ModifiedBaylor Scott & White Health PlanPolicy 301

Lecanemab-irmb (Leqembi) Coverage

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This policy governs prior authorization and medical-necessity coverage for lecanemab-irmb used to treat Alzheimer’s disease across lines of business, subject to applicable benefit plan, federal, and state requirements.

Policy Summary

PayerBaylor Scott & White Health Plan

PolicyLecanemab-irmb (Leqembi) Coverage

Policy CodePolicy 301

Change TypeModified

Effective DateSeptember 1, 2026

Last ReviewAug 27, 2026

Next Review DateAugust 27, 2027

Key ActionPrior authorization is required for lecanemab treatment.

SourceLink

POLICY UPDATE CHANGES

Renewal authorization MRI requirements were updated to align with prescribing information.

Authorization duration is twelve months.

12 monthsAuthorization duration

50–90Eligible age range

4 MRIsRenewal MRI monitoring

Not coveredOther indications

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ModifiedBaylor Scott & White Health PlanPolicy 301

Lecanemab-irmb (Leqembi) Coverage

Customize your policy alerts

Sign up for baylor_scott_and_white_health_plan Policy 301 alerts

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Policy Summary

PayerBaylor Scott & White Health Plan

PolicyLecanemab-irmb (Leqembi) Coverage

Policy CodePolicy 301

Change TypeModified

Effective DateSeptember 1, 2026

Last ReviewAug 27, 2026

Next Review DateAugust 27, 2027

Key ActionPrior authorization is required for lecanemab treatment.

SourceLink

POLICY UPDATE CHANGES

Renewal authorization MRI requirements were updated to align with prescribing information.

Authorization duration is twelve months.

12 monthsAuthorization duration

50–90Eligible age range

4 MRIsRenewal MRI monitoring

Not coveredOther indications

Coverage Criteria

Initial Therapy

Covered when ALL of the following initial-therapy criteria are met.

Initial therapy

Disease stage and confirmation
- Qualifying cognitive test
  - MMSE score is 21–30.21–30
  - CDR-GS score is 0.5 or 1.0.5 or 1
  - MoCA score is at least 16.≥16
- Confirmed amyloid pathology
  - Amyloid PET confirms amyloid pathology consistent with Alzheimer’s disease.
  - Lumbar-puncture CSF assay results are consistent with Alzheimer’s disease; biomarkers may include Aβ42, P-tau, T-tau, and the ATI index.
Required treatment and safety conditions
- Baseline MRI and clinical exclusions absent: A baseline MRI obtained within 1 year does not show more than four microhemorrhages, a single microhemorrhage greater than 10 mm, superficial siderosis, vasogenic edema, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, infection lesion, multiple lacunar infarcts, major-territory stroke, severe small-vessel or white-matter disease, space-occupying lesion, or disqualifying brain tumor. Meningiomas or arachnoid cysts under 10 mm at greatest diameter are not exclusionary.
- Other exclusions absent: The member has no other medical or neurologic condition contributing to cognitive impairment, seizure, stroke, or TIA within the past 12 months; no history of cerebrovascular abnormalities; and no inadequately controlled bleeding disorder, including platelet count below 50,000 or INR above 1.5 when not on warfarin.
- No concurrent amyloid antibody: Lecanemab will not be used in combination with another amyloid beta-directed antibody.

Continuation/Renewal Therapy

Renewal is covered when ALL of the following criteria are met.

Continuation/Renewal therapy

Required MRI monitoring: MRI is conducted and documentation is submitted before infusions 3, 5, 7, and 14 to monitor for amyloid-related imaging abnormalities.
Renewal exclusions absent: The member has not started a medication that increases ARIA risk without documented ARIA-risk discussion and a monitoring plan; has not missed more than two consecutive doses or more than two doses in a six-month period; has no other medical or neurologic condition contributing to cognitive impairment; has had no seizure, stroke, or TIA within the past 12 months; has no history of cerebrovascular abnormalities; and has no inadequately controlled bleeding disorder.
Cognitive stability
- MMSE is greater than 20.>20

Other Indications

All other indications are not covered under this policy.

Experimental and investigational indications: Lecanemab used for indications other than the covered early Alzheimer’s disease population is considered experimental and investigational because effectiveness has not been established.

Initial coverage is not available when the baseline MRI, obtained within 1 year, shows more than four microhemorrhages, a single microhemorrhage greater than 10 mm, superficial siderosis, vasogenic edema, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, infection lesions, multiple lacunar infarcts, major-territory stroke, severe small-vessel or white-matter disease, space-occupying lesions, or brain tumors. Meningiomas or arachnoid cysts smaller than 10 mm at greatest diameter are not exclusionary.

Initial therapy also requires specialist exclusion of other medical or neurologic conditions that could contribute to cognitive impairment, including conditions that may mimic Alzheimer’s disease. Coverage is excluded for seizures, stroke, or transient ischemic attack within the past 12 months; a history of cerebrovascular abnormalities; or an inadequately controlled bleeding disorder, including platelet count below 50,000 or INR above 1.5 in patients not taking warfarin. Lecanemab must be administered according to FDA-approved labeling and may not be used with another amyloid beta-directed antibody.

For renewal, coverage requires documentation that no new medication increasing ARIA risk—such as tissue plasminogen activator, an antiplatelet, or an anticoagulant—was started without a documented discussion of ARIA risk and a monitoring plan. Renewal may also be denied when more than two consecutive doses or more than two doses within a 6-month period were missed, when another medical or neurologic condition contributes to cognitive impairment, or when there has been a seizure, stroke, or TIA within 12 months, a cerebrovascular abnormality, or an inadequately controlled bleeding disorder.

Lecanemab used for indications other than the covered population with early Alzheimer’s disease is considered experimental and investigational because the effectiveness of those uses has not been established under this policy.

Initial Therapy

Initial requests require ALL criteria to be met.

Initial lecanemab therapy

Qualifying disease stage
- Qualifying cognitive testing
  - MMSE score is 21–30.21–30
  - CDR-GS score is 0.5 or 1.0.5 or 1
  - MoCA score is at least 16.≥16
- Amyloid confirmation
  - Amyloid PET confirms amyloid pathology consistent with Alzheimer’s disease.
  - Lumbar-puncture CSF assay results are consistent with Alzheimer’s disease.
    CSF biomarkers may include Aβ42, P-tau, T-tau, and the ATI index.
Safety and administration requirements
- Baseline MRI requirements: A baseline MRI within 1 year shows no more than four microhemorrhages, no single microhemorrhage greater than 10 mm, no superficial siderosis, vasogenic edema, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, infection lesion, multiple lacunar infarcts, major-territory stroke, severe small-vessel or white-matter disease, space-occupying lesion, or disqualifying brain tumor.
- Clinical and laboratory exclusions absent: There is no contributing non-Alzheimer medical or neurologic condition, seizure, stroke, or TIA within the past 12 months; no history of cerebrovascular abnormalities; and no inadequately controlled bleeding disorder, including platelet count below 50,000 or INR above 1.5 when not on warfarin.

Step	Therapy	Requirement	Stable duration
1	Alzheimer’s symptomatic treatment (e.g., donepezil, rivastigmine, galantamine, or memantine)	The member must be taking the therapy at a stable dose before lecanemab administration.	12 weeks

Step	Therapy	Requirement	Stable duration
2	Anticoagulant therapy (e.g., enoxaparin, warfarin, Eliquis, Pradaxa, or Xarelto)	The member must be taking the therapy at a stable dose before lecanemab administration.	4 weeks

Codes and Clinical Thresholds

HCPCS CodesHCPCS

J0174

Injection, lecanemab-irmb, 1 mg

ICD-10 CodesICD-10

Z00.6	Encounter for examination for normal comparison and control in clinical research program
G30.0	Alzheimer's disease w/early onset
G30.1	Alzheimer's disease w/late onset
G30.8	Other Alzheimer's disease
G30.9	Alzheimer's disease, unspecified
G31.84	Mild cognitive impairment, so stated

MMSE

Initial-therapy rangeMMSE score 21–30

Renewal progression thresholdMMSE score 20 or lower indicates progression beyond the renewal threshold

Renewal requirementThe same cognitive tests used for initial approval must show cognition has not worsened to moderate or advanced disease

CDR-GS

Initial-therapy rangeCDR-GS score 0.5 or 1

Renewal progression thresholdCDR-GS score greater than 1 indicates progression beyond the renewal threshold

Renewal requirementThe same cognitive tests used for initial approval must show cognition has not worsened to moderate or advanced disease

MoCA

Initial-therapy thresholdMoCA score ≥16

Renewal progression thresholdMoCA score <16 indicates progression beyond the renewal threshold

Renewal requirementThe same cognitive tests used for initial approval must show cognition has not worsened to moderate or advanced disease

Baseline MRI microhemorrhages

Maximum numberNo more than four microhemorrhages

Maximum individual sizeNo single microhemorrhage may be greater than 10 mm at greatest diameter

Baseline MRI requirementA baseline MRI obtained within 1 year must not show disqualifying microhemorrhages

Bleeding-risk laboratory thresholds

Platelet countMust not be below 50,000

INRMust not be above 1.5 for patients not on warfarin

Clinical requirementBleeding disorders must be under adequate control

Authorization and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for lecanemab-irmb (Leqembi®). Submit documentation supporting the initial-treatment criteria and the member’s eligibility before administration.

Include the diagnosis, prescriber or specialist consultation, age, disease stage, cognitive testing, and amyloid-confirmation results.
Lecanemab must be dosed and administered according to FDA-approved labeling.

Documentation Required

Initial Diagnosis and Disease-Stage Documentation

For an initial request, document Alzheimer’s disease and that the medication is prescribed by or in consultation with a neurologist, geriatric psychiatrist, or geriatrician. The member must be 50–90 years old and have mild cognitive impairment due to Alzheimer’s disease or mild dementia-stage Alzheimer’s disease.

Submit at least one qualifying cognitive test score: MMSE 21–30, CDR-GS 0.5 or 1, or MoCA ≥16.
Confirm amyloid beta deposits consistent with Alzheimer’s disease using amyloid PET or lumbar-puncture CSF assay results; submit the imaging results or diagnostic immunoassay, including applicable Aβ42, P-tau, T-tau, or ATI results.

Documentation Required

Initial Safety and Treatment Documentation

Before treatment, document that the specialist has excluded other conditions or causative factors that could explain the cognitive impairment. Submit evidence that required therapies are stable and that ARIA risks and treatment safety have been addressed.

If used, AD symptomatic treatment such as donepezil, rivastigmine, galantamine, or memantine must be stable for 12 weeks.
If used, anticoagulant therapy such as enoxaparin, warfarin, Eliquis, Pradaxa, or Xarelto must be stable for 4 weeks.
Apolipoprotein E ε4 genetic testing must be performed to assess ARIA risk; document discussion of ARIA risks with the member or caregiver.
Document FDA-label dosing and administration.

Documentation Required

Renewal MRI Monitoring Required

For renewal requests, submit MRI documentation obtained before the 3rd, 5th, 7th, and 14th infusions to monitor for amyloid-related imaging abnormalities (ARIA), including brain swelling and bleeding.

Submit the required MRI monitoring documentation with each applicable renewal.
Continue to document that renewal eligibility requirements are met and that cognition has not progressed to moderate or advanced disease.

Denial Risk

Disqualifying Baseline Clinical or MRI Findings

Initial treatment is not eligible when baseline clinical or MRI findings create an unacceptable safety risk or indicate another cause of cognitive impairment.

Baseline MRI within 1 year must not show more than four microhemorrhages, a single microhemorrhage >10 mm, superficial siderosis, vasogenic edema, cerebral contusion, encephalomalacia, aneurysm, vascular malformation, infection lesion, multiple lacunar infarcts, major-territory stroke, severe small-vessel or white-matter disease, space-occupying lesion, or brain tumor. Meningiomas or arachnoid cysts <10 mm are not exclusionary.
The member must not have another medical or neurological cause of cognitive impairment, seizures, stroke, or TIA within the past 12 months, or a history of cerebrovascular abnormalities.
Bleeding disorders must be adequately controlled; examples of disqualifying values include platelet count <50,000 or INR >1.5 in patients not taking warfarin.

Denial Risk

Concurrent Amyloid Antibody Therapy

Do not use lecanemab in combination with another amyloid beta-directed antibody, such as aducanumab. Concurrent amyloid antibody therapy may result in denial.

Confirm that the member is not receiving another amyloid beta-directed antibody.

Denial Risk

Renewal Eligibility Failures

Renewal may be denied when treatment adherence, medication changes, safety status, or disease stage no longer meet coverage requirements.

Deny or do not renew when the member has started medications that increase ARIA risk, including tPA, antiplatelets, or anticoagulants, without documented discussion of ARIA risk and a monitoring plan.
Deny or do not renew after more than two consecutive missed doses or more than two missed doses in a 6-month period.
The member must not develop another condition contributing to cognitive impairment, seizures, stroke or TIA within the past 12 months, a cerebrovascular abnormality, or an inadequately controlled bleeding disorder.
Submit the same cognitive tests used for initial approval. Renewal documentation must not show progression to moderate or advanced disease: MMSE ≤20, CDR-GS >1, or MoCA <16.
Document manageable or absent side effects.

Denial Risk

Uncovered Indications

BSWHP considers lecanemab treatment for indications other than the covered Alzheimer’s disease criteria to be experimental and investigational because effectiveness has not been established.

Other indications are not covered under this policy.

Lecanemab-irmb (Leqembi) Coverage

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Lecanemab-irmb (Leqembi) Coverage

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Coverage Criteria

Initial Therapy

Renewal Therapy

Required Treatment Stability

Codes and Clinical Thresholds

Authorization and Documentation Requirements

Disease and Treatment Context

Key Definitions