Citing lack of scientific rigor, Eisai says CMS decision undermines US regulator

Aduhelm (aducanumab) co-developer Eisai (TYO: 4523) has submitted its response to a much-anticipated reimbursement  decision from the US Centers for Medicare & Medicaid Services (CMS).

The provisional guidance, announced in January, would restrict access to the novel Alzheimer’s med, to include only those Medicare patients currently enrolled in a clinical trial.

The decision, due to be finalized in April, would also present a barrier to future anti-amyloid monoclonal antibody products in this therapy area.