Dementia drugs that help manage symptoms, such as confusion, have been approved in the past.
It was lauded for being the first drug to do something, anything, to slow the course of Alzheimer’s disease.
Lecanemab does not cure, reverse or halt Alzheimer’s disease.
A more potent drug with a clearer impact on the course of Alzheimer’s disease could swing those cost-effectiveness calculations.
It then requires an infusion into a vein every two weeks to administer and further expensive brain scans to monitor known side effects.
However, these are difficult to design and manufacture, which inevitably makes them expensive drugs.
Dangers of these drugs include brain swelling and brain bleeds or haemorrhages, and some have been fatal.
For the first time a drug has been licensed that can slow the pace of Alzheimer’s disease.
According to a decision made by the medicine’s regulator, the first medication that has been shown to slow the degeneration of the brain in Alzheimer’s disease will not be provided by the NHS.
Those who were hoping that lecanemab would help fight a terrible and devastating disease are upset and disappointed by the decision to not fund the drug.
However, the choice is also not unexpected.
There is nothing magical about lecanemab. Using the same data as the UK, the European Medicines Agency determined that the medication should only be prescribed to patients participating in clinical trials.
However, what steps would have to be taken for an Alzheimer’s drug to be approved by the NHS?
The task of determining what is a wise use of tax payer money falls to the National Institute of Health and Care Excellence. Here is where the cold, hard calculations of cost-effectiveness clash with emotion, desperate need, and therapy lobbying.
There have previously been approved dementia medications that aid in the management of symptoms like confusion.
This, however, is the first time a medication that alters the course of the illness has been evaluated. In other diseases, this is a more common occurrence. Because it was too costly, the cancer treatment Enhertu, which can prolong the lives of some patients with incurable breast cancer, was rejected earlier this summer.
Nevertheless, if the benefit is great enough, even extremely costly medications—I recently wrote about a one-time gene therapy that has an official cost of £2.6 million—can be approved.
There are problems with lecanemab’s cost, effectiveness, and safety.
Being the first medication to do anything at all to slow the progression of Alzheimer’s disease, it was highly praised. When the data was released in 2022, it was a very important time for a field that had experienced repeated failure. Nevertheless, the impact is minimal, as I noted at the time.
Lecanemab does not stop, reverse, or cure Alzheimer’s disease. The rate of decline is slowed by it.
While the disease still reduced cognitive function in trial subjects, over the course of the 18-month treatment, this decline was slowed by about 25%. Those receiving the medication were 0 points45 points better off on an 18-point scale that went from normal dementia to severe dementia.
Scholars continue to disagree sharply about the significance of those effects.
There are those who contend that they are extending people’s essential freedom. Others claim that the effects are so slight that a physician would not be able to distinguish between a patient receiving lecanemab for eighteen months and another receiving a placebo (fake treatment). There are others who argue that patients ought to have the freedom to decide for themselves what matters most.
A large-scale trial with 1,795 volunteers who had early-stage Alzheimer’s disease provided the drug’s data. However, those who participated were younger and healthier than those who receive a typical diagnosis. It calls into question the “real-world” efficacy of the medication in frailer, elderly patients with a variety of medical issues, including “mixed” dementia, which may consist of some Alzheimer’s disease and other illnesses.
Those cost-benefit analyses might be impacted by a stronger medication that has a more noticeable effect on the progression of Alzheimer’s disease.
Yes, lecanemab might still be involved. Perhaps receiving treatment for a longer period of time or even earlier in the course of the illness would have a bigger impact. It hasn’t been confirmed yet.
Alternatively, it’s possible that lecanemab merely paves the way for a more beneficial drug down the road. Medical research frequently requires the first discovery upon which others can build. Eventually, the first HIV medications cleared the path for contemporary anti-retroviral therapy, which extends a person’s life expectancy to almost normal.
The other side of this equation consists of costs. That value-for-money threshold can be met by a less expensive medication by doing less.
Lecanemab is not cheap. Based on US prices, the medication itself costs roughly £20,000 per patient annually. However, that NHS cost is doubled by the surrounding care (and private fees are probably even higher).
As there are several forms of dementia, it takes a costly PET (positron emission tomography) scan or a lumbar puncture to obtain a sample of cerebrospinal fluid to determine whether a patient truly has Alzheimer’s disease. Only then can treatment begin.
After that, it needs to be administered via a vein infusion every two weeks, and additional costly brain scans are needed to keep an eye on any known side effects.
One way to get a better deal is to haggle, and since there will be competition from upcoming medications like donanemab, prices may drop.
That is still possible to occur. On Thursday, NICE released a draft decision that will be finalized later this year.
Yet, pharmaceutical companies are looking to recoup the years’ worth of R&D expenses, and this area has yielded many costly failures and dead ends.
Lecanemab and donanemab belong to the class of very expensive drugs known as monoclonal antibodies. These are the synthetic counterparts of the naturally occurring antibodies produced by your body to fight illness.
Targeting the sticky protein known as amyloid that clogs the spaces between brain cells is the plan for treating Alzheimer’s disease. The antibodies eliminate amyloid, which is a crucial indicator of Alzheimer’s disease.
They are, however, unavoidably costly medications due to their challenging design and production. Monoclonal antibodies are not available for aspirin-like prices.
An additional requirement is a genetic test because the drug is not permitted in individuals with specific genetic mutations that actually raise their risk of Alzheimer’s.
These medications carry the risk of cerebral edema, cerebral hemorrhages, and some fatalities. Thus, monitoring raises the expenses.
The cost of care associated with these drugs may be decreased in theory by blood tests for Alzheimer’s, medications that require fewer infusions or cause fewer side effects, or improved methods of identifying patients who are susceptible to side effects.
However, as things stand, treating the 70,000 individuals in England who would theoretically qualify for the medication might cost up to £1.44 billion annually, not including the cost of NHS care. According to evaluations, that is a poor use of tax payer dollars for a medication whose effects are generally regarded as “small.”.
This week has still been historic. A medication that slows the progression of Alzheimer’s disease has been approved for the first time.
Prior to it being discovered that dementia was a disease, it was thought to be an inevitable aspect of aging for many years. There is hope right now that we will soon be able to take action.
