Donanemab-azbt (Kisunla) (CPB 1066, reviewed 2025-10-17)
Summary
Aetna considers Kisunla (donanemab-azbt) medically necessary for Alzheimer's disease when the member is 50 or older, or is younger with an APP, PSEN1 or PSEN2 mutation or other documentation of early onset AD, is in Clinical Stage 3 or 4, has objective cognitive impairment, and has amyloid pathology confirmed by PET or by cerebrospinal fluid results. The initial criteria also require a brain MRI within one year before treatment, ApoE e4 genotype testing, a baseline CDR-GS of 0.5 or 1, MMSE of 21 to 30, or MoCA of 16 or greater within 12 months of treatment initiation, and participation in a provider-enrolled registry such as ALZ-NET. Anticoagulants may not be used with the drug, any antiplatelet agent must be used as monotherapy at a standard therapeutic dose, and precertification is required.
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