A new Alzheimer’s drug has been rejected for widespread use in health services in England after the health spending watchdog said it “currently demonstrates no value to the NHS”.
The news comes as the UK’s medicines regulator said donanemab could be authorized for use in the UK.
This is the second disease-modifying drug for Alzheimer’s disease to be rejected by the National Institute of Excellence in Health and Care (Nice) in a few months.
A charity said the news was a “frustrating setback” for people with Alzheimer’s.
Alzheimer’s Research UK said the announcement “also risks signaling that the UK is no longer a good place to launch new dementia treatments”.
Donanemab, made by pharmaceutical giant Eli Lilly, is a targeted antibody that slows the early stages of Alzheimer’s disease.
This drug, along with another new Alzheimer’s drug called lecanemab, have been touted as a huge step forward in research because they target a known cause of the disease, rather than just treating symptoms.
The British appear to have developed the disease transmitted by corpses GETTYHelen Knight, director of medicines evaluation at Nice, said: “For Nice to approve a medicine for use in the NHS, it must provide additional benefits to patients, and it must also represent good use of medicines. NHS resources and taxpayers’ money.
“Our independent committee has reviewed all available evidence, including the benefits for carers. This shows that donanemab could slow cognitive decline by four to seven months, but this is simply not enough of a benefit to justify the additional cost to the NHS. The cost-effectiveness estimate for donanemab is five to six times what Nice normally considers an acceptable use of NHS resources.
“I know this will be disappointing news, but this is an emerging medical area and other treatments are being developed.”
The decision sparked public outcry, with one person tweeting: “Such a heartbreaking decision. This gives families a little more time with their loved ones before the disease progresses.
A second user wrote: “This is so unfair. »
While a third posted: “As sad as it is, the business case has to come first. Especially since the NHS is so heavily in debt.
This comes from health regulators who deemed lecanemab too expensive to be justified in August.
Lecanemab has been approved by medicines regulator the Medicines and Healthcare products Regulatory Agency (MHRA), making it the first medicine of its type to be authorized for use in the UK.
But Nice quickly said the benefits of lecanemab, made by Eisai and sold under the brand Leqembi, are “simply too small to justify the significant cost to the NHS”, and in draft guidelines it said the drug should not be deployed on a large scale. use across the NHS.
Concerns have been raised that the decision would lead to a two-tier system for Alzheimer’s patients: those who can afford the drug would be able to access it privately while others who are dependent on care of the NHS would not be deprived of it.
Donanemab and lecanemab bind to amyloid, a protein that builds up in the brains of people living with Alzheimer’s disease.
By binding to amyloid, medications are designed to help clear the buildup and slow cognitive decline.
Data suggests that patients obtain the greatest benefit if they receive treatment at an early stage of the disease.
Clinical trials testing the safety and effectiveness of donanemab, also known as Kisunla, found that it could slow the rate at which memory and thinking deteriorate by more than 20%.
The results also suggest that the drug leads to a 40 percent reduction in decline in daily activities such as driving, enjoying hobbies and managing money.
The drug, which is given to patients intravenously once every four weeks, carries a risk of side effects, some serious, including brain swelling and cerebral microhemorrhages.
Donanemab and lecanemab have been approved for use in the United States, although the European drug regulator rejected lecanemab earlier this year.
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The move sparked public outcry, with one user calling the decision “heartbreaking.”
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The MHRA’s Julian Beach said the safety of the drug will be subject to “careful review”, adding: “Authorizing medicines that meet acceptable standards of safety, quality and effectiveness is a key priority for us.
“We are assured that, along with the conditions of license approval, the appropriate regulatory standards for this medicine have been met.”
Hilary Evans-Newton, chief executive of Alzheimer’s Research UK, said: “Today’s announcement marks another frustrating setback for people affected by Alzheimer’s.
“We finally have two new treatments authorized in Britain for Alzheimer’s disease, but it is incredibly disappointing that NHS patients in England and Wales are not receiving them.
“Although these drugs are not a cure and carry risks of side effects, trials show that they are the first treatments to slow the decline in memory and thinking skills associated with Alzheimer’s disease, rather than simply relieve the symptoms.
“We have written again to the Health Secretary asking him to bring Nice, NHS England and industry together so that people with dementia in the UK are not left behind.
“Today’s decision also risks signaling that the UK is no longer a good place to launch new dementia treatments.”
Professor Fiona Carragher, Director of Policy and Research at the Alzheimer’s Society, said: “Disease-modifying therapies like donanemab and lecanemab offer a new horizon of hope in the fight against dementia.
“The MHRA’s approval of donanemab marks another important step in this journey, but it is accompanied by a draft decision from Nice to not recommend the use of donanemab in the NHS. Although this is discouraging, we respect the regulator’s decision.
Manufacturer Lilly welcomed the news that the drug has been authorized in the UK and said it “remains confident in the clinical and economic effectiveness of donanemab and the value it can bring to patients and the NHS “.
Chris Stokes, President and Managing Director of UK and Northern Europe at Lilly, said: “After more than 35 years of commitment to scientific progress in Alzheimer’s disease, we are delighted that the donanemab has been authorized in Britain for eligible adults who need effective treatment. treatment options.
“Donanemab is part of a new class of drugs and has demonstrated significant results for people with mild cognitive impairment and mild dementia due to Alzheimer’s disease.