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CompilationTom Lee
A few days ago, the Centers for Medicare and Medicaid Services (CMS) officially decided to strictly limit the medical insurance coverage of Biogen's controversial Alzheimer's disease drug Aduhelm to only patients participating in clinical trials
Just after CMS' decision last week, the Alzheimer's Association vigorously condemned the move, saying Aduhelm's decision to restrict coverage would create unnecessary barriers to treatment for Alzheimer's patients in the United States
To this end, several pharmaceutical companies are accelerating the advancement of potential Alzheimer's disease treatment options or add-on therapies, including Eli Lilly, Eisai, Diadem, ProMis Neurosciences and Roche, among others
After the restrictive ruling, the US CMS specifically pointed out that the Alzheimer's disease antibody therapy needs to prove its efficacy on cognitive decline in patients in a comparative study before it can be covered by medical insurance in the future
After Aduhelm, Eisai and Biogen are currently actively developing lecanemab therapy
Eisai and Biogen submitted a rolling application for lecanemab to the FDA in September last year
Eisai said in a statement that the company expects to complete a rolling submission for lecanemab through the accelerated approval pathway in the coming months, following last week's CMS decision on Aduhelm's restrictive coverage
Also affected by the US CMS, Eli Lilly recently decided to postpone the rolling submission seeking accelerated approval for donanemab
In addition, Roche is also actively promoting its anti-Alzheimer's disease monoclonal antibody gantenerumab to enter the Phase III trial as soon as possible
Reference source: It's Full Speed Ahead for Many Alzheimer's Players Following CMS Decision