A new drug, the first Alzheimer's treatment to be developed in more than 20 years, has been heralded as 'the beginning of the end' for the devastating degenerative disease, which affects nearly one million people in Britain.
Clinical trials suggest the drug may slow the rate of deterioration among patients in the early stages of the disease by nearly a third and some doctors claim it could delay the need to move into a care home by up to two years.
The drug, Lecanemab, also known by the brand name Leqembi is taken twice a month and removes proteins in the brain called ‘amyloid plaques’ which are thought to cause cognitive decline in Alzheimer's sufferers.
Despite having been approved by Britain's medicine regulators, the new drug was immediately rejected for use in the NHS by spending watchdog the National Institute for Health and Care Excellence (NICE). At £60,000 a year, the treatment is not particularly expensive and NICE has approved other treatments which cost more than £1 million a dose. However, they have ruled that 'the relatively small benefits which Lecanemab provides to patients means it cannot be considered good value'.
These contradictory reactions have left many people confused, but it is important to understand that different criteria are being applied.
The Medicines and Healthcare Products Regulatory Agency (MHRA) is focused on drug safety and assessing if the benefits of the treatment exceed its risks. While some experts have warned of side effects, including brain bleeds, MHRA have decided on balance to approve.
NICE on the other hand are looking at whether the improvement the treatment provides is worth the expense. Given that the NHS only has a finite amount of money, any new treatment takes resource away from others and based on value, rather than cost NICE have decided Lecanemab isn’t worth it.
Campaigners and patient groups have reacted with understandably disappointment. David Thomas, of the charity Alzheimer's Research UK, commented that it meant “the game-changing drug would probably be out of reach for all but the most wealthy individuals who will be able to buy the treatment under a private prescription.”
Professor John Hardy, of UCL, honorary vice president of Alzheimer's Research UK and the scientist who first discovered the role of amyloid in the disease said, “Based on data from recent clinical trials, I believe that the drug will give patients more time and reduce their nursing home costs. This is the first drug that has worked and it slows Alzheimer's by an average of 25%.”
He acknowledged the NICE ruling and suggested that he didn’t think their decision was forever appreciating that they would want to see more data. He also recognised that those considering going private face a tough decision and commented, “There are similar drugs in the pipeline which may have fewer side-effects, and one doesn't know how they may work out. But if I was in the early stage of the disease, I would take the drug.”
However, medical opinion on the effectiveness of the drug is not uniform. Professor Dennis Chan, neurologist and Alzheimer's expert commented, “It's not a wonder drug. We don't have enough information about how the medication works as the disease progresses. It is the first drug found to have a clinical benefit and I don't want to downplay that, but the risk-benefit ratio is on the edge for me.”
Dr Sebastian Walsh, public health researcher at the University of Cambridge commented, 'The trials showed that if you take this drug before your disease has progressed, you have some sort of increased benefit. This is further indication that the drug is affecting the underlying progression of the disease, not just causing small cognitive change – which is good news for similar Alzheimer's medications in development.
Part of the reason for these different medical views may relate to the fact that the drug is only given to people in the very early stages of Alzheimer's, when they've just begun to experience cognitive impairment and more trials will be needed across different stages of the disease.
As well as the potential health benefits, some may consider the cost of private treatment may be justified by the savings of a delay to the need to move into a residential care home as the disease progresses.
Private clinics have reported a surge in enquiries for the treatment but have advised patients that there will be subject to an extensive screening process as MHRA approval only extends to patients without certain genetic characteristics. Other medication, such as blood thinners can dramatically increase the likelihood of side-effects while those with vascular dementia, as well as those with Lewy body dementia and frontotemporal dementia, cannot take the drug.
In addition, the drug has only been proven to benefit people at an early stage of the disease before a significant amyloid build-up in the brain and given the NHS screening system has a severe backlog, many won't have even received an Alzheimer's diagnosis at this point.
So, while it may be too early to label Lecanemab as a wonder drug, the fact that it has slowed the progression of the condition at all suggests that targeting amyloid plaque in the brain could eventually pave the way for better and more effective treatments.
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