Pharmacy Prior Authorization Criteria

Monoclonal Antibody Agents for Alzheimer's Disease - PA, NF

Indications for Prior Authorization

Aduhelm (aducanumab-avwa)

For diagnosis of Alzheimer's Disease
Indicated for the treatment of Alzheimer's disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).

Kisunla (donanemab-azbt)

For diagnosis of 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.

Leqembi (lecanemab-irmb)

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

Criteria

Aduhelm

Prior Authorization, Non-Formulary (Initial Authorization)

Length of Approval: 6 Month(s)
For diagnosis of Alzheimer's Disease

Both of the following:

Based on the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria, one of the following: [16,17,24]

Diagnosis of mild cognitive impairment due to Alzheimer's disease
Diagnosis of probable Alzheimer's disease dementia

AND

Submission of medical records (e.g., chart notes) confirming both of the following: [18-19]

Clinical Dementia Rating-Global (CDR-G) score of 0.5 or Clinical Dementia Rating Sum of Boxes (CDR-SB) score of 0.5-4
Mini-Mental State Examination score of 24-30

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

Both of the following:

Attestation that the patient does not have access to amyloid PET scanning
Cerebrospinal fluid (CSF) biomarker or blood testing documents abnormalities suggestive of beta-amyloid accumulation (e.g., Aβ42 level, Aβ42:Aβ40 ratio)

AND

Provider attests that the patient's ApoE e4 carrier status is known prior to initiating treatment and a shared decision-making conversation regarding the results has been completed

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, etc.) have been ruled out

AND

Both of the following: [18-19]

Patient is not currently taking an anticoagulant or antiplatelet agent (unless aspirin 325 mg/day or less)
Patient has no history of transient ischemic attack (TIA) or stroke within previous year prior to initiating treatment

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 [20]

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

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

AND

Prescribed by a neurologist, geriatrician, or geriatric psychiatrist

Aduhelm

Prior Authorization, Non-Formulary (Reauthorization)

Length of Approval: 6 Month(s)
For diagnosis of Alzheimer's Disease

Patient is benefitting from therapy as defined by both of the following:

Based on the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria, one of the following: [16,17,24]

Patient continues to have a diagnosis of mild cognitive impairment due to Alzheimer's disease
Patient continues to have a diagnosis of probable Alzheimer's disease dementia

AND

Submission of medical records (e.g., chart notes) confirming both of the following: [18-19]

Clinical Dementia Rating-Global (CDR-G) score of 0.5 or Clinical Dementia Rating Sum of Boxes (CDR-SB) score of 0.5-4
Mini-Mental State Examination score of 24-30

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 infusion treatment to show one of the following:

Both of the following:

Less than 10 new incident microhemorrhages
2 or less focal areas of superficial siderosis

If 10 or more new incident microhemorrhages or greater than 2 focal areas of superficial siderosis are present then both of the following:

Patient has been clinically evaluated for ARIA related signs or symptoms (e.g., dizziness, visual disturbances)
Follow-up MRI demonstrates radiographic stabilization (i.e., no increase in size or number of ARIA-H)

AND

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

AND

Prescribed by a neurologist, geriatrician, or geriatric psychiatrist

Kisunla

Prior Authorization, Non-Formulary (Initial Authorization)

Length of Approval: 6 Month(s)
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

AND

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

Kisunla

Prior Authorization, Non-Formulary (Reauthorization)

Length of Approval: 6 Month(s)
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 [A]

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

Leqembi

Prior Authorization, Non-Formulary (Initial Authorization)

Length of Approval: 6 Month(s)
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 all of the following [12-13]:

Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0
CDR Memory Box score of 0.5 or greater
Mini-Mental State Examination score of 22 or greater

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 [9, 12-13]:

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

AND

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

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 Leqembi as part of a clinical trial

AND

Prescribed by a neurologist, geriatrician, or geriatric psychiatrist

Leqembi

Prior Authorization, Non-Formulary (Reauthorization)

Length of Approval: 6 Month(s)
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 all of the following [12-13]:

Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0
CDR Memory Box score of 0.5 or greater
Mini-Mental State Examination score of 22 or greater

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, Kisunla)

AND

Patient is not being treated with Leqembi as part of a clinical trial

AND

Prescribed by a neurologist, geriatrician, or geriatric psychiatrist

Guideline ID
GL-150756
Formulary
Premium
Effective date
Aug 16, 2024
P&T approval date
Feb 18, 2021

P & T Revisions

2024-08-01, 2024-04-24, 2023-05-03, 2023-03-31, 2023-02-16, 2022-06-01, 2022-04-25, 2021-06-24, 2021-06-16

References

Kisunla Prescribing Information. Eli Lilly and Company. Indianapolis, IN. July 2024.
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.
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.
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.
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.
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.
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.
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.
Leqembi Prescribing Information. Eisai, Inc. Nutley, NJ. July 2023.
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.
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.
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.
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.
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.
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
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.
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.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02477800.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT02484547.
Aducanumab [unapproved dossier], Cambridge, MA: Biogen; 2020.
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.
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.
Sevigny, J., Chiao, P., Bussière, T. et al. The antibody aducanumab reduces Aβ plaques in Alzheimer’s disease. Nature 537, 50–56 (2016).
Per clinical consult with neurologist, January 21, 2021.
Aduhelm prescribing information. Biogen, Inc. Cambridge, MA. February 2023.
Blennow K, Mattsson N, Scholl M, et al. Amyloid biomarkers in Alzheimer's disease. Trends Pharmacol Sci 2015;36:297–309.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT01677572.
ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT04241068.
Wolk DA, Dickerson BC. Clinical features and diagnosis of Alzheimer disease. UpToDate Web site. http://www.uptodate.com. Accessed February 1, 2023.

Revision History

2024-08-01: update guideline
2024-04-24: 2024 Annual Review
2023-05-03: Annual review - updated references.
2023-03-31: Updated GPIs
2023-02-16: Add submission of medical records where applicable, criterion to not to be used in combination with other mAbs for AD, and clarified follow-up MRI requirements. Added criterion regarding ApoE e4 testing. Added additional blood testing option. Updated references.
2022-06-01: Remove submission of records from ORx standard
2022-04-25: Annual Review
2021-06-24: Program Update
2021-06-16: Program Update

Monoclonal Antibody Agents for Alzheimer's Disease - PA, NF

Indications for Prior Authorization

Aduhelm (aducanumab-avwa)

Kisunla (donanemab-azbt)

Leqembi (lecanemab-irmb)

Criteria

Aduhelm

Aduhelm

Kisunla

Kisunla

Leqembi

Leqembi

P & T Revisions

References

Revision History

Provider Tools