Alzheimer's drug deemed too costly by UK health service

The new Alzheimer’s drug lecanemab, which can slow the progression of the disease, has been approved by the UK regulator, the MHRA. But it won’t be available to patients on the NHS in England because the National Institute for Clinical Excellence, NICE, which weighs up the cost-effectiveness and economics of healthcare interventions says the benefits “are too small to justify the costs”. Sir John Hardy is the chair of molecular biology of neurological disease at the UCL Institute of Neurology and a leading expert on Alzheimer’s…

John - Lecanemab is an antibody which binds to amyloid. Amyloid is a protein that builds up in the brain and when this lecanemab is injected into the bloodstream, it binds to the amyloid and basically sucks the amyloid out of the brain and that slows the dementia process.

Chris - And to what extent can it do that? What do the trial data that we have so far suggest is being achieved?

John - It suggests it slows the disease by about 25%. Very typically an Alzheimer's patient will go about seven years from diagnosis to death. This will improve that to be about nine years. It's a real improvement, but as those figures show, it doesn't stop the disease.

Chris - How did we arrive at those findings? As in, who was studied, and at what stage of the disease? Because some people always criticise disease interventions on the grounds that we started too late after the horse has already bolted. Could that be a consideration here?

John - That is a consideration. By the time somebody is diagnosed with Alzheimer's disease, often they are three or four years into the disease process. By that stage they've got a huge amount of amyloid in their brain. Also, a lot of damage has started, and just taking the amyloid away at that late stage of disease may not give the full clinical benefit that you would get if you could catch the disease earlier. In almost every disease you can think of, it's worth starting to treat the disease early in the disease process rather than late.

Chris - Are we in a position to make Alzheimer's diagnoses earlier, though? At the moment we're doing this clinically, aren't we? People notice that there might be a memory problem creeping in, they notice a behavioural change in a close relative, for example, they'll then get assessed. By then, they're already manifesting the disease, they already have some of the changes you just outlined. Are we in a position to move that diagnostic window forward though?

John - Yes, we are. In a few special cases we can already do that quite well in, for example, the cases of people who carry the rare mutations which cause the disease. In those families, we can really get better at very early, in fact, presymptomatic diagnosis. In the general population, it's possible, but it's difficult. We don't do blood studies routinely for dementia markers, which we are moving towards but haven't yet achieved to try and pick up the disease earlier. But those are quite tricky scientifically and very difficult at the moment, organisationally, within the NHS.

Chris - The medicines and healthcare products regulatory agency have given this the nod on the basis of the trials we've done. There were some side effects, but the National Institute for Clinical Excellence, whose job it is to sanction the cost effectiveness of interventions, they haven't given this the thumbs up. They have said in their words, the outcomes are too small to justify the costs. It's about 20,000 pounds a year per person. Where does this leave us, then, in terms of using these agents?

John - Well, frankly, it leaves us in a bit of a mess. I'm sure we're going to have GoFundMe campaigns for people to pay it. It's obviously going to be, at the moment, a drug for the wealthy, and poorer people are going to not be able to easily get access. It's going to leave us at the moment in a mess. But I think this is a temporary situation because one of the points that NICE make is that there isn't enough clinical use data in normal clinical practice. The only data that's available is clinical trial data, which is quite specialised. I think that over the next year we'll start to see real clinical data reports, particularly from the US, and that might change NICE's opinion. I think they leave the door open to reconsider their decision.

Chris - One of the things that's not often immediately obvious is when you take into account the high care costs of looking after someone with advanced Alzheimer's disease, 21,000 pounds a year is actually not very much money in those terms. If you can prevent that happening because someone might, for instance, die of something else in the meantime, it might actually translate by spending this money into an overall cost saving.

John - That's right. That's, I'm sure, been part of the submission that the drug companies and the Alzheimer charities have made, that this type of health economics is quite complicated because you are measuring NHS costs against family costs in terms of people taking time off to look after their relatives. Yes, as you've said, care home costs and the economics of this gets very, very difficult. You are right to bring those things up and I'm sure that's going to be part of the ongoing argument that is had to try and change this decision.