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Introduction
Alzheimer’s disease, the leading cause of death in the UK and the most common form of dementia, has long been a formidable opponent in the medical world. There was hope today (22 August 2024) with news of an Alzheimer’s breakthrough with the development of the first drug to slow the progression of early stage Alzheimer’s.
However, that hope soon evaporated in a cloud of exasperation when it was revealed that Lecanemab won’t be available on the NHS in England because NICE (the National Institute for Health and Care Excellence) said the benefits “are too small to justify the costs”.
Alzheimer’s Breakthrough: The Promise of Lecanemab
Lecanemab represents a significant advancement in Alzheimer’s treatment, targeting the amyloid beta proteins that accumulate in the brain, which are believed to play a critical role in the progression of the disease.
This drug, administered as an intravenous infusion every two weeks, was shown in trials to slow cognitive decline by about a quarter over 18 months for patients in the early stages of Alzheimer’s.
An Alzheimer’s breakthrough such as this is rare and hailed as historic by Alzheimer’s researchers. This is no exaggeration given that this is the first time a drug has convincingly shown that the disease’s underlying mechanism can be affected.
Regulatory Challenges in the UK
Despite its potential, Lecanemab’s journey through the UK’s medical regulatory framework has been fraught with obstacles.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Lecanemab, allowing it to be prescribed privately.
However, the National Institute for Health and Care Excellence (NICE) has decided against recommending the drug for NHS use, citing that the benefits, which include slowing the progression from mild to moderate Alzheimer’s by only four to six months, do not justify the high costs and intensive care required, including fortnightly hospital visits and monitoring for severe side effects.
The Alzheimer’s Society commented: “While we welcome the MHRA approval, it is disappointing that NICE has not recommended approving lecanemab for use on the NHS at this stage. The news that lecanemab will be restricted to certain groups of patients will also lead to uncertainty for many people with Alzheimer’s disease and their loved ones.”
Concerns Over Cost and Side Effects
The costs associated with this Alzheimer’s breakthrough are significant, not only due to the price of the drug itself—approximately £20,000 per patient per year in the US—but also because of the need for ongoing patient monitoring.
Patients undergoing treatment with Lecanemab require frequent MRI scans to check for amyloid-related imaging abnormalities (ARIA), which can include small brain bleeds and temporary swelling. While most cases of ARIA are mild or asymptomatic, some have required hospital treatment, raising concerns about the drug’s safety profile.
Diagnostic Challenges
One of the hurdles in deploying Lecanemab effectively is the requirement for precise diagnostic measures to confirm amyloid levels in the brain. This typically involves either a PET brain scan or a lumbar puncture—methods that are primarily used in research settings and are not standard for patients with suspected dementia. Currently, only about 2% of Alzheimer’s patients have access to these diagnostic tools, limiting the potential reach of this treatment.
Broader Implications
The decision by NICE has been met with disappointment and concern from various stakeholders, including Alzheimer’s Research UK and the Alzheimer’s Society. They argue that the rejection leads to uncertainty and confusion for nearly one million people living with dementia in the UK. Furthermore, the European Medicines Agency (EMA) also rejected the drug, citing that the benefits did not outweigh the risks of serious side effects.
A Turning Point in Alzheimer’s Treatment
Despite these setbacks, many in the field, including Professor Cath Mummery from the Dementia Research Centre at University College London, see lecanemab’s development as a turning point. For the first time, there is robust evidence that the course of Alzheimer’s disease can be altered, representing a beacon of hope for future treatments.
Conclusion
Lecanemab’s story is emblematic of the broader challenges faced in bringing new Alzheimer’s treatments to market. Balancing efficacy, safety, and cost remains a delicate endeavour. As the medical community continues to wrestle with these issues, the need for early and accurate diagnosis and the development of more accessible and effective treatments remains clear. The journey of Lecanemab, despite its hurdles, marks a significant step forward in the ongoing fight against Alzheimer’s disease.
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