ModifiedPremera BluecrossPolicy N/A

Amyloid Antibodies for the Treatment of Alzheimer's Disease

Clinical/medical coverage policy for use of amyloid beta-directed monoclonal antibodies (donanemab-azbt, lecanemab-irmb) for treatment of adults with Alzheimer's disease, specifying eligibility, dosing limits, required testing, prescribing specialist and benefit pathway.

Policy Summary

PayerPremera Bluecross

PolicyAmyloid Antibodies for the Treatment of Alzheimer's Disease

Policy CodePolicy N/A

Change TypeCriteria added/updateddosing and testing clarified

Effective DateNov. 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document amyloid positivity (PET or CSF), ApoE ε4 testing and baseline brain MRI within 12 months before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

Maintenance dosing option for Leqembi amended to once every four weeks after 18 months of biweekly dosing.

Kisunla (donanemab-azbt) maintenance dose limited to 1,400 mg every 4 weeks.

Requirement for documented presence of beta-amyloid pathology by PET or CSF for treatment eligibility.

Added coverage criteria for Kisunla (donanemab-azbt) for the treatment of Alzheimer's disease.

Updated criteria for Leqembi to include test results that indicate mild cognitive impairment or mild Alzheimer's disease dementia and added requirement for testing for ApoE ε4 status and that potential ARIA risks have been discussed.

Updated Leqembi dosing to include 10 mg/kg once every 4 weeks after 18 months of initial therapy.

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

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

Added coverage criteria for Leqembi (lecanemab-irmb) for the treatment of Alzheimer's disease.

2Products named

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Amyloid-Directed Antibodies

Billing and Coding

HCPCS codesHCPCS

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

Policy HCPCS coding historyHCPCS

J0174	Leqembi (lecanemab) HCPCS code added
J0175	Kisunla (donanemab) HCPCS code added
J0172	Previously used for Aduhelm (removed when Aduhelm discontinued)
J3590	Previously used UNL code for Aduhelm/Leqembi (removed)

Cognitive test thresholds

Global CDR0.5 or 1.0

CDR Memory Box≥0.5

MMSE≥22

MoCA≥17

tau PET low/medium SUVR

tau PET SUVR (low/medium)≥1.10 and ≤1.46

definition contextLow/medium tau population defined by visual assessment and SUVR range above

SUVR reduction (Leqembi efficacy)

Leqembi Week 79 SUVR changeMean difference −0.31 SUVR (−73.5 Centiloids) vs placebo

Dose/regimenLeqembi 10 mg/kg biweekly (study arm showing SUVR reduction)

Provider Actions, Authorization, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Leqembi (lecanemab-irmb) and Kisunla (donanemab-azbt). Initial and reauthorization approvals may be issued for up to 12 months. Providers must submit a PA request prior to initiation of therapy and ensure dosing consistent with the product FDA labeling and this policy.

Prior authorization required for Leqembi and Kisunla
Initial and reauthorization approvals may be up to 12 months (see Length of Approval)
Ensure dosing follows FDA prescribing information and policy limits (e.g., maintenance 1,400 mg q4w for Kisunla; Leqembi dosing per label)

Step Therapy

No specific step-therapy sequence is specified within this policy. Approvals are limited to uses, doses, and durations consistent with FDA indications and the policy's coverage criteria.

Definitions and Clinical Staging

ARIA — definitions and imaging findings

ARIA-EAmyloid‑related imaging abnormality with edema/effusion (edema) observed on MRI

ARIA-HAmyloid‑related imaging abnormality with hemosiderin deposition/hemorrhage including microhemorrhages and superficial siderosis

Clinical relevanceAssociated with anti-amyloid antibody therapies; requires counseling and MRI monitoring

NIA‑AA numeric clinical staging (selected stages)

Stage 1Pre-clinical; performance within expected range on objective cognitive tests

Stage 3MCI due to Alzheimer's disease; impaired performance on objective tests with mild functional impact

Background and Evidence Summary

Alzheimer's disease is a progressive neurodegenerative disorder characterized by extracellular beta-amyloid plaques and intracellular tau neurofibrillary tangles, leading to progressive decline in memory, language, and other cognitive functions. Pathophysiologic changes begin years to decades before clinical symptoms emerge, and staging schemes such as the NIA-AA numeric clinical staging describe progression from preclinical biomarker changes through mild cognitive impairment and mild dementia.

Amyloid-directed monoclonal antibodies target aggregated beta-amyloid in the brain with the goal of reducing amyloid burden and slowing clinical decline. Confirmation of amyloid pathology with validated testing (for example, amyloid PET or cerebrospinal fluid biomarkers) is required to identify patients most likely to benefit and is a prerequisite for treatment under this policy.

Because amyloid-targeting therapies are associated with imaging findings termed amyloid-related imaging abnormalities (ARIA)—including ARIA-E (edema/effusion) and ARIA-H (microhemorrhage and superficial siderosis)—patients should be counseled about ARIA risk, undergo baseline MRI within 12 months prior to initiation, and have appropriate MRI monitoring during treatment as clinically indicated.

Policy Revision History

08/01/2023coding update

Added HCPCS code J0174 for Leqembi and removed UNL code J3590 previously used to report Leqembi.

05/01/2024policy addition

Annual review approved April 9, 2024; added coverage criteria for Leqembi (lecanemab-irmb) for treatment of Alzheimer's disease.

01/01/2025interim review

Interim review approved December 10, 2024; added coverage criteria for Kisunla (donanemab-azbt), added HCPCS code J0175 for Kisunla, and updated Leqembi criteria to require ApoE ε4 testing and discussion of ARIA risks; criteria effective April 6, 2025 after 90-day provider notification.

Policy Summary

PayerPremera Bluecross

PolicyAmyloid Antibodies for the Treatment of Alzheimer's Disease

Policy CodePolicy N/A

Change TypeCriteria added/updateddosing and testing clarified

Effective DateNov. 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization and document amyloid positivity (PET or CSF), ApoE ε4 testing and baseline brain MRI within 12 months before initiating therapy.

SourceLink

On This Page

Documentation Required

Required Diagnostic Documentation

Providers must document patient's age, clinical diagnosis of Alzheimer’s disease, cognitive testing results consistent with MCI or mild dementia (eg, CDR 0.5–1.0, CDR Memory Box ≥0.5, MMSE ≥22, or MoCA ≥17), and evidence of amyloid pathology (positive amyloid PET or CSF biomarkers). A baseline brain MRI performed within 12 months prior to treatment start must be included.

Age ≥18 documented
Diagnosis of Alzheimer's disease documented
Cognitive test results (CDR, CDR Memory Box, MMSE, or MoCA)
Positive amyloid biomarker: amyloid PET or CSF biomarker report
Baseline brain MRI within 12 months prior to treatment initiation

Documentation Required

ApoE ε4 Testing and ARIA Counseling Documentation

For donanemab (Kisunla) and lecanemab (Leqembi), chart notes must document ApoE ε4 testing prior to initiation and that the patient (or decisionmaker) was counseled about ARIA risks (ARIA-E and ARIA-H), monitoring plans, and implications for concurrent antithrombotic therapy. For Kisunla specifically, ApoE ε4 status is used to inform ARIA risk during treatment.

Document ApoE ε4 test result in chart prior to starting Kisunla or Leqembi
Document that ARIA risks (ARIA‑E and ARIA‑H), symptoms, MRI monitoring schedule, and anticoagulant/antithrombotic considerations were discussed
Include counseling note in medical record before treatment initiation

Note

Amyloid‑PET–Guided Continuation and Reauthorization

Continuation or reauthorization decisions may incorporate amyloid-PET results and trial-based PET-guided stopping/continuation rules (e.g., percentages of participants eligible for switch based on PET at Weeks 24, 52, 76 in Kisunla trials). Operationally, providers should submit interval clinical response documentation and MRI findings (when warranted) with PA renewal requests.

Amyloid-PET–guided stopping/continuation data may inform treatment duration decisions (trial data reported at Weeks 24, 52, 76)
Submit documentation of continued clinical benefit for reauthorization
Include interval MRI results when ARIA monitoring indicated

Denial Risk

Triggers for Denial and Risk‑Based Exclusions

Denials may be issued if required eligibility elements or safety criteria are not met. Common denial triggers include lack of documented amyloid pathology, patient age below policy threshold, cognitive testing not meeting MCI/mild dementia thresholds, documented contraindicating safety risks (eg, prior intracerebral hemorrhage >1 cm, >4 microhemorrhages, superficial siderosis), or missing required testing/counseling documentation.

No documented positive amyloid PET or CSF biomarker — potential denial
Age <18 — potential denial
Cognitive test scores below policy thresholds — potential denial
Baseline MRI absent or safety-risk MRI findings (prior hemorrhage >1 cm, >4 microhemorrhages, superficial siderosis) — potential denial
Missing documentation of ApoE ε4 testing or ARIA counseling — potential denial