…but NICE says it does not demonstrate value for the NHS
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for donanemab, an injection for intravenous infusion every four weeks to treat mild cognitive impairment and mild dementia due to Alzheimer’s disease in eligible adults in Great Britain. Eligible patients are limited to apolipoprotein E ε4 (ApoE ε4) heterozygotes or non-carriers, which is a requirement for the class of currently approved amyloid-targeting therapies in Great Britain. Donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed. Great Britain is the third major market to approve donanemab, marketed as Kisunla.
I believe we can improve the standard of care for people living with Alzheimer’s disease. Despite years of medical research, until recently, there has been little progress in treatment options for this disease. The authorisation of donanemab for eligible adults is welcome news. Great Britain now needs to rapidly increase National Health Service (NHS) capacity and expertise in diagnostics and treatment facilities to enhance the management of Alzheimer’s disease for the benefit of people today and tomorrow.
Professor Cath Mummery, Consultant Neurologist at University College London Hospitals NHS Foundation Trust and Chair of the NIHR Dementia Translational Research Collaboration.
However, the costs of providing donanemab, including regular infusions and intensive monitoring for serious side effects, balanced against the relatively small benefit it provides to patients, means it cannot currently be considered good value for the taxpayer, according to NICE.
The clinical trial evidence suggests that the monthly injection can slow Alzheimer’s disease progression by 4 to 7 months. However, there are significant uncertainties about how much benefit donanemab provides, and how long this lasts after stopping treatment.
There are also significant health risks associated with the treatment. A third of donanemab recipients experienced amyloid-related imaging abnormalities (ARIA) caused by brain swelling and bleeding.
NICE has asked the company and NHS England to provide additional information to address areas of uncertainty in the evidence.
The consultation on the draft NICE guidance on donanemab will close on 20 November 2024. The independent committee will consider all responses, including any additional analyses, at a second committee meeting before producing its final recommendations.
