Kisunla™ (donanemab-azbt)

EviCore does not recommend approval or coverage of Kisunla (donanemab‑azbt) for Alzheimer’s disease due to insufficient evidence of clinically meaningful benefit and demonstrated safety concerns. If requested, documentation must show an FDA‑approved Alzheimer’s diagnosis and initiation in the mild cognitive impairment or mild dementia stage with compliance with specific coverage and safety criteria, though current data are inadequate to support coverage.

"When requesting Kisunla (donanemab-azbt), the individual requiring treatment must be diagnosed with a FDA-approved indication and meet the specific coverage guidelines and applicable safety criteri..."

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