The U.S. Food and Drug Administration (FDA) approved Kisunla?? (donanemab-azbt, 350 mg/20 mL once-monthly injection for IV infusion), Eli Lilly and Company's Alzheimer's treatment for adults with early symptomatic Alzheimer's disease (AD), which includes people with mild cognitive impairment (MCI) as well as people with the mild dementia stage of AD, with confirmed amyloid pathology.1, 2 Once-monthly Kisunla is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which can result in lower treatment costs and fewer infusions. The total cost of Kisunla will vary by patient based on when they complete treatment.

The FDA's dosing instructions state that prescribers can consider stopping the dosing of Kisunla based on removal of amyloid plaques to minimal levels as observed on amyloid PET imaging. The potential to complete treatment after a limited-duration course of therapy, along with 30-minute infusions once per month, could result in lower patient out-of-pocket treatment costs and fewer infusions compared to other amyloid-targeting therapies. Patients' out-of-pocket cost for treatment with Kisunla will depend on their length of trea tment and their insurance.

Coverage and reimbursement for Kisunla are now available for eligible patients on Medicare under a National Coverage Determination with Evidence Development. Also, as of October 2023, broad coverage and reimbursement for amyloid PET scans are available for eligible patients on Medicare.