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Q: What are the side effects of donanemab?

A: Amyloid-related imaging abnormalities (ARIA) are the most common side effect in clinical trials. ARIA was more common in patients with ApoE4 genotype. There are two types of ARIA, ARIA-E refers to vasogenic edema identified on FLAIR MRI sequences and ARIA-H microhemorrhages and hemosiderosis. ARIA is monitored through MRIs performed before an infusion unless a patient develops any symptoms in between infusions. While most cases of ARIA in the clinical trials were asymptomatic, a subset developed associated symptoms. Infusion reactions are also a possible side effect of this class of drugs. (this was taken from the monoclonal antibody Q&A) The AAN is developing an edition of "Emerging Issues in Neurology" to help our members understand the role donanemab may play in the AD treatment landscape.

Q: What Alzheimer’s patient population is approved for donanemab?

A: Patients in the study were diagnosed with mild cognitive impairment or mild dementia stages of Alzheimer's Disease with proven amyloid beta pathology.

Q: What are the next steps?

A: The AAN submitted comments to CMS requesting that the NCD restricting coverage of donanemab to randomized controlled trials be reconsidered. The AAN has met with CMS on numerous occasions to discuss this issue and is working closely with the agency's Coverage and Analysis Group to determine the best path forward to ensure appropriate access to this therapy upon full approval of donanemab. CMS has stated that the agency will continue to assess the developing body of evidence throughout the coverage with evidence development process prior to modifying requirements mandating participation in a prospective comparative study as a condition of coverage.