Aduhelm is the first approved treatment for Alzheimer's disease since 2003 and the first therapy that addresses the fundamental pathophysiology of the disease. Its recent approval in the United States has divided scientists.
One of the great concerns of families who are closely aware of the effects of Alzheimer's is whether there will ever be a treatment that can combat the disease. The answer so far had been clear: no. However, something is changing in the field of the pharmaceutical industry and it is that recently the United States has given some hope to Alzheimer's patients and their loved ones.
The Food and Drug Administration (FDA) recently approved (June 7, 2021) the drug Aduhelm, also known as aducanumab, developed by Biogen, to treat Alzheimer's. This decision has caused controversy among the pharmaceutical industry and has divided experts in the sector since after three years of clinical trials there has been inconsistency in its efficacy.
There is no doubt that the FDA has approved this drug in some way because of the pressing need to create new drugs and give hope to families because, in fact, we did not have any treatment that would modify the course of the disease, says Dr. Juan Fortea, coordinator of the Group for the Study of Behavior and Dementias of the Spanish Neurology Society.
The neurologist Juan Fortea believes that this drug is great news because it is the first that can act against the course of the disease, that is, against the cause and not against the symptom, as was done until now. All the drugs that we had so far, the last one was approved in 2003, were symptomatic treatments, that is, they improved symptoms. This is the first that shows that it impacts a key pathophysiological process of the disease (beta-amyloid) with a possible clinical effect.
However, the doctor emphasizes, it has not yet been approved by the European Medicines Agency (EMA) and therefore sends a message of caution to families. When there are cases of controversial evidence, as is the case, there could be a divergence of opinions between two regulatory agents, clarifies Fortea.
Although the Aduhelm data is complicated with respect to its clinical benefits, the FDA has determined that there is substantial evidence that Aduhelm reduces beta-amyloid plaques in the brain and that reducing these plaques is reasonably likely to predict important benefits for patients, the agency said in a statement.
The creators of the drug claim that aducanumab is capable of acting on a protein called beta-amyloid, one of the two protein aggregates that mainly cause brain damage in Alzheimer's disease. These lodge outside the neurons and give rise to amyloid plaques, causing brain damage. Through this drug, it is possible to act against these plaques in the form of an antibody. "There is no doubt that this drug is capable of removing these amyloid plaques and that is the key to its approval," explains the neurologist. Although perhaps the aspect that has stood out the most among scientists has been that it is not only capable of acting in the initial stages of the disease, it is also possible that this drug be used in any phase of the disease.
Valued at 56,000 euros
It is not the first time that the FDA has approved a drug, but then it is the insurers who decide not to go ahead with it due to its high price, which could only be supplied by private health. In the United States, not only insurance companies will now have to pronounce, but also Medicare, the social security coverage program administered by the US government, because their opinion on the matter is crucial.
The company assured that the price of the drug will amount to 56,000 dollars (46,000 euros) a year. Assuming a quarter of eligible patients take it, that would mean more than $ 20 billion (€ 16 billion) in revenue. To this should be added the medical costs, nursing, biomarkers, etc. Unaffordable costs for a public health system like ours right now qualifies the Spanish neurologist.
Suppose that the drug is approved by the different organisms, could a health system like the Spanish assume this expense? Dr. Fortea believes that right now Spain is not ready because, even if there was funding, there is a great lack of specialized professionals. In addition, the cost would be tremendously disproportionate because, unlike cancer or other expensive treatments, hundreds of patients would come at once who can benefit.
It is not a problem in terms of prices, but the disease is too frequent. The drama is that guaranteeing access to so many people is impossible. We are going to have tremendous problems.
What it will mean is a change in the level of the diagnosis of the treatment of degenerative diseases. With dementia it was generalized that there was nothing to do anymore, neurologists have been denouncing these iniquities for years, argues Fortea. The new drug is somehow going to get us out of nihilism as a positive consequence regardless of whether social security is going to approve it or not. However, keep in mind that although aducanumab has been shown to be disease-modifying, there are still reasonable doubts about its clinical efficacy, which have prompted the FDA to request an additional trial. Many scientists believe it should not have been approved Hence the controversy.
These doubts have to be clarified as soon as possible because it will pose such a significant challenge to the system that the sooner they do it the better. It will be a revolution and it will generate tremendous concern among the population because families are desperate to find treatment.
The coordinator of the Group of Conduct and Dementias of the Spanish Neurology Society believes that although it is not yet known what will happen in Spain with this drug, we must start working in that direction as soon as possible. It may be that in a few years a new treatment will emerge that will reliably demonstrate that it is useful and we are going to have the same problem, not be prepared, he emphasizes the change is already here.