ModifiedCentenePolicy CP PHAR.594

Clinical Policy: Donanemab-azbt (Kisunla)

Defines medical necessity criteria, authorization requirements, and coding guidance for Kisunla (donanemab-azbt) for treatment of patients with mild cognitive impairment due to Alzheimer disease or mild AD dementia for Centene-affiliated health plans.

Policy Summary

PayerCentene

PolicyClinical Policy: Donanemab-azbt (Kisunla)

Policy CodePolicy CP PHAR.594

Change TypeMaterial revisions to initial/continued criteria, MRI monitoring, exclusions, dosing and authorization durations

Effective DateJul 2, 2024

Next Review Date

Key ActionSubmit prior authorization with specialist prescriber documentation, amyloid confirmation, baseline cognitive/functional testing, and required MRI reports to support initial or continued approval.

SourceLink

POLICY UPDATE CHANGES

Initial approval criteria revised to remove requirement for enrollment in an NIH-sponsored trial and added specialist prescriber requirement and exclusions for concomitant anticoagulant/antiplatelet therapy and other anti-amyloid monoclonal antibodies.

Initial 3-month authorization duration clarified to cover the first 3 monthly infusions (rather than 4).

Requirement for follow-up MRIs prior to specified infusions to monitor for ARIA was added to continued therapy criteria.

HCPCS code updated to J0175 and reauthorization cadence aligned with Kisunla prescribing information; perpetual reauth shortened to 6 infusions per PA approval for members with ≥7 total infusions.

Removed the age limit of 60-85 years.

700→1400dosing ramp

3 monthsinitial approval

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Coverage Criteria for Donanemab-azbt (Kisunla)

Initial Therapy

Covered when ALL of the following are met for Initial Approval:

Initial Approval - AD diagnosis and staging: Diagnosis of mild cognitive impairment (MCI) due to Alzheimer disease or mild Alzheimer disease dementia (see Appendix E)

Prescribed by or in consultation with a geriatrician or neurologist

Amyloid confirmation: Documentation of presence of beta-amyloid plaques verified by PET scan OR cerebrospinal fluid testing

Baseline cognitive testing: Documentation of baseline cognitive test: MMSE 20-28 OR MoCA >=16MMSE 20-28; MoCA >=16

See Appendix D for scale details

Baseline functional testing: Documentation of baseline functional test: FAQ <9 OR FAST 3-4 OR CDR‑SB 0.5-9FAQ <9; FAST 3-4; CDR-SB 0.5-9

See Appendix D

MRI and hemorrhage limits: Recent brain MRI (within the past 12 months) demonstrating: absence of ARIA‑E; <4 cerebral microhemorrhages; <1 area of superficial siderosis; absence of any macrohemorrhage; and no severe white matter disease<4 microhemorrhages; <1 superficial siderosis

Concomitant therapy and exclusions: Member is not currently taking concomitant anticoagulant or antiplatelet therapy; Kisunla is not prescribed concurrently with Leqembi or other anti-amyloid monoclonal antibodies; no pre-existing stroke, TIA, or seizures

Prescriber must attest that an ApoE4 risk discussion occurred

Dosing limit and duration: Initial dosing regimen: 700 mg IV every 4 weeks x 3 doses then 1400 mg IV every 4 weeks; dose does not exceed 1,400 mg every 4 weeksmax 1400 mg q4w

Initial approval duration: 3 months (covers the first 3 monthly infusions)

Continuation Therapy

Covered when ALL of the following are met for Continued Therapy:

Eligibility for continuation: Member is currently receiving medication via a Centene benefit OR member previously met initial approval criteria

Clinical response: Member is responding positively to therapy as evidenced by slowed decline in cognition and remains within mild AD stage

Cognitive and functional testing results must be provided to document response and continued mild staging

Ongoing safety monitoring: Prior to the 4th and 7th infusions provide a recent (within the last month) brain MRI and ARIA symptom assessment showing either absence of ARIA‑E symptoms or only mild ARIA‑E symptoms, ARIA‑H limited (<4 cerebral microhemorrhages), FLAIR hyperintensity confined and <5 cm in any one location, and no symptomatic macrohemorrhageMRI within 1 month prior to specified infusions; FLAIR <5 cm; <4 microhemorrhages

Member must not be on anticoagulant/antiplatelet therapy and cannot be on Leqembi concurrently

Not Authorized / Off-Label

Not Authorized Indications: Non‑FDA approved indications not addressed in this policy are not authorized unless supported by sufficient documentation consistent with applicable off‑label or formulary policies

Refer to CP.CPA.09 (commercial), HIM.PA.154 (marketplace), or CP PMN.53 (Medicaid) as applicable

Summary Coverage Criteria

Covered with specific criteria and exclusions

Initial Approval: Initial approval requires a specialist prescriber (geriatrician or neurologist), diagnosis and staging aligned with TRAILBLAZER‑ALZ 2 design and FDA labeling, documented amyloid confirmation, baseline cognitive and functional testing, MRI safety criteria, and adherence to dosing limits; enrollment in an NIH‑sponsored trial is not required

Initial authorization covers the first 3 monthly infusions

Continued Therapy: Continued therapy requires follow‑up MRIs to identify new‑onset ARIA, provision of cognitive and functional testing to confirm member remains in the mild stage of AD, adherence to dosing limits and reauthorization cadence; concomitant use with other anti‑amyloid mAbs or anticoagulant/antiplatelet therapy is excludedPer‑PA reauthorizations provided in 6‑infusion increments for members with >=7 total infusions

NIH trial enrollment is not required for continuation

Contraindications include serious hypersensitivity to donanemab-azbt or any excipients. The product carries a boxed warning for increased risk of amyloid-related imaging abnormalities (ARIA). General exclusions for coverage include members with pre-existing stroke, transient ischemic attack (TIA), or seizures, and situations where baseline MRI safety criteria are not met (for example, presence of any macrohemorrhage, ≥1 area of superficial siderosis, or severe white matter disease). Initial therapy also requires that MRI demonstrate absence of ARIA‑E and meet the policy’s hemorrhage limits (see MRI criteria).

Concomitant therapy exclusions: Kisunla (donanemab-azbt) must not be prescribed concurrently with Leqembi or other anti-amyloid monoclonal antibodies. Members must not be receiving concomitant anticoagulant or antiplatelet therapy while on therapy per both initial and continued therapy criteria. These exclusions were added to align with the Leqembi policy and to reflect safety considerations noted in the clinical review and prescribing information. Requests that indicate concurrent use with another anti-amyloid mAb or with anticoagulant/antiplatelet agents are subject to denial.

Off‑label and non‑FDA indications that are not explicitly addressed within this policy are not authorized unless supported by the applicable off‑label use or formulary/non‑formulary policies for the member’s line of business (see policy references CP.CPA.09, HIM.PA.154, CP PMN.53, etc.). Requests for unsupported off‑label use lacking sufficient documentation of efficacy and safety per those referenced policies will be considered not medically necessary.

Prescriber and documentation requirements: Initial prescriptions must be written by or in consultation with a geriatrician or neurologist. Providers must submit supporting documentation including office chart notes, baseline cognitive and functional test scores, laboratory and imaging reports (including baseline brain MRI), and amyloid confirmation (PET or cerebrospinal fluid testing) to establish medical necessity. For continued therapy, timely follow‑up MRIs (within 1 month prior to the 4th and 7th infusions) and documentation of ARIA symptom status and repeat cognitive/functional testing are required to confirm continued eligibility.

Billing and Coding Guidance

HCPCS CodesHCPCS

J0175

Injection,donanemab-azbt2 mg

Covered HCPCS CodesHCPCSCovered

J0175

Injection,donanemab-azbt 2 mg

Cerebral microhemorrhages — eligibility threshold

Eligibility thresholdFewer than 4 total cerebral microhemorrhages on recent brain MRI (i.e., <4)

Superficial siderosisLess than 1 area of superficial siderosis on MRI (<1)

MacrohemorrhageAbsence of any macrohemorrhage on MRI

MMSE score — baseline cognitive score requirement

Required MMSE rangeMMSE score of 20–28 documented at baseline

Scale maximumMMSE maximum score is 30 points (see Appendix D)

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior Authorization Required and Approval Durations

Prior authorization is required. Initial authorization covers the first 3 monthly infusions (approval duration: 3 months / 3 doses). Reauthorization durations align with total number of infusions: members with <4 total infusions — approval up to the 4th infusion; members with 4–6 total infusions — approval up to the 7th infusion; members with ≥7 total infusions — approvals issued for 6 infusions per PA approval.

Initial approval: first 3 infusions covered
Reauthorization: up to 4th infusion, up to 7th infusion, or 6 infusions per PA for ≥7 infusions

Documentation Required

Required Documentation — What to Submit

Provider must submit supporting documentation demonstrating the member meets all approval criteria. Required documentation may include office chart notes, prescriber attestation, lab results, diagnostic test reports, and imaging. Failure to provide required documentation may result in denial or return of the request.

Background on Donanemab-azbt

Donanemab‑azbt (Kisunla) is a monoclonal antibody that targets amyloid beta and is indicated for treatment of Alzheimer disease when initiated in patients with mild cognitive impairment due to Alzheimer disease or mild Alzheimer dementia. Treatment requires confirmation of beta‑amyloid pathology and active surveillance for amyloid‑related imaging abnormalities (ARIA) per the policy’s MRI monitoring requirements.

Definitions and Key Terms

ARIA-E / ARIA-H definitions — imaging abnormality definitions

ARIA‑E definitionARIA‑E: amyloid‑related imaging abnormalities with edema

ARIA‑H definitionARIA‑H: amyloid‑related imaging abnormalities with hemosiderin deposition/hemorrhagic changes

MRI surveillance requirementARIA requires MRI surveillance per policy to detect new‑onset events prior to specified infusions

MCI due to Alzheimer's disease — definition of mild cognitive impairment due to AD

Diagnostic featuresRequires concern regarding change in cognition and objective evidence from history or testing (bedside mental status or neuropsychological testing)

Exclusion of other causesCognitive deficits should not be explained by delirium, major psychiatric disorder, substantial cerebrovascular disease, or other neurologic conditions

Policy Summary

PayerCentene

PolicyClinical Policy: Donanemab-azbt (Kisunla)

Policy CodePolicy CP PHAR.594

Change TypeMaterial revisions to initial/continued criteria, MRI monitoring, exclusions, dosing and authorization durations

Effective DateJul 2, 2024

Next Review Date

SourceLink

On This Page

Note

Formulary / Off‑Label Routing

For uses that are not addressed within this policy, route requests according to formulary, non‑formulary, or off‑label policies for the relevant line of business. If the requested diagnosis, age, or dosing regimen is not listed in this policy and criterion 1 under section III does not apply, refer to the off‑label use policy for the applicable line of business.

Formulary/non‑coverage policies: CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid)
Non‑formulary policies: CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid)
Off‑label policies: CP.CPA.09 (commercial), HIM.PA.154 (marketplace), CP.PMN.53 (Medicaid)

Denial Risk

Exclusion — Concomitant Use with Other Anti‑amyloid mAbs and Anticoagulants/Antiplatelets

Concurrent use with other anti‑amyloid monoclonal antibodies is excluded. Kisunla must not be prescribed concurrently with Leqembi (and other anti‑amyloid mAbs as specified). Concomitant use with anticoagulant or antiplatelet therapy is also excluded. Requests for members receiving excluded concomitant therapies will be denied.

No concurrent prescription of Kisunla with Leqembi or other anti‑amyloid monoclonal antibodies
Member must not be on anticoagulant or antiplatelet therapy at time of treatment

Documentation Required

Continued Therapy — Required Documentation and Monitoring

Continued therapy requires documentation that the member is responding to treatment and remains within the eligible disease stage. Required elements for continuation include follow‑up MRIs and cognitive/functional testing as described below.

Member currently receiving medication via Centene benefit or previously met initial approval criteria
Evidence of slowed decline in cognition or clinical benefit per treating provider
Follow‑up brain MRI and ARIA symptom assessment prior to the 4th and 7th infusions (MRI within last month)
Repeat cognitive and functional testing (MMSE or MoCA; FAQ, FAST, or CDR‑SB) demonstrating member has not progressed beyond mild AD

Denial Risk

Failure to Document Required Criteria / Triggers for Denial

Requests that do not include the required baseline or follow‑up documentation, or that show use contrary to exclusions (for example, prescriber is not a specialist or member is on excluded concomitant therapy), may be denied or returned for additional information.

Missing baseline confirmation of amyloid pathology (PET or CSF)
Absent or outdated MRI or missing ARIA assessment
No baseline or follow‑up cognitive/functional test scores
Prescriber not a neurologist or geriatrician and no documented specialist consultation
Concurrent use of excluded therapies (other anti‑amyloid mAbs, anticoagulants/antiplatelets)