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The Prescription Drug Searches will be unavailable Friday, July 10th from 9:00 PM until Saturday, July 11th at 1:00 AM.
The Prescription Drug Searches will be unavailable Friday, July 10th from 9:00 PM until Saturday, July 11th at 1:00 AM.
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S.5.01.595
Kisunla (donanemab-azbt) injection
Leqembi (lecanemab-irmb) injection
Please perform a search of the State Health Plan Medical Drug Formulary for drugs administered and billed through the medical setting.
Alzheimer’s disease (AD) is a neurodegenerative disorder of uncertain cause and pathogenesis that is the most common cause of dementia. The hallmark neuropathologic changes of AD are diffuse and neuritic plaques, marked by extracellular amyloid beta deposition, and neurofibrillary tangles, comprised of the intracellular accumulation of hyperphosphorylated tau protein. The most essential and earliest clinical manifestation of AD is selective memory impairment, although there are exceptions. While treatments are available that can ameliorate some symptoms of the illness, there is no cure currently available, and the disease inevitably progresses in all patients.
Kisunla (donanemab-azbt) and Leqembi (lecanemab-irmb) are monoclonal antibodies directed against amyloid beta and are indicated for the treatment of Alzheimer’s disease. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of AD. The reduction of amyloid plaque burden is, therefore, believed to be disease modifying. Treatment 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.
The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements.
Initial Criteria
Leqembi (lecanemab-irmb) may be considered medically necessary when ALL of the following criteria are met:
The individual has a documented diagnosis of ONE of the following based on National Institute on Aging and the Alzheimer’s Association (NIA-AA) criteria:
Mild cognitive impairment due to Alzheimer’s disease; OR
Mild dementia due to Alzheimer’s disease;
Documentation of BOTH of the following:
Positive Emission Tomography (PET) scan positive for amyloid beta plaque or CSF assessment positive for beta-amyloid accumulation (i.e., hybrid ratios of Aβ 42/40, CSF p-tau 181/Aβ 42, or t-tau/Aβ 42); AND
ONE of the following:
Clinical Dementia Rating (CDR)-Global score of 0.5-1.0 with Memory Box score of at least 0.5;
Mini-Mental State Examination (MMSE) score of 20-28; OR
Montreal Cognitive Assessment (MoCA) score of 18-25;
Cognitive impairment or dementia as a result of an underlying condition or different etiology (e.g., dementia with Lewy bodies (DLB), frontotemporal dementia (FTD), vascular dementia, pseudodementia due to a mood disorder, vitamin B12 deficiency, encephalopathy, etc.) has been ruled out;
Baseline brain magnetic resonance imaging (MRI) has been completed at least 12 months prior to initiation of the requested agent to evaluate for pre-existing Amyloid Related Imaging Abnormalities (ARIA);
ONE of the following:
Genotype testing for apolipoprotein Eε4 (ApoEε4) status (i.e., homozygote, heterozygote, or noncarrier) has been completed, and the prescriber has informed those who are homozygotes of the higher incidence of ARIA; OR
ApoEε4 genotype testing has not been performed, and the prescriber has informed the individual that it cannot be determined if they are at a higher risk of developing ARIA;
The individual does NOT have any of the following risk factors for intracerebral hemorrhage: findings suggestive of cerebral amyloid angiopathy (prior cerebral hemorrhage > 1 cm in greatest diameter, > 4 microhemorrhages, superficial siderosis, vasogenic edema) or other lesions (aneurysm, vascular malformation) that could potentially increase the risk of intracerebral hemorrhage;
The individual does NOT have a history of stroke or transient ischemic attack (TIA) within the previous 12 months;
If the individual is concurrently taking an antithrombotic medication (e.g. aspirin, other antiplatelets, or anticoagulants), the dose has been stable for at least 4 weeks;
The prescriber is a specialist or has consulted with a specialist in an area of the individual diagnosis (i.e., neurologist, geriatric psychiatrist, geriatrician);
The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.
Length of Approval: 6 months
Renewal Criteria
Leqembi (lecanemab-irmb) may be approved for RENEWAL when ALL of the following criteria are met:
The individual has been previously approved for therapy with the requested agent through BCBSMS PA process and continues to have a documented diagnosis of ONE of the following based on National Institute on Aging and the Alzheimer’s Association (NIA-AA) criteria:
Mild cognitive impairment due to Alzheimer’s disease; OR
Mild dementia due to Alzheimer’s disease;
The individual has documented clinical improvement, stability, or slowing of cognitive/functional impairment as evidenced by disease severity assessment score (documentation must be provided using the same disease severity tools used at baseline [i.e., Global CDR, CDR Memory Box, MMSE, MoCA] and must be completed within 30 days prior to renewal request);
The individual has been evaluated for evidence of amyloid-related imaging abnormalities (ARIA) on MRI after the initiation of therapy (prior to the 5th, 7th, and 14th infusions and as indicated by clinical evaluation) and ONE of the following:
ARIA has not been observed; OR
ARIA has been observed and dosing has been adjusted or suspended based on clinical symptoms and radiographic severity as outlined in the “Monitoring and Dosing Interruption for Amyloid Related Imaging Abnormalities” section within prescribing information;
The prescriber is a specialist or has consulted with a specialist in an area of the individual’s diagnosis (i.e., neurologist, geriatric psychiatrist, geriatrician);
The individual does not have any FDA-labeled contraindication(s) to therapy with the requested agent; AND
The prescribed dosage is within the program quantity limits based on FDA approved labeled dosage.
Length of Approval: 12 months
Leqembi (lecanemab-irmb) is unproven and not medically necessary for any indication other than mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia.
Kisunla (donanemab-azbt) is considered not medically necessary as other formulary options are covered by the Plan for treatment of Alzheimer’s disease.
Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary.
None
Medical Policy Manual coverage guidelines should not be used in lieu of the Participant's specific benefit plan language outlined in the Mississippi's State and School Employees’ Life and Health Insurance Plan.
National Institute on Aging and the Alzheimer’s Association: Clinical staging for individuals on the Alzheimer’s disease continuum*
Stage 0: Asymptomatic, deterministic gene
No evidence of clinical change
Biomarkers in normal range
Stage 1: Asymptomatic, biomarker evidence only
Performance within expected range on objective cognitive tests
No evidence of recent cognitive decline or new symptoms
Stage 2: Transitional decline: mild detectable change, but minimal impact on daily function
Normal performance within expected range on objective cognitive tests
Decline from previous level of cognitive or neurobehavioral function that represents a change from individual baseline within the past 1 to 3 years, and has been persistent for at least 6 months
May be documented by evidence of subtle decline on longitudinal cognitive testing, which may involve memory or other cognitive domains but performance still within normal range
May be documented through subjective report of cognitive decline
May be documented with recent-onset change in mood, anxiety, motivation not explained by life events
Remains fully independent with no or minimal functional impact on activities of daily living (ADLs)
Stage 3: Cognitive impairment with early functional impact
Performance in the impaired/abnormal range on objective cognitive tests
Evidence of decline from baseline, documented by the individual’s report or by an observer’s (e.g., study partner) report or by change on longitudinal cognitive testing or neurobehavioral assessments
Performs daily life activities independently but cognitive difficulty may result in detectable functional impact on complex ADLs (i.e., may take more time or be less efficient but still can complete—either self-reported or corroborated by an observer)
Stage 4: Dementia with mild functional impairment
Progressive cognitive and mild functional impairment on instrumental ADLs, with independence in basic ADLs.
Stage 5: Dementia with moderate functional impairment
Progressive cognitive and moderate functional impairment on basic ADLs requiring assistance.
Stage 6: Dementia with severe functional impairment
Progressive cognitive and functional impairment, and complete dependence for basic ADLs.
CDR-SB: Dementia Severity Categories based on Sum of Boxes Scores
The Washington University Clinical Dementia Rating (CDR) scale is frequently utilized to stage dementia severity and yields both a Global (CDR-GS) and Sum of Boxes (CDR-SB) score. Cognitive status is rated in six domains of functioning including memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. The Sum of Boxes score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18. The global CDR score is computed via an algorithm that can be found at < >.
Mini-Mental State Examination (MMSE)
The MMSE is scored on a 30-point scale and assesses orientation (temporal and spatial; 10 points), memory (registration and recall; 6 points), attention/concentration (5 points), language (verbal and written; 8 points), and visuospatial function (1 point). Scores <23 are most commonly regarded as abnormal and indicative of cognitive impairment.
Montreal Cognitive Assessment (MoCA)
The MoCA is scored on a 30-point scale and assesses delayed word recall (5 points), visuospatial/executive function (7 points; includes clock-drawing), language (6 points), attention/concentration (6 points), and orientation (6 points). MoCA Normal and Mild cognitive impairment score ranges were derived from the JAGS 2005 MoCA Validation study where MoCA MCI score ranges were defined by Petersons’ Criteria. The moderate and severe groups were arbitrary defined by default as below:
Normal Cognitive performance - 26 and above
Mild impairment - 18-25
Moderate impairment - 10-17
Severe impairment - 0-9
Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Participant's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:
A. consistent with the symptoms or diagnosis and treatment of the Participant's condition, illness, or injury; and
B. appropriate with regard to standards of good medical practice; and
C. not solely for the convenience of the Participant, his or her Provider; and
D. the most appropriate supply or level of care which can safely be provided to the Participant. When applied to the care of an Inpatient, it further means that services for the Participant's medical symptoms or conditions require that the services cannot be safely provided to the Participant as an Outpatient.
For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.
BCBSMS may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
07/01/2023: New policy added.
08/24/2023: Code Reference section updated to add new HCPCS code J0174.
06/03/2025: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated to add generic drug name for Leqembi. Investigational policy statement updated to state that Leqembi (lecanemab-irmb) is considered not medically necessary as there are other treatment options covered by the Plan for treatment of Alzheimer’s disease (AD). Sources updated.
09/01/2025: Policy title changed from "State and School Employees' Health Insurance Plan - Leqembi (lecanemab-irmb)" to "State and School Employees' Health Insurance Plan - Monoclonal Antibodies for Treatment of Alzheimer’s Disease." Policy description updated to add indication for Kisunla (donanemab-azbt). Policy statement updated to state that Kisunla (donanemab-azbt) is considered not medically necessary as there are other treatment options covered by the Plan for treatment of Alzheimer’s disease (AD). Sources updated. Code Reference section updated to add HCPCS code J0175.
04/01/2026: Code Reference section updated to revise the code description for HCPCS code J0174.
07/01/2026: Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated regarding treatment in patients with mild cognitive impairment or mild dementia. Policy section updated to add medically necessary criteria for Leqembi (lecanemab-irmb). Added the following statement: The use of samples by an individual will not be considered current or stable therapy to satisfy Medical Policy requirements. Added statement that Leqembi (lecanemab-irmb) is unproven and not medically necessary for any indication other than mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia. Revised policy statement to state that Kisunla (donanemab-azbt) is considered not medically necessary as other formulary options are covered by the Plan for treatment of Alzheimer’s disease. Policy Guidelines updated regarding clinical staging for individuals on the Alzheimer's disease continuum. Sources updated. Code Reference section updated to move HCPCS code J0174 from Investigational to Medically Necessary. Added ICD-10 diagnosis codes G30.0 - G30.9.
Cruz-Oliver DM, Malmstrom TK, Allen CM, Tumosa N, Morley JE. The Veterans Affairs Saint Louis University mental status exam (SLUMS exam) and the Mini-mental status exam as predictors of mortality and institutionalization. J Nutr Health Aging. 2012 Jul;16(7):636-41. doi: 10.1007/s12603-012-0098-9. PMID: 22836706.
Epidemiology, pathology, and pathogenesis of Alzheimer disease. UpToDate. Last updated July 2025. www.uptodate.com. Last accessed April 2026.
Gluhm S, Goldstein J, Loc K, Colt A, Liew CV, Corey-Bloom J. Cognitive performance on the mini-mental state examination and the montreal cognitive assessment across the healthy adult lifespan. Cogn Behav Neurol. 2013 Mar;26(1):1-5. doi: 10.1097/WNN.0b013e31828b7d26. PMID: 23538566; PMCID: PMC3638088.
Jack CR, Andrews JS, Beach TG, et al. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's Association Workgroup. Alzheimer's Dement. 2024; 20: 5143–5169. https://doi.org/10.1002/alz.13859
Kisunla prescribing information. Eli Lilly and Company. December 2025. Last accessed April 2026.
Leqembi prescribing information. Eisai, Inc. January 2026. Last accessed April 2026.
Mendez MF. Mental status scales to evaluate cognition. In: UpToDate, Connor RF (Ed), Wolters Kluwer. https://www.uptodate.com/contents/mental-status-scales-to-evaluate-cognition (Accessed on June 12, 2026)
MoCA Cognition. https://mocacognition.com/faq. Accessed June 12, 2026.
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. doi:10.1001/archneur.65.8.1091
Press D, Buss SS. Treatment of Alzheimer disease. In: UpToDate, Connor RF (Ed), Wolters Kluwer. (Last accessed June 2026)
Treatment of Alzheimer disease. UpToDate. Last updated March 2026. www.uptodate.com. Last accessed April 2026.
This may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
Medically Necessary Codes
Code Number | Description |
CPT-4 | |
HCPCS | |
J0174 | Injection, lecanemab-irmb, for intravenous injection 1 mg (Revised 04/01/2026) |
ICD-10 Procedure | |
ICD-10 Diagnosis | |
G30.0 - G30.9 | Alzheimer's disease |
Code Number | Description |
CPT-4 | |
HCPCS | |
J0175 | Injection, donanemab-azbt, 2 mg |
ICD-10 Procedure | |
ICD-10 Diagnosis |
CPT copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.