KISUNLA (donanemab-azbt)

KISUNLA (donanemab-azbt)

Office-Administration - intravenous (IV) infusion

Diagnosis considered for coverage:

• Alzheimer's Disease: Indicated for the treatment of Alzheimer’s disease. Treatment with Kisunla should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in the clinical trials. 

Coverage Criteria:

For diagnosis of Alzheimer's Disease:

• Both of the following: 

  • 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, AND 

  • Submission of medical records (e.g., chart notes) confirming Mini-Mental State Examination score of 20-28, AND 

• 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 

  • Attestation that patient does not have access to amyloid PET scanning and cerebrospinal fluid (CSF) biomarker testing documents abnormalities suggestive of beta-amyloid accumulation (e.g., Aβ42 level, Aβ42:Aβ40 ratio, Tau, p-Tau), AND

• Both of the following: 

  • 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, AND 

• 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, AND 

• 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, AND 

• Both of the following: 

  • 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), AND 

• Counseling has been provided on the risk of amyloid-related imaging abnormalities (ARIA-E and ARIA-H) and patient and/or caregiver are aware to monitor for headache, dizziness, visual disturbances, nausea, and vomiting, AND 

• Provider will enroll patient in a registry [e.g., Alzheimer's Network for Treatment and Diagnostics (ALZ-Net)], AND

• Patient is not being treated with Kisunla as part of a clinical trial, AND 

• Prescribed by a neurologist, geriatrician, or geriatric psychiatrist 

Reauthorization Criteria:

For diagnosis of Alzheimer's Disease:

• Both of the following: 

  • 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, AND 

  • Submission of medical records (e.g., chart notes) confirming Mini-Mental State Examination score of 20-28, AND  

• 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, AND

• 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, AND 

• Not used in combination with other Aβ monoclonal antibodies (mAbs) for Alzheimer's Disease (e.g., Aduhelm, Leqembi), AND 

• Patient is not being treated with Kisunla as part of a clinical trial, AND 

• Prescribed by a neurologist, geriatrician, or geriatric psychiatrist 

Coverage Duration: 

• Initial: 6 months

• Reauthorization: 6 months

Dosing: 

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Providers should encourage patients to participate in real world data collection (e.g., registries) to help further the understanding of Alzheimer's disease and the impact of Alzheimer's disease treatments. Providers and patients can contact 1-800-LillyRx (1-800-545-5979) for a list of currently enrolling programs.

Policy Updates:

• 12/01/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 11/20/2024) (P&T meeting date)  12/1/2024 (policy effective date)

References:

1. Kisunla Prescribing Information. Eli Lilly and Company. Indianapolis, IN. July 2024. 
2. Alzheimer’s Association: Criteria for Diagnosis and Staging of Alzheimer’s Disease. Available at: https://www.alz.org/research/for_researchers/diagnostic-criteria-guidelines. Accessed July 22, 2024. 
3. Jack Jr, Clifford, Andrews, J Scott, Beach, T., et al. Revised criteria for diagnosis and staging of Alzheimer’s disease: Alzheimer’s Association Workgroup. Available at: https://alz-journals.onlinelibrary.wiley.com/doi/epdf/10.1002/alz.13859. Accessed July 22, 2024. 
4. Barthelemy, N., Salvado, G., Schindler, S., et al. Highly accurate blood test for Alzheimer’s disease is similar or superior to clinical cerebrospinal fluid tests. Available at: https://www.nature.com/articles/s41591-024-02869-z. Accessed July 22, 2024. 
5. Schneider, Tamara. Alzheimer’s blood test performs as well as FDA- approved spinal fluid tests. Available at: https://medicine.wustl.edu/news/alzheimers-blood-test-performs-as-well-as-fda-approved-spinal-fluid-tests/. Accessed July 22, 2024. 
6. AlMansoori, M., Jemimah, S., Abuhantash, F., et al. Predicitng early Alzheimer’s with blood biomarkers and clinical features. Available at: https://www.nature.com/articles/s41598-024-56489-1. Accessed July 22, 2024. 
7. Sims, J., Zimmer, J., Evans, C., et al. Donanemab in Early Symptomatic Alzheimer Disease, The Trailblazer-ALZ 2 Randomized Clinical Trial. Available at: Donanemab in Early Symptomatic Alzheimer Disease: The TRAILBLAZER-ALZ 2 Randomized Clinical Trial | Dementia and Cognitive Impairment | JAMA | JAMA Network. Accessed July 22, 2024. 
8. ClinicalTrials.gov. A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2). Available at: https://clinicaltrials.gov/study/NCT04437511#participation-criteria. Accessed July 22, 2024. 
9. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):263-269. 
10. Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):270-279. 
11. A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease (Clarity AD): https://www.clinicaltrials.gov/ct2/show/NCT03887455. Accessed January 6, 2023. 
12. A study to Evaluate Safety, Tolerability, and Efficacy of Lecanemab in Subjects with Early Alzheimer’s Disease. https://www.clinicaltrials.gov/ct2/show/NCT01767311. Accessed January 6, 2023. 
13. Oudart, Jean., Djerada, Z., et al. Incremental Value of CSF Biomarkers in Clinically Diagnosed AD and Non-AD Dementia. Available at: Incremental Value of CSF Biomarkers in Clinically Diagnosed AD and Non-AD Dementia - PMC (nih.gov). Accessed July 20, 2023. 
14. Anoop, A., Singh, P., et al. CSF Biomarkers for Alzeheimer’s Disease Diagnosis. Available at: CSF Biomarkers for Alzheimer's Disease Diagnosis - PMC (nih.gov). Accessed July 20, 2023 
15. McKhann GM, Knopman DS, Chertkow H, et al. The diagnosis of dementia due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):263-269. 
16. Albert MS, DeKosky ST, Dickson D, et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7(3):270-279. 
17. ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02477800. 
18. ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02484547. 
19. Aducanumab [unapproved dossier], Cambridge, MA: Biogen; 2020. 
20. O’Bryant SE, Waring SC, Cullum CM, et al. Staging Dementia Using Clinical Dementia Rating Scale Sum of Boxes Scores: A Texas Alzheimer's Research Consortium Study. Arch Neurol. 2008;65(8):1091–1095. 
21. Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975;12(3):189-198. 
22. Sevigny, J., Chiao, P., Bussière, T. et al. The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease. Nature 537, 50–56 (2016). 
23. Per clinical consult with neurologist, January 21, 2021. 
24. Blennow K, Mattsson N, Scholl M, et al. Amyloid biomarkers in Alzheimer's disease. Trends Pharmacol Sci 2015;36:297–309. 
25. ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT01677572. 
26. ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04241068. 
27. Wolk DA, Dickerson BC. Clinical features and diagnosis of Alzheimer disease. UpToDate Web site. http://www.uptodate.com. Accessed February 1, 2023.