Today, the UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the marketing authorisation for lecanemab in the treatment of early Alzheimer’s disease. This news follows similar approvals in Japan, United Arab Emirates, China, Israel and the United States. The MHRA assess and regulates medicines, medical devices and blood components for transfusion in the UK.
The MHRA posted the following information on their website relating to their decision:
Lecanemab is approved to treat adults in the early stages of Alzheimer’s disease who have one or no copies of the apolipoprotein E4 gene (ApoE4). A person can have no copies, one copy or two of this gene. Approximately 15% of those diagnosed with Alzheimer’s have two copies of this gene, known as homozygous patients, and are at increased risk of developing Alzheimer’s disease, while people with one copy also have an increased risk.
Despite regulatory agency approval, the National Institute for Health and Care Excellence (NICE) have not recommended that lecanumab be made available or reimbursed by the UK’s publicly funded health care agency, National Health Service (NHS), due to the benefits being “too small to justify the costs”. This decision means that the treatment will only be available privately, for those that can afford it, creating disparity and limiting choice.
This approval comes shortly after EMA’s advisory committee (CHMP) recommendation not to grant marketing authorization for lecanemab in July 2024 in Europe. This discrepancy between Europe and the UK raises the possibility of health tourism.
On the news ADI CEO, Paola Barbarino said:
Today’s announcement will hopefully bring further research and investment in this sector – which we badly need- as well as healthcare infrastructure to support its usage. However this news is disappointing for all those in the UK who would have hoped to have access to this treatment, but do not have the resources to afford treatment privately. Just as the Europeans were disappointed by the recommendation of the European Medicine Agency (EMA)’s CHMP in July. As we have been highlighting since last spring, now the risk of health tourism is a tangible concern, those who can afford it can easily have access to this medication and this will lead to disparities in health outcomes for those living with dementia across Europe and further afield.
We will continue to provide further information on this process when it becomes available.