Latest news with #lecanemab
The Independent
2 days ago
- Health
- The Independent
How do the new antibody drugs for Alzheimer's disease work?
Two new drugs for Alzheimer's have been rejected for use on the NHS. They slow progression of the disease, but they can have serious side-effects. – What are the medicines? Donanemab and lecanemab are targeted antibody drugs that slow down the early stages of Alzheimer's. They represent a huge step forward in research because they target a known cause of the disease, rather than just treating the symptoms. Both drugs bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's disease. By binding to amyloid, the drugs are designed to help clear the build-up and slow down cognitive decline. – How effective are they? Donanemab has been shown in clinical trials to slow the rate at which memory and thinking get worse by more than 20%. Evidence suggests that people get the most benefit if they are given the treatment earlier in the disease. Results also suggest the drug leads to a 40% slowing in the decline of everyday activities such as driving, enjoying hobbies and managing money. Lecanemab has also been shown to successfully remove protein build-up from the brains of people living with early Alzheimer's disease. For people taking lecanemab, this meant the decline in their thinking and memory skills was slowed down by 27%. It also slowed down the decline in quality of life by up to 56%. – How are the drugs given? Donanemab, developed by the pharmaceutical company Lilly, is given to patients via an intravenous drip once every four weeks. Lecanemab, developed by Eisai, is also given this way but fortnightly. – Are there any side-effects? Side-effects of the drugs can be serious and people undergo monitoring to check for them. In one clinical trial published in the Journal of the American Medical Association (JAMA) in 2023, 24% of people receiving donanemab had side-effects including brain swelling and infusion-related reactions. Four people died during the trial, with their deaths thought to be related to the drug's side-effects. Lecanemab resulted in infusion-related reactions in around 26% of people on the trial and followed up, while 14% suffered amyloid-related imaging abnormalities causing brain swelling. Others suffered minor bleeds picked up on scans. Around one in 10 people suffered headaches, according to updated results published in May 2024. Overall, four deaths during the follow-up period were thought to be due to treatment. – How much do the drugs cost? NHS England published a briefing paper last year suggesting the cost of bringing the drugs to the health service could be £500 million to £1 billion per year. Around 50%-60% of the total estimated cost relates to the drug price, with remaining cash spent on patient assessment, diagnosis and administering the treatment. – How many people in England might the drugs have worked for? NHS England estimated between 50,000 and 280,000 patients could be eligible for the new treatments if they were approved for the NHS. To get the drugs, patients need a baseline MRI scan and then either a PET-CT scan or lumbar puncture to confirm Alzheimer's. It is possible that blood tests will be available in the future to diagnose the disease, so NHS England did warn there should be caution about driving a 'massive expansion' in other diagnostics which could become redundant in the longer term. -What do scientists think? Scientists and doctors have been divided on whether the drugs represent a real clinical benefit that is noticeable in patients day-to-day. Some argue the drugs represent a huge advance and people should be given the chance to try them. But others say the benefits are too small. Jennifer Keen, associate director of evidence, policy and influencing at the Alzheimer's Society, has said: 'we remain at an important and exciting moment', adding: 'There are currently 182 active clinical trials for Alzheimer's disease… We are on the cusp of major scientific breakthroughs beginning to improve the outlook for those with the disease.' Professor Rob Howard, from University College London, said: 'Nobody should be surprised that Nice have confirmed their earlier view that the new Alzheimer's disease treatments would not be cost-effective if used within the NHS. 'Well-conducted clinical trials demonstrated that the actual size of benefits experienced by patients were too small to be noticeable, treatment carries risks of side-effects, and the annual cost of the drugs and safety monitoring required would have been close to the cost of a nurse's salary for each treated patient. We need better treatments that can make an appreciable difference to the lives of people with dementia and these can only come from further research and study.'
BBC News
2 days ago
- Health
- BBC News
Breakthrough Alzheimer's drugs too pricey to be offered on NHS
Two breakthrough Alzheimer's drugs have been deemed far too expensive, for too little benefit, to be offered on the medicines are the first to slow the disease, which may give people extra time living National Institute for Health and Care Excellence (NICE) concluded they were a poor use of taxpayers' money and said funding them could lead to other services being say it is a disappointment, but dementia experts have also supported the decision. The two drugs, donanemab and lecanemab, both help the body clear a gungy protein that builds up in the brains of people with Alzheimer's medicines do not reverse or even stop the disease, rather brain power is lost more slowly with trials of these drugs were celebrated as a scientific triumph as they showed, for the first time, it was possible to change the course of Alzheimer' since then a row has developed over the cost of the drugs and how meaningful the benefit is. The official price in the US is £20,000-£25,000 per patient per year. What the NHS would pay is 70,000 people in England with mild dementia would have been eligible, potentially putting the bill in the region of £1.5bn a year for the drugs resources, including regularly infusing the drugs directly into spinal fluid and frequent brain scans to manage dangerous side effects, would also massively ramp up the cost. The benefit of the drugs is also debated. They potentially delay the transition from mild to moderate dementia by four-to-six months. That could mean more time without needing daily care, driving, being present for significant family events and Prof Rob Howard, from University College London, said real-world benefits "were too small to be noticeable". In trials of lecanemab, patients were better off by 0.45 points, on an 18-point scale ranging from healthy to severe he said the cost would "have been close to the cost of a nurse's salary for each treated patient".The decision not to fund the drugs is not a surprise. The first assessment last year concluded they were not Knight, director of medicines evaluation at NICE, acknowledged the latest news would be "disappointing" but said the benefits were "modest" at best while requiring "substantial resources"."If they were approved they could displace other essential treatments and services that deliver significant benefits to patients," she said. NICE said its appraisal had factored in potential savings in the cost of providing care, but the drugs were still deemed decisions apply to the NHS in England, but are normally adopted by Wales and Northern Ireland too. Scotland has its own method for approving pharmaceutical companies have three weeks to raise concerns about how the review was performed, otherwise the decision becomes final on 23 pharmaceutical companies involved, Eisai for lecanemab and Eli Lilly for donanemab, say they will appeal against the decision. Nick Burgin, from Eisai said the NHS "is not ready" for the challenge of tackling Alzheimer's and flaws in the process meant their drug would have been rejected "even if Eisai provided lecanemab to the NHS for free".Eli Lilly, the company behind donanemab, has already expressed its disappointment. "If the system can't deliver scientific firsts to NHS patients, it is broken," said Chris Stokes, Eli Lilly's president and general manager of UK and Northern Europe. Is this a distraction or a disappointment? The sentiment was echoed by both the Alzheimer's charities. Prof Fiona Carragher, from the Alzheimer's Society said "the science is flying but the system is failing" and it was "highly disappointing" the drugs were not available on the Evans-Newton, the chief executive at Alzheimer's Research UK, said the result was "painful" and patients will miss out on this and future innovations "not because science is failing, but because the system is".However, others say NICE has made the right call. Tom Dening, professor of dementia research at the University of Nottingham, said he was "in complete support" as the benefits of the drugs were "minimal" and a "distraction" from the real issues in dementia."[Namely the] unglamorous challenge of providing people with dementia and their families with activities, care and support that we already know are beneficial for their mental and physical health," he Atticus Hainsworth, from St George's, University of London, said: "NICE is simply doing its job."Beyond lecanemab and donenamab there are 138 dementia medicines being tested in 182 trials around the Tara Spires-Jones, director of the centre for discovery brain sciences at the University of Edinburgh, said: "There is hope for safer, more effective treatments on the horizon."
Daily Mail
2 days ago
- Health
- Daily Mail
Alzheimer's drugs rejected for NHS because the benefits 'are too small to justify the cost', watchdog says
Two drugs to treat Alzheimer's disease have been rejected for use on the NHS because their benefits are 'too small' to justify their cost, the health spending watchdog has said. The National Institute for Health and Care Excellence (Nice) is standing by its earlier decision to turn down donanemab and lecanemab after considering new information submitted by manufacturers. Charities described the decision as 'disappointing' and a 'painful setback' for patients, while the firms Lilly, which makes donanemab, and Eisai, which makes lecanemab, said they would appeal. Donanemab and lecanemab are targeted antibody drugs that slow down the early stages of Alzheimer's. They represent a huge step forward in research because they target a known cause of the disease, rather than just treating symptoms. Both drugs bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's disease. By binding to amyloid, the drugs are designed to help clear the build-up and slow down cognitive decline. Publishing its final draft guidance, Nice said the treatments have been shown to delay progression from mild to moderate Alzheimer's by four to six months. But it said the medicines cannot be provided on the NHS because they are not good value for money and 'only provide modest benefits at best'. Last year, NHS England published a briefing paper suggesting the cost of bringing the drugs to the health service could be £500 million to £1 billion per year. Professor Fiona Carragher, Alzheimer's Society's chief policy and research Officer, said the decision was 'disappointing'. The fact is, even if donanemab and lecanemab were made available on the NHS tomorrow, too many patients wouldn't be able to access them because the health system isn't ready to deliver them Professor Fiona Carragher, Alzheimer's Society She said: 'There is no doubt that today's decision is a setback for people with Alzheimer's disease. 'It is highly disappointing that we are in a situation where treatments that slow the progression of the condition are not available on the NHS. 'The reality we're faced with is that these treatments remain out of reach of both the NHS and most eligible people with Alzheimer's disease. 'In other diseases like cancer, treatments have become more effective, safer and cheaper over time. It's essential we see similar progress in dementia. 'The fact is, even if donanemab and lecanemab were made available on the NHS tomorrow, too many patients wouldn't be able to access them because the health system isn't ready to deliver them. 'The science is flying but the system is failing.' While we recognise the hope these treatments offer, the evidence shows they only provide modest benefits at best and substantial resources would be needed to provide them Helen Knight, director of medicines evaluation at Nice She said the Government must now commit to 'the long-term investment needed to fundamentally change dementia diagnosis so that we are ready for new treatments', including bringing in earlier diagnosis and access to specialist diagnostic tests. She added: 'We are heading towards a future where disease-slowing treatments reduce the devastating impact of dementia, and we cannot afford to delay preparing the NHS for them.' Hilary Evans-Newton, chief executive of Alzheimer's Research UK, said: 'This rejection is a painful setback for people affected by Alzheimer's – but sadly not a surprising one. 'The drugs' modest benefits, combined with the significant costs of delivering them in the NHS, meant they faced insurmountable challenges. 'People with early Alzheimer's in England and Wales now face a long wait for innovative new treatments as they won't be able to access lecanemab or donanemab unless they can afford to pay privately. 'This decision sends a troubling signal to the life sciences sector – undermining confidence in the UK as a home for research, innovation and clinical trials. That risks lasting damage to both patients and the economy. People with early Alzheimer's in England and Wales now face a long wait for innovative new treatments as they won't be able to access lecanemab or donanemab unless they can afford to pay privately Hilary Evans-Newton, Alzheimer's Research UK 'Nice's decision should ring alarm bells for a Government that, only a year ago, pledged to make the UK a global leader in dementia treatments. 'With over 30 Alzheimer's drugs now in late-stage trials globally, momentum is building – and more will enter regulatory systems in the years ahead. 'Without intervention from Government, people with Alzheimer's will continue to miss out — not because science is failing, but because the system is.' Helen Knight, director of medicines evaluation at Nice, said: 'While we recognise the hope these treatments offer, the evidence shows they only provide modest benefits at best and substantial resources would be needed to provide them. 'The committee accepted that any slowing of the disease getting worse would be meaningful for people with mild cognitive impairment or mild dementia caused by Alzheimer's disease and their carers because it could mean more time socialising, driving and being independent, so needing less help day-to-day from family members. 'But the committee concluded the small benefits to patients shown in the clinical trials and the lack of long-term evidence of effectiveness balanced with the substantial resources the NHS would need to commit to the treatments would be too great and could displace other essential treatments and services that deliver substantial benefits to patients. 'We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments, including providing an additional opportunity for evidence to be submitted. 'We realise today's news will be disappointing for many, but we now need to focus on the encouraging pipeline of new Alzheimer's drugs in development, a number of which are already earmarked for Nice evaluation.' Drug firms and registered patient groups now have until July 8 to appeal against the decision. In clinical trials, donanemab, which is given via a drip, has been shown to slow the rate at which memory and thinking get worse by more than 20%. Results also suggest the drug leads to a 40% slowing in the decline of everyday activities such as driving, enjoying hobbies and managing money. Lecanemab – also administered via drip – has been shown to successfully remove protein build-up from the brains of people living with early Alzheimer's disease. For people taking lecanemab, this meant the decline in their thinking and memory skills was slowed down by 27%. It also slowed down the decline in quality of life by up to 56%. However, side-effects of the drugs can be serious, including brain bleeds and risk of death. A reformulation of lecanemab is being developed so it can be administered subcutaneously under the skin. Nice could then review the drug in this form. There are several other Alzheimer's treatments in development, and the NHS stands ready to offer patients access to new treatments as soon as they are deemed by regulators to be clinically and cost effective Dr Jeremy Isaacs, NHS England Lilly said it would appeal the Nice decision on the grounds it was unreasonable based on the evidence submitted. Chris Stokes, president and general manager of UK and Northern Europe at Lilly, said: 'If the system can't deliver scientific firsts to NHS patients, it is broken. 'If the Government is to deliver on its goals to reduce lives lost to the biggest killers and put Britain at the forefront of transforming treatment for dementia, it must keep pace with licensed medical breakthroughs.' Dr Jeremy Isaacs, national clinical director for dementia at NHS England, said: 'NHS England has a dedicated team preparing for the rollout of new Alzheimer's treatments. 'There are several other Alzheimer's treatments in development, and the NHS stands ready to offer patients access to new treatments as soon as they are deemed by regulators to be clinically and cost effective.'
The Independent
2 days ago
- Health
- The Independent
Breakthrough Alzheimer's drugs rejected for use on the NHS. Here's how they work
Two drugs to treat Alzheimer's disease have been rejected for use on the NHS because their benefits are 'too small' to justify their cost, the health spending watchdog has said. Donanemab and lecanemab are targeted antibody drugs that slow down the early stages of Alzheimer's by targeting a known cause, rather than just treating symptoms. Both drugs bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's disease, and are designed to help clear the build-up and slow down cognitive decline. However, in publishing its final draft guidance, the National Institute for Health and Care Excellence (Nice) said the treatments have been shown to delay progression from mild to moderate Alzheimer's by four to six months, which it described as only 'modest benefits at best'. What are the medicines? Donanemab and lecanemab are targeted antibody drugs that slow down the early stages of Alzheimer's. They represent a huge step forward in research because they target a known cause of the disease, rather than just treating the symptoms. Both drugs bind to amyloid, a protein which builds up in the brains of people living with Alzheimer's disease. By binding to amyloid, the drugs are designed to help clear the buildup and slow down cognitive decline. How effective are they? Donanemab has been shown in clinical trials to slow the rate at which memory and thinking get worse by more than 20 per cent. Evidence suggests that people get the most benefit if they are given the treatment earlier in the disease. Results also suggest the drug leads to a 40 per cent slowing in the decline of everyday activities such as driving, enjoying hobbies and managing money. Lecanemab has also been shown to successfully remove protein build-up from the brains of people living with early Alzheimer's disease. For people taking lecanemab, this meant the decline in their thinking and memory skills was slowed down by 27 per cent. It also slowed down the decline in quality of life by up to 56 per cent. How are the drugs given? Donanemab, developed by the pharmaceutical company Lilly, is given to patients via an intravenous drip once every four weeks. Lecanemab, developed by Eisai, is also given this way, but fortnightly. Are there any side effects? Side effects of the drugs can be serious, and people undergo monitoring to check for them. In one clinical trial published in the Journal of the American Medical Association (JAMA) in 2023, 24 per cent of people receiving donanemab had side effects, including brain swelling and infusion-related reactions. Four people died during the trial, with their deaths thought to be related to the drug's side effects. Lecanemab resulted in infusion-related reactions in around 26 per cent of people on the trial and followed up, while 14 per cent suffered amyloid-related imaging abnormalities, causing brain swelling. Others suffered minor bleeds, picked up on scans. Around one in 10 people suffered headaches, according to updated results published in May 2024. Overall, four deaths during the follow-up period were thought to be due to treatment. How much do the drugs cost? NHS England published a briefing paper last year suggesting the cost of bringing the drugs to the health service could be £500 million to £1 billion per year. Around 50 per cent to 60 per cent of the total estimated cost relates to the drug price, with the remaining cash spent on patient assessment, diagnosis and administering the treatment. How many people in England might the drugs have worked for? NHS England estimated that between 50,000 and 280,000 patients could be eligible for the new treatments if they were approved for the NHS. To get the drugs, patients need a baseline MRI scan and then either a PET-CT scan or lumbar puncture to confirm Alzheimer's. It is possible that blood tests will be available in the future to diagnose the disease, so NHS England did warn there should be caution about driving a 'massive expansion' in other diagnostics, which could become redundant in the longer term. What do scientists think? Scientists and doctors have been divided on whether the drugs represent a real clinical benefit that is noticeable in patients' day-to-day. Some argue the drugs represent a huge advance, and people should be given the chance to try them. But others say the benefits are too small. Jennifer Keen, associate director of evidence, policy and influencing at the Alzheimer's Society, has said that 'we remain at an important and exciting moment'. 'There are currently 182 active clinical trials for Alzheimer's disease… We are on the cusp of major scientific breakthroughs beginning to improve the outlook for those with the disease.' Professor Rob Howard, from University College London, said that 'nobody should be surprised that Nice have confirmed their earlier view that the new Alzheimer's disease treatments would not be cost-effective if used within the NHS. 'Well-conducted clinical trials demonstrated that the actual size of benefits experienced by patients were too small to be noticeable, treatment carries risks of side-effects, and the annual cost of the drugs and safety monitoring required would have been close to the cost of a nurse's salary for each treated patient. 'We need better treatments that can make an appreciable difference to the lives of people with dementia and these can only come from further research and study.'
The Independent
5 days ago
- Health
- The Independent
Why the NHS may never use breakthrough Alzheimer's drugs
The National Institute for Health and Care Excellence (Nice) is expected to refuse the use of Alzheimer's drugs lecanemab and donanemab on the NHS, despite their success in slowing the disease's progression. The regulator's decision will reportedly be based on cost-effectiveness, as the drugs are estimated to cost between £20,000 to £25,000, which is considered too high for the limited benefit they provide. Trials showed lecanemab can slow Alzheimer's progression by 27 per cent over 18 months by removing build-ups of the protein beta-amyloid from the brain, while donanemab teaches the body's immune cells to remove the amyloid protein. Around 70,000 adults would have been eligible for treatment if the drugs had been approved. Both drugs have UK drug licenses and are available privately, but Nice estimates that the cognitive decline slowed by donanemab is not enough to justify the cost to the NHS. Alzheimer's Research UK expressed disappointment, stating that while the treatments are not perfect, they represent a vital foundation for further scientific progress.
