The newly approved Alzheimer's drug Lecanemab is not available on the NHS

The British Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light for the sale of the Alzheimer's drug Lecanemab in Great Britain.

However, the drug has been deemed not to be value for money by the NHS. A provisional ruling by the National Institute of Health and Care Excellence (NICE) means that, as things stand, people in the early stages of the disease will not be able to access lecanemab on the NHS. For the foreseeable future, it will only be available to those who can afford the high price in the private sector – which will be unaffordable for many.

Alzheimer's disease is the most common form of dementia, affecting six in ten people in the UK. Current treatments can temporarily relieve symptoms but do not slow the progression of the underlying disease.

The MHRA's landmark decision makes lecanemab the first approved treatment in England, Scotland and Wales that can slow the progression of early-stage Alzheimer's disease, rather than just relieving people's symptoms.

Hilary Evans-Newton, chief executive of Alzheimer's Research UK, described the news as “bittersweet”.

“It is a remarkable achievement that science is now providing approved treatments that can slow the devastating effects of Alzheimer's rather than just relieve symptoms. However, it is clear that our health care system is not ready to embrace this new wave of Alzheimer's drugs,” she explained.

What is lecanemab?

Lecanemab (lek-an-e-mab), also called LEQEMBI®, is manufactured by the pharmaceutical company Eisai. It is an antibody-based treatment administered through an infusion in the arm and is designed to remove one of the typical proteins that accumulates in the brains of Alzheimer's patients: amyloid.

The MHRA's decision that lecanemab is safe and effective enough to be approved is based on the results of Eisai's CLARITY AD Phase 3 clinical trial, published in November 2022. The trial enrolled 1,800 patients over 18 months. The drug slowed participants' cognitive decline by 27% and the decline in their quality of life by up to 56%.

Experts warned that, like first-generation drugs for other diseases, lecanemab has only modest benefits but also side effects that need to be carefully monitored.

Lecanemab carries the risk of a potentially serious side effect called amyloid-related imaging abnormalities (ARIAs), which are changes in the brain that are visible on MRI scans and are accompanied by swelling or bleeding.

About one in eight people who received lecanemab during the study developed ARIA. However, most of these people (80%) did not experience any symptoms. However, there were three deaths attributed to lecanemab during the study – just under 0.2% of the total number of participants.

Who can receive lecanemab?

Until it is approved for use in the NHS, lecanemab is only available privately.

The MHRA approval allows it to be given to people diagnosed with mild Alzheimer's disease or people with mild cognitive impairment (MCI) who also have high levels of amyloid in the brain, which must be confirmed by PET brain scans.

Unlike other regulators around the world, the MHRA has decided to exclude certain people from receiving lecanemab. These include people who carry two copies of a gene called APOE4 and people who take blood-thinning medications, as these put them at higher risk of side effects. Around 15% of people with Alzheimer's disease carry two copies of this gene.

How effective is lecanemab?

Larry Woelk, who suffers from mild cognitive impairment, has been participating in the lecanemab trial since 2020. The 76-year-old retired businessman and his wife Rita, who live in East Hampshire, believe the drug has helped slow the progression of his symptoms.

“There has been some decline, but it has been slow and unnoticeable. He is still able to lead a full life. He can drive a car, ride a bike and socialise. We are very happy, but we know that our situation is not the same for all Alzheimer's patients,” said Rita.

“We hope that advances in research will help bring Alzheimer's out of the shadows and encourage people to seek help and get a diagnosis when they first notice a problem.”

When asked why he is participating in dementia research, Larry explained, “My son works in biomedical research and was involved in AIDS research for about 10 years, where there were many breakthroughs in new treatments. I found this very interesting and it motivated me to participate in this study. It would be great to see similar developments in new treatments for Alzheimer's, and hopefully lecanemab is the beginning of that.”

Will Lecanemab ever be available on the NHS?

Today's NICE decision is provisional and applies only to England and Wales. Further negotiations will take place between NICE, the NHS and the manufacturer of lecanemab in the coming months – which Evans-Newton said “could provide a way forward”.

“But the heartbreaking reality is that those who could benefit from drugs like lecanemab don't have time to wait,” she warned.

A separate decision for Scotland will be made by the Scottish Medicines Consortium (SMC). A result is not expected until 2025.

In a letter to the new Health Minister, Alzheimer's Research UK called on him to find a solution to ensure that dementia patients in the UK are not further denied access to innovative treatments.

As well as addressing how to make drugs such as lecanemab available, experts have called for a focus on improving dementia diagnosis on the NHS. There have been previous concerns about the NHS's ability to provide lecanemab, particularly because of the way patients are diagnosed. This was highlighted earlier this year in the BBC programme Panorama – Alzheimer's: A turning point?

Lecanemab is only suitable for people in the early stages of Alzheimer's disease who have an official diagnosis. Just a few weeks ago, the NHS announced that dementia diagnosis rates in England had reached a record high, although still below the national target of 66.7%. However, one in three people with dementia in England never receive a diagnosis, and those who do receive one must wait up to a year.

What’s next in dementia research?

Looking to the future, experts pointed out that research efforts need to be focused on developing treatments that address several different aspects of Alzheimer's disease.

“There are currently over 160 trials worldwide involving over 125 experimental treatments for Alzheimer's, 30 of which are in advanced stages of trials. Despite today's frustrating news, it is really only a matter of time before new treatments become available, not if,” said Evans-Newton.

• If you have any questions about lecanemab, want to find out more about dementia research, or how you and your loved ones can take part in trials, our Dementia Research Infoline can help. You can call us on 0300 111 5 111 (9am-5pm Monday to Friday – excluding bank holidays) or email [email protected]..