We all wish there were effective or better tolerated medicines and treatments for all diseases. In reality, though, many medications have limitations and unintended side-effects, and sometimes are very expensive.
Lecanemab
Recently the National Institute for Health and Care Excellence (NICE) has decided that lecanemab, a new medication intended to slow down the progression of Alzheimer’s disease, should not be used by the NHS.
Alzheimer’s disease is the most common type of dementia and, until recently, it has only been possible to attenuate some of the symptoms but not to arrest the disease progression. Thus, there was much hope that lecanemab would turn out to be a game changer.
However, when the results of the lecanemab trial were published, many were disappointed. Lecanemab did not stop the progression of Alzheimer’s. Patients taking this medication continued to worsen, though at a slower pace.
Whether we regard the benefits of lecanemab as significant or not, it depends on how we look at the data. Proponents of this drug argue that there was a 27% reduction in cognitive decline.
Critical commentators
More critical commentators point out that the difference in cognitive function, between those taking the medication or not, was only 0.45 points on an 18-point scale. This small benefit was counterbalanced by potentially serious side-effects and very high costs.
Lecanemab can only be used in patients with early Alzheimer’s and provided that they do not have any exclusion criteria, such as a history of brain cancer or bleeding, being on anticoagulants, or carrying certain genes which are found in 15% of patients with Alzheimer’s.
Adverse events leading to discontinuation of lecanemab occurred in 7% of patients, whereas infusion reactions occurred in almost a third but were mostly not severe.
About 2 in 10 people who received lecanemab developed brain changes due to brain bleeding or brain swelling, though only a much smaller subset experienced symptoms (such as headache, visual changes, and confusion) or had severe changes on brain MRI scans.
The cost of purchasing lecanemab is about £ 20,000 for one year treatment, but there are also significant additional costs for the administration, the MRI monitoring and the handling of the side-effects. Thus, the true cost of lecanemab could be about £ 60,000 for each year of treatment.
The UK medicines agency
No doubt the public will be confused by the fact that the UK medicines agency (MHRA) has licensed this medication for use in the UK, whereas NICE has ruled out its use in the NHS, which means that lecanemab could only be taken by private patients.
There are similar contradictions across the world: lecanemab has been approved in the US and a handful of other countries, but has been rejected by the EU drugs regulator.
The decision of blocking the use of lecanemab in the NHS has been criticised by Alzheimer’s Research UK and by Debbie Abrahams, the former chair of the all-party parliamentary group on dementia. Hower the counterargument is that the benefits of lecanemab are just too small to justify the risk of serious adverse events and the significant cost to the NHS.
There are a number of ongoing treatment trials for dementia and, whilst we wait for better medications to come along, an important strategy already available to us is to target the risk factors that increase the risk of dementia, such as smoking, physical inactivity, obesity, hypertension, excessive alcohol, low social contact, hearing impairment and air pollution.
Risk factors
Tackling these risk factors would prevent or delay up to 40% of dementia cases and could slow down progression in those with early dementia. Tackling these risk factors is not just about our individual effort: better public health policies are also required.
There is a strong analogy with the actions required to control obesity. There are obesity medications, like semaglutide, which help to reduce weight, but getting an NHS prescription for these medications is difficult. Semaglutide is also expensive and has limitations and side-effects.
Obesity treatment cannot just be about medications or bariatric surgery, it also requires a personal effort in relation to better eating and more exercise, and there is a strong need for public health policies.
Better medicines would help, but medicines are not always the answer.
