Newly approved Alzheimer's treatment, recanemab, not available on the NHS

The UK's medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), has approved the Alzheimer's treatment recanemab to be sold in the UK.

However, the drug has been deemed not to be worth the money on the NHS. An interim decision from the National Institute for Health and Care Excellence (NICE) states that people in the early stages of the disease will be denied access to recanemab on the NHS at present. In the near future, it will only be available in the private sector to those who can afford the hefty price tag, which will be prohibitive for many.

Alzheimer's disease is the most common form of dementia, affecting six in 10 people in the UK with the condition. Current treatments can temporarily relieve symptoms, but do not slow the progression of the underlying disease.

A landmark decision by the MHRA means recanemab becomes the first treatment licensed in England, Scotland and Wales to slow the progression of early-stage Alzheimer's disease rather than just manage people's symptoms.

Hilary Evans-Newton, chief executive of Alzheimers Research UK, described the news as bittersweet.

It is an amazing achievement that science now has approved treatments that can not only alleviate the symptoms of Alzheimer's, but also slow its devastating effects. But it is clear that our health system is not ready for these new Alzheimer's drugs, she explained.

What is recanemab?

Lecanemab (lek-an-e-mab), also known as LEQEMBI, is manufactured by the pharmaceutical company Eisai. It is an antibody-based treatment administered by injection into the arm. It is designed to remove amyloid, one of the characteristic proteins that accumulate in the brains of Alzheimer's patients.

The MHRA’s decision that lecanemab is safe and effective enough to be licensed is based on the results of the Eisais CLARITY AD Phase 3 clinical trial, announced in November 2022, which involved 1,800 patients over 18 months. The drug was shown to slow cognitive decline in participants by 27% and slow declines in quality of life by up to 56%.

Experts warn that, like first-generation treatments for other conditions, recanemab has minimal efficacy and side effects that require careful monitoring.

Recanemab carries a risk of a potentially serious side effect known as amyloid-related imaging abnormalities (ARIA), which are brain changes seen on MRI scans and are associated with swelling or bleeding.

During the trial, about 1 in 8 people who received recanemab developed ARIA. However, most of these (80%) were asymptomatic. However, there were 3 deaths attributed to recanemab during the trial, which is only about 0.2% of the total number of participants.

Who can receive recanemab?

Until it is approved for use on the NHS, recanemab will only be available privately.

The MHRA licence allows it to be given to people diagnosed with mild Alzheimer's disease or mild cognitive impairment (MCI) with high levels of amyloid in the brain, which must be confirmed with a PET brain scan.

Unlike other regulators around the world, the MHRA has decided that certain people should not receive recanemab. These include people who have two copies of a gene called APOE4 and people who take blood-thinning drugs because they are at a higher risk of side effects. About 15% of people with Alzheimer's have two copies of this gene.

How effective is recanemab?

Larry Woelk, who has MCI, has been taking lecanemab since 2020. The 76-year-old retired businessman from East Hampshire and his wife Rita believe the drug has helped slow the progression of his symptoms.

“There has been some decline, but it has been gradual and subtle. He can still live a full life. He can drive, ride his bike, be social. We feel very fortunate, but we know that our situation is not the same for everyone with Alzheimer’s disease,” Rita said.

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

Larry explained why he got involved in the dementia study: “My son works in biomedical research and has been involved in AIDS research for about 10 years. There have been a lot of breakthroughs in new treatments in that research. I found that very exciting and motivated me to get involved in this trial. I would like to see similar progress in new treatments for Alzheimer’s, and I hope lecanemab is the start of that.”

Will recanemab become available on the NHS?

Today’s decision from NICE is temporary and only applies to England and Wales. Further negotiations between NICE, the NHS and the lecanemabs manufacturer will take place over the coming months, and Evans-Newton said this could provide a way forward.

But she warned that the heartbreaking reality for people who could benefit from drugs like recanemab is that there is no time to wait.

In Scotland, a separate decision will be made by the Scottish Medicines Consortium (SMC), with results not expected until 2025.

Alzheimer's Research UK has written to the new Health Secretary, asking him to find solutions to ensure people with dementia in the UK continue to miss out on innovative treatments.

Experts have argued that, in addition to considering how drugs like recanemab could be made available, there should be a focus on improving how dementia is diagnosed within the NHS. Concerns have previously been raised about the NHS’s ability to provide recanemab, particularly because of the way people are diagnosed. This was highlighted in the BBC’s Panorama earlier this year. Alzheimer’s: Turning point?

Lecanemab is only suitable for people with early-stage Alzheimer's who have been formally diagnosed. Just a few weeks ago, the NHS reported that dementia diagnosis rates in England had reached a record high, but were still below the national target of 66.7%. However, one in three people with dementia in England are not diagnosed, and those who are can wait up to a year.

What's next for dementia research?

Experts point out the need to focus future research efforts on developing treatments that address various aspects of Alzheimer's disease.

There are currently more than 160 trials testing more than 125 treatments for Alzheimer's disease worldwide, 30 of which are in late-stage trials. Despite today's disappointing news, the question is not if new treatments will become available, but when, Evans-Newton said.

If you have any questions about recanemab, want to know more about dementia research, or want to know how you and your family can get involved in research, our dementia research information line can help. Call 0300 111 5 111 (Monday to Friday 9am to 5pm – except bank holidays) or email infoline@alzheimersresearchuk.org. Get our email and take a stand for a cure.

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