Clinical Policy: Lecanemab-irmb (Leqembi, Leqembi Iqlik)

Reference Number: CP.PHAR.596
Effective Date: 01.06.23
Last Review Date: 05.26
Line of Business: Commercial, HIM/ICHRA, Medicaid

[Coding Implications](Coding Implications)
[Revision Log](Revision Log)

See [Important Reminder](Important Reminder) at the end of this policy for important regulatory and legal information.

Description

Lecanemab-irmb (Leqembi®, Leqembi Iqlik™) is a monoclonal antibody targeting amyloid beta.

FDA Approved Indication(s)

Leqembi and Leqembi Iqlik are indicated for the treatment of Alzheimer’s disease (AD). Treatment with Leqembi and Leqembi Iqlik should be initiated in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

Policy/Criteria

Approval duration: 6 months

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.

II. Continued Therapy

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

a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria;
b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B;

2. Member is responding positively to therapy as evidenced by slowed decline in cognition;
3. Documentation of recent (within the last month) results of one of the following cognitive tests (a or b; see Appendix D):
   a. MMSE score ≥ 22;
   b. MoCA score ≥ 16;
4. Documentation of recent (within the last month) results of one of the following functional tests and the resulting score (a, b, or c):
   a. FAQ score ≤ 9;
   b. FAST score of 3-4;
   c. CDR-SB of 0.5-9;
5. Member is not currently taking concomitant anticoagulant or antiplatelet therapy;
6. Leqembi or Leqembi Iqlik is not prescribed concurrently with Kisunla;
7. If request is for a dose increase, new dose does not exceed any of the following (a or b):
   a. IV infusions: 10 mg/kg once every 2 weeks;
   b. SC injections: 360 mg once weekly.

Approval duration:

• Medicaid/HIM/ICHRA – 12 months
• Commercial – 6 months or to the member’s renewal date, whichever is longer

B. Other diagnoses/indications (must meet 1 or 2):

1. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b):
   a. For drugs on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace/ICHRA, and CP.PMN.255 for Medicaid; or
   b. For drugs NOT on the formulary (commercial, health insurance marketplace/ICHRA) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace/ICHRA, and CP.PMN.16 for Medicaid; or
2. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 2 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid.

III. Diagnoses/Indications for which coverage is NOT authorized:

A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace/ICHRA, and CP.PMN.53 for Medicaid, or evidence of coverage documents.

IV. Appendices/General Information

Appendix A: Abbreviation/Acronym Key

• AD: Alzheimer’s disease
• ARIA: amyloid-related imaging abnormalities
• CDR-SB: Clinical Dementia Rating-Sum of Boxes
• FAQ: Functional Assessment Questionnaire
• FAST: Functional Assessment Staging Test
• FDA: Food and Drug Administration
• IADL: instrumental activity of daily living
• MCI: mild cognitive impairment
• MMSE: Mini-Mental State Examination
• MRI: magnetic resonance imaging
• TIA: transient ischemic attack

Appendix B: Therapeutic Alternatives

Not applicable

Appendix C: Contraindications/Boxed Warnings

• Contraindication(s): serious hypersensitivity to lecanemab-irmb or to any of the excipients of Leqembi or Leqembi Iqlik
• Boxed Warning(s): increased risk of ARIA

Appendix D: Dementia Rating Scales

• MoCA is a highly sensitive tool for early detection of MCI and has been widely adopted in clinical settings. The maximum score is 30 points. The following ranges may be used to grade severity: 18-25 = mild cognitive impairment, 10-17 = moderate cognitive impairment and < 10 = severe cognitive impairment. However, research for these severity ranges has not been established yet. The average MoCA score for MCI is 22 (range 19-25) and the average MoCA score for Mild AD is 16 (range 11-21).
• MMSE is a series of questions asked by a health professional designed to test a range of everyday mental skills. The maximum score is 30 points where the following levels of dementia are indicated with a score of:
  
  • 25 to 30 suggests normal cognition,
  • 21 to 24 suggests mild dementia,
  • 13 to 20 suggests moderate dementia, and
  • less than 12 indicates severe dementia.
  • On average, the MMSE score of a person with Alzheimer’s declines about two to four points each year.
• The FAQ measures instrumental activities of daily living (IADLs), such as preparing balanced meals and managing personal finances. Since functional changes are noted earlier in the dementia process with IADLs that require a higher cognitive ability compared to basic activities of daily living, this tool is useful to monitor these functional changes over time. The score range is 0-30. A cut-point of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment.
• FAST is a measure commonly used to assess functional status in patients with dementia. It provides a comprehensive evaluation of functional ability and the potential for a functional decline over time, including physical functional abilities (dressing and grooming), functional language abilities (memory and recognition), and functional activities such as mobility or self-feeding. The FAST score ranges from 1 to 7, categorizing the stages of AD into one of the below:
  
  • 1: normal aging
  • 2: possible mild cognitive impairment
  • 3: mild cognitive impairment
  • 4: mild dementia
  • 5: moderate dementia
  • 6: moderately severe dementia
  • 7: severe dementia
• CDR-SB assessment is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to Alzheimer’s disease and related dementias: memory, orientation, judgment, and problem solving, community affairs, home and hobbies, and personal care. The information is obtained through an interview of the patient and a reliable informant (e.g., family member). This score is useful for characterizing and tracking a patient’s level of impairment/dementia.
  
  • 0 suggests normal
  • 0.5 to 4 suggests questionable cognitive impairment
  • 0.5 to 2.5 suggests questionable impairment
  • 3.0 to 4.0 suggests very mild dementia
  • 4.5 to 9.0 suggests mild dementia
  • 9.5 to 15.5 suggests moderate dementia
  • 16.0 to 18.0 suggests severe dementia

Appendix E: Diagnosis of Alzheimer’s Disease

• AD
  
  • Interference with ability to function at work or at usual activities
  • A decline from a previous level of functioning and performing
  • Not explained by delirium or major psychiatric disorder
  • Cognitive impairment established by history-taking from the patient and a knowledgeable informant; and objective bedside mental status examination or neuropsychological testing
  • Cognitive impairment involves a minimum of two of the following domains:
    
    • Impaired ability to acquire and remember new information
    • Impaired reasoning and handling of complex tasks, poor judgment
    • Impaired visuospatial abilities
    • Impaired language functions (speaking, reading, writing)
    • Changes in personality, behavior, or comportment
  • Insidious onset (gradual onset over months to years, not over hours to days)
  • Clear-cut history of worsening
  • Initial and most prominent cognitive deficits are one of the following:
    
    • Amnestic presentation (impairment in learning and recall of recently learned information)
    • Nonamnestic presentation in either a language presentation (prominently word-finding deficits), a visuospatial presentation with visual deficits, or executive dysfunction (prominently impaired reasoning, judgment and/or problem solving)
  • No evidence of substantial concomitant cerebrovascular disease, core features of dementia with Lewy bodies (DLB), prominent features of behavioral variant frontotemporal dementia (FTD) or prominent features of semantic or nonfluent/agrammatic variants of primary progressive aphasia (PPA), or evidence of another concurrent, active neurologic or non-neurologic disease or use of medication that could have a substantial effect on cognition
• MCI due to AD – core clinical criteria
  
  • Concern regarding change in cognition obtained from the patient, from an informant who knows the patient well, or from a skilled clinician observing the patient
  • Objective evidence of impairment in one or more cognitive domains that is not explained by age or education
  • Preservation of independence in functional abilities
  • Not demented
• Although tests for blood-based biomarkers are now available to aid in diagnosing Alzheimer’s disease, their proper use in clinical practice is unestablished. They are not currently able to fully replace the need for confirmatory testing with positron emission tomography scan or cerebrospinal fluid testing, and as such, their ability to determine eligibility for treatment with Leqembi is unconfirmed.

V. Dosage and Administration

VI. Product Availability

Coding Implications

Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services.

Reviews, Revisions, and Approvals

Important Reminder