Lecanemab-irmb (Leqembi®)

Restricted Product(s):

• lecanemab-irmb (Leqembi®) intravenous infusion for administration by a healthcare professional 

FDA Approved Use:

• For treatment of Alzheimer’s disease. 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. 

Criteria for Medical Necessity:

The restricted product(s) may be considered medically necessary when the following criteria are met:

Initial Criteria for Approval:

1. The patient is 50 to 90 years of age; AND
2. The patient has a diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) OR mild dementia due to Alzheimer’s disease (AD) [medical record documentation required]; AND
3. The patient’s diagnosis has been confirmed by ALL of the following within the last 6 months [medical record documentation required]:
   1. Clinical Dementia Rating (CDR)-Global score of 0.5 to 1.0; AND
   2. CDR Memory Box score of 0.5 or greater; AND
   3. Mini-Mental State Examination (MMSE) score between 22 to 30, inclusive; AND
4. The patient has had a baseline disease severity assessment conducted within the last 6 months using ONE of the following objective measurement tools [medical record documentation required]:
   1. Mini-Mental State Examination (MMSE); OR
   2. Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog-13); OR
   3. Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory-Mild Cognitive Impairment version (ADCS-ADL-MCI); OR
   4. Clinical Dementia Rating-Sum of Boxes (CDR-SB); AND
5. The patient has presence of amyloid beta protein deposition consistent with a diagnosis of Alzheimer’s disease, as confirmed by ONE of the following within the last 6 months:
   1. A positive amyloid load indicated by positron emission tomography (PET) brain scan [medical record documentation required]; OR
   2. Cerebrospinal fluid (CSF) biomarker testing of Aβ(1-42) demonstrating abnormalities suggestive of amyloid beta (Aβ) accumulation in the brain (e.g., Aβ42, Aβ42/Aβ40 ratio, tau/Aβ42 ratio) [medical record documentation required]; AND
6. The patient has had a baseline brain magnetic resonance imaging (MRI) completed within 1 year prior to initiating treatment with the requested agent AND the patient does NOT have any of the following risk factors for intracerebral hemorrhage present [medical record documentation required]:
   1. Findings suggestive of cerebral amyloid angiopathy (e.g., prior cerebral hemorrhage greater than 1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, vasogenic edema); OR
   2. Other lesions (e.g., aneurysm, vascular malformation) that could potentially increase the risk of intracerebral hemorrhage; AND
7. The patient will be monitored for amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E) and -hemosiderin deposition (ARIA-H) by obtaining periodic MRIs prior to the 5^th, 7^th, and 14^th infusions, and if suggestive symptoms of ARIA develop while being treated with the requested agent [medical record documentation required]; AND
8. ONE of the following:
   1. The patient has had genetic testing performed to determine apolipoprotein E ε4 (ApoE ε4) carrier status (i.e., homozygote, heterozygote, or noncarrier) prior to initiating treatment with the requested agent AND the patient has been informed that those who are homozygotes have a higher incidence of developing ARIA [medical record documentation required]; OR
   2. The patient has NOT had genetic testing performed to determine ApoE ε4 carrier status prior to initiating treatment with the requested agent AND the patient has been informed that it cannot be determined if they are at higher risk for developing ARIA [medical record documentation required]; AND
9. The patient does NOT have a history of cerebrovascular abnormalities or bleeding disorder(s) that would present a risk for ARIA-related bleeding [medical record documentation required]; AND
10. The patient does NOT have a history of stroke, transient ischemic attacks, or seizures within the last 12 months prior to initiating treatment with the requested agent [medical record documentation required]; AND
11. The patient does NOT have a bleeding disorder that is inadequately controlled (e.g., platelet count <50,000 or international normalized ratio [INR] >1.5) [medical record documentation required]; AND
12. The patient does NOT have another neurological or psychiatric condition(s), other than MCI or AD, that is contributing to cognitive impairment (e.g., vascular dementia, Lewy body dementia, cerebrovascular disease, frontotemporal dementia, normal pressure hydrocephalus, Parkinson’s disease, vitamin B12 deficiency, encephalopathy, etc.) [medical record documentation required]; AND
13. If the patient is receiving antithrombotic medication (e.g., aspirin, other antiplatelets, anticoagulants), the patient has been on a stable dose for at least 4 weeks prior to initiating treatment with the requested agent [medical record documentation required]; AND
14. The patient will NOT be using the requested agent in combination with other amyloid beta monoclonal antibodies (mAbs) for Alzheimer’s disease (e.g., donanemab-azbt [Kisunla], aducanumab-avwa [Aduhelm]) [medical record documentation required]; AND
15. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, neuropsychiatrist, gerontologist who specializes in treating dementia) or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]; AND
16. The requested dose is within FDA labeled dosing for the requested indication, and the requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below) [medical record documentation required]; AND
17. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 180 days (6 months)

NOTE: Lecanemab-irmb (Leqembi) is considered experimental or investigational for any other indications due to insufficient clinical evidence to establish safety, efficacy, and improved health outcomes.

Continuation Criteria for Approval:

1. The patient was approved through Blue Cross NC initial criteria for approval; OR
2. The patient would have met initial criteria for approval at the time they started therapy; AND
3. The patient has not experienced any significant side effects from the requested agent (e.g., amyloid related imaging abnormalities-edema [ARIA-E] and -hemosiderin deposition [ARIA-H], intracerebral hemorrhage, severe hypersensitivity reactions) [medical record documentation required]; AND
4. The patient has responded to treatment with the requested agent compared to pre-treatment baseline as demonstrated by improvement, stability, or slowing in cognitive and/or functional impairment in one or more of the following objective measurement tools: ADAS-Cog-13, ADCS-ADL-MCI, MMSE, CDR-SB [medical record documentation required]; AND
5. The patient has NOT progressed to moderate or severe dementia or Alzheimer’s disease [medical record documentation required]; AND
6. The patient continues to be monitored for amyloid-related imaging abnormalities (ARIA)-edema (ARIA-E) and -hemosiderin deposition (ARIA-H) by obtaining periodic MRIs according to FDA labeled dosing [medical record documentation required]; AND
7. The patient will NOT be using the requested agent in combination with other amyloid beta monoclonal antibodies (mAbs) for Alzheimer’s disease (e.g., donanemab-azbt [Kisunla], aducanumab-avwa [Aduhelm]) [medical record documentation required]; AND
8. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, neuropsychiatrist, gerontologist who specializes in treating dementia) or has consulted with a specialist in the area of the patient’s diagnosis [medical record documentation required]; AND
9. The requested dose is within FDA labeled dosing for the requested indication, and the requested quantity does NOT exceed the maximum units allowed for the duration of approval (see table below) [medical record documentation required]; AND
10. For requests for injection or infusion administration of the requested medication in an inpatient or outpatient hospital setting, Site of Care Criteria applies (outlined below)*

Duration of Approval: 180 days (6 months)

NOTE: Lecanemab-irmb (Leqembi) is considered experimental or investigational for any other indications due to insufficient clinical evidence to establish safety, efficacy, and improved health outcomes.

References:

All information referenced is from FDA package insert unless otherwise noted below. 

1. Institute for Clinical and Economic Review. Beta-amyloid antibodies for early Alzheimer’s disease. Draft Evidence Report. December 22, 2022. https://icer.org/wp-content/uploads/2021/12/ICER_Alzheimers-Disease_Draft-Report_12222022.pdf. Accessed January 12, 2023. 
2. Morris JC. The clinical dementia rating (CDR): Current version and scoring rules. Neurology. 1993;43(11):2412-2414.
3. 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.
4. Sperling RA, Jack CR Jr, Black SE, et al. Amyloid-related imaging abnormalities in amyloid-modifying therapeutic trials: recommendations from the Alzheimer's Association Research Roundtable Workgroup. Alzheimers Dement. 2011;7(4):367-385. 
5. Swanson CJ, Zhang Y, Dhadda S, et al. A randomized, double-blind, phase 2b proof-of-concept clinical trial in early Alzheimer's disease with lecanemab, an anti-Abeta protofibril antibody. Alzheimers Res Ther. 2021 Apr 17;13(1):80. Erratum In: Alzheimers Res Ther. 2022 May 21;14(1):70. 
6. Tzeng RC, Yang YW, Hsu KC, et al. Sum of boxes of the clinical dementia rating scale highly predicts conversion or reversion in predementia stages. Front Aging Neurosci. 2022 Sep 23;14:1021792.
7. Van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. N Engl J Med. 2023;388(1):9-21. 

Policy Implementation/Update Information:

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q4 annually.

January 2025: Criteria change: Updated policy to coverage position. Medical policy coverage criteria issued. Clarified maintenance dosing in dosing reference table per updated FDA label.

January 2024: Criteria update: Adjusted FDA approved use section to reflect traditional FDA approval for clarity with no change to policy intent. Added clarification that use is considered investigational for Alzheimer’s disease due to insufficient clinical evidence to establish safety, efficacy, and improved health outcomes.

July 2023: Coding change: Added HCPCS code J0174 to dosing reference table effective 7/6/2023; deleted C9399, J3490, and J3590 termed 7/5/2023.

January 2023: Original medical policy criteria issued: Use of lecanemab-irmb is considered investigational for all indications including treatment of Alzheimer’s disease.