ModifiedCentenePolicy CP.PHAR.594

Donanemab-azbt (Kisunla) — Coverage Criteria

Criteria and coverage policy for Centene-affiliated health plans governing use of donanemab-azbt (Kisunla) for treatment of MCI due to Alzheimer's disease or mild Alzheimer's dementia; applies to prescribers requesting prior authorization across Commercial, HIM/ICHRA, and Medicaid lines of business.

Policy Summary

PayerCentene

PolicyDonanemab-azbt (Kisunla) — Coverage Criteria

Policy CodePolicy CP.PHAR.594

Change TypeMaterial updates to criteria, dosing, HCPCS, exclusions, and authorization durations

Effective Date07.02.24

Next Review DateN/A

Key ActionSubmit prior authorization with supporting clinical documentation including amyloid confirmation (PET or CSF), baseline cognitive/functional scores, recent brain MRI, and specialist attestation.

SourceLink

POLICY UPDATE CHANGES

Establishes detailed initial and continued therapy criteria for Kisunla including diagnostic, imaging, cognitive/functional scoring, contraindications, and dosing limits.

Updated HCPCS code to J0175 and aligned criteria with FDA labeling and Kisunla PI including MRI schedule and dosing regimen changes.

Added exclusion against concomitant use with other anti-amyloid monoclonal antibodies and with anticoagulant/antiplatelet therapy; added specialist prescriber and ApoE4 attestation requirements.

Removed requirement for enrollment in NIH-sponsored trial for initial and continued approval.

Adjusted authorization durations and reauthorization cadence (initial and continued approval durations extended; perpetual reauth shortened from 12 to 6 infusions for members with ≥7 infusions).

Removed the age limit of 60-85 years.

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 Donanemab-azbt (Kisunla)

Initial Therapy

Covered when ALL of the following are met for Initial Approval (Alzheimer's Disease):

Initial Approval Criteria for AD: 1. Diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s dementia (see Appendix E).; 2. Prescribed by, or in consultation with, a geriatrician or neurologist.; 3. Documentation of presence of beta-amyloid plaques verified by PET scan OR cerebrospinal fluid (CSF) testing.; 4. Baseline cognitive assessment: MMSE score 20-28 OR MoCA score ≥ 16.; 5. Baseline functional assessment: FAQ score ≤ 9 OR FAST score 3-4 OR CDR-SB 0.5-9.; 6. Recent (within the last year) brain MRI demonstrating: absence of ARIA-E; ≤ 4 cerebral microhemorrhages; ≤ 1 area of superficial siderosis; absence of any macrohemorrhage; absence of severe white matter disease.; 7. No history of transient ischemic attack (TIA), stroke, or seizures within the past 12 months.; 8. Not currently taking concomitant anticoagulant or antiplatelet therapy.; 9. Prescriber attestation that the prescriber discussed the potentially increased risk of ARIA in ApoE4 homozygotes with the member.; 10. Not prescribed concurrently with Leqembi or Leqembi Iqlik.; 11. Dose does not exceed 1,050 mg every 4 weeks.see text

Approval duration: 6 months

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy (Alzheimer's Disease):

Continued Therapy Criteria for AD: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies for the member's state/product.; 2. Member is responding positively to therapy as evidenced by slowed decline in cognition.; 3. Recent (within the last month) cognitive test results: MMSE 20-28 OR MoCA ≥ 16.; 4. Recent (within the last month) functional test results: FAQ ≤ 9 OR FAST 3-4 OR CDR-SB 0.5-9.; 5. Member is not currently taking concomitant anticoagulant or antiplatelet therapy.; 6. Kisunla is not prescribed concurrently with Leqembi or Leqembi Iqlik.; 7. If requesting a dose increase, the new dose does not exceed 1,400 mg every 4 weeks.see text

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

Coverage criteria and policy updates

Policy criteria were updated iteratively to align with TRAILBLAZER-ALZ 2, the Kisunla prescribing information, CMS patient registry requirements, and payer decisions; key changes are summarized below.

Exclusions: Concomitant use with other anti-amyloid monoclonal antibodies is excluded; concomitant anticoagulant or antiplatelet therapy is excluded; pre-existing stroke, TIA, or seizures may preclude coverage.

Added across revisions

Prescriber and documentation requirements: Specialist prescriber requirement (geriatrician or neurologist) and prescriber attestation of discussion of ApoE4 status; neurocognitive and functional testing required for continued therapy and clarified to be recent (within the last month) as of 4Q2025; MRI follow-up requirements for ARIA were required historically and were later removed for continued therapy in 2026.

Documentation (office notes, labs, imaging) required at prior authorization

Authorization durations and dosing limits were revised: HCPCS code updated to J0175; initial approval duration clarified and later extended to 6 months for certain lines of business; continued approval durations updated to 12 months for Medicaid/HIM/ICHRA and 6 months or to renewal date for Commercial; perpetual reauthorization shortened from 12 infusions to 6 infusions for members with ≥ 7 total infusions; recommended dosing regimen updated per Prescribing Information with maximum initial dose limit of 1,050 mg every 4 weeks and dose increase cap at 1,400 mg every 4 weeks.

Use of donanemab-azbt (Kisunla) for indications that are not FDA-approved is not authorized under this policy unless the provider supplies sufficient supporting documentation consistent with the applicable off‑label use policies. Refer to the off‑label use guidance for the member's line of business (CP.CPA.09 for Commercial, HIM.PA.154 for Health Insurance Marketplace/ICHRA, or CP.PMN.53 for Medicaid) or other evidence of coverage documents when submitting requests for non‑FDA indications.

Donanemab-azbt (Kisunla) will not be authorized for concurrent use with other anti‑amyloid monoclonal antibodies. The policy also excludes use in members who are taking concomitant systemic anticoagulant or antiplatelet therapy; these exclusions were added to align criteria with other anti‑amyloid policies and to address safety concerns described in the clinical program.

Treatment with Kisunla is considered not medically necessary when the policy criteria are not met. Examples include lack of documented beta‑amyloid confirmation (PET or CSF), diagnosis outside the specified disease stage (not mild cognitive impairment due to AD or not mild AD dementia), baseline cognitive or functional scores outside the required ranges, disqualifying brain MRI findings (e.g., presence of ARIA‑E, >4 microhemorrhages, macrohemorrhage, or severe white matter disease), recent TIA/stroke or seizures within 12 months, concurrent use of anticoagulant/antiplatelet therapy, concurrent prescription with Leqembi/Leqembi Iqlik, known serious hypersensitivity to donanemab‑azbt or excipients, or dosing that exceeds the specified limits.

Use outside the policy's specified criteria — for example, concurrent administration with other anti‑amyloid therapies or anticoagulant/antiplatelet agents, or continuing therapy after documented progression beyond the mild disease stage as demonstrated by recent cognitive or functional testing — is excluded and will be considered not medically necessary. The policy updates reflect alignment with trial design and prescribing information to ensure therapy is limited to the indicated population.

Product Availability, Dosing, and Codes

Product Availability / vial strengthmixed

350 mg/20 mL

Single-dose vial strength/availability

Referenced HCPCS CodesHCPCS

J0175

Injection, donanemab-azbt, 2 mg

Dosing limits — donanemab-azbt

Titration schedule (first 3 infusions)Infusion 1: 350 mg; Infusion 2: 700 mg; Infusion 3: 1,050 mg (must reach 1,050 mg by third infusion)

Maintenance dosingInfusion 4 and beyond: 1,400 mg every 4 weeks

Initial approval dose ceilingDose for initial approval must not exceed 1,050 mg every 4 weeks

Maximum permitted dose on therapyDose increases under continued therapy must not exceed 1,400 mg every 4 weeks

Maximum dose statementPolicy maximum dose = 1,400 mg every 4 weeks

Cognitive and functional score thresholds for eligibility

Prior Authorization, Documentation, and Provider Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Provider must submit supporting clinical documentation (office chart notes, laboratory results, neuroimaging, cognitive and functional testing) demonstrating the member meets all policy criteria for initiation or continuation of Kisunla (donanemab‑azbt). Prior authorization is required before treatment is initiated.

Initial approval requires confirmation of MCI due to AD or mild AD dementia, specialist prescriber (geriatrician or neurologist), beta‑amyloid confirmation (amyloid PET or CSF), baseline cognitive and functional scores, recent brain MRI within 12 months meeting ARIA/microhemorrhage/siderosis/white matter criteria, no recent TIA/stroke/seizures, not on anticoagulant/antiplatelet therapy, prescriber attestation re: ApoE4 discussion, not concurrent with Leqembi/Leqembi Iqlik, dose limits (≤1,050 mg q4w).
Continued therapy requires evidence of clinical benefit (slowed cognitive decline), recent cognitive/functional testing and MRI as specified, not on anticoagulant/antiplatelet therapy, not concurrent with Leqembi/Leqembi Iqlik, and dose increase limits (≤1,400 mg q4w if applicable).
Approval durations vary by line of business and status (initial and continued authorizations per policy timelines).

Diagnostic and Assessment Definitions

Alzheimer's disease / MCI diagnostic criteria

Objective impairment for AD diagnosisCognitive impairment established by history and objective bedside mental status exam or neuropsychological testing; impairment involves ≥2 cognitive domains and insidious, progressive decline

MCI due to AD core criteriaConcern for change in cognition, objective evidence of impairment in ≥1 domain not explained by age/education, preservation of functional independence, and not demented

Functional impairment threshold for mild ADInterference with ability to function at work/usual activities and decline from previous level of functioning

Cognitive and functional assessment scales — interpretations and policy ranges

MMSE interpretation and rangeMMSE maximum 30; MMSE 21–24 suggests mild dementia; policy requires MMSE 20–28 for eligibility

Background

Donanemab‑azbt (brand name Kisunla) is a monoclonal antibody that targets aggregated amyloid‑beta plaques in the brain and is indicated for treatment of patients with early Alzheimer’s disease (mild cognitive impairment due to AD or mild AD dementia). The policy criteria require confirmation of beta‑amyloid pathology (PET or CSF), specialist prescriber involvement, and the use of standardized cognitive and functional assessments to identify and maintain treatment in those who remain in the mild stage of disease.

Policy Revision History

2024-07-11criteria_revision

RT4: Following FDA approval, criteria updated per FDA labeling: clarified initial authorization covers the first 3 monthly infusions, updated follow-up MRI schedule, treatment discontinuation thresholds, MRI-contingent reauthorization durations per Kisunla PI, and HCPCS code updated to J0175.

2024-08-07policy_update

4Q2024: Perpetual reauthorization shortened from 12 to 6 infusions for members with ≥7 total infusions; exclusion against concomitant use with Aduhelm removed; references reviewed and updated.

2024-10-25criteria_removal

P&T 11.24: Age limit of 60–85 years removed from the policy.

Policy Summary

PayerCentene

PolicyDonanemab-azbt (Kisunla) — Coverage Criteria

Policy CodePolicy CP.PHAR.594

Change TypeMaterial updates to criteria, dosing, HCPCS, exclusions, and authorization durations

Effective Date07.02.24

Next Review DateN/A

SourceLink

On This Page

Denial Risk

Common Authorization Denial Reasons

Common authorization denials typically result from missing or incomplete documentation and failure to meet objective criteria. Providers should ensure submitted records clearly document diagnosis, amyloid confirmation, baseline and follow‑up cognitive and functional scores, recent MRI results, specialist prescriber information, and required attestations.

Lack of documented beta‑amyloid confirmation (amyloid PET or CSF).
Missing baseline or recent cognitive (MMSE or MoCA) and functional (FAQ, FAST, or CDR‑SB) scores or scores outside required ranges.
No recent brain MRI demonstrating absence of ARIA‑E, excessive microhemorrhages, macrohemorrhage, or severe white matter disease.
Absence of specialist prescriber documentation or missing prescriber attestation regarding ApoE4 discussion.
Concurrent use of excluded therapies (e.g., Leqembi, Leqembi Iqlik, or other anti‑amyloid mAbs) or concomitant anticoagulant/antiplatelet therapy.
History of recent (within 12 months) TIA, stroke, or seizures when exclusions apply.

Documentation Required

Concomitant Therapy Exclusions

Concomitant Therapy Exclusion: Kisunla is not authorized for concurrent use with other anti‑amyloid monoclonal antibodies (eg, Leqembi or Leqembi Iqlik). Members must not be receiving anticoagulant or antiplatelet therapy while on Kisunla per policy exclusions. If prior anti‑amyloid therapy was given, sequential use considerations and required washout or clinical justification should be documented per plan operations.

Do not initiate Kisunla concurrently with other anti‑amyloid mAbs (including Leqembi and Leqembi Iqlik).
Document any prior anti‑amyloid therapy and provide rationale and timing for switching; include any required washout per operational guidance.
Members on anticoagulant or antiplatelet therapy are excluded from treatment with Kisunla unless and until therapy is safely discontinued and documented.
Prescribers must attest that they have reviewed and will adhere to concomitant therapy exclusions and document discussions regarding risks (eg, increased ARIA risk).

ARIA — imaging abnormalities and monitoring notes

ARIA definition and monitoringARIA (amyloid-related imaging abnormalities) referenced as ARIA-E (edema) and ARIA-H (hemosiderin); initial MRI must show absence of ARIA-E and related exclusionary findings

Policy monitoring historyFollow-up MRI requirements to monitor for new-onset ARIA were added in earlier revisions and the timing was updated (prior month → prior week) before being removed for continued therapy in 2026

MRI exclusionary findings related to ARIAPolicy excludes members with MRI findings such as >4 cerebral microhemorrhages, >1 superficial siderosis area, macrohemorrhage, or severe white matter disease