently suffers from the condition and resides in a care home.

Rita expressed their sense of luckiness at Larry having access to this medication, but also noted: "We know our situation is not the case for everyone who has Alzheimer's."

She also voiced hope that with a treatment available which can demonstrably slow the disease's progression, it will move Alzheimer's into the spotlight, motivating people to actively seek help and diagnosis upon first experiencing symptoms.

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