LONDON — On Wednesday, the drug Kisunla, which aims to treat Alzheimer’s disease, received approval from Britain’s drug regulatory authority. However, the government has decided against funding the drug after a review by an independent watchdog concluded that the treatment is not a justified expense for taxpayers.
This marks the second Alzheimer’s therapy to face a mixed response in recent months. In August, another drug, Leqembi, was also authorized by regulators, yet the same watchdog recommended against its use within the National Health Service (NHS). In their recent statement, Britain’s Medicines and Healthcare Products Regulatory Agency acknowledged that Kisunla demonstrated potential in slowing the progression of Alzheimer’s in patients at the early stages of the disease. Kisunla, or donanemab, is designed to eliminate a damaging sticky protein from the brain thought to contribute to Alzheimer’s.
However, the National Institute for Health and Care Excellence (NICE) has called for more evidence to substantiate Kisunla’s value, as the manufacturer, Eli Lilly, claims that a year-long treatment costs around $32,000. The U.S. Food and Drug Administration approved Kisunla in July, but the adoption of its competitor, Leqembi, in the U.S. has faced delays due to inconsistent insurance coverage, logistical challenges, and financial concerns.
NICE pointed out that the cost implications associated with Kisunla, which necessitates regular intravenous infusions and careful monitoring for serious side effects like brain swelling or bleeding, indicate that it currently cannot be considered a good value for taxpayers.
NICE experts acknowledged the need for new treatment options for Alzheimer’s and have asked Eli Lilly and the NHS to furnish additional information that could clarify uncertainties surrounding the evidence.
In the UK’s healthcare system, while most medical services are provided free of charge by the government, individuals have the option to secure Kisunla through private payment.
“The news will understandably disappoint those living with dementia and their families,” stated Tara Spires-Jones, who leads the Centre for Discovery Brain Sciences at the University of Edinburgh. She added that it is encouraging to see that new treatments can help to slow the disease even slightly, expressing optimism that ongoing research will yield safer and more effective options in the future.
Fiona Carragher, chief policy and research officer at the Alzheimer’s Society, expressed her dismay at NICE’s decision but noted that approximately 20 Alzheimer’s therapies are currently undergoing advanced trials, with the anticipation of more submissions for approval in the coming years. “We’ve seen improvements in treatments for other diseases like cancer, becoming safer and more affordable over time,” she remarked, hoping for similar advancements in the field of dementia.