CurrentPremera BluecrossPolicy 5.01.38

Amyloid Antibodies for the Treatment of Alzheimer's Disease

Defines medical necessity coverage criteria, dosing limits, testing and monitoring requirements, and benefit management (medical vs pharmacy) for Kisunla (donanemab-azbt), Leqembi (lecanemab-irmb) IV, and Leqembi Iqlik (lecanemab-irmb) SC in adults with Alzheimer's disease.

Policy Summary

PayerPremera Bluecross

PolicyAmyloid Antibodies for the Treatment of Alzheimer's Disease

Policy CodePolicy 5.01.38

Change TypeAdded Leqembi Iqlikupdated Leqembi dosingadded Kisunlaremoved Aduhelm

Effective DateNov. 1, 2025

Next Review Date

Key ActionInitial and re-authorization reviews for Kisunla, Leqembi, and Leqembi Iqlik are subject to medical necessity review and may be approved for up to 12 months; documentation must meet the policy criteria.

SourceLink

POLICY UPDATE CHANGES

Added coverage criteria for Leqembi Iqlik (lecanemab-irmb).

Updated Leqembi dosing to include once every 4 weeks maintenance after 18 months.

Added coverage criteria for Kisunla (donanemab-azbt).

Removed Aduhelm (aducanumab) from the policy as manufacturer discontinued the product.

3Drugs addressed (Leqembi, Leqembi Iqlik, Kisunla)

4Required biomarkers/tests (CDR/CDR Memory Box/MMSE/MoCA)

12Months for baseline MRI recency

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Maximum approval duration (months)

Coverage Summary

This policy covers the amyloid-targeting monoclonal antibodies Leqembi (lecanemab-irmb) IV, Leqembi Iqlik (lecanemab-irmb) SC, and Kisunla (donanemab-azbt) for adults with early Alzheimer’s disease. Key clinical requirements for medical necessity include documentation of an Alzheimer's diagnosis and staging consistent with mild cognitive impairment or mild dementia (e.g., Global CDR 0.5–1.0, CDR Memory Box ≥ 0.5, MMSE ≥ 22, or MoCA ≥ 17), evidence of brain beta-amyloid deposition by amyloid PET or CSF biomarkers, documented testing for ApoE ε4 and counseling about ARIA risks, and a baseline brain MRI within 12 months prior to initiating treatment. Dosing and maintenance rules differ by product (includes IV dosing and authorized SC conversion/maintenance for Leqembi Iqlik). Kisunla and Leqembi IV are managed through the medical benefit; Leqembi Iqlik is managed through both pharmacy and medical benefits.

High-level threshold highlights

CDR Memory Box>= 0.5

MMSE>= 22

MoCA>= 17

Baseline MRI recencywithin 12 months prior to initiating treatment

Leqembi initial dosing10 mg/kg once every two weeks for 18 months

Leqembi maintenance dosing10 mg/kg once every 2 weeks or 10 mg/kg once every 4 weeks after 18 months

Kisunla maintenance dosing1,400 mg every 4 weeks

Maximum approval durationUp to 12 months per authorization

Kisunla (donanemab-azbt) — Medical Necessity (Initial)

Kisunla (donanemab-azbt) - Medical Necessity (Initial)

Kisunla may be considered medically necessary when ALL the following are met:

ALL of the following

Eligibility: Individual is aged 18 years or older
Diagnosis: Diagnosed with Alzheimer's disease
Cognitive test evidence (ONE of)
- Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0

Leqembi (lecanemab-irmb) IV — Medical Necessity (Initial and Maintenance)

Leqembi (lecanemab-irmb) IV - Medical Necessity (Initial and Maintenance)

Leqembi may be considered medically necessary when ALL the following are met:

ALL of the following

Eligibility: Individual is aged 18 years or older
Diagnosis: Diagnosed with Alzheimer's disease
Cognitive test evidence (ONE of)
- Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0

Leqembi Iqlik (lecanemab-irmb) SC — Medical Necessity (Conversion / Maintenance)

Leqembi Iqlik (lecanemab-irmb) SC - Medical Necessity (Conversion/Maintenance)

Leqembi Iqlik may be considered medically necessary when ALL the following are met:

ALL of the following

Eligibility: Individual is aged 18 years or older
Diagnosis: Diagnosed with Alzheimer's disease
Prior IV therapy: Has received at least 18 months of therapy with intravenous Leqembi (lecanemab-irmb)
Cognitive test evidence (ONE of)

Investigational / Not Covered Uses

Investigational / Not Covered

Uses considered investigational:

Investigational uses

Aduhelm (aducanumab) - removed from policy as manufacturer discontinued product; prior uses considered investigational per history

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Authorization Duration and Re-authorization Criteria

Length of approval and re-authorization:

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Documentation Required

Document cognitive testing and amyloid biomarker evidence

Required documentation prior to initiating therapy and for reviews includes the following elements.

Patient age (≥ 18 years)
Diagnosis of Alzheimer's disease
Cognitive testing results: Global CDR (0.5 or 1.0), CDR Memory Box score (≥ 0.5), MMSE (≥ 22) or MoCA (≥ 17)
Evidence of beta-amyloid deposition: positive amyloid PET OR supportive CSF biomarker testing

Coding

HCPCS codes for product administrationHCPCS

J0174	Injection, lecanemab-irmb (Leqembi), 1 mg
J0175	Injection, donanemab-azbt (Kisunla), 2 mg

Prior Authorization

Prior authorization required

Initial and re-authorization reviews for Kisunla, Leqembi, and Leqembi Iqlik are subject to medical necessity review; authorizations may be granted for up to 12 months and re-authorization requires that drug-specific policy criteria are met.

Referenced HCPCS codes for administration: J0174 and J0175

Provider Actions & Documentation Requirements

Documentation Required

Specialist involvement

Prescription must be by, or in consultation with, a dementia specialist such as a neurologist, geriatric psychiatrist, neuropsychiatrist, or geriatrician; this specialist involvement should be documented in the chart.

Prior Authorization

Prior authorization required

Authorizations (initial and re-authorization) may be approved for up to 12 months. Re-authorization reviews require documentation that the individual continues to meet the drug-specific policy coverage criteria and demonstrates continued clinical benefit.

Affected HCPCS codes: J0174 and J0175

Documentation Required

MRI monitoring for ARIA

Baseline brain MRI must be completed within 12 months prior to initiating treatment. Surveillance MRIs for ARIA should be performed according to the product prescribing information, and ARIA monitoring and any MRI findings must be documented in the medical record.

Background, Evidence Highlights, and Definitions

The evidence base includes the Phase 3 Clarity AD (Leqembi) and TRAILBLAZER-ALZ 2 (Kisunla) trials plus earlier Study 201 for lecanemab. In Clarity AD, Leqembi reduced decline on the primary CDR-SB at 18 months (mean difference -0.45, P<0.0001) and showed a cumulative benefit over three years (CDR-SB difference -0.95 versus a matched natural history cohort). TRAILBLAZER-ALZ 2 showed Kisunla produced statistically significant benefit on the iADRS at Week 76 (combined population 2.92, P<0.0001; low/medium tau 3.25, P<0.0001) with supportive CDR-SB results (-0.70 at Week 76). Study 201 provided dose-finding, biomarker, and longer-term extension data supporting lecanemab's amyloid reduction and informed maintenance dosing strategies.

Key evidence items

Leqembi CDR-SB change at 18 months (Clarity AD)-0.45 (P<0.0001) versus placebo

Leqembi cumulative CDR-SB over 3 years-0.95 versus matched natural history cohort

Kisunla iADRS at Week 762.92 (P<0.0001) combined population; 3.25 (P<0.0001) low/medium tau

Definitions

Revision History

2024-12-10added

Added coverage criteria for Kisunla (donanemab-azbt); interim review approved Dec 10, 2024 with effective date Apr 6, 2025 (90-day provider notification).

2025-04-06effective

Coverage criteria for Kisunla (donanemab-azbt) became effective Apr 6, 2025 per 90-day provider notification following the Dec 10, 2024 interim review.

2025-04-21removed

Removed Aduhelm (aducanumab) from the policy as manufacturer discontinued the product (approved Apr 21, 2025).

Policy Summary

PayerPremera Bluecross

PolicyAmyloid Antibodies for the Treatment of Alzheimer's Disease

Policy CodePolicy 5.01.38

Change TypeAdded Leqembi Iqlikupdated Leqembi dosingadded Kisunlaremoved Aduhelm

Effective DateNov. 1, 2025

Next Review Date

SourceLink

On This Page

CDR Memory Box score of at least 0.5

Mini-Mental Status Examination (MMSE) score of at least 22>= 22

Montreal Cognitive Assessment (MoCA) score of at least 17>= 17

Evidence of beta-amyloid deposition (ONE of)

Positive amyloid positron emission tomography (PET) scan
Cerebrospinal fluid (CSF) biomarker testing documents abnormalities suggestive of beta-amyloid accumulation in the brain

ApoE testing and counseling: Chart notes document testing for ApoE ε4 status and that potential risks have been discussed including risk of ARIA-E and ARIA-H

ApoE ε4 testing required and counseling about ARIA risks documented

MRI recency: Baseline brain magnetic resonance imaging (MRI) completed within 12 months prior to initiating treatment<= 12 months

Exclusions: Does not have cognitive impairment due to other medical conditions (e.g., dementia with Lewy bodies, frontotemporal dementia, vascular dementia, vitamin B12 deficiency, encephalopathy, pseudodementia due to mood disorder, or untreated thyroid disease)

Combination therapy exclusion: Will not be used in combination with other monoclonal antibodies for Alzheimer's disease (e.g., lecanemab)

Prescriber: Prescribed by or in consultation with a specialist in dementia (neurologist, geriatric psychiatrist, neuropsychiatrist, or geriatrician)

Dose limit: Maintenance dose is limited to 1,400 mg every 4 weeks

Dose limit for maintenance therapy

Prior Authorization

Prior authorization required

Initial and re-authorization reviews for Kisunla, Leqembi, and Leqembi Iqlik are subject to medical necessity review and may be approved for up to 12 months. Documentation must meet the policy criteria for initial authorization and re-authorization.

Affected HCPCS codes: J0174 (lecanemab-irmb) and J0175 (donanemab-azbt)

CDR Memory Box score of at least 0.5>= 0.5

Mini-Mental Status Examination (MMSE) score of at least 22>= 22

Montreal Cognitive Assessment (MoCA) score of at least 17>= 17

Evidence of beta-amyloid deposition (ONE of)

Positive amyloid positron emission tomography (PET) scan
Cerebrospinal fluid (CSF) biomarker testing documents abnormalities suggestive of beta-amyloid accumulation in the brain

ApoE testing and counseling: Chart notes document testing for ApoE ε4 status and that potential risks have been discussed including risk of ARIA-E and ARIA-H

ApoE ε4 testing required and counseling about ARIA risks documented

MRI recency: Baseline brain MRI completed within 12 months prior to initiating treatment<= 12 months

Combination therapy exclusion: Will not be used in combination with other monoclonal antibodies for the treatment of Alzheimer's disease (e.g., donanemab)

Prescriber: Prescribed by or in consultation with a specialist in dementia (neurologist, geriatric psychiatrist, neuropsychiatrist, or geriatrician)

Dose/maintenance options

Initial dosing: 10 mg/kg once every two weeks for 18 months
Maintenance dosing: After 18 months, 10 mg/kg once every 2 weeks or 10 mg/kg once every 4 weeks (per Jan 2025 FDA update allowing once every 4 weeks maintenance)

Documentation Required

MRI monitoring for ARIA

A baseline brain MRI must be completed within 12 months prior to initiating treatment. Surveillance MRIs for detection of amyloid related imaging abnormalities (ARIA) should be performed per the product prescribing information and MRI results and ARIA monitoring should be documented in the medical record.

Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0

CDR Memory Box score of at least 0.5>= 0.5

Mini-Mental Status Examination (MMSE) score of at least 22>= 22

Montreal Cognitive Assessment (MoCA) score of at least 17>= 17

Evidence of beta-amyloid deposition (ONE of)

Positive amyloid PET scan
CSF biomarker testing documents abnormalities suggestive of beta-amyloid accumulation in the brain

ApoE testing and counseling: Chart notes document testing for ApoE ε4 status and that potential risks have been discussed including risk of ARIA-E and ARIA-H

MRI recency: Brain MRI completed within the previous 12 months<= 12 months

Combination therapy exclusion: Will not be used in combination with other monoclonal antibodies for the treatment of Alzheimer's disease (e.g., donanemab)

Prescriber: Prescribed by or in consultation with a specialist in dementia (neurologist, geriatric psychiatrist, neuropsychiatrist, or geriatrician)

Billing Rule

Benefit management

Kisunla and Leqembi IV are managed under the medical benefit. Leqembi Iqlik is managed through both the pharmacy and medical benefits.

Affected HCPCS codes: J0174 (lecanemab-irmb) and J0175 (donanemab-azbt)

ApoE ε4 testing performed and counseling documented regarding ARIA-E and ARIA-H risks

Baseline brain MRI completed within 12 months prior to initiating treatment

ARIA-EAmyloid related imaging abnormality with edema

ARIA-HAmyloid related imaging abnormality with hemosiderin deposition (microhemorrhage, superficial siderosis)

ApoE ε4Apolipoprotein E epsilon 4 allele, genetic risk factor for Alzheimer's and ARIA risk modifier

2025-07-07revised

Interim review approved Jul 7, 2025: Updated Leqembi dosing to include once every 4 weeks maintenance after 18 months (reflects Jan 2025 FDA dosing update).

2025-10-14approvedLatest

Approved Oct 14, 2025; effective Nov 1, 2025: Added coverage criteria for Leqembi Iqlik (lecanemab-irmb).