2025 Leqembi FDA Label Addendum

This addendum covers MRI Brain without and with contrast (CPT® 70553) and MRI Brain without contrast (CPT® 70551) to monitor for amyloid‑related imaging abnormalities with edema (ARIA‑E) in individuals with Alzheimer's disease receiving Leqembi (lecanemab). Coverage is limited to requests made prior to the 3rd dose/infusion and only for the specified CPT codes per the FDA's recommendation for earlier MRI monitoring, and does not authorize other MRI timing or patients not on Leqembi.

"The document does not provide additional frequency limits or broader indications beyond the single earlier MRI prior to the 3rd infusion."

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