ModifiedMolina HealthcarePolicy C28657-A

Kisunla (donanemab-azbt) Coverage Criteria

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Coverage and prior authorization requirements for intravenous Kisunla (donanemab-azbt) for members with Alzheimer's disease under the applicable pharmacy or medical benefit.

Policy Summary

PayerMolina Healthcare

PolicyKisunla (donanemab-azbt) Coverage Criteria

Policy CodePolicy C28657-A

Change TypeModified

Effective DateJune 28, 2025

Next Review DateApril 1, 2026

Key ActionSubmit prior authorization requests with documentation of the Alzheimer's disease diagnosis, qualifying cognitive assessment, confirmed amyloid pathology, and required clinical criteria.

SourceLink

POLICY UPDATE CHANGES

The policy identifies a notable background revision in Q2 2025.

New coverage criteria were created in Q4 2024.

60+Minimum age

3 monthsInitial authorization

6 monthsContinuation authorization

700 mg x3, then 1400 mgDosing schedule

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ModifiedMolina HealthcarePolicy C28657-A

Kisunla (donanemab-azbt) Coverage Criteria

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Sign up for Molina Healthcare Policy C28657-A alerts

Get alerted when Policy C28657-A changes without checking for updates manually.

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Coverage and prior authorization requirements for intravenous Kisunla (donanemab-azbt) for members with Alzheimer's disease under the applicable pharmacy or medical benefit.

Policy Summary

PayerMolina Healthcare

PolicyKisunla (donanemab-azbt) Coverage Criteria

Policy CodePolicy C28657-A

Change TypeModified

Effective DateJune 28, 2025

Next Review DateApril 1, 2026

Key ActionSubmit prior authorization requests with documentation of the Alzheimer's disease diagnosis, qualifying cognitive assessment, confirmed amyloid pathology, and required clinical criteria.

SourceLink

POLICY UPDATE CHANGES

The policy identifies a notable background revision in Q2 2025.

New coverage criteria were created in Q4 2024.

60+Minimum age

3 monthsInitial authorization

6 monthsContinuation authorization

700 mg x3, then 1400 mgDosing schedule

Administration route

Hospital outpatientAdministration setting

Coverage Criteria

Initial Therapy

Initial therapy is covered when ALL of the following are met.

Initial therapy requirements

Eligible Alzheimer's disease stage
- Mild cognitive impairment due to Alzheimer's disease: A concern regarding cognition is reported by the patient or informant or observed by the clinician; objective impairment exists in one or more cognitive domains not explained by age or education; independence in functional abilities is preserved; and the member is not demented.
- Probable Alzheimer's disease dementia: The member has a diagnosis of Alzheimer's disease dementia based on NIA-AA criteria for probable Alzheimer's disease dementia.
Qualifying cognitive assessment: The member has a Clinical Dementia Rating Scale Global Score of 0.5 or 1, a Mini-Mental State Examination score between 20 and 28, or a Montreal Cognitive Assessment score of at least 16.CDR Global Score 0.5 or 1; MMSE 20-28; or MoCA >=16
Confirmed amyloid pathology: Underlying amyloid beta pathology is confirmed through a PET scan or lumbar puncture for cerebrospinal fluid.PET scan or lumbar puncture for CSF
No alternate contributor: The medical record documents that the member does not have another medical or neurological condition, other than Alzheimer's disease, that might contribute to the cognitive impairment.
Age requirement: The member is 60 years of age or older.Age >=60 years
Qualified prescriber: Kisunla is prescribed by or in consultation with a neurologist, geriatrician, geropsychiatric specialist, or Alzheimer's Disease Specialist.
If prescribed in consultation, consultation notes must be submitted with the initial request and reauthorization requests.

Continuation Therapy

Continuation therapy is covered when ALL of the following are met.

Continuation therapy requirements

Adherence is at least 85% as verified by the prescriber or member medication fill history, or adherence is below 85% because surgery or treatment of an infection caused temporary discontinuation.>=85% adherence unless temporary interruption for surgery or infection treatment
Tolerability: The prescriber attests, or clinical review finds, no evidence of intolerable adverse effects or drug toxicity such as amyloid-related imaging abnormalities.
Positive clinical response: There is improvement or stabilization in baseline cognitive scoring using the same testing method used for the initial authorization request.Improvement or stabilization

Initial treatment for Alzheimer's disease

Kisunla is covered for FDA-approved treatment of Alzheimer's disease when treatment is initiated in the mild cognitive impairment or mild dementia stage and the clinical diagnosis supports probable Alzheimer's disease dementia.

Initial Kisunla eligibility

Core dementia criteria: Cognitive or behavioral symptoms interfere with the ability to function at work or usual activities, represent a decline from previous functioning, and are not explained by delirium or a major psychiatric disorder. Cognitive impairment is established through patient and knowledgeable-informant history plus an objective cognitive assessment; neuropsychological testing should be performed when routine history and bedside examination are insufficient for a confident diagnosis.All core conditions
Affected cognitive or behavioral domains: Impairment involves at least two domains: acquiring and remembering new information; reasoning and handling complex tasks; visuospatial abilities; language functions; or personality, behavior, or comportment.At least 2 domains

Noncovered or investigational uses: All uses of Kisunla (donanemab-azbt) other than the covered treatment of Alzheimer's disease are considered experimental or investigational and are subject to Molina's Off-Label policy.

Serious hypersensitivity exclusion: Treatment is excluded for patients with known serious hypersensitivity to donanemab-azbt or any of its excipients.

Diagnostic exclusions: Probable Alzheimer's disease dementia should not be diagnosed when there is substantial concomitant cerebrovascular disease, including a stroke temporally related to the onset or worsening of cognitive impairment, multiple or extensive infarcts, or severe white matter hyperintensity burden. The diagnosis should also not be applied when core features of dementia with Lewy bodies other than dementia itself, prominent behavioral-variant frontotemporal dementia features, prominent semantic-variant or nonfluent/agrammatic primary progressive aphasia features, another concurrent active neurologic disease, a non-neurologic medical comorbidity, or medication could substantially affect cognition are present.

Initial Therapy Criteria

Initial Therapy

Initial Kisunla therapy is covered when ALL of the following are met.

Initial therapy requirements

Eligible Alzheimer's disease stage
- Mild cognitive impairment due to Alzheimer's disease: A concern regarding cognition is reported by the patient or informant or observed by the clinician; objective impairment exists in one or more cognitive domains not explained by age or education; independence in functional abilities is preserved; and the member is not demented.
- Probable Alzheimer's disease dementia: The member has a diagnosis of Alzheimer's disease dementia based on NIA-AA criteria for probable Alzheimer's disease dementia.
Qualifying cognitive assessment:

Continuation Criteria

Kisunla continuation therapy

Continuation of Kisunla requires ALL of the following criteria.

Continuation requirements

Adherence is at least 85% as verified by the prescriber or member medication fill history, or adherence is below 85% because surgery or treatment of an infection caused temporary discontinuation.>=85% adherence unless temporary interruption for surgery or infection treatment
Tolerability: The prescriber attests, or clinical review finds, no evidence of intolerable adverse effects or drug toxicity such as amyloid-related imaging abnormalities.
Positive clinical response: There is improvement or stabilization in baseline cognitive scoring using the same testing method used for the initial authorization request.Improvement or stabilization

Quantity Limits and Dosing

Kisunla dosing schedule

Initial dose700 mg every four weeks for infusions 1, 2, and 3

Transition dose1400 mg every four weeks beginning with infusion 4

ScheduleDosing continues every four weeks after the transition

Site of Care

Documentation Required

Provider Action Required

For infused medications under this policy, confirm coverage under the pharmacy or medical benefit and administer in a non-inpatient hospital facility-based location. Before treatment and billing, verify eligibility and required clinical documentation; correct or withhold requests when coverage requirements are not met.

Age or specialist requirement not met: Do not proceed as meeting policy criteria; document the applicable requirement and address any exception or alternative coverage pathway before treatment.
Inappropriate billing or non-covered benefit: Use the benefit and place of service that apply to the administration setting; do not bill this policy for an inappropriate setting or a non-covered benefit.
General supporting documentation: Submit complete records supporting the diagnosis, medical necessity, requested drug, dose, treatment plan, administration location, and applicable coverage requirements.
Initial clinical documentation: Include the baseline clinical assessment and all information required to establish eligibility before the first infusion.
Continuation monitoring documentation: For ongoing treatment, document response to therapy, safety monitoring, relevant clinical findings, and the rationale for continuing treatment.
ApoE ε4 risk assessment and counseling: Document ApoE ε4 risk assessment, discussion of the associated treatment risks, and counseling provided to the patient or representative.

Coding and Clinical Coding Requirements

HCPCS CodeHCPCS

J0175

Injection, donanemab-azbt, 2 mg

HCPCS CodeHCPCS

J0175

Injection, donanemab-azbt, 2 mg

Clinical Dementia Rating Scale

AssessmentClinical Dementia Rating Scale (CDR) Global Score

Qualifying score0.5 or 1

Coverage roleOne qualifying cognitive assessment option for initial therapy

Mini-Mental State Examination

AssessmentMini-Mental State Examination (MMSE)

Qualifying score rangeBetween 20 and 28

Coverage role

Provider Actions and Authorization Requirements

Prior Authorization

Obtain initial prior authorization

Prior authorization is required for Kisunla coverage. Initial authorization is granted for 3 months when the initial Alzheimer’s disease criteria, age requirement, and qualified prescriber requirement are met.

Member is at least 60 years of age.
Initial clinical criteria and required documentation are submitted.
The drug is prescribed by or in consultation with a qualified specialist.

Prior Authorization

Submit six-month reauthorization requests

Continuation or reauthorization is granted for 6 months when all continuation requirements are met, including adherence, tolerability, clinical response, plaque monitoring, and required MRI monitoring.

Submit the continuation documentation with each reauthorization request.
Document adherence, absence of intolerable adverse effects or toxicity, and improvement or stabilization in cognitive scoring.

Background

Kisunla (donanemab-azbt) is an intravenous anti-amyloid antibody indicated for the treatment of Alzheimer's disease. It is intended for patients in the mild cognitive impairment or mild dementia stage, consistent with the population studied in clinical trials. Before treatment begins, the underlying amyloid beta pathology must be confirmed, and patients should be monitored for amyloid-related imaging abnormalities and other treatment-related toxicity.

Definitions

Mild cognitive impairment due to Alzheimer’s disease

Cognitive concernA concern regarding cognition is reported by the patient or informant, or observed by the clinician

Objective impairmentObjective impairment exists in one or more cognitive domains and is not explained by age or education

Functional statusIndependence in functional abilities is preserved

Dementia statusThe patient is not demented

Amyloid beta pathology confirmation

Required confirmationUnderlying amyloid beta pathology must be confirmed

PET option

Policy Summary

PayerMolina Healthcare

PolicyKisunla (donanemab-azbt) Coverage Criteria

Policy CodePolicy C28657-A

Change TypeModified

Effective DateJune 28, 2025

Next Review DateApril 1, 2026

Key ActionSubmit prior authorization requests with documentation of the Alzheimer's disease diagnosis, qualifying cognitive assessment, confirmed amyloid pathology, and required clinical criteria.

SourceLink

On This Page

Amyloid plaque monitoring: Amyloid plaque levels are monitored as clinically indicated.

Consider stopping Kisunla when amyloid plaques are reduced to minimal levels.

MRI monitoring: A new MRI is obtained before the second, third, fourth, and seventh infusions, if applicable, and shows radiographic stability.MRI before infusions 2, 3, 4, and 7 when applicable

If 10 or more new incident microhemorrhages or more than 2 focal areas of superficial siderosis are observed, treatment may continue cautiously only after clinical evaluation and follow-up MRI demonstrates radiographic stabilization with no increase in the size or number of ARIA-H findings.

Probable Alzheimer's disease features: Symptoms have an insidious onset over months to years, cognition has clearly worsened, and the initial and most prominent deficits are amnestic, language, visuospatial, or executive in presentation, with deficits in other cognitive domains as applicable.All applicable features

Probable Alzheimer's disease dementia should not be diagnosed when substantial concomitant cerebrovascular disease, core features of dementia with Lewy bodies other than dementia itself, prominent behavioral-variant frontotemporal dementia, prominent semantic-variant or nonfluent/agrammatic primary progressive aphasia, another active neurologic disease, a non-neurologic medical comorbidity, or medication substantially affecting cognition is present.

The member has a Clinical Dementia Rating Scale Global Score of 0.5 or 1, a Mini-Mental State Examination score between 20 and 28, or a Montreal Cognitive Assessment score of at least 16.

CDR Global Score 0.5 or 1; MMSE 20-28; or MoCA >=16

Confirmed amyloid pathology: Underlying amyloid beta pathology is confirmed through a PET scan or lumbar puncture for cerebrospinal fluid.PET scan or lumbar puncture for CSF

No alternate contributor: The medical record documents that the member does not have another medical or neurological condition, other than Alzheimer's disease, that might contribute to the cognitive impairment.

Age requirement: The member is 60 years of age or older.Age >=60 years

Qualified prescriber: Kisunla is prescribed by or in consultation with a neurologist, geriatrician, geropsychiatric specialist, or Alzheimer's Disease Specialist.

Consultation notes are required when applicable.

Initial Kisunla therapy

Initiate Kisunla when ALL of the following Alzheimer's disease diagnostic and disease-stage criteria are met.

Initial Kisunla eligibility

Core dementia criteria: Cognitive or behavioral symptoms interfere with the ability to function at work or usual activities, represent a decline from previous functioning, and are not explained by delirium or a major psychiatric disorder. Cognitive impairment is established through patient and knowledgeable-informant history plus an objective cognitive assessment; neuropsychological testing should be performed when routine history and bedside examination are insufficient for a confident diagnosis.
Affected cognitive or behavioral domains: Impairment involves at least two domains: acquiring and remembering new information; reasoning and handling complex tasks; visuospatial abilities; language functions; or personality, behavior, or comportment.At least 2 domains
Probable Alzheimer's disease features: Symptoms have an insidious onset over months to years, cognition has clearly worsened, and the initial and most prominent deficits are amnestic, language, visuospatial, or executive in presentation, with deficits in other cognitive domains as applicable.
The diagnosis should not be applied when specified competing neurologic, cerebrovascular, psychiatric, medical, or medication-related explanations are present.

Amyloid plaque monitoring: Amyloid plaque levels are monitored as clinically indicated.

Consider stopping Kisunla when amyloid plaques are reduced to minimal levels.

MRI monitoring: A new MRI is obtained before the second, third, fourth, and seventh infusions, if applicable, and shows radiographic stability.MRI before infusions 2, 3, 4, and 7 when applicable

If severe ARIA-H is observed, treatment may continue cautiously only after clinical evaluation and follow-up MRI demonstrates radiographic stabilization with no increase in the size or number of ARIA-H findings.

One qualifying cognitive assessment option for initial therapy

Montreal Cognitive Assessment

AssessmentMontreal Cognitive Assessment (MoCA)

Qualifying thresholdAt least 16

Coverage roleOne qualifying cognitive assessment option for initial therapy

Therapy adherence

Standard adherence requirementAt least 85% of the time

VerificationVerified by the prescriber or the member’s medication fill history

Temporary-discontinuation exceptionAdherence below 85% may qualify when surgery or treatment of an infection caused temporary discontinuation

Severe ARIA-H

Microhemorrhage threshold10 or more new incident microhemorrhages

Superficial siderosis thresholdMore than 2 focal areas of superficial siderosis

Policy classificationEither threshold defines radiographic severe ARIA-H

Documentation Required

Submit complete supporting documentation

Provide complete medical rationale for exceptions and supporting records requested for the coverage determination. Molina may request patient records, test results, and credentials of the ordering or performing provider.

Medical rationale for any exception request
Patient records
Test results
Ordering or performing provider credentials

Documentation Required

Document initial clinical eligibility

For the initial request, document the Alzheimer’s disease diagnosis, qualifying cognitive assessment, confirmed amyloid beta pathology, and absence of another medical or neurological condition contributing to cognitive impairment.

CDR Global Score 0.5 or 1, MMSE score 20–28, or MoCA score of at least 16
Amyloid beta pathology confirmed by PET scan or lumbar puncture for CSF
No alternate medical or neurological contributor documented

Documentation Required

Include specialist consultation notes

When Kisunla is prescribed in consultation, submit the consultation notes with the initial request and each reauthorization request.

Consultation with a neurologist, geriatrician, geropsychiatric specialist, or Alzheimer’s Disease Specialist

Documentation Required

Document continuation monitoring

For continuation requests, document adherence, adverse effects or toxicity, clinical response using the same cognitive testing method as the initial request, amyloid plaque monitoring when clinically indicated, and required MRI results.

Adherence of at least 85%, unless lower adherence resulted from temporary discontinuation for surgery or infection treatment
No intolerable adverse effects or drug toxicity, including ARIA
Improvement or stabilization in baseline cognitive scoring
New MRI before the second, third, fourth, and seventh infusions when applicable, showing radiographic stability

Documentation Required

Provide member-specific dosing data

When dosing is based on weight, body surface area, or another member-specific measurement, include the applicable measurement in the medical necessity request.

Provide the member-specific measurement used to determine the dose.

Documentation Required

Assess ApoE ε4 status and counsel on ARIA

Before treatment initiation, perform ApoE ε4 testing to inform ARIA risk. Before testing, discuss ARIA risk across genotypes and the implications of genetic testing results with the patient.

Discuss the potential risk of serious ARIA-related adverse events.
Consider the benefits and risks of Kisunla when deciding whether to initiate treatment.

Documentation Required

Support the clinical Alzheimer’s diagnosis

Document the dementia diagnosis, decline from prior functioning, objective cognitive assessment, and cognitive or behavioral impairment in at least two domains. The record should also support the clinical features of probable Alzheimer’s disease dementia.

Symptoms interfere with work or usual activities and are not explained by delirium or a major psychiatric disorder.
Document impairment in at least two cognitive or behavioral domains.
Document insidious onset, clear worsening of cognition, and the predominant amnestic, language, visuospatial, or executive presentation.

Denial Risk

Incomplete documentation creates denial risk

Molina may deny reimbursement or take other appropriate action when submitted documentation does not support medical necessity, non-investigational or non-experimental status, benefit eligibility, or appropriate billing practices.

Ensure the submitted records support the requested treatment and medical necessity.
Respond to additional documentation requests.

Denial Risk

Document every initial clinical criterion

Coverage requires documentation of an eligible Alzheimer’s disease presentation, a qualifying cognitive score, confirmed amyloid beta pathology, and no other medical or neurological condition contributing to the cognitive impairment.

Eligible stage: mild cognitive impairment due to Alzheimer’s disease or probable Alzheimer’s disease dementia
CDR 0.5 or 1, MMSE 20–28, or MoCA at least 16
Amyloid pathology confirmed by PET scan or lumbar puncture for CSF
No alternate contributor to cognitive impairment

Denial Risk

Meet age and specialist requirements

The member must be 60 years of age or older, and Kisunla must be prescribed by or in consultation with a neurologist, geriatrician, geropsychiatric specialist, or Alzheimer’s Disease Specialist.

Minimum age: 60 years
Submit consultation notes when the prescription is issued in consultation.

Denial Risk

Meet all continuation requirements

Continuation coverage requires adherence, no intolerable adverse effects or drug toxicity, positive clinical response, amyloid plaque monitoring, and MRI monitoring showing radiographic stability.

Adherence is at least 85%, unless temporarily reduced because of surgery or infection treatment.
Cognitive scoring shows improvement or stabilization using the initial testing method.
MRI is obtained before infusions 2, 3, 4, and 7 when applicable.

Denial Risk

Avoid noncovered or investigational use

Uses of Kisunla other than the covered Alzheimer’s disease use are considered experimental or investigational and follow Molina’s Off-Label policy.

Coverage is limited to Alzheimer’s disease treatment initiated in the mild cognitive impairment or mild dementia stage.

Denial Risk

Screen for serious hypersensitivity

Known serious hypersensitivity to donanemab-azbt or any of its excipients is a contraindication and precludes treatment.

Review the patient’s history for serious hypersensitivity before treatment.

Billing Rule

Bill accurately under the applicable benefit

Use applicable industry-standard coding practices and confirm that the service is a covered benefit under the member’s benefit document. Molina may reject or deny claims and recover payments when a service is billed inappropriately or is not a covered benefit.

HCPCS J0175: Injection, donanemab-azbt, 2 mg
Code listing does not guarantee coverage.
Confirm benefit eligibility and billing applicability before submission.

Confirmation may be obtained through a PET scan

Cerebrospinal fluid optionConfirmation may be obtained through lumbar puncture for cerebrospinal fluid (CSF)

Radiographic severe ARIA-H

Microhemorrhages10 or more new incident microhemorrhages

Superficial siderosisMore than 2 focal areas of superficial siderosis

DefinitionEither radiographic finding meets the policy definition of severe ARIA-H

Dementia

SymptomsCognitive or behavioral symptoms interfere with the ability to function at work or at usual activities

Functional declineThe symptoms represent a decline from previous levels of functioning and performing

Required exclusionsThe symptoms are not explained by delirium or a major psychiatric disorder

Affected domainsCognitive or behavioral impairment involves at least two specified domains

Probable Alzheimer’s disease dementia

Onset and progressionDementia has an insidious onset over months to years with a clear-cut worsening of cognition

Predominant presentationThe initial and most prominent deficits are amnestic, language, visuospatial, or executive

Additional dysfunctionThe amnestic presentation includes dysfunction in at least one other cognitive domain; non-amnestic presentations also include deficits in other domains

Competing explanationsThe diagnosis should not be applied when specified cerebrovascular, neurologic, medical, psychiatric, or medication-related explanations substantially affect cognition

ARIA

MeaningARIA means amyloid-related imaging abnormalities

ARIA-EARIA with edema

ARIA-HARIA with hemosiderin deposition