Reacción a "EMA revises earlier decision and decides to approve lecanemab for Alzheimer's disease"

I think it is to be welcomed that the EMA has rectified a previous decision that had been taken on flimsy grounds. It took the decision on the basis that the beneficial effect of this drug did not outweigh the risks of possible side effects. It was an argument that was not supported by the data from the clinical trials that have been done.

It is a drug that manages to change the natural history of the disease in its earliest stages, when there is no dependence or dementia yet. It changes the progression of the disease in people who are diagnosed with Alzheimer's when they are still living a normal or near-normal life. Therefore, it contributes to the promotion of people's autonomy, which is what the Dependency Law is all about, which is not about dependency, but about the promotion of autonomy.

It is true that this treatment will not be indicated for all people with Alzheimer's, but only for people diagnosed very early, with a diagnosis based on the use of biomarkers, either by puncture or PET. The news has to be given with this caution, it is not a treatment for everyone.

There is something important: we Europeans working on Alzheimer's felt a little embarrassed when talking to researchers in other countries where it had been approved, such as the US and Japan, because our European Medicines Agency had taken an attitude that could be interpreted as ‘well, let the drug be tested in other countries and if people don't die there and we see the effect, then we will apply it here’.  This is to be congratulated, Europe is jumping on the bandwagon of research and its own guidelines. Let us remember that, in 2011, the European Commission and the European Parliament came out in favour of declaring Alzheimer's a priority disease, with an opinion that spoke of research into new drugs, the creation of diagnostic units, etc.

I understand that the Spanish Agency for Medicines and Health Products (AEMPS) will follow the guidelines of the European Medicines Agency (EMA), which, as I say, are based on clinical trial data. Our 17 health systems will have to prepare to facilitate early diagnosis for people, they will have to prepare to decide whether to fund it or not. Now public-private creativity comes into play so that the company and the administrations agree on prices that are reasonable according to the calculations that are already more than done and published. I trust in the creativity of our politicians so that they know how to agree on affordable prices and that not only is marketing approved in Spain, but also that the drug reaches people's homes, that it is not a treatment for the rich.