Alzheimer’s Drug, lecanemab Approved but “Too Costly” for NHS
The UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) – has given the green light for Alzheimer’s drug lecanemab to be sold in Great Britain.
However, the drug has not been deemed value for money for the NHS.
A provisional decision, made by the National Institute of Health and Care Excellence (NICE), means that as things stand, people in the early stages of the disease will be denied access to lecanemab through the NHS.
For the foreseeable future, it will only be available to those who can afford its steep price tag in the private sector – which will be prohibitive for many.
The MHRA’s landmark decision makes lecanemab the first licensed treatment in England, Scotland and Wales that can slow down early-stage Alzheimer’s disease, rather than manage people’s symptoms.
Alzheimer’s Research UK’s Chief Executive, Hilary Evans-Newton, described the news as “bittersweet.”
“It’s a remarkable achievement that science is now delivering licensed treatments that can slow down the devastating effects of Alzheimer’s, rather than just alleviating its symptoms. However, it’s clear our health system isn’t ready to embrace this new wave of Alzheimer’s drugs,” she explained.
The MHRA’s decision that lecanemab is safe and effective enough to be granted a license is based on Eisai’s CLARITY AD Phase 3 clinical trial results published in November 2022. The trial involved 1,800 patients over an 18-month period. The drug was shown to slow participants’ cognitive decline by 27% and slow their decline in quality of life by up to 56%.
Experts warned that, like first-generation treatments for other diseases, lecanemab has modest benefits and side effects that need careful monitoring.
Lecanemab carries the risk of a potentially serious side effect, known as ‘amyloid related imaging abnormalities’ (ARIA). These are changes in the brain that can be seen on MRI scans, that are linked to swelling or bleeding.
Around one in eight people who received lecanemab during the trial developed ARIA. Although most of those people (80%) did not have symptoms. However there were three deaths attributed to lecanemab during the trial – just under 0.2% of the total number of participants.
Fiona Carragher, Chief Policy and Research Officer at Alzheimer’s Society said:
“Today’s MHRA approval of the first safe and effective Alzheimer’s disease treatment, shown to slow progression, is a defining moment for people with early-stage Alzheimer’s disease in the UK and a significant step towards a more hopeful future.
“While we welcome the MHRA approval, it is disappointing that NICE has not recommended approving lecanemab for use on the NHS at this stage. The news that lecanemab will be restricted to certain groups of patients will also lead to uncertainty for many people with Alzheimer’s disease and their loved ones.
“We respect the decisions regulators have made, however we know these announcements will bring a mix of emotions for those who have been waiting a long time since the promising trial results were first announced.
“The NICE recommendation reflects the urgent challenges which must be addressed regarding how we diagnose and treat people with dementia. A third of people affected by dementia have not received a diagnosis, and for those who have been diagnosed, it’s often not early or accurate enough for a person to be eligible for new treatments.
“A dementia diagnosis not only opens up the potential for treatment. It is also the single most effective route to the care, support and information we know is so important for everyone living with dementia and their loved ones.
