The FDA label for the amyloid antibody aducanumab (Aduhelm) started off exceedingly broad, basically including anyone with Alzheimer’s disease, but was subsequently narrowed to patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer disease. Should, though, the label be even more restrictive to mirror the populations studied in the two still unpublished trials of the drug, EMERGE and ENGAGE? Or should CMS consider restricting coverage for aducanumab to populations meeting trial eligibility criteria and requiring additional evidence on clinical outcomes in groups excluded from the trials? In this podcast, GeriPal talks with Tim Anderson and Marco Canevelli, the authors of two recent articles published about the real world eligibility of aducanumab.
Links: GeriPal (10/2021)