‘I took Alzheimer’s wonderdrug – it’s stopped me having two main symptoms’

A man says his life was transformed after taking a drug designed to ward off the symptoms of Alzheimer’s. Retired journalist Peter Almond, 78, took donanemab for three years in trials and said he has not had memory or thinking problems. 

Tens of thousands of patients facing the heartache of dementia are to be denied NHS access to a drug hailed as the most effective yet at treating the underlying cause of Alzheimer’s disease.

Donanemab this morning received the green light from the UK medicines regulator after trials involving people with early Alzheimer’s showed it slowed brain decline by 35 percent over 18 months. The result was even more impressive than the 27 percent slowing seen with similar drug lecanemab.

However, it has been rejected for use on the NHS by the National Institute for Health and Care Excellence (NICE), which weighs a drug’s benefits against its cost to the taxpayer.

Peter said: “I understand why NICE is unable to accept the drug because of the cost involved. 

“But the government has to pay many millions of pounds to support people in the latter stages of Alzheimer’s disease and the care home sector needs much more income from the State.

“I think it is clear the drug does work to some degree, particularly for people who are or may be in the early stages of Alzheimer’s.”

NICE’s subsequent rejection follows a similar ruling on lecanemab in August. Lecanemab was the world’s first treatment proven to both slow progression of symptoms and tackle the underlying cause of Alzheimer’s.

The decision means both drugs will now only be available to those able to pay for a private prescription. 

Peter was diagnosed in 2018 with mild cognitive impairment – memory and thinking problems that are often a precursor to dementia.

He took part in two 18-month studies of donanemab which finished in September and said: “I can’t say for certain that the drug has been slowing down my condition, but I feel that donanemab has helped keep me at the same level as when I started on the trial three years ago.

“I understand the benefits of the drug are modest and that is as much as we can expect from any of these new Alzheimer’s drugs at this point.

“But if it has been stopping my condition developing into Alzheimer’s then it has had a significant impact on my life.”

Peter received infusions every four weeks centre near his home in Esher, Guildford. He had regular MRI and PET scans and did not experience any side-effects.

But having now come off the drug, he fears his MCI will develop into Alzheimer’s disease. Peter added: “I feel as normal as a 78-year-old can be. I can read, write, think, plan, walk, drive and even run. 

“But I don’t know what will happen in the future. Will the amyloid build back up again in my brain now I’m no longer taking the drug?

“The thought of Alzheimer’s disease, of not understanding where I am or what I am doing, is scary to say the least.”

Peter is a passionate fundraiser for Alzheimer’s Research UK. He said: “Donanemab and the other new drugs currently in trials are just the start. 

“So it’s vital to raise money for research to continue the progress and help the hundreds of thousands of people who are living with dementia.”

Donanemab was approved for use in the US in July. It has also recieved the green light in Japan.

NICE acknowledged that the drug appeared to slow Alzheimer’s disease progression by four to six months. But it found the benefits were “too small to justify the additional costs”.

Around 70,000 patients would have been eligible for treatment in England.

Donanemab works by clearing toxic amyloid protein – a hallmark of Alzheimer’s disease – from the brain. Experts hailed a “turning point in the fight against Alzheimer’s” when results from a trial of 1,800 patients were unveiled in the summer of 2023.

According to manufacturer Lilly, the drug slowed brain decline by around a third and patients taking it saw 40 percent less decline in their ability to perform daily activities such as managing finances, driving and hobbies.

Almost half (47 percent) of those on donanemab had no clinical progression of disease after a year, compared with 29 percent on placebo.

However, concerns were raised about rare but serious side effects of brain swelling and bleeding. Three deaths among patients taking the drug were linked to the treatment. 

Some experts also questioned whether the drug’s “modest” effects are significant enough to be noticed by patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved a UK licence for the drug after considering the evidence. It said donanemab should only be given to patients with early stage Alzheimer’s who have one or no copies of the apolipoprotein E4 gene (ApoE4). Having two copies raises risk of the disease.

The agency’s interim executive director of healthcare quality and access, said: “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 safety study to be undertaken after licensing, we will ensure that the benefit risk of donanemab is closely followed up post-authorisation.’’

NICE said it has asked Lilly and NHS England to provide additional information to address areas of uncertainty in the evidence.

Helen Knight, the institute’s director of medicines evaluation, said: “For NICE to be able to approve a medicine for use in the NHS it must provide additional benefits to patients, and it must also represent a good use of NHS resources and taxpayers’ money.

“Our independent committee looked at all the available evidence, including the benefits for carers. This shows donanemab could slow down cognitive decline by 4-7 months, but this is just not enough benefit to justify the additional cost to the NHS. The cost-effectiveness estimate for donanemab is 5 to 6 times above what NICE normally considers an acceptable use of NHS resources.

“I know this will be disappointing news, but this is an emerging field of medicine and there are other treatments being developed.”

Professor Fiona Carragher, chief policy and research officer at Alzheimer’s Society, said that although the decision was “disheartening, we respect the decision of the regulator”.

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

“With around 20 Alzheimer’s disease drugs in late-stage clinical trials, more drugs will be submitted for approval within the next few years.”

Hilary Evans-Newton, chief executive at Alzheimer’s Research UK, said the news was “another frustrating setback for people affected by Alzheimer’s disease”. She added: “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.”