Alzheimer's Association Praises UK Approval of Leqembi, Criticizes NHS Access Denial

The Alzheimer's Association has acknowledged the recent decision by the United Kingdom's Medicines and Healthcare Products Regulatory Agency (MHRA) to approve Leqembi® (lecanemab) for the treatment of Alzheimer's disease. This approval marks a significant milestone as it is the first treatment of its kind to be approved in the U.K. However, this milestone is marred by the decision of the National Institute for Health and Care Excellence (NICE) to deny access to this treatment through the National Health Service (NHS), which is expected to exacerbate global health inequities.

"Today is a day of mixed emotions for many in the U.K.," said Joanne Pike, DrPH, President and CEO of the Alzheimer's Association. "The approval decision holds the possibility of extending the time people can live with this fatal and devastating disease, but this benefit can only be realized if people have access to the treatment."

The MHRA's decision aligns with the scientific consensus and the positions of multiple health regulatory agencies worldwide, which have recognized lecanemab as a safe, effective, and beneficial treatment for individuals in the early stages of Alzheimer's or those living with mild cognitive impairment (MCI). The U.K. now joins a list of countries including the U.S., China, South Korea, Israel, Hong Kong, and Japan in approving Leqembi.

"It is baffling that NICE has chosen to deny its taxpayers the option of this treatment. This decision is not in line with scientific evidence, it contradicts the decisions of other regulatory agencies, including those in the U.S., and it is simply wrong," Pike remarked. "We strongly urge NICE to reconsider and change its decision immediately."

Leqembi operates by targeting amyloid beta, the main constituent of amyloid plaques, which are a defining hallmark in the brains of individuals with Alzheimer's disease. Clinical trials have demonstrated that removing amyloid from the brain provides significant and measurable benefits for those in the early stages of Alzheimer's.

"Despite the setback of lack of coverage through the NHS, today's approval is a crucial milestone for Alzheimer's treatment that deserves celebration. Yet, more therapies that target the disease from various angles are still needed," Pike added. "Recent advancements in Alzheimer's and dementia therapies and diagnostic tools were highlighted at the record-breaking Alzheimer's Association International Conference® (AAIC®), and we remain optimistic about the future of Alzheimer's and dementia treatment."

The Alzheimer's Association is a global voluntary health organization dedicated to Alzheimer's care, support, and research. Their mission is to spearhead efforts to end Alzheimer's and all other forms of dementia by accelerating global research, promoting risk reduction and early detection, and maximizing quality care and support. Their vision is a world without Alzheimer's and all other dementia.

This recent approval by the MHRA is a significant step forward, but the denial of access through the NHS underscores the challenges that remain in ensuring equitable access to groundbreaking treatments. The Alzheimer's Association will continue to advocate for policy changes that provide broader access to life-changing therapies for Alzheimer's patients worldwide.