Donanemab (Kisunla) is a recombinant human immunoglobulin gamma 1 (IgG1) monoclonal antibody, directed against aggregated soluble and insoluble forms of amyloid beta. The accumulation of amyloid beta plaques in the brain is a pathophysiological feature of Alzheimer’s disease.

Policy (Criteria)

Kisunla may be considered MEDICALLY NECESSARY when all of the following criteria have been met:

• Diagnosis of one of the following, based on the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria:
  • Mild cognitive impairment due to Alzheimer's disease
  • Mild dementia due to Alzheimer's disease
• Submission of medical records (e.g., chart notes) confirming Mini-Mental State Examination score of 20 – 28
• Submission of medical records (e.g., chart notes) confirming the presence of beta-amyloid protein deposition, as evidenced by one of the following:
  • Positive amyloid positron emission tomography (PET) scan or beta-amyloid
  • lumbar puncture cerebral spinal fluid (CSF) assay.
• Provider attests that testing regarding the patient's ApoE e4 carrier status has been performed prior to initiating treatment
• Prior to testing, a shared decision-making conversation has occurred, regarding the risk of amyloid-related imaging abnormalities (ARIA), across genotypes, and the implications of genetic testing results
• Submission of medical records (e.g., chart notes) confirming a baseline brain magnetic

resonance imaging (MRI) has been completed within 12 months prior to initiating treatment

• Other differential diagnoses (e.g., dementia with Lewy bodies (DLB), frontotemporal dementia (FTD), vascular dementia, pseudodementia due to mood disorder, vitamin B12
• deficiency, encephalopathy) have been ruled out
• Patient is not currently taking an anticoagulant (e.g., warfarin, dabigatran)
• Patient has no history of intracerebral hemorrhage (e.g., transient ischemic attack [TIA], stroke) prior to initiating treatment
• Not used in combination with other Aβ monoclonal antibodies (mAbs) for Alzheimer's Disease (e.g., Aduhelm, Leqembi)
• Counseling has been provided on the risk of amyloid-related imaging abnormalities (ARIAE and ARIA-H) and patient and/or caregiver are aware to monitor for headache, dizziness, visual disturbances, nausea, and vomiting
• Provider will enroll patient in a registry [e.g., Alzheimer's Network for Treatment and
• Diagnostics (ALZ-Net)]
• Patient is not being treated with Kisunla as part of a clinical trial
• Prescribed by a neurologist, geriatrician, or geriatric psychiatrist

Reauthorization Criteria

Continuation of Kisunla may be considered MEDICALLY NECESSARY when all of the following criteria have been met: 

• Patient continues to have one of the following diagnoses based on the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria:
  • Mild cognitive impairment due to Alzheimer's disease
  • Mild dementia due to Alzheimer's disease
• Submission of medical records (e.g., chart notes) confirming Mini-Mental State Examination score of 20 – 28
• Submission of medical records (e.g., chart notes) confirming that at least one amyloid PET brain scan is performed every 6 months and the result is positive for amyloid based on visual read
• Submission of medical records (e.g., chart notes) confirming follow-up brain magnetic resonance imaging (MRI) has been completed after the initiation of therapy prior to the 5th and 7th infusion treatment to show one of the following radiographic evidence of amyloid related imaging abnormalities (i.e., ARIA-E, ARIA-H):
  • Patient has mild radiographic severity of Aria – E on MRI and is asymptomatic
  • Patient has mild radiographic severity of Aria – E on MRI and has mild clinical symptoms
  • Patient has mild radiographic severity of Aria-H on MRI and is asymptomatic
  • ARIA (i.e., ARIA E, ARIA H) has not been observed on MRI
• Not used in combination with other Aβ monoclonal antibodies (mAbs) for Alzheimer's Disease (e.g., Aduhelm, Leqembi)
• Patient is not being treated with Kisunla as part of a clinical trial
• Prescribed by a neurologist, geriatrician, or geriatric psychiatrist

References

1. Mintun MA, Lo AC, Evans CD, et al. Donanemab in early alzheimer’s disease. NEJM. 2021; 384(18):1691-1704.
2. Sims JR, Zimmer JA, Evans CD, et al. Donanemab in early symptomatic alzheimer’s disease: the TRAILBLAZER-ALZ 2 randomized clinical trial. JAMA. 2023; 330(6):512-527.
3. Kisunla (donanemab-azbt), injection for intravenous use [package insert]. Eli Lily, Inc. Indianapolis, IN. Revised 07/2024.
4. Clinical PharmacologyTM Compendium. 2024. Tampa FL: Gold Standard, Inc. Donanemab-azbt.
5. Micromedex DrugDex Compendium®. 2024. Donanemab-azbt.

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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