Leqembi, a new treatment against Alzheimer’s disease, will not immediately be reimbursed in France. The High Health Authority (HA) spoke on Tuesday, September 9 against an accelerated approval procedure in France for Leqembi, an anti-alzheimer drug aroused important expectations but far from being unanimous in terms of its clinical interest.
Leqembi (Lecanémab) shows “modest efficiency (…) associated with a worrying tolerance profile”, this independent authority estimates in an opinion, therefore, rejecting a “early access” access procedure to this treatment developed by the American biogen and the Japanese EISAI.
Controversial treatment despite the slight medical progress
This treatment has been the cause of a great medical controversy in recent years. With another drug with similar functioning, Kisunia (Donenémab) developed by Eli Lilly, have been the first for several decades to demonstrate a slight deceleration in the degradation of the status of patients with Alzheimer’s.
Some of the specialists judge that these medications mark a significant advance against Alzheimer’s disease, the most common dementia with dozens of millions of patients in the world. Patient and relative associations are mostly favorable to approval. But other experts believe that the benefits are too modest to make a difference for patients, especially because these treatments are frequently associated with severe effects (hemorrhages and cerebral edema, which can be fatal.
Leqembi has been authorized to the European Union (EU) in terms of April, but the European health authorities had initially rejected their green light and then gave it to the restriction of patients less at risk and only at the beginning of Alzheimer’s disease.
A negative of early access justified by the risks that are considered too high
In this context, he has had to decide on the merits of “early access” to Leqembi in France for patients with little advanced disease. This procedure allows the immediate refund of the medicine, at the prices established by its manufacturer.
The health authority, whose opinions are only advised but generally followed by the Government, finally considered that nothing justified such an emergency approval because it judged the too heavy and frequent side effects with respect to thin profits.
“It is not likely that the evaluated treatment satisfies a medical need insufficiently covered,” says Ha.
“There is still a disappointment”
However, this opinion does not exclude that Leqembi be reimbursed by health insurance. He will decide later a possible procedure of “customary law”, which would imply longer and complex negotiations between manufacturers and health authorities.
But “it is obvious that we cannot expect an evaluation of Mirobal,” said Pierre Cochat, president of the Ha Transparency Committee. Within the medical world, this decision has aroused contrasting reactions, between Leqembi convinced and skeptical.
“There is still a disappointment,” admits the researcher Bruno Dubois, neurologist at the Piti-Salpêtrière (AP-HP) researcher, asking not to neglect the interest of “a few more months to talk to their grandchildren or go to the theater.”
On the contrary, “this is the best decision for patients with Alzheimer’s disease and their families,” said the AFP, the British psychiatrist Rob Howard, a specialist in the great age of the University College of London, according to whom the most recent data confirms that Leqembi and Kisunla “really do not modify the disease.”
Source: BFM TV
