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L.5.01.595
Kisunla (donanemab-azbt) injection
Leqembi (lecanemab-irmb) injection
Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
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.
Kisunla (donanemab-azbt) and Leqembi (lecanemab-irmb) are considered not medically necessary as there are other treatment options covered by the Plan for treatment of Alzheimer’s disease (AD).
Services related to delivery and/or administration of a medication which have not been approved through the BCBSMS PA review process will be considered not medically necessary.
State Health Plan (State and School Employees) Participants
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
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 Member'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:
consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and
appropriate with regard to standards of good medical practice; and
not solely for the convenience of the Member, his or her Provider; and
the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member 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 [ie, 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.
05/15/2023: New policy added.
07/01/2023: Policy Exceptions updated regarding State Health Plan (State and School Employees) Participants.
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 "Leqembi (lecanemab-irmb)" to "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.
Epidemiology, pathology, and pathogenesis of Alzheimer disease. UpToDate. Last updated August 2022.
. Last accessed May 2025.
Kisunla prescribing information. Eli Lilly and Company. July 2025. Last accessed August 2025.
Leqembi prescribing information. Eisai, Inc. January 2025. Last accessed August 2025.
Treatment of Alzheimer disease. UpToDate. Last updated January 2025.
. Last accessed May 2025.
This may not be a comprehensive list of procedure codes applicable to this policy.
Investigational Codes
Code Number | Description |
CPT-4 | |
HCPCS | |
J0174 | Injection, lecanemab-irmb, 1 mg |
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.