Alzheimer’s patients in the UK’s state-run health service are unlikely to gain access to Leqembi, a new drug developed by Eisai and Biogen, after it received approval from the country’s regulator but was deemed too costly for widespread use.
The Medicines and Healthcare products Regulatory Agency (MHRA) announced on Thursday that lecanemab, the drug’s generic name, is the first Alzheimer’s treatment licensed in the UK that provides evidence of slowing disease progression.
However, in draft guidance released concurrently, the National Institute for Health and Care Excellence (NICE) stated that the high price of the medication, along with the need for intensive monitoring of potential side effects, makes it “not good value for the taxpayer.” NICE also noted a lack of evidence regarding the long-term effects of lecanemab, as clinical trials only reported outcomes after 18 months of treatment.
The findings from NICE represent another setback for the drug manufacturers, reflecting slow adoption of the treatment in the U.S. due to concerns over costs, efficacy, and side effects. This situation underscores the challenges associated with a new class of drugs that are beneficial for early-stage Alzheimer’s patients but carry risks of rare yet serious side effects.
NICE’s guidance is open for public consultation until September 20, after which a final recommendation will be made based on the feedback received. It is estimated that around 70,000 adults in England would qualify for treatment with Leqembi.
Eisai and Biogen stated they are collaborating with NICE, the Scottish Medicines Consortium, and the National Health Service to make Leqembi available “as soon as possible.”
Following the announcement, shares of Biogen fell by 1.3% to $203.52 in early trading.
Professor Paul Morgan, Interim Director of the UK Dementia Research Institute at Cardiff University, acknowledged that while NICE’s decision may disappoint those with high expectations for the new therapy, the cautious approach is justified due to “unanswered questions” regarding long-term impacts and side effects.
Another expert, Professor Vanessa Raymont, an associate professor in psychiatry at the University of Oxford, emphasized the importance of developing blood tests for diagnosing Alzheimer’s alongside new treatments.
Despite ongoing development, experts and company executives indicate that it may take another few years before such diagnostic tests become routine.
In clinical trials, lecanemab demonstrated a 27% reduction in Alzheimer’s progression compared to a placebo. The drug has received approval in several countries, including the U.S., China, Hong Kong, Israel, Japan, South Korea, and the UAE.
However, last month, the European Union’s drug regulator rejected lecanemab, stating that the risk of serious brain swelling outweighed its minimal impact on cognitive decline. The companies announced their intention to seek a re-evaluation of this decision, although they did not disclose the new information they would provide.
An approval in the UK is crucial for the estimated $1.6 billion in potential revenue from Europe for Leqembi, which BMO Capital Markets analyst Evan Seigerman described as “a critical approval needed to further accelerate sales for the drug.”
Leqembi is administered twice a month and works by removing amyloid beta protein clumps from the brain, which are considered a hallmark of Alzheimer’s disease. However, it has been linked to severe side effects, including brain swelling and bleeding.
In the U.S., the annual price for Leqembi is set at $26,500. NICE’s draft guidance indicates that the drug’s price in the UK will remain confidential until announced by the Department for Health and Social Care.
Currently, aside from Leqembi, the only other Alzheimer’s drug designed to slow disease progression on the market is Eli Lilly’s donanemab, which was approved by the U.S. Food and Drug Administration last month.
