Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
The use of donanemab (Kisunla) may be considered medically necessary when the following criteria are met:
- The individual must have been diagnosed with mild cognitive impairment or mild Alzheimer's disease dementia, as evidenced by ONE of the following
- A positron emission tomography (PET) scan confirming the presence of amyloid pathology; or
- Have results for a lumbar puncture confirming the presence of elevated phosphorylated tau (P-tau) protein and/or elevated total tau (T-tau) protein, and reduced beta amyloid-42 (AB42) OR a low AB42/AB40 ratio as determined by the lab assay detected in cerebrospinal fluid (CSF); and
- The prescriber is a specialist in neurology or gerontology or consulted with a specialist in neurology or gerontology; and
- Donanemab (Kisunla) will not be used concurrently with other anti-amyloid immunotherapies.
The use of donanemab (Kisunla) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
