New Alzheimer's Drug Approved In The UK
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has approved a new drug, Leqembi (lecanemab), which is the first treatment shown to slow the progression of early-stage Alzheimer's.
However, despite this significant medical milestone, the National Institute for Health and Care Excellence (NICE) has ruled that the drug will not be available through the National Health Service (NHS) due to its high cost and modest benefits.
Leqembi, developed by Eisai and Biogen, requires bi-weekly hospital infusions and intensive monitoring for side effects and has been shown in trials to slow cognitive decline by 27% over 18 months in patients with mild Alzheimer's. However, NICE has concluded that this benefit, which translates to an average of four to six months of slowed disease progression, does not justify the drug's substantial cost.
Concerns over the drug's side effects have also played a role in NICE’s decision. Leqembi has been associated with brain swelling and microhemorrhages, leading the European Medicines Agency (EMA) to reject the drug last month. NICE and other regulators have pointed out the risks and the limited evidence on the long-term benefits of the drug.
Despite these concerns, many in the field view Leqembi as a breakthrough. Professor Cath Mummery of the Dementia Research Centre at University College London highlighted that for the first time, there is a drug that can alter the course of Alzheimer's, calling it an "extraordinary" development.
The decision by NICE is still open for public consultation until September 20, with a final recommendation expected later this year. Meanwhile, Eisai and Biogen have stated they are working with NICE, the Scottish Medicines Consortium, and the NHS to explore ways to make the drug available in the UK.
Alzheimer's Research UK described the situation as "bittersweet." While the approval of Leqembi marks a "milestone moment," the decision by NICE to withhold it from the NHS is "deeply disappointing," according to the charity’s head of policy, David Thomas. This sentiment is echoed by many in the medical community who had hoped the drug would be a game-changer in Alzheimer's treatment.
The drug's approval by the MHRA means it can be prescribed privately in the UK, but at a steep cost, potentially around £20,000 per year, similar to its price in the US. This decision leaves around 70,000 people in England, who would have been eligible for the treatment, without access through the NHS.
For now, patients like Mavis Guinn, one of the few in the UK receiving Leqembi through a clinical trial, continue to experience the benefits, albeit modest. Her husband, Rodney, has noticed a positive change, saying, "It’s making a difference to your life, isn’t it," a sentiment that resonates with many families affected by Alzheimer's.
While the future of Leqembi in the NHS remains uncertain, the approval signals a new era in Alzheimer's treatment, offering hope that further advancements could bring more effective and accessible options in the near future.
