¿Cuándo llegará a España el tratamiento Leqembi para el Alzheimer?
After more than 20 years without news in Alzheimer’s treatment, the European Commission (EC) granted final approval for Lecanemab, marketed by Eisai and Biogen as «Leqembi», the first approved drug in Europe that reduces cognitive decline in the early stages of the disease.
Following the recommendation issued in November last year by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), which ensured that the benefits of Lecanemab outweigh its risks, based on an extended clinical study provided by Pharmaceutics.
This drug is the first to demonstrate clinical benefits for a disease that affects more than 800,000 people in Spain, with around 40,000 new cases diagnosed each year, according to data from the Spanish Neurology Society (SEN). However, the CHMP’s opinion is not without risks, and its use must be restricted and subject to a series of conditions.
«What is ‘Leqembi’? Who is it indicated for?»
«Leqembi», developed by Eisai and Biogen pharmaceuticals, is indicated in the European Union, Iceland, Liechtenstein, and Norway for the treatment of mild cognitive impairment or dementia in patients who have only one copy of APOE4, a gene associated with the risk of developing Alzheimer’s disease and presenting amyloid-PLA. In clinical studies provided by marketing companies, it has shown the ability to slow the progression of the disease by 27%.
The active substance in «Leqembi», Lecanemab, is a monoclonal antibody (a type of protein) that binds to and eliminates toxic protofibrils, as well as targeting and reducing beta-amyloid plaques that form in the brains of people with Alzheimer’s. Protofibrils are a key toxic form of beta-amyloid that accumulates in the brain and causes neuronal damage.
The drug will not be available to all dementia patients, but a controlled access program will be launched to ensure that the drug is used only in the patient population for whom it is indicated and is administered safely and efficiently.
In fact, this is one of the conditions set out in its annex of conditions that must be implemented by Member States, so countries must ensure that the start of drug administration in all patients is done with the help of a mandatory centralized registry system.
«What side effects can it produce?»
Regarding its most common side effects, studies analyzed by the EMA include infusion reactions, ARIA-H area, and headaches. Additionally, the drug should not be used by people receiving anticoagulant treatment, as this could increase the risk of developing ARIA-H and cerebral bleeding.
Changes in neuroimaging related to anti-amyloid treatments, known by their acronym in English, can occur naturally in all Alzheimer’s patients but are exacerbated by drugs like «Leqembi». ARIA can manifest as edema accumulating fluid in the brain (ARIA-E) or as small hemorrhage in the brain (ARIA-H).
«When will it be available in Spain?»
After announcing the European Commission’s authorization on the European Scale, pharmaceutical companies must apply for its registration in Spain, something that, initially, as they did in other countries, is expected to take time to do, as well as funding the drug through interministerial drug pricing and products (CIPM).
That being said, it is unknown the exact term in which Alzheimer’s patients in Spain can start benefiting from «Leqembi», but if the latest report on «access to innovative therapies in Europe 2023», by the European Federation of Pharmaceutical Industries and Associations (EFPIA), highlights that the new drug takes 661 days to reach Spanish patients.
In summary, based on existing information, it can be estimated that «Leqembi» could be available in the Spanish pharmaceutical market in less than two years.
«How much will it cost the patient?»
Regarding its cost per patient, CIPM will establish this, making a decision on its pricing and reimbursement, taking into account the potential document and the use of drugs within the National Health System (SNS).
If the pricing set in other countries is taken as a reference, we find that in the United States, the Pharmaceutical Laboratory Eisai has set it at $26,500 per patient per year, which corresponds to approximately $23,308.
FUENTE
