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 to patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer disease (AD).  Should, though, the label be even more restrictive to mirror the populations studied in the two still unpublished trials of the drug, EMERGE and ENGAGE?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 today's podcast, we talk with Tim Anderson and Marco Canevelli, the authors of two recent articles published about the real world eligibility of aducanumab:

Tim Anderson was first author of a JAMA research letter that found that more than 92% of Medicare beneficiaries with Alzheimer's Dementia and 85% of those with MCI would have been excluded in the clinical trials of aducanumab based on their age or comorbid conditions. 

Marco was first author of a JAGS letter to the editor that systematically applied the EMERGE and ENGAGE exclusions to 911 patients with cognitive complaints who went to A geriatric outpatient unit in Milan (Italy). Only six patients (i.e., 0.66%) of these patients would potentially be candidates to aducanumab.

For more podcasts on aducanumab, check out these two:

• All things Amyloid, including Aducanumab and Amyloid PET scans with Gil Rabinovici
• Aducanumab (Aduhelm) for the Treatment of Alzheimers: A Podcast with Aaron Kesselheim and Jason Karlawish