Print This PostIn 2023, I wrote a blog about the findings from recent Alzheimer’s disease drug trials hailed as “the beginning of the end”, and tried to unpack whether this truly was the turning point for treating the most common cause of dementia that we’d been waiting decades for. Following the subsequent approval of these drugs for use in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA), they were not recommended for use on the NHS, meaning only those who could afford to pay for private treatment would benefit from these “game-changer” drugs. This highlights the need to address inequalities in access to dementia treatment, which I discuss in this blog.
Last year, when the trial results for the first disease-modifying treatments for Alzheimer’s disease were published (these are drugs which directly impact on the progression of the disease rather than solely managing the symptoms), there was considerable debate about their effectiveness and concern about their safety. The drugs, lecanemab and donanemab, were shown to only have a relatively modest benefit in slowing down the progression of Alzheimer’s disease in its earliest stages, meaning they couldn’t stop the progression of it altogether nor reverse any effects of the disease which had already occurred. Concerns over the safety of the drugs stemmed from reports that some trial participants experienced brain swelling or bleeding, meaning regular and costly brain imaging would be necessary to monitor patients on these treatments.
Following MHRA approval for lecanemab in August 2024 and donanemab in October 2024, attention naturally turned to whether or not these drug treatments would be recommended for use on the NHS, a decision that is made by the National Institute for Care Excellence (NICE) technologies appraisals process. We now know that both lecanemab and donanemab did not achieve this recommendation, meaning they can only be used privately by those who can afford to pay for them. In effect, this results in people from lower socioeconomic backgrounds being financially excluded from “game-changer” treatments, despite being the group most at risk of developing dementia due to greater exposure to various modifiable risk factors across the lifespan. There are already significant inequalities relating to dementia risk, accessing diagnosis, and subsequent treatment. Adding an additional financial barrier whereby only those who can afford effective treatment will get it, risks dementia being a condition that will, over time, only exclusively impact on people and families from lower socioeconomic groups. Estimates from NICE have suggested that between 50,000-280,000 patients would have met the criteria to be eligible for these new treatments, so what led to the decision for them not being recommended for use on the NHS?
As previously mentioned, a cost-benefit analysis is used to determine whether or not a new treatment is to be recommended for use on the NHS. These new drugs for treating Alzheimer’s disease are associated with low clinically meaningful benefit, but potentially high cost, both in terms of risk of side effects for patients and the significant financial cost of treatment, regular clinic appointments, and MRI scans. The cost of implementation has been estimated to be between £500million and £1billion per year. Almost half of this cost is related to how patients would be assessed, diagnosed, and subsequently treated. Just to be eligible to receive these new drug treatments, patients would need confirmation of β-amyloid in the brain through an MRI scan and either a PET-CT scan or lumbar puncture. For treatment with lecanemab, drug infusions every two weeks would be required, or every four weeks with donanemab. In addition, regular MRI scans would be needed for safety monitoring to ensure no adverse side effects occur.
The significant cost associated with these new Alzheimer’s disease drug treatments is cited as the primary reason for not offering them for use on the NHS.
Whilst recognising the significant number of people who may have experienced some benefit from the slowing of disease progression, due to their limited efficacy and risk of potentially serious side effects, this was, on balance, considered a sensible decision.
Currently, approximately 944,000 people in the UK are living with dementia with an economic burden of ~£25billion per year. With an increasingly ageing population these numbers are only set to increase. Significantly improved therapies are on the horizon; ones which have improved efficacy and safety for patients. However, we need to ensure that global health systems are in a position to be able to support the delivery of the next generation of drug treatments to everyone in society who needs them, and avoid creating barriers in access to dementia treatment which exacerbates already existing health inequalities.
Dr Kamar Ameen-Ali
Author
Dr Kamar Ameen-Ali is a Lecturer in Biomedical Science at Teesside University & Affiliate Researcher at Glasgow University. In addition to teaching, Kamar is exploring how neuroinflammation following traumatic brain injury contributes to the progression of neurodegenerative diseases that lead to dementia. Having first pursued a career as an NHS Psychologist, Kamar went back to University in Durham to look at rodent behavioural tasks to completed her PhD, and then worked as a regional Programme Manager for NC3Rs.
National Centre for Research Methods
Dementia Researcher
NIHR