Kisunla™ (donanemab-azbt)

Kisunla (donanemab‑azbt), although FDA‑approved for Alzheimer’s disease initiated in patients with MCI or mild dementia, is not recommended for approval/coverage by this policy due to insufficient evidence of clinically meaningful benefit and demonstrated safety concerns. If requested, the patient must have the FDA‑approved indication and meet applicable coverage and safety criteria, but the policy lists no specific documentation (tests or clinical notes) required.

"FDA-approved indication: treatment of Alzheimer's disease."

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