ModifiedPremera BluecrossPolicy 5.01.38

Amyloid antibody therapy for Alzheimer's disease

This policy governs medical necessity criteria, documentation, coding, and approval duration for the amyloid‑directed monoclonal antibodies donanemab (Kisunla) and lecanemab (Leqembi) in adults with Alzheimer’s disease for Premera Blue Cross.

Policy Summary

PayerPremera Bluecross

PolicyAmyloid antibody therapy for Alzheimer's disease

Policy CodePolicy 5.01.38

Change TypeMaterial coverage updates (added Kisunla, revised Leqembi dosing and testing requirements)

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization and document amyloid biomarker evidence, ApoE ε4 testing and ARIA risk discussion before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

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

Updated coverage criteria for Leqembi to include test results indicating mild cognitive impairment or mild Alzheimer's disease dementia and requirement for ApoE e4 testing and discussion of ARIA risks.

Added dosing option of 10 mg/kg once every four weeks after 18 months of initial biweekly Leqembi therapy.

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

2FDA-approved products discussed

12 monthsInitial/reauthorization window

J0174, J0175Covered HCPCS codes

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Within 12 moBaseline MRI required

55%ARIA incidence (ApoE e4 homozygotes)

Coverage Criteria for Amyloid Antibody Therapy

Authorization duration and reauthorization

Authorization duration and reauthorization:

ALL of the following

Initial authorization duration: authorization may be granted for up to 18 months to allow completion of the initial dosing phase and assessment period (consistent with clinical trial and FDA guidance timeframes).
Request should include baseline cognitive testing, biomarker documentation, ApoE testing documentation, and baseline MRI.
Reauthorization (continuation) criteria: after the initial authorization period, reauthorization may be approved for maintenance dosing (per product labeling) when ALL of the following are documented: clinical benefit or lack of rapid progression compared with baseline as assessed by treating clinician; ongoing evidence of adherence to monitoring for ARIA (including interval MRIs as recommended by product labeling); continued absence of contraindicating medical conditions; and documentation that risks and benefits were reviewed with the patient/caregiver.
Reauthorization duration: reauthorizations may be approved for up to 12 months at a time for maintenance dosing; frequency of renewal should align with clinical monitoring intervals and documentation updates.
Discontinuation criteria: consider stopping therapy and not authorizing further treatment if there is documented clinical decline attributable to causes other than expected disease progression, serious ARIA or other severe adverse events related to therapy, or if required monitoring is not performed.

Coding and Diagnostic Thresholds

Covered HCPCS CodesHCPCSCovered

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

HCPCS codes referencedHCPCS

J0174	HCPCS code previously added for Leqembi
J0175	HCPCS code added for Kisunla
J0172	HCPCS code (historical) added/removed for Aduhelm or related updates

Cognitive test cutoffs — CDR, CDR Memory Box, MMSE, MoCA

Global CDRScore of 0.5 or 1.0

CDR Memory BoxScore ≥ 0.5

MMSEScore ≥ 22

MoCAScore ≥ 17

Baseline MRI timing

Required imagingBaseline brain MRI must be completed within 12 months prior to initiating treatment

PurposeEstablish pre‑treatment status and for subsequent ARIA monitoring

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kisunla (donanemab-azbt) and Leqembi (lecanemab-irmb). Initial authorizations and non-formulary exception approvals may be granted for up to 12 months. Re-authorization may be approved for up to 12 months when product-specific coverage criteria continue to be met, medical records document continued positive clinical response, and follow-up brain MRI is performed as warranted to evaluate for ARIA.

Prior authorization required for Kisunla and Leqembi
Initial and re-authorization windows: up to 12 months

Step Therapy

Concurrent Therapy Restriction

Do not administer Kisunla and Leqembi concurrently. Requests to combine these agents or to use either agent together with other monoclonal antibodies for Alzheimer’s disease will not meet coverage and are subject to denial.

Avoid concurrent therapy: Kisunla + Leqembi
Avoid combining with other monoclonal antibodies for AD

Background and Clinical Context

Alzheimer disease is a progressive neurodegenerative disorder characterized pathologically by extracellular beta‑amyloid plaques and intracellular neurofibrillary tau tangles that lead to progressive cognitive decline. Amyloid‑directed monoclonal antibodies such as donanemab (Kisunla) and lecanemab (Leqembi) target beta‑amyloid pathology and are intended for adults with early disease (mild cognitive impairment due to AD or mild AD dementia) with biomarker confirmation of amyloid deposition. Because these agents carry risks of amyloid‑related imaging abnormalities (ARIA‑E and ARIA‑H), policy coverage requires biomarker confirmation of amyloid, baseline brain MRI within 12 months prior to treatment, specialist involvement, and documentation of ApoE testing and discussion of ARIA risks where specified to ensure appropriate patient selection and monitoring.

Definitions and Key Terms

Biomarker confirmation of amyloid

Positive amyloid PETEvidence of beta‑amyloid deposition on amyloid PET scan qualifies as biomarker confirmation

CSF testingCerebrospinal fluid biomarker testing showing abnormalities suggestive of beta‑amyloid accumulation also qualifies

Requirement contextBiomarker confirmation is required for coverage of Kisunla and Leqembi

Appropriate disease stage — MCI or mild AD dementia

Acceptable stagesMild cognitive impairment (MCI) due to AD or mild Alzheimer’s disease dementia

Supported test evidenceDocumented by Global CDR 0.5 or 1.0, CDR Memory Box ≥0.5, MMSE ≥22, or MoCA ≥17

Policy Summary

PayerPremera Bluecross

PolicyAmyloid antibody therapy for Alzheimer's disease

Policy CodePolicy 5.01.38

Change TypeMaterial coverage updates (added Kisunla, revised Leqembi dosing and testing requirements)

Effective DateAug 1, 2025

Next Review Date

Key ActionObtain prior authorization and document amyloid biomarker evidence, ApoE ε4 testing and ARIA risk discussion before initiating therapy.

SourceLink

On This Page

Applies toKisunla and Leqembi eligibility criteria

Amyloid PET eligibility thresholds for Kisunla — switch to placebo

Week 2417% eligible for switch to placebo based on amyloid PET

Week 5247% eligible for switch to placebo based on amyloid PET

Week 7669% eligible for switch to placebo based on amyloid PET

Denial Risk

Triggers for Denial

Denial risk exists when documentation does not support the policy coverage criteria. Examples include cognitive impairment primarily due to other conditions (e.g., dementia with Lewy bodies, frontotemporal dementia, vascular dementia, vitamin B12 deficiency, untreated thyroid disease, pseudodementia from mood disorder), absence of required amyloid biomarker evidence, or requests inconsistent with product-specific inclusion requirements.

Denial triggers: cognitive impairment attributable to other medical conditions
Denial triggers: missing confirmatory amyloid biomarker (PET or CSF) evidence
Denial triggers: requests inconsistent with product-specific inclusion criteria (e.g., age, disease stage, testing)

Documentation Required

Required Documentation

Medical records submitted for prior authorization must demonstrate that all medical necessity criteria are met. Documentation should include office visit notes with diagnosis, relevant history, physical exam, and medication history; cognitive testing results (eg, CDR, CDR memory box, MMSE, or MoCA) documenting mild cognitive impairment or mild AD dementia; documentation of amyloid pathology (positive amyloid PET or CSF biomarkers); baseline brain MRI within 12 months prior to initiation; documentation of ApoE ε4 testing and that ARIA risks were discussed; and follow-up MRI results as clinically indicated for monitoring ARIA during therapy.

Office visit notes: diagnosis, history, physical exam, medication history
Cognitive test scores: CDR (0.5 or 1.0) or CDR memory box ≥0.5 or MMSE ≥22 or MoCA ≥17
Confirmatory amyloid biomarker: positive amyloid PET or abnormal CSF
Baseline brain MRI within 12 months prior to treatment start; follow-up MRI as warranted
Documentation of ApoE ε4 testing and counseling about ARIA risks
Clinical notes showing ongoing positive response for re-authorization

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

Early Alzheimer's disease — definition used in pivotal trials

Definition used in pivotal trialsEarly Alzheimer disease defined as mild cognitive impairment (MCI) due to AD or mild AD dementia

Trial populationsPivotal trials enrolled participants with confirmed amyloid pathology and MCI or mild dementia (Stage 3/4)

Regulatory contextThis clinical stage aligns with FDA approvals and trial inclusion criteria

ARIA — definition, subtypes, and clinical relevance

ARIA definitionAmyloid-related imaging abnormalities (ARIA) are imaging findings associated with amyloid‑targeting therapies

ARIA-EARIA with edema/effusion (vasogenic edema) — may be symptomatic and requires MRI monitoring

ARIA-HARIA with hemosiderin deposition including microhemorrhage and superficial siderosis — clinically relevant for bleeding risk and monitoring

Clinical relevanceARIA events influenced by ApoE e4 status and may necessitate treatment modification or increased monitoring