Lecanemab represents a groundbreaking new treatment for Alzheimer’s Disease, aiming to slow the progression of the debilitating condition
Alzheimer’s Disease is the most common type of dementia, accounting for between 50% – 75% of all cases. Current research indicates that the brain damage in Alzheimer’s relates to an abnormal build-up of a protein known as beta amyloid.
Until recently, medicine for Alzheimer’s disease treated the symptoms without directly impacting the disease process itself. Now, however, new treatments for Alzheimer’s Disease are emerging which aim to slow the progression of the disease by targeting the build-up of amyloid protein.
What is Lecanemab?
Lecanemab is one of the first drugs launched as a new treatment for Alzheimer’s Disease. It is already available to patients in America, and health chiefs are currently exploring its suitability for use in the UK.
Lecanemab is considered groundbreaking because it’s one of the first dementia modifying disease treatments (DMDTs). However, it does have some important limitations which include its modest benefits, patient suitability, and potentially serious side effects.
Modest Benefits
Lecanemab is not a cure for Alzheimer’s and has no impact on other types of dementia. It works by slowing the rate of disease progression to a fairly modest degree. Eighteen months of regular treatment can result in a six-month delay in symptoms progressing.
Patient Suitability
Not everyone with Alzheimer’s is suitable for Lecanemab. It is only effective for patients in the very early stages of the disease and only in those who, after clinical tests, are proven to have the sensitive clumps of amyloid in the brain. Currently, these tests include special brain scans (amyloid beta positron emission tomography (PET) scans) or lumbar punctures. However, research is underway to find less invasive blood tests that can diagnose Alzheimer’s and determine suitability for DMDTs.
What are the Side Effects of Lecanemab?
Currently, Lecanemab is a treatment rather than a pill. It is given intravenously in a hospital setting every two weeks. Those receiving treatment need close monitoring for serious, even life threatening, complications.
Common side effects include fever, flu-like symptoms, nausea, vomiting, dizziness, changes in heart rate, and shortness of breath. Some patients can also experience seizures, brain swelling, or bleeds.
The risk of bleeding in the brain is higher amongst patients with medical conditions or who are taking certain medicines. Is it also more likely in patients with a specific genetic make-up. Carriers of the gene known as APOE e4 appear to have a higher risk of developing serious potentially fatal complications.
How Can I Get Lecanemab?
Lecanemab is not yet available in the NHS. There are a number of stages which must take place before new drugs such as Lecanemab can be prescribed.
Regulatory Approval of Lecanemab:
Firstly, the national medicine regulatory body (MHRA) must formally authorise the drug as safe and effective for widescale use . The MHRA is still reviewing Lecanemab and some crucial evidence, such as information about its long term safety, is not yet available.
NHS Approval of Lecanemab:
Once the MHRA authorises a drug, the National Institute for Health and Care Excellence (NICE) must decide whether to recommend its use for patients in the NHS. In making its recommendations, NICE considers whether the drug is effective and also whether it provides value for money i.e. whether the scale of the benefits outweighs the costs. The costs include the price of the drug as well as other costs such as the risks of causing other problems.
NICE has a challenging decision to make. Lecanemab is groundbreaking but it isn’t cheap or straightforward. It costs around 26,500 US Dollars (approx. £20,640) per patient per year but that doesn’t include all the genetic tests, counselling, care and brain scans which go with it. NICE will need to decide whether the benefits of Lecanemab are sufficient enough to outweigh all the costs and treatment risks that go with it. It might conclude that the effects of Lecanemab are too modest, or that it would be better to wait until cheaper blood tests are available to diagnose and monitor suitable patients.
If NICE recommends Lecanemab for use in the NHS, then that will require significant changes to current dementia diagnosis and treatment services. All sorts of extra staff, equipment and clinics will be needed to provide a timely diagnosis for people in the early stages of dementia, to identify those who might benefit from Lecanemab and to organise adequate services for intravenous treatment alongside the necessary imaging to monitor side effects and complications.
How Will New Government Plans to Review and Reform Our NHS Affect the Rollout of New Treatments for Alzheimer’s Disease?
All of these new dementia treatment services will need to be developed in the context of what the new Government’s described as a broken NHS. This could mean further delays whilst the NHS review is conducted and plans to mend the NHS are developed. It will certainly mean that new dementia treatment services will have to compete with other essential services for funding and policy priorities such as reducing waiting times for cancer treatment.
Balancing competing demands is never easy in the NHS and historically, rather than mass roll out, health services have favoured a more piecemeal or cautious approach for innovations. This can mean that new services are developed in selected areas known as “demonstrator sites”.
These demonstrator sites can act as test beds, flagging problems and successes and paving the way for wider roll out across the country. In the case of Lecanemab, test beds might also help to avoid widespread investment in services such as brain scans and lumbar punctures which might be unnecessary if blood tests become widely available in the near future.
Hope lies ahead
The coming months will be challenging for all of those responsible for deciding whether to approve new DMDTs for use in the NHS. Decisions about advances in dementia treatment will need to reflect pressures on the public purse and immediate NHS challenges such as staff shortages and long waiting times.
But, whether Lecanemab is approved or not, the fact that it is being considered at all is immensely positive. The decision process is prompting wider debate and accelerating research into DMDTs and diagnostic tests. These critical steps will take us ever closer towards a future in which dementia treatment centres become an everyday reality.
Sources of information
House of Commons Library (2023) New dementia treatments
BBC (2024) The NHS is broken
NICE (2023) HTA Innovation Laboratory report
The Lancet (2023)Affordability of Lecanemab
