ModifiedCentenePolicy CP.PHAR.596

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

Clinical coverage policy defining medical necessity criteria, dosing, and authorization rules for lecanemab-irmb (Leqembi, Leqembi Iqlik) for patients with early Alzheimer's disease across Centene lines of business.

Policy Summary

PayerCentene

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

Policy CodePolicy CP.PHAR.596

Change TypeMaterial updates to dosing, formulations, and authorization rules

Effective Date01.06.23

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, amyloid confirmation, baseline and recent cognitive/functional scores, MRI findings, and dosing limits to support approval.

SourceLink

POLICY UPDATE CHANGES

Updated the maintenance dosing regimen to include option for every 4 week dosing after initial 18 months of therapy.

Added SC formulation Leqembi Iqlik and dosing/auth limits for the SC prefilled autoinjector; specified it should not be used concomitantly with Kisunla.

Removed requirement for follow-up MRIs in the Continued Therapy section.

Removed age limit of 50-90 years.

Clarified that neurocognitive testing results used for reauthorization should be recent (within the last month) and follow-up pre-infusion MRIs to be done within the prior week.

Extended initial and continued approval durations to 6 and 12 months respectively for Medicaid/HIM and other LOB-specific reauth changes; added ICHRA LOB.

10 mg/kg q2wMax IV dose

360 mg weeklySC dose

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6 moInitial approval

12 moContinued approval (Medicaid/HIM)

Amyloid confirmationBiomarker

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Approval for Alzheimer's Disease: Member has diagnosis of mild cognitive impairment (MCI) due to Alzheimer disease (AD) or mild AD dementia; prescribed by or in consultation with a geriatrician or neurologist; documentation of beta-amyloid plaques confirmed by PET scan or cerebrospinal fluid (CSF) testing; baseline cognitive testing with MMSE ≥ 22 OR MoCA ≥ 16; baseline functional testing with FAQ ≤ 9 OR FAST score 3–4 OR CDR‑SB 0.5–9; brain MRI within the last year showing fewer than 4 microhemorrhages (≤ 10 mm), no macrohemorrhages > 10 mm, no superficial siderosis, and absence of vasogenic edema, cerebral contusion, encephalomalacia, aneurysm, or vascular malformation; no history of transient ischemic attack (TIA), stroke, or seizures within the past 12 months; not currently taking concomitant anticoagulant or antiplatelet therapy; prescriber attestation that increased ARIA risk in ApoE4 homozygotes was discussed with the member; Leqembi is not prescribed concurrently with Kisunla; dose does not exceed 10 mg/kg every 2 weeks.all criteria

Approval duration: 6 months

Continuation Therapy

Continued therapy covered when ALL of the following are met

Continued Therapy for Alzheimer's Disease: Member currently receiving medication via Centene benefit or previously met initial approval criteria (or enrolled under applicable continuity-of-care rules); member demonstrates positive response to therapy as evidenced by slowed cognitive decline; documentation of recent (within the last month) cognitive testing with MMSE ≥ 22 OR MoCA ≥ 16; documentation of recent (within the last month) functional testing with FAQ ≤ 9 OR FAST score 3–4 OR CDR‑SB 0.5–9; member is not taking concomitant anticoagulant or antiplatelet therapy; Leqembi or Leqembi Iqlik is not prescribed concurrently with Kisunla; any requested dose increase must not exceed IV 10 mg/kg every 2 weeks or SC 360 mg once weekly.all criteria

Approval duration: Medicaid/HIM/ICHRA 12 months; Commercial 6 months or to member renewal date

Covered with criteria

Covered when members meet clinical criteria and authorization requirements per policy (summary of present criteria and operational changes):

Dosing options: Member will receive either IV infusions (10 mg/kg every 2 weeks; after 18 months may continue every 2 weeks or transition to maintenance dosing of 10 mg/kg every 4 weeks) OR SC injections (360 mg weekly).

Maintenance every-4-week option added; maximum dosing limits apply.

Formulation availability: Leqembi is available as 200 mg/2 mL and 500 mg/5 mL vials; Leqembi Iqlik is available as a 360 mg/1.8 mL prefilled autoinjector.

SC formulation (Leqembi Iqlik) should not be used concomitantly with Kisunla.

Safety and contraindications: Concomitant use with anticoagulant or antiplatelet therapy is an exclusion; assess baseline MRI and history of stroke, TIA, and seizures to identify increased ARIA risk; prescriber must attest that ARIA risks (including higher risk in ApoE4 homozygotes) were discussed.

Boxed warnings updated to include ARIA; serious hypersensitivity to lecanemab-irmb or excipients is contraindicated.

Requests for indications that are not FDA‑approved and are not explicitly addressed in this policy are excluded from coverage unless adequate supporting documentation is submitted in accordance with the referenced off‑label use policies (for example, CP.CPA.09 for commercial lines and CP.PMN.53 for Medicaid).

Use of lecanemab-irmb in patients who are receiving concurrent anticoagulant or antiplatelet therapy is an explicit exclusion and may result in denial of coverage. Similarly, the subcutaneous formulation Leqembi Iqlik must not be used concomitantly with Kisunla; requests that indicate both agents will be used together are excluded.

Lecanemab-irmb is contraindicated in patients with a history of serious hypersensitivity to lecanemab-irmb or to any excipients of Leqembi or Leqembi Iqlik. Use in such patients is considered not medically necessary and is excluded from coverage.

Therapy should not be continued for members who have progressed beyond the mild stage of Alzheimer's disease to the moderate stage; neurocognitive and functional testing results must confirm the member remains in the mild stage prior to reauthorization. The policy clarifies that test results used for redetermination should be recent (within the last month) to ensure continued eligibility, and follow-up MRI requirements for continued therapy were modified/removed per later updates.

Provider Actions & Prior Authorization

Prior Authorization

Initial Authorization Requirements

Prior authorization required. Requests must include documentation that all initial approval criteria are met (diagnosis of MCI due to AD or mild AD dementia; specialist prescriber or consultation; demonstration of beta‑amyloid plaques by PET or CSF; baseline cognitive and functional test results meeting score thresholds; recent baseline brain MRI demonstrating MRI safety criteria; no recent TIA/stroke/seizure; prescriber attestation re: ApoE4 ARIA risk; not taking concomitant anticoagulant or antiplatelet therapy; not prescribed concurrently with Kisunla; dose within limits). Approval duration: 6 months for initial approvals.

Baseline cognitive test: MMSE ≥ 22 or MoCA ≥ 16 (Appendix D).
Baseline functional test: FAQ ≤ 9, FAST 3-4, or CDR‑SB 0.5–9.
Baseline brain MRI within last year showing: <4 microhemorrhages (≤10 mm), no macrohemorrhage >10 mm, no superficial siderosis, and no vasogenic edema/contusion/encephalomalacia/aneurysm/vascular malformation.
Member with history of TIA, stroke, or seizure in past 12 months not eligible.
Prescriber attestation required regarding discussion of increased ARIA risk in ApoE4 homozygotes.

Coding & Product Presentations

Product availability (presentation strengths)mixed

200 mg/2 mL	single-dose vial strength
500 mg/5 mL	single-dose vial strength
360 mg/1.8 mL	single-dose prefilled autoinjector strength

Product availability (presentation strengths)mixed

200 mg/2 mL	single-dose vial strength
500 mg/5 mL	single-dose vial strength
360 mg/1.8 mL	single-dose prefilled autoinjector strength

HCPCS CodesHCPCSCovered

J0174

Lecanemab-irmb, 1 mg

Cognitive and functional score thresholds

Cognitive test thresholdsMMSE ≥ 22 OR MoCA ≥ 16 (documented as baseline)

Functional test thresholdsFAQ ≤ 9 OR FAST stage 3–4 OR CDR-SB 0.5–9 (documented as baseline)

Reauthorization testing timingFor continued therapy, cognitive and functional test results must be recent (within 1 month)

MRI microhemorrhage and major vascular lesion thresholds

Microhemorrhage limitFewer than 4 cerebral microhemorrhages (each defined as ≤ 10 mm at greatest diameter)

Macrohemorrhage exclusionNo macrohemorrhages > 10 mm at greatest diameter on baseline MRI

Definitions

ARIA (amyloid-related imaging abnormalities)

DefinitionARIA = amyloid-related imaging abnormalities (imaging findings associated with anti-amyloid therapies)

Risk communicationBoxed warnings updated to include ARIA risk per product labeling and policy updates

Clinical relevanceBaseline MRI and history of stroke/TIA/seizures required to identify patients at increased risk for ARIA

CDR-SB

NameCDR-SB — Clinical Dementia Rating - Sum of Boxes

PurposeA scale assessing six cognitive/functional domains to stage dementia and track impairment over time

Background

Lecanemab-irmb is a monoclonal antibody targeting amyloid beta indicated for treatment of Alzheimer's disease when initiated in patients with mild cognitive impairment due to AD or mild AD dementia. Treatment eligibility requires confirmation of brain amyloid and baseline cognitive and functional assessments consistent with early disease; baseline MRI and a history assessment for stroke, TIA, and seizures are required to identify ARIA risk. The formulation options include IV and the recently FDA‑approved SC prefilled autoinjector, with specific dosing and authorization limits defined in the policy.

Revision History

2023-03-11material_update_added

Updated the maintenance dosing regimen to include option for 10 mg/kg IV every 4 weeks after initial 18 months of therapy per prescribing information and P&T review.

2024-10-25material_update_revised

Removed the age limit of 50–90 years from the policy per P&T approval.

2025-05-01clarification

Clarified Continued Therapy language to remove 'baseline' reference for cognitive and functional tests to prevent continuation in members who progressed to moderate disease.

Policy Summary

PayerCentene

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

Policy CodePolicy CP.PHAR.596

Change TypeMaterial updates to dosing, formulations, and authorization rules

Effective Date01.06.23

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, amyloid confirmation, baseline and recent cognitive/functional scores, MRI findings, and dosing limits to support approval.

SourceLink

On This Page

Authorization documentation and operational changes: Prior authorization must document indication, amyloid confirmation, baseline and recent neurocognitive and functional testing as required, and required imaging/history; prior authorization and adherence to dosing/authorization limits are required. Follow-up pre-infusion MRI and reauthorization timing requirements have been revised or removed in recent updates per policy; initial and continued approval durations have been adjusted for certain lines of business.

Reauth timing and MRI follow-up requirements modified; initial approval duration 6 months and continued approval duration may be 12 months for Medicaid/HIM/ICHRA per update.

Prior Authorization & Approval Durations

Prior authorization required with documentation of indication and adherence to dosing limits. Initial approvals are authorized for 6 months. Continued/renewal approvals require demonstration that the member meets continued therapy criteria (see documentation callout) and are authorized per line of business and policy updates (e.g., Medicaid/HIM: 6 months initial and 12 months continued; Commercial: 6 months or renewal date as specified).

If the product label has changed within the last 6 months and the change is not yet reflected in this policy, follow the referenced formulary/non‑formulary or off‑label policies (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable).
Providers should reference the specific line‑of‑business renewal timing in the policy revision notes.

Denial Risk

Excess Dosing

Requests exceeding maximum dosing limits may be denied. Do not request doses above the specified maximums.

IV infusions: limit 10 mg/kg every 2 weeks.
SC injections (Leqembi Iqlik): limit 360 mg once weekly.

Denial Risk

Concomitant Anticoagulant/Antiplatelet Exclusion

Concomitant use with anticoagulant or antiplatelet therapy is an exclusion and may result in denial. Ensure member is not currently taking these agents before submitting a request.

Document current medication list confirming absence of anticoagulant or antiplatelet therapy.

Denial Risk

Concomitant Kisunla Exclusion

Concomitant use with Kisunla (and Leqembi Iqlik concurrent use with Kisunla) is excluded and may result in denial. Do not prescribe Leqembi or Leqembi Iqlik concurrently with Kisunla.

Document medication list to confirm Kisunla is not being used concurrently.

Documentation Required

Continued Therapy Documentation

For continued therapy prior authorization, submit recent clinical documentation demonstrating positive response and ongoing eligibility. Required documentation must include recent cognitive and functional testing and evidence of clinical benefit.

Evidence member is responding (slowed cognitive decline).
Recent (within the last month) cognitive test: MMSE ≥ 22 or MoCA ≥ 16.
Recent (within the last month) functional test: FAQ ≤ 9, FAST 3-4, or CDR‑SB 0.5–9.
If requesting a dose increase, document new dose does not exceed IV 10 mg/kg q2w or SC 360 mg weekly.

Note

Label‑Change Routing

If the drug label has changed recently (within the last 6 months) and the change is not yet reflected in this policy, route utilization per the referenced formulary/non‑formulary or off‑label policies for the relevant line of business.

Formulary/no‑coverage and non‑formulary policy references provided in policy (see CP.CPA.190, HIM.PA.33, CP.PMN.255, HIM.PA.103).
Off‑label use policies: CP.CPA.09, HIM.PA.154, CP.PMN.53.

Superficial siderosis and major vascular lesionsNo superficial siderosis and absence of vasogenic edema, contusion, encephalomalacia, aneurysm, or vascular malformation on MRI

Used as one of the functional assessment options for baseline and reauthorization (policy uses CDR-SB 0.5–9 to indicate mild stage)

ARIA (policy definition and updates)

AcronymARIA — amyloid-related imaging abnormalities

Policy updateBoxed warnings and labeling updated to include ARIA risk per prescribing information

Programmatic impactBaseline MRI and history required to assess ARIA risk; monitoring and exclusions related to ARIA documented in policy

2025-09-02clarification

Clarified that neurocognitive testing results used for continued-therapy reauthorization should be recent (within the last month) and updated timing for follow-up pre-infusion MRIs per P&T review.

2026-04-13material_update_addedLatest

Added SC formulation Leqembi Iqlik with dosing and authorization limits and explicit exclusion against concomitant use with Kisunla; removed requirement for follow-up MRIs in Continued Therapy; extended initial and continued approval durations (6 and 12 months respectively for Medicaid/HIM) and added ICHRA line of business.