Second ‘game-changing’ Alzheimer’s drug docanemab gets green light in UK – but WON’T be available on NHS

NHS PATIENTS battling Alzheimer’s will miss out on a second “game-changing” drug proven to halt the devastating disease.

Donanemab has been hailed as the “best ever” medicine for dementia after studies showed it slowed the memory-robbing illness by 35 per cent – better than any previous treatments.

Today it was given the green light by the Medicines and Healthcare Products Regulatory Agency (MHRA).

This means the medicine is safe and effective for people in the early stages of the disease and can now be prescribed privately in Britain for the first time.

But in a cruel twist, the NHS spending watchdog has ruled the benefits of the drug “too small” to justify the cost to the health service. 

The draft guidance from the National Institute for Health and Care Excellence (NICE), means patients will only be able to get the drug from private clinics.

No price for the medicine has been publicly announced in the UK, but it costs around £25,000 ($32,000) a year per patient in the United States.

Hilary Evans-Newton, chief executive at Alzheimer’s Research UK blasted the “frustrating setback” for dementia patients.

She said: “We finally have two new treatments licensed in Britain for Alzheimer’s, but it’s incredibly disappointing that NHS patients in England and Wales won’t receive them. 

“While these drugs are not cures and come with risk of side effects, trials show they are the first treatments to slow the decline in memory and thinking skills linked to Alzheimer’s, rather than just alleviating symptoms.”

The decision on donanemab – the second drug found to slow the progress of Alzheimer’s disease – mirrors one taken in August when lecanemab, the first breakthrough treatment for the condition.

Professor Fiona Carragher, chief policy and research officer at Alzheimer’s Society, added:  “Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia.

“MHRA’s approval of donanemab marks another milestone in this journey, but it comes alongside a draft NICE decision not to recommend donanemab for use on the NHS. 

“While this is disheartening, we respect the decision of the regulator.

“In other diseases like cancer, treatments have become more effective, safer and cheaper over time and we hope to see similar progress in dementia.”

‘THESE DRUGS CAN GIVE PEOPLE ANOTHER TWO YEARS AT HOME’

Donanemab is an antibody-based treatment that works by removing amyloid – a protein that builds up in the brains of people with Alzheimer’s.

Amyloid plaques have become a hallmark of the debilitating disease, which is the most common form of dementia.

The immunotherapy drug is given as an infusion into a person’s arm once a month.

Clinical trials have found it cleared these toxic proteins from patients’ brains and slowed mental decline by up to 35 per cent for 4.4 months.

Scientists said it could mean patients were able to live at home with a better quality of life for an extra two years.

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

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

Prof Sir John Hardy, one of the world’s leading researchers in the field, NICE has once again “come down on the wrong side of the argument” about drugs which were “game-changing”.

“These drugs can give people an extra two years at home, rather than in a nursing home,” he told The Telegraph.

“That is time enjoying their lives, having holidays – this is important stuff,” he added.

Prof Tara Spires-Jones, president of the British Neuroscience Association, said while people will “undoubtedly” be upset by the ruling, there is a “small amount of hope”.

She said: “While people living with dementia and their loved ones will undoubtedly be disappointed by the decision not to fund this new treatment on the NHS, the good news that new treatments can slow disease even a small amount is hopeful. 

“New research is bringing us closer to treatments that should be safer and more effective.

“Donanemab is an antibody that removes amyloid pathology from the brain. This is not a cure.

“The treatment slows disease progression modestly but does not stop or reverse symptoms. 

“The treatment also comes with potentially serious side effects of brain swelling and brain bleeding.”

It is estimated that 982,000 people in the UK live with dementia, and that number is expected to spiral to a staggering 1.4million by 2040, according to the Alzheimer’s Society.

Dementia and Alzheimer’s disease were the leading cause of death in the UK from 2012 to 2021. In 2022, it remained the leading cause of death in women, in England and Wales.

FIRST ‘GAME-CHANGER’ DRUG NOT AVAILABLE ON NHS

Lecanemab works in a similar way, helping to clear the build-up and slow cognitive decline.

The key difference is that while both target the amyloid proteins, they attack it at different stages.

Lecanemab targets amyloid as it begins to form fibres in the brain, while donanemab binds to the protein once the fibres have clumped together to become a plaque on the brain.

Lecanemab is already licensed for use in the US, China, Japan, Hong Kong, South Korea and Israel.

But in the summer, the European Medicines Agency rejected the drug, saying the benefits of lecanemab did not outweigh the risk of serious side effects, such as bleeding and swelling in the brain.

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

But in a blow to patients, NICE advised that “the benefits are too small to justify the cost”, so the drug won’t be available to patients on the NHS.