June 9, 2021
On June 7, the U.S. Food and Drug Administration (FDA) approved aducanumab (Aduhelm) for the treatment of patients in the early stages of Alzheimer’s disease. Aducanumab selectively targets and removes beta amyloid plaques. it is the first drug that targets the underlying pathology of Alzheimer’s disease rather than treating its symptoms.
SNMMI recognizes the importance of this landmark approval, which was based on data from the ENGAGE trial. One of the key inclusion criteria for patients in this trial was to have had a positive beta amyloid positron emission tomography (PET) scan. However, amyloid PET scans are not mentioned as a requirement for prescribing the biologic on the label.
In order to ensure that aducanumab is administered to properly selected patients who are likely to benefit from it, SNMMI believes that PET scans should be performed on patients who are candidates for aducanumab to show that those patients have amyloid plaque, and on patients who are taking aducanumab to ensure that the amount of amyloid plaque has decreased. SNMMI plans to engage with the Centers for Medicare & Medicaid Services to ensure that beta amyloid PET imaging is covered and reimbursed for these indications.