CurrentSecurity Health Plan of Wisconsin, Inc.Policy IC-0763

Kisunla (donanemab-azbt) Intravenous Therapy for Early Alzheimer's Disease

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This policy governs prior authorization, dosing, renewal, administration, and billing requirements for intravenous Kisunla in adults with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia. It applies to providers requesting or administering treatment under Security Health Plan of Wisconsin.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyKisunla (donanemab-azbt) Intravenous Therapy for Early Alzheimer's Disease

Policy CodePolicy IC-0763

Change TypeNo material clinical or coverage change

Effective DateN/A

Last ReviewNov 4, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Kisunla and document that the patient meets the universal and Alzheimer's disease criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization validity

AnnualRenewal authorization interval

Every 4 weeksInfusion frequency

18 years

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy IC-0763

Kisunla (donanemab-azbt) Intravenous Therapy for Early Alzheimer's Disease

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyKisunla (donanemab-azbt) Intravenous Therapy for Early Alzheimer's Disease

Policy CodePolicy IC-0763

Change TypeNo material clinical or coverage change

Effective DateN/A

Last ReviewNov 4, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Kisunla and document that the patient meets the universal and Alzheimer's disease criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial authorization validity

AnnualRenewal authorization interval

Every 4 weeksInfusion frequency

18 years

<11 CentiloidsTreatment discontinuation threshold

5Covered diagnosis codes

Medical Necessity and Coverage Criteria

Initial approval and universal criteria

Covered when all universal and initial requirements are met.

All universal criteria

Patient and clinical prerequisites
- Patient is at least 18 years of age.Age ≥18
- Baseline disease severity has been assessed using at least one objective measure or tool, such as MMSE, ADAS-Cog, ADCS-ADL-MCI, CDR-SB, or MoCA.
- Patient does not have findings suggestive of cerebral amyloid angiopathy or other specified intracerebral hemorrhage risk factors, including prior cerebral hemorrhage greater than 1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, or vasogenic edema.
- If the patient was receiving aspirin, another antiplatelet, or an anticoagulant before starting Kisunla, the antithrombotic therapy has been stable for at least 4 weeks.Stable therapy ≥4 weeks
ApoE ε4 testing or counseling pathway
- ApoE ε4 genotype testing was performed before treatment, and the prescriber informed the patient that ApoE ε4 homozygotes have a higher incidence of ARIA.
- ApoE ε4 genotype testing was not performed, and the prescriber informed the patient that it cannot be determined whether the patient is an ApoE ε4 homozygote and therefore whether the patient has the associated higher ARIA risk.
Provider and imaging requirements
- Kisunla is prescribed by, or prescribed in consultation with, a specialist in neurology or gerontology.
- A baseline brain MRI was obtained before treatment, with periodic MRI monitoring during therapy according to the prescribing information.
- Kisunla will not be used concurrently with another anti-amyloid immunotherapy, including lecanemab.

Alzheimer's disease initial therapy

Covered for early symptomatic Alzheimer's disease when all disease-specific requirements are met.

Early Alzheimer's disease criteria

Patient has mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia.
Amyloid pathology is confirmed by a positive amyloid PET scan or qualifying cerebrospinal fluid assessment, including positive hybrid ratios of Aβ 42/40, CSF p-tau 181/Aβ 42, or CSF t-tau/Aβ 42.
One qualifying cognitive or functional severity pathway
- Clinical Dementia Rating Global Score is 0.5–1.0 with a Memory Box Score of at least 0.5.CDR-Global 0.5–1.0; Memory Box ≥0.5
- Mini-Mental State Examination score is 20–28, inclusive.

Continuation and renewal therapy

Renewal is covered when all renewal requirements are met.

Renewal criteria

Patient continues to meet the universal and other applicable indication-specific criteria.
There is no unacceptable toxicity from Kisunla, including ARIA-E, ARIA-H, intracerebral hemorrhage, hypersensitivity reactions such as anaphylaxis or angioedema, or infusion-related reactions.
Patient has responded to therapy, demonstrated by disease stability or slowing of cognitive and/or functional impairment on one or more appropriate assessments, such as ADAS-Cog, ADCS-ADL-MCI, MMSE, CDR-SB, or MoCA.
Treatment will be discontinued when amyloid plaques are reduced to minimal levels on amyloid PET imaging: less than 11 Centiloids on a single PET scan, or 11 to less than 25 Centiloids on two consecutive PET scans.<11 Centiloids on one scan, or 11 to <25 Centiloids on two consecutive scans

ARIA-E management

Management of ARIA-E is based on clinical symptoms and MRI radiographic severity.

ARIA-E dosing management

Patient is asymptomatic or mildly symptomatic and MRI shows mild ARIA-E; dosing may continue.Mild: FLAIR hyperintensity confined to the sulcus and/or cortex/subcortical white matter in one location measuring <5 cm
Patient is asymptomatic or mildly symptomatic and MRI shows moderate or severe ARIA-E; suspend administration until MRI demonstrates radiographic resolution and symptoms, if present, resolve.Moderate: 5–10 cm in the single greatest dimension, or more than one site with each site <10 cm; severe: >10 cm with gyral swelling and sulcal effacement
Patient has moderate to severe symptoms with mild, moderate, or severe ARIA-E on MRI; suspend administration until MRI demonstrates radiographic resolution and symptoms, if present, resolve.Mild <5 cm; moderate 5–10 cm or multiple sites; severe >10 cm with gyral swelling and sulcal effacement

ARIA-H management

Management of ARIA-H is based on clinical symptoms and MRI radiographic severity.

ARIA-H dosing management

Patient is asymptomatic and MRI shows mild ARIA-H; dosing may continue.Mild microhemorrhage: ≤4 new incident microhemorrhages; mild superficial siderosis: 1 new focal area
Patient is asymptomatic and MRI shows moderate ARIA-H; suspend administration until MRI demonstrates radiographic stabilization and symptoms, if present, resolve.Moderate microhemorrhage: 5–9 new incident microhemorrhages; moderate superficial siderosis: 2 new focal areas
Patient is symptomatic and MRI shows mild or moderate ARIA-H; suspend administration until MRI demonstrates radiographic stabilization and symptoms, if present, resolve.Mild to moderate ARIA-H

Treatment is excluded when the patient has findings suggestive of cerebral amyloid angiopathy or other risk factors for intracerebral hemorrhage, including prior cerebral hemorrhage greater than 1 cm in greatest diameter, more than 4 microhemorrhages, superficial siderosis, or vasogenic edema.

Kisunla must not be used concurrently with another anti-amyloid immunotherapy, including lecanemab administered intravenously or subcutaneously.

Coverage is not supported for patients with moderate or severe Alzheimer's disease. The covered population is limited to mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia.

Kisunla is not medically necessary for moderate or severe Alzheimer's disease because the policy identifies insufficient evidence to support treatment at those disease stages.

Kisunla is not medically necessary when amyloid pathology has not been confirmed by a positive amyloid PET scan or qualifying cerebrospinal fluid assessment, when the patient does not demonstrate the required cognitive severity, or when alternative non-Alzheimer's dementia etiologies have not been ruled out.

Coding and Administration Requirements

Covered HCPCS CodesHCPCSCovered

J0175

Injection, donanemab-azbt, 2 mg: 1 billable unit = 2 mg

Covered NDC CodesNDCCovered

00002-9401-xx

Kisunla 350 mg/20 mL (17.5 mg/mL) solution in a single-dose vial

Covered Diagnosis CodesICD-10Covered

G30.0	Alzheimer's disease with early onset
G30.1	Alzheimer's disease with late onset
G30.8	Other Alzheimer's disease
G30.9	Alzheimer's disease, unspecified
G31.84	Mild cognitive impairment of uncertain or unknown etiology

Clinical Dementia Rating Global Score

CDR-Global qualifying range0.5–1.0

Memory Box Score requirementAt least 0.5

Assessment useQualifying cognitive or functional severity pathway for mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia

Mini-Mental State Examination

Qualifying MMSE score20–28, inclusive

Assessment useQualifying cognitive or functional severity pathway for mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia

Authorization, Documentation, and Claims Actions

Prior Authorization

Initial and Renewal Authorization

Prior authorization is required. Initial authorization is valid for 6 months; renewal authorization may be granted annually thereafter when applicable criteria continue to be met.

Initial authorization: 6 months.
Renewal authorization: annually.

Prior Authorization

Prior Authorization Applies

Prior authorization is supported for Kisunla when the indication, safety and efficacy, and drug-cost considerations warrant utilization management. Potential for misuse or abuse was not identified as a priority factor.

Indication: consider for prior authorization.
Safety and efficacy: consider for prior authorization.
Drug cost: consider for prior authorization.
Potential misuse/abuse: prior authorization not a priority factor.

Therapy Overview

Kisunla (donanemab-azbt) is an intravenous anti-amyloid therapy for early symptomatic Alzheimer's disease. This policy addresses adults with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia who have biomarker-confirmed amyloid pathology and limited cognitive impairment. Treatment requires baseline and periodic brain MRI monitoring because amyloid-related imaging abnormalities may require dosing suspension or discontinuation.

Clinical and Policy Definitions

ARIA-E

DefinitionAmyloid-related imaging abnormality with edema or effusion, graded by MRI FLAIR hyperintensity

MildFLAIR hyperintensity confined to the sulcus and/or cortex/subcortical white matter in one location measuring less than 5 cm

ModerateFLAIR hyperintensity measuring 5 to 10 cm in a single greatest dimension, or more than one site of involvement with each site measuring less than 10 cm

SevereFLAIR hyperintensity measuring more than 10 cm with associated gyral swelling and sulcal effacement; separate or independent sites may also be present

ARIA-H

DefinitionAmyloid-related imaging abnormality involving hemosiderin deposition, including microhemorrhages and superficial siderosis

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyKisunla (donanemab-azbt) Intravenous Therapy for Early Alzheimer's Disease

Policy CodePolicy IC-0763

Change TypeNo material clinical or coverage change

Effective DateN/A

Last ReviewNov 4, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Kisunla and document that the patient meets the universal and Alzheimer's disease criteria.

SourceLink

On This Page

MMSE 20–28, inclusive

Montreal Cognitive Assessment score is 18–25, inclusive.MoCA 18–25, inclusive

Other conditions that mimic Alzheimer's dementia but have a non-Alzheimer's etiology have been ruled out, including vascular dementia, dementia with Lewy bodies, frontotemporal dementia, and normal pressure hydrocephalus.

Patient has not progressed to moderate or severe Alzheimer's disease.

A pre-infusion MRI was completed before the 2nd, 3rd, 4th, and 7th infusions to monitor for ARIA-E and ARIA-H microhemorrhages.

MRI shows severe ARIA-H; suspend administration until MRI demonstrates radiographic stabilization and symptoms, if present, resolve.Severe microhemorrhage: ≥10 new incident microhemorrhages; severe superficial siderosis: >2 new focal areas

Alternative assessmentsAlternative cognitive assessment tests may be reviewed case by case

Montreal Cognitive Assessment

Qualifying MoCA score18–25, inclusive

Assessment useQualifying cognitive or functional severity pathway for mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia

Alternative assessmentsAlternative cognitive assessment tests may be reviewed case by case

Amyloid PET Treatment Discontinuation Threshold

Single PET scan thresholdTreatment is discontinued when amyloid PET level is less than 11 Centiloids on a single PET scan

Two consecutive PET scansTreatment is discontinued when amyloid PET level is 11 to less than 25 Centiloids on two consecutive PET scans

ApplicationThe thresholds define minimal amyloid plaque levels for treatment discontinuation during renewal

Stable Antithrombotic Therapy

Required stabilityAt least 4 weeks

Applies toPatients receiving antithrombotic medication before starting Kisunla

Included medicationsAspirin, other antiplatelets, or anticoagulants

Kisunla Dose and Billable Units

Infusion frequencyEvery 4 weeks by intravenous infusion over approximately 30 minutes

Infusion 1350 mg; 175 billable units

Infusion 2700 mg; 350 billable units

Infusion 31,050 mg; 525 billable units

Infusion 4 and beyond1,400 mg; 700 billable units every 4 weeks thereafter

Documentation Required

Baseline Diagnosis and Severity

Document mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia, with objective evidence of amyloid pathology and disease severity. Alternative cognitive assessments may be reviewed case by case.

Document a diagnosis of MCI due to AD or mild Alzheimer’s dementia; evidence is insufficient for moderate or severe AD.
Confirm amyloid pathology with a positive amyloid PET scan or qualifying positive CSF assessment.
Document at least one objective severity measure, such as CDR-Global with Memory Box, MMSE 20–28, or MoCA 18–25.
Rule out non-Alzheimer’s causes that mimic dementia, including vascular dementia, DLB, FTD, and normal pressure hydrocephalus.

Documentation Required

Safety and Provider Documentation

Before treatment, verify the patient meets the universal safety and provider requirements and retain supporting records. Kisunla must not be used concurrently with another anti-amyloid immunotherapy.

Patient must be at least 18 years old.
Prescriber must be a neurologist or gerontologist, or prescribe in consultation with one.
Obtain a baseline brain MRI before initiation and repeat MRI monitoring throughout therapy according to prescribing information.
Exclude findings suggestive of cerebral amyloid angiopathy, including prior cerebral hemorrhage >1 cm, more than 4 microhemorrhages, superficial siderosis, or vasogenic edema.
If the patient uses aspirin, another antiplatelet, or an anticoagulant, document a stable dose for at least 4 weeks before starting treatment.
Do not use concurrently with other anti-amyloid immunotherapies.

Documentation Required

ApoE and ARIA Risk Counseling

Address ApoE ε4 status before treatment and document counseling that ApoE ε4 homozygotes have a higher incidence of amyloid-related imaging abnormalities (ARIA). If testing is not performed, document that homozygote status and the associated higher ARIA risk cannot be determined.

Document ApoE ε4 testing and the patient’s homozygote, heterozygote, or noncarrier status; or document the no-testing counseling pathway.
Discuss ARIA risk before treatment, including the higher incidence in ApoE ε4 homozygotes.
Retain documentation that the patient was informed when genotype testing was not performed.

Prior Authorization

Renewal and Monitoring Records

For renewal, submit records showing continued eligibility, absence of unacceptable toxicity, treatment response or stability, amyloid-PET results, disease stage, and required MRI monitoring. Treatment should stop when amyloid plaques reach minimal levels under the policy thresholds.

Confirm continued compliance with universal and indication-specific criteria.
Document disease stability or slowed cognitive and/or functional progression using an appropriate measure.
Document no progression to moderate or severe AD.
Discontinue when amyloid PET is <11 Centiloids on one scan or 11 to <25 Centiloids on two consecutive scans.
Submit MRI results obtained before the 2nd, 3rd, 4th, and 7th infusions for ARIA-E and ARIA-H monitoring.
Report ARIA-E, ARIA-H, intracerebral hemorrhage, hypersensitivity or anaphylaxis/angioedema, infusion reactions, and other unacceptable toxicity.

Denial Risk

Failure to Meet Universal Criteria

Authorization is at risk when universal requirements are not documented or are not met. Review age, specialist oversight, baseline MRI, antithrombotic stability, concurrent therapy, and cerebral amyloid angiopathy exclusions before submitting the request.

Patient younger than 18 years.
No neurology or gerontology specialist prescriber or consultation.
Missing baseline brain MRI or required monitoring plan.
Cerebral amyloid angiopathy risk findings, including prior cerebral hemorrhage >1 cm, >4 microhemorrhages, superficial siderosis, or vasogenic edema.
Unstable antithrombotic therapy for less than 4 weeks before initiation.
Concurrent use of another anti-amyloid immunotherapy.

Denial Risk

Diagnosis or Disease-Stage Mismatch

Coverage may be denied when the documented diagnosis, amyloid confirmation, cognitive severity, or disease stage does not match the policy. Kisunla is supported for MCI due to AD or mild Alzheimer’s dementia, not moderate or severe AD.

No qualifying diagnosis of MCI due to AD or mild Alzheimer’s dementia.
No positive amyloid PET or qualifying CSF result.
Severity measure outside the policy ranges or otherwise insufficiently documented.
Alternative non-Alzheimer’s causes of dementia have not been ruled out.
Moderate or severe Alzheimer’s disease.

Denial Risk

Renewal, Response, or Safety Failure

Renewal may be denied or dosing suspended for unacceptable toxicity, disease progression, inadequate response, or failure to complete required safety monitoring. Clinical judgment determines whether treatment is continued or permanently discontinued after ARIA or hemorrhage.

Unacceptable toxicity, including ARIA-E, ARIA-H, intracerebral hemorrhage, hypersensitivity, angioedema, or infusion-related reactions.
No documented disease stability or slowing of cognitive or functional decline.
Progression to moderate or severe AD.
Missing required pre-infusion MRI monitoring.
For ARIA-E or ARIA-H requiring suspension, hold administration until MRI shows radiographic resolution or stabilization and symptoms, if present, resolve.
If intracerebral hemorrhage >1 cm occurs, suspend dosing until radiographic stabilization and symptom resolution; consider follow-up MRI 2–4 months after identification.

Billing Rule

Dose and Billable-Unit Limits

Bill Kisunla as an intravenous infusion every 4 weeks using the policy’s HCPCS billable-unit limits. Do not exceed the scheduled dose or corresponding units without applicable authorization.

Infusion 1: 350 mg; 175 billable units.
Infusion 2: 700 mg; 350 billable units.
Infusion 3: 1,050 mg; 525 billable units.
Infusion 4 and beyond: 1,400 mg; 700 billable units every 4 weeks.
Administer each infusion over approximately 30 minutes.

Note

Medicare Coverage Rules Must Be Followed

For Medicare determinations, apply the Medicare Benefit Policy Manual provisions for Part B drugs and any applicable CMS National Coverage Determination, Local Coverage Determination, and Local Coverage Article requirements.

The policy’s preceding information is intended for non-Medicare coverage determinations.
Follow applicable NCD, LCD, and LCA requirements for coverage and claims payment.
Additional indications may be applied at the health plan’s discretion.

Microhemorrhages—mild, moderate, severeMild: 4 or fewer new incident microhemorrhages; moderate: 5 to 9; severe: 10 or more

Superficial siderosis—mild, moderate, severeMild: 1 new focal area; moderate: 2 new focal areas; severe: more than 2 new focal areas

Clinical Symptom Severity

Mild symptomsNoticeable discomfort without disruption of normal daily activity

Moderate symptomsDiscomfort sufficient to reduce or affect normal daily activity

Severe symptomsIncapacitating, with inability to work or perform normal daily activity

Non-Quantitative Treatment Limitation

DefinitionMethods, guidelines, standards of evidence, or other conditions that can restrict how long or to what extent benefits are provided under a health plan

ExamplesUtilization review and prior authorization

Policy applicationThe utilization management NQTL applies comparably, and not more stringently, to mental health/substance use disorder and medical/surgical medical benefit prescription drugs