ModifiedMolina HealthcarePolicy C28657-A

Kisunla (donanemab-azbt) Coverage Criteria

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This policy governs Molina Healthcare coverage and prior authorization for intravenous Kisunla used to treat Alzheimer's disease. It applies to members meeting the specified age, diagnostic, clinical, prescriber, monitoring, and administration requirements.

Policy Summary

PayerMolina Healthcare

PolicyKisunla (donanemab-azbt) Coverage Criteria

Policy CodePolicy C28657-A

Change TypeModified

Effective DateDecember 1, 2025

Next Review DateApril 1, 2026

Key ActionFor initial authorization, document MCI due to Alzheimer's disease or probable Alzheimer's disease dementia under NIA-AA criteria, the applicable cognitive score, amyloid beta pathology confirmed by PET or CSF lumbar puncture, and no other medical or neurological condition contributing to cognitive impairment.

SourceLink

POLICY UPDATE CHANGES

The revision history records creation of new coverage criteria in Q4 2024.

The revision history identifies a notable Quantity revision in Q4 2025.

The revision history identifies a notable Background revision in Q2 2025.

60+Minimum member age

3 moInitial authorization

6 moContinuation authorization

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ModifiedMolina HealthcarePolicy C28657-A

Kisunla (donanemab-azbt) Coverage Criteria

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Policy Summary

PayerMolina Healthcare

PolicyKisunla (donanemab-azbt) Coverage Criteria

Policy CodePolicy C28657-A

Change TypeModified

Effective DateDecember 1, 2025

Next Review DateApril 1, 2026

SourceLink

POLICY UPDATE CHANGES

The revision history records creation of new coverage criteria in Q4 2024.

The revision history identifies a notable Quantity revision in Q4 2025.

The revision history identifies a notable Background revision in Q2 2025.

60+Minimum member age

3 moInitial authorization

6 moContinuation authorization

85%Minimum adherence

350–1,400 mgInfusion dose range

Coverage Criteria

Initial Therapy

Covered when ALL of the following are met:

ALL of the following

ONE of the following diagnostic pathways
- Mild cognitive impairment due to Alzheimer's disease
  - Documentation of a diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease based on NIA-AA diagnostic criteria: a concern regarding cognition reported by the patient or informant or observed by the clinician; objective evidence of impairment in one or more cognitive domains that is not explained by age or education; preservation of independence in functional abilities; and not demented.
- Probable Alzheimer disease dementia
  - Documentation of a diagnosis of Alzheimer disease dementia based on NIA-AA criteria for probable AD dementia, as described in the probable Alzheimer disease dementia criteria below.
Documentation of a Clinical Dementia Rating Scale (CDR) Global Score of 0.5 or 1, OR a Mini-Mental State Examination (MMSE) score between 20 and 28, OR a Montreal Cognitive Assessment (MoCA) score of at least 16.
Documentation confirming underlying amyloid beta pathology through PET scan or lumbar puncture (LP) for cerebrospinal fluid (CSF).
Documentation in the medical record that the member does not have any medical or neurological condition, other than Alzheimer's disease, that might be a contributing cause of the member's cognitive impairment.

Continuation Therapy

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

ALL of the following

Adherence to therapy is at least 85% of the time as verified by the prescriber or member medication fill history, OR adherence is less than 85% due to the need for surgery or treatment of an infection causing temporary discontinuation.
The prescriber attests to, or the clinical reviewer finds, no evidence of intolerable adverse effects or drug toxicity, such as amyloid-related imaging abnormalities (ARIA).
Documentation of a positive clinical response, demonstrated by improvement or stabilization in baseline cognitive scoring using the same testing method provided during the initial authorization request.
Documentation of monitoring amyloid plaque levels as clinically indicated. Consider stopping Kisunla dosing based on reduction of amyloid plaques to minimal levels.

All-Cause Dementia Core Clinical Criteria

All of the following core clinical criteria must be met for all-cause dementia:

ALL of the following

Cognitive or behavioral (neuropsychiatric) symptoms interfere with the ability to function at work or at usual activities.
Cognitive or behavioral (neuropsychiatric) symptoms represent a decline from previous levels of functioning and performing.
The cognitive or behavioral symptoms are not explained by delirium or a major psychiatric disorder.
Cognitive impairment is detected and diagnosed through both history-taking from the patient and a knowledgeable informant and an objective cognitive assessment, either a bedside mental status examination or neuropsychological testing. Neuropsychological testing should be performed when routine history and bedside mental status examination cannot provide a confident diagnosis.
At least TWO of the following cognitive or behavioral domains are impaired

Probable Alzheimer Disease Dementia Criteria

Probable Alzheimer disease dementia requires ALL of the following in addition to the all-cause dementia core clinical criteria:

ALL of the following

The patient meets the core criteria for dementia described above.
Insidious onset: symptoms have a gradual onset over months to years, not sudden over hours or days.
There is a clear-cut history of worsening cognition by report or observation.
The initial and most prominent cognitive deficits are evident in ONE of the following presentations
- Amnestic presentation
  - Impairment in learning and recall of recently learned information, with evidence of cognitive dysfunction in at least one other cognitive domain.

All other uses of Kisunla (donanemab-azbt) are considered experimental or investigational and follow Molina's Off-Label policy.

Kisunla (donanemab-azbt) is contraindicated in patients with known serious hypersensitivity to donanemab-azbt or any of the excipients.

Coding and Clinical Measures

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 result0.5 or 1

Coverage useOne accepted measure of cognitive severity for initial authorization

Mini-Mental State Examination

AssessmentMini-Mental State Examination (MMSE)

Qualifying rangeBetween 20 and 28

Coverage use

Provider Requirements and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial authorization is approved for 3 months; continuation authorization is approved for 6 months. Coverage review may also require additional case-by-case information, including member-specific dosing data when applicable.

Member must be 60 years of age or older.
Initial authorization: 3 months.
Continuation authorization: 6 months.

Documentation Required

General Documentation Requirements

Submit complete supporting documentation when requested for coverage determination, quality improvement, or fraud, waste, and abuse prevention. Molina may request patient records, test results, and credentials of the provider ordering or performing the drug or service.

Background

Kisunla (donanemab-azbt) is an intravenous anti-amyloid antibody for Alzheimer's disease. The policy limits treatment initiation to patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia, consistent with the population studied in clinical trials. Coverage requires objective cognitive assessment and confirmation of underlying amyloid beta pathology.

Clinical Definitions

Mild Cognitive Impairment Due to Alzheimer's Disease

Diagnostic frameworkSupported by NIA-AA diagnostic criteria

Cognitive featuresA reported or observed concern regarding cognition and objective impairment in one or more cognitive domains not explained by age or education

Functional statusIndependence in functional abilities is preserved

Dementia statusThe person is not demented

Radiographic Severe ARIA-H

DefinitionRadiographic severe ARIA-H

Microhemorrhage finding

Initial Authorization

Initial authorization requires ALL of the following:

Initial authorization

Qualifying diagnosis
- Mild cognitive impairment due to Alzheimer's disease based on NIA-AA diagnostic criteria, including a cognitive concern, objective impairment not explained by age or education, preserved independence in functional abilities, and no dementia.
- Alzheimer disease dementia based on NIA-AA criteria for probable Alzheimer disease dementia.
Objective cognitive assessment
- Clinical Dementia Rating Scale Global Score is 0.5 or 1.

Continuation Authorization

Continuation authorization requires ALL of the following:

Continuation authorization

Adherence
- Adherence to therapy is at least 85% as verified by the prescriber or member medication fill history.
- Adherence is less than 85% because surgery or treatment of an infection caused temporary discontinuation.
The prescriber attests, or clinical review finds, no evidence of intolerable adverse effects or drug toxicity, such as amyloid-related imaging abnormalities (ARIA).
There is a positive clinical response, demonstrated by improvement or stabilization in baseline cognitive scoring using the same testing method used for the initial authorization request.

Infusion Dosing

Kisunla (donanemab-azbt) Dosing Escalation

Administration intervalEvery 4 weeks

Infusion 1350 mg

Infusion 2700 mg

Infusion 31,050 mg

Infusion 4 and beyond1,400 mg

Site of Care

Note

Administer in a hospital outpatient setting

Infused Kisunla is recommended for pharmacy or medical benefit coverage when administered in a non-inpatient hospital facility-based location.

Policy Summary

PayerMolina Healthcare

PolicyKisunla (donanemab-azbt) Coverage Criteria

Policy CodePolicy C28657-A

Change TypeModified

Effective DateDecember 1, 2025

Next Review DateApril 1, 2026

SourceLink

On This Page

Documentation of a new MRI prior to the 2nd, 3rd, 4th, and 7th infusions, if applicable, showing radiographic stability. If 10 or more new incident microhemorrhages or more than 2 focal areas of superficial siderosis (radiographic severe ARIA-H) are observed, treatment may be continued with caution only after clinical evaluation and a follow-up MRI demonstrates radiographic stabilization, meaning no increase in the size or number of ARIA-H.

Impaired ability to acquire and remember new information; symptoms may include repetitive questions or conversations, misplacing personal belongings, forgetting events or appointments, or getting lost on a familiar route.
Impaired reasoning and handling of complex tasks or poor judgment; symptoms may include poor understanding of safety risks, inability to manage finances, poor decision-making ability, or inability to plan complex or sequential activities.
Impaired visuospatial abilities; symptoms may include inability to recognize faces or common objects or to find objects in direct view despite good acuity, inability to operate simple implements, or inability to orient clothing to the body.
Impaired language functions, including speaking, reading, or writing; symptoms may include difficulty thinking of common words while speaking, hesitations, or speech, spelling, and writing errors.
Changes in personality, behavior, or comportment; symptoms may include uncharacteristic mood fluctuations such as agitation, impaired motivation, initiative, apathy, loss of drive, social withdrawal, decreased interest in previous activities, loss of empathy, compulsive or obsessive behaviors, or socially unacceptable behaviors.

Non-amnestic presentations

ANY of the following
- Language presentation: the most prominent deficits are in word-finding, with deficits in other cognitive domains also present.
- Visuospatial presentation: the most prominent deficits are in spatial cognition, including object agnosia, impaired face recognition, simultanagnosia, or alexia, with deficits in other cognitive domains also present.
- Executive dysfunction: the most prominent deficits are impaired reasoning, judgment, and problem solving, with deficits in other cognitive domains also present.

The diagnosis of probable Alzheimer disease dementia is not applied when there is evidence of substantial concomitant cerebrovascular disease, defined by a history of a stroke temporally related to onset or worsening of cognitive impairment, multiple or extensive infarcts, or severe white matter hyperintensity burden; core features of dementia with Lewy bodies other than dementia itself; prominent features of behavioral-variant frontotemporal dementia; prominent features of semantic-variant primary progressive aphasia or nonfluent/agrammatic-variant primary progressive aphasia; or another concurrent, active neurological disease, non-neurological medical comorbidity, or medication use that could have a substantial effect on cognition.

One accepted measure of cognitive severity for initial authorization

Montreal Cognitive Assessment

AssessmentMontreal Cognitive Assessment (MoCA)

Minimum qualifying scoreAt least 16

Coverage useOne accepted measure of cognitive severity for initial authorization

Continuation Adherence

Standard adherence requirementAt least 85% of therapy

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

Temporary interruption exceptionAdherence below 85% may qualify when surgery or infection treatment caused temporary discontinuation

Radiographic Severe ARIA-H

Microhemorrhage threshold10 or more new incident microhemorrhages

Superficial siderosis thresholdMore than 2 focal areas of superficial siderosis

Continuation implicationTreatment may continue with caution only after clinical evaluation and follow-up MRI demonstrates radiographic stabilization

Provide complete medical records and applicable test results.

Provide credentials of the ordering or performing provider when requested.

Documentation Required

Initial Clinical Documentation

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

Document mild cognitive impairment due to Alzheimer's disease under NIA-AA diagnostic criteria, or probable Alzheimer's disease dementia under NIA-AA criteria.
Document a CDR Global Score of 0.5 or 1, or MMSE score of 20–28, or MoCA score of at least 16.
Document amyloid beta pathology confirmation by PET scan or lumbar puncture for CSF.
Document that the member does not have another medical or neurological condition contributing to cognitive impairment.

Documentation Required

Continuation Documentation

For continuation authorization, document adherence, absence of intolerable toxicity, clinical response, amyloid monitoring, and required pre-infusion MRI findings. Continue treatment cautiously after severe ARIA-H only following clinical evaluation and MRI-confirmed radiographic stabilization.

Document adherence of at least 85%, or explain temporary discontinuation for surgery or infection.
Prescriber must attest to no intolerable adverse effects or drug toxicity, including ARIA.
Document improvement or stabilization from baseline cognitive scoring using the same testing method used for initial authorization.
Document monitoring of amyloid plaque levels as clinically indicated and consider stopping when plaques are reduced to minimal levels.
Submit a new MRI before the 2nd, 3rd, 4th, and 7th infusions, if applicable, showing radiographic stability.
If there are 10 or more new incident microhemorrhages or more than 2 focal areas of superficial siderosis, document clinical evaluation and follow-up MRI showing no increase in size or number of ARIA-H.

Documentation Required

Consultation Documentation

Kisunla must be prescribed by, or in consultation with, a qualified specialist. When prescribed in consultation, submit the consultation notes with both the initial request and every reauthorization request.

Qualifying specialists include a neurologist, geriatrician, geropsychiatric specialist, or Alzheimer's Disease Specialist.
Submit consultation notes with the initial authorization request when applicable.
Submit consultation notes with reauthorization requests when applicable.

Documentation Required

ApoE ε4 Testing and Counseling

Perform ApoE ε4 status testing before initiating Kisunla and document counseling about ARIA risk and the implications of genetic testing results.

Discuss ARIA risk across ApoE ε4 genotypes before testing.
Discuss the implications of the genetic testing results.
Consider the benefits of Kisunla against the risk of serious ARIA-related adverse events.

Denial Risk

Insufficient Supporting Documentation

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

Documentation must support that the drug or service is medically necessary.
Documentation must support that the use is not investigational or experimental and is within the member's benefits.
Inappropriate or excessive billing or other practices may result in denial or additional action.

Denial Risk

Initial Clinical Criteria Not Met

Initial coverage is at risk of denial when the record does not support the qualifying disease stage, required cognitive score, amyloid confirmation, or other initial clinical requirements.

Qualifying MCI due to Alzheimer's disease or probable Alzheimer's disease dementia is not documented.
CDR, MMSE, or MoCA requirements are not met or unsupported.
Amyloid beta pathology is not confirmed by PET or CSF lumbar puncture.
A potentially contributing medical or neurological condition is not addressed.

Denial Risk

Continuation Criteria Not Met

Continuation coverage is at risk of denial when adherence, tolerability, clinical response, amyloid monitoring, or required pre-infusion MRI documentation is inadequate.

Required adherence or an allowable temporary interruption is not documented.
Intolerable adverse effects, drug toxicity, or ARIA are present or insufficiently evaluated.
Improvement or stabilization using the baseline cognitive assessment method is not documented.
Amyloid plaque monitoring or required MRI evidence of radiographic stability is missing.

Denial Risk

Unapproved or Investigational Use

All other uses of Kisunla (donanemab-azbt) are considered experimental or investigational and follow Molina's Off-Label policy.

Covered use must align with this policy and applicable benefit requirements.

Denial Risk

Serious Hypersensitivity

Kisunla is contraindicated for patients with known serious hypersensitivity to donanemab-azbt or any of its excipients.

Do not administer when a known serious hypersensitivity contraindication is present.

Billing Rule

Improper Billing or Noncovered Benefit

Claims may be rejected or payment may be recovered when Kisunla is billed incorrectly or for a service that is not a covered benefit. Code listings do not guarantee coverage; providers must use current, industry-standard coding and comply with the member's benefit document.

HCPCS J0175: Injection, donanemab-azbt, 2 mg.
Deleted, inactive, or otherwise inapplicable codes may not be eligible for reimbursement.
Molina may reject or deny claims and recover payments for inappropriate billing or noncovered services.

10 or more new incident microhemorrhages

Superficial siderosis findingMore than 2 focal areas of superficial siderosis

Amyloid-Related Imaging Abnormalities (ARIA)

MeaningAmyloid-related imaging abnormalities (ARIA) are imaging abnormalities associated with amyloid-targeted treatment

Possible imaging changesEvidence of edema or hemorrhagic changes

Continuation relevanceEvaluation includes intolerable toxicity and radiographic stability during continuation therapy

Amyloid-Related Imaging Abnormalities (ARIA)

ARIA-EARIA with edema

ARIA-HARIA with hemosiderin deposition

Typical presentationUsually asymptomatic

Serious riskRarely, ARIA can cause serious or life-threatening events, including intracerebral hemorrhage

All-Cause Dementia

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

Change from baselineSymptoms represent a decline from previous levels of functioning and performance

ExclusionsSymptoms are not explained by delirium or a major psychiatric disorder

Affected domainsImpairment involves at least two cognitive or behavioral domains

Probable Alzheimer Disease Dementia

Core requirementThe patient meets criteria for dementia

OnsetInsidious onset with gradual symptoms over months to years

ProgressionA clear-cut history of worsening cognition by report or observation

Predominant presentationAmnestic, language, visuospatial, or executive dysfunction, with deficits in at least one other cognitive domain

Mini-Mental State Examination score is between 20 and 28.

Montreal Cognitive Assessment score is at least 16.

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

The medical record documents that the member does not have another medical or neurological condition, other than Alzheimer's disease, that might contribute to cognitive impairment.

Amyloid plaque levels are monitored as clinically indicated.

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

A new MRI obtained before the second, third, fourth, and seventh infusions, if applicable, shows radiographic stability.

If 10 or more new incident microhemorrhages or more than 2 focal areas of superficial siderosis are observed, treatment may continue with caution only after clinical evaluation and follow-up MRI demonstrates radiographic stabilization.