The UK’s NHS spending watchdog has been directed to reassess the evidence related to medications that can impede the advancement of Alzheimer’s disease. This decision comes after successful appeals by the manufacturers of Donanemab and Lecanemab, which were approved for use in the UK in 2024 but were initially denied NHS availability due to the National Institute for Health and Care Excellence (Nice) deeming their benefits insufficient to justify the cost.
The cost of these treatments was estimated to be significantly higher than the typical threshold that Nice recommends. However, following appeals by Eli Lilly, the producer of Donanemab, and Eisai, the manufacturer of Lecanemab, the watchdog is now tasked with revisiting its final guidance.
The reassessment will focus on various aspects, including the impact on the quality of life of Alzheimer’s caregivers and the cost of administering the treatments via infusion, as estimated by NHS England. The pharmaceutical companies argued that the information on infusion costs was provided only four days before the third committee meeting, leaving inadequate time for proper examination.
Both Donanemab and Lecanemab are antibody treatments designed to target amyloid, a protein that accumulates in the brains of Alzheimer’s patients. This mechanism aids in clearing the protein buildup and reducing cognitive decline, representing a significant advancement in addressing the root cause of the disease rather than just its symptoms.
Nice had previously issued draft guidance indicating that these treatments could delay the progression of Alzheimer’s from mild to moderate stages by four to six months. However, the medicines were deemed not cost-effective for the NHS, offering only modest benefits at best.
In response to the appeal outcomes, representatives from Eli Lilly and Eisai expressed optimism about the potential impact of these medications on the Alzheimer’s community in England, emphasizing the urgency of evaluating the treatments promptly to address the ongoing challenges posed by the disease.
Helen Knight, director of medicines evaluation at Nice, acknowledged the need for further consideration on certain elements that influenced the cost-effectiveness assessment of Donanemab and Lecanemab. Stakeholders will be given an opportunity to provide additional information to address areas of uncertainty highlighted by the appeal panel.
Alzheimer’s Society chief executive Michelle Dyson welcomed the decision to reassess the case for these treatments, particularly emphasizing the significant effects of dementia on unpaid caregivers and the urgent need for new therapies to slow symptom progression and enhance independence for patients. With numerous Alzheimer’s drugs in late-stage trials globally, the UK is urged to adapt swiftly to emerging treatment options.