Accessing lecanemab, a new drug for early-stage Alzheimer’s disease, has become a hot topic in the UK since the Medicines and Healthcare products Regulatory Agency (MHRA) granted a license for its availability. Marketed under the brand name Leqembi, lecanemab has been approved for individuals in the early stages of Alzheimer’s disease. However, there are certain exclusions to consider. The MHRA has excluded individuals with moderate or late-stage dementia caused by Alzheimer’s disease, those with other forms of dementia such as vascular dementia, Lewy body dementia, or frontotemporal dementia, and people who carry two copies of the APOE4 gene variant. These exclusions were made based on the higher risk of side effects in these individuals.
While lecanemab has been approved by the MHRA, the National Institute for Health and Care Excellence (NICE) has not recommended it for use on the NHS at this stage. NICE determines which medicines should be made available on the NHS, and their draft guidance suggests that lecanemab does not meet their criteria for clinical and cost effectiveness. A month-long consultation will take place on this guidance, with a final decision on NHS availability to be made at a later date.
The approval of lecanemab by the MHRA marks a significant milestone in dementia treatment. However, the NICE recommendation highlights the challenges in diagnosing and treating individuals with dementia. Lecanemab is most effective in the early stages of the disease, emphasizing the importance of early diagnosis. Currently, a significant portion of people with dementia do not receive a diagnosis, and those who do often live with the condition for years before being diagnosed. Alzheimer’s Society is urging the NHS in England, Wales, and the HSC system in Northern Ireland to publish plans for transforming diagnosis and delivering new treatments.
In terms of efficacy, lecanemab has shown promising results in clinical trials. The phase 3 trial, Clarity-AD, conducted by Eisai, involved 1,795 individuals with early-stage Alzheimer’s disease. The trial demonstrated that lecanemab slowed down the progression of memory and thinking skills decline by 27% compared to a placebo. Additionally, the drug reduced the loss of quality of life by up to 56% and decreased the amount of amyloid protein in the brain, blood, and spinal fluid.
Despite its effectiveness, lecanemab, like all drugs, comes with potential side effects. During the clinical trial, some participants experienced reactions to the drug infusion, swelling, or microbleeds in the brain, known as Amyloid Related Imaging Abnormalities (ARIA). There were also three deaths related to taking lecanemab, although this accounted for less than 0.2% of trial participants. The MHRA will continue to monitor the safety and effectiveness of lecanemab, and patients receiving the treatment can report any adverse effects through the Yellow Card Scheme.
In conclusion, lecanemab represents a significant advancement in the treatment of early-stage Alzheimer’s disease. While its approval by the MHRA is a positive step, further considerations are needed regarding its availability on the NHS and the management of potential side effects. As research and development in dementia treatment continue to progress, it is crucial for healthcare systems to adapt and ensure that individuals with dementia receive timely diagnosis and access to innovative treatments like lecanemab.
