Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Leqembi (lecanemab-irmb) requires prior authorization.

2)    Leqembi is used to treat Alzheimer’s Disease.

3)    Leqembi is covered under the medical benefit.

I.             Initial Approval Criteria

Alzheimer’s Disease (must meet all):

A. Diagnosis of MCI or mild AD dementia;

B. Prescribed by or in consultation with a geriatrician or neurologist;

C. Age >50 and <90 years;

D. Documentation of the presence of beta-amyloid plaques verified by one of the following (1 or 2):

1. Positron emission tomography scan;

2. Cerebrospinal fluid testing;

E. Documentation of one of the following baseline cognitive tests (1 or 2):

       1. Mini-Mental State Examination (MMSE) score > 22;

       2. Montreal Cognitive Assessment (MoCA) score > 16;

F. Documentation of one of the following baseline functional tests and the resulting score (1, 2, or 3):

       1. Functional Assessment Questionnaire (FAQ) score < 9;

       2. Functional Assessment Staging Test (FAST) score of 3-4;

       3. Clinical Dementia Rating-Sum of Boxes (CDR-SB) of 0.5-9;

G. Documentation of recent (within the last year) brain magnetic resonance imaging (MRI) demonstrating all of the following (1-4):

1. Fewer than 4 microhemorrhages (defined as < 10mm at the greatest diameter);

       2. Absence of any macrohemorrhages > 10mm at greatest diameter;

       3. Absence of superficial siderosis;

4. Absence of vasogenic edema, cerebral contusion, encephalomalacia, aneurysms, or vascular malformations;

H. Prescriber attestation that the prescriber has discussed with the member the potentially increased risk of amyloid-related imaging abnormalities (ARIA) in those who are ApoE4 genetic homozygotes and in those who are currently taking, or who may eventually need, concomitant anticoagulant or antithrombotic therapy;

I.             Member has no history of transient ischemic attacks (TIA), stroke, or seizures within the past 12 months;

J. Dose does not exceed 10mg/kg every 2 weeks

Approval Duration: 3 months (6 doses of infusion only)

II. Continued Therapy

A. Alzheimer’s Disease (must meet all):

1. Member is responding positively to therapy as evidenced by slowed decline in cognition;

2. Documentation of one of the following baseline cognitive tests (a or b):\

               a. Mini-Mental State Examination (MMSE) score >22;

               b. Montreal Cognitive Assessment (MoCA) score > 16;

3. Documentation of one of the following baseline functional tests and the resulting score (a, b, or c):

                   a. Functional Assessment Questionnaire (FAQ) score < 9;

                   b. Functional Assessment Staging Test (FAST) score of 3-4;

                   c. Clinical Dementia Rating-Sum of Boxes (CDR-SB) of 0.5-9;

4. Prior to the 7th and 14th infusions, documentation of a recent (within the last month) brain MRI showing all of the following (a, b, and c):

a. Absence of any microhemorrhage (> 10mm at greatest diameter; symptomatic or not);

       b. Fewer than 10 cerebral microhemorrhages cumulatively (symptomatic or not);

            c. Absence of symptomatic cerebral microhemorrhages or symptomatic superficial siderosis;

5. If request is for a dose increase, new dose does not exceed 10mg/kg once very 2 weeks.

Approval duration:

·         Members with < 7 total infusions: up to the 6th total infusion

·         Member with < 14 total infusions but > 7 total infusions: up to the 13th total infusion

·         Member with > 14 total infusions: 12 infusions per PA approval

Codes Used In This BI:

1)    J0174 – Injection, lecanemab-irmb, 1mg

1. Leqembi Prescribing Information. Nutley, NJ: Eisai Inc.; January 2023. Available at: https://www.leqembi.com/-/media/Files/Leqembi/Prescribing-Information.pdf?hash=3d7bf1a2-5db2-4990-8388-81086f415676. Accessed January 10, 2023.

2. Van Dyck CH, Swanson CJ, Aisen P, et al. Lecanemab in early Alzheimer’s disease. NEJM 2023 Jan 5;388(1):9-21.

3. 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-Aβ protofibril antibody. Alz Res Therapy 2021;13(80):1-14.

4. Centers for Medicare & Medicaid Services. Monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. Medicare Coverage Database. CAG099469N; 2022. Available at: https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=Y&NCAId=305. Accessed October 4, 2022.

5. Andrews JS, Desai U, Kirson NY, et al. Disease severity and minimal clinically important differences in clinical outcome assessments for Alzheimer’s disease clinical trials. Alzheimer’s & Dementia 2019 Aug;5:354-63.

6. Trzepacz PT, Hochstetler H, Wang S, et al. Relationship between the Montreal Cognitive Assessment and Mini-Mental State Examination for assessment of mild cognitive impairment in older adults. BMC Geriatrics 2015;15:107.