CurrentCommunity Health ChoicePolicy N/A

Prior Authorization Criteria for Kisunla

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This policy governs Medicaid and CHIP prior authorization for Kisunla infusion therapy for clients with Alzheimer's disease in Texas. It establishes initial approval, treatment monitoring, and renewal requirements for providers.

Policy Summary

PayerCommunity Health Choice

PolicyPrior Authorization Criteria for Kisunla

Policy CodePolicy N/A

Change TypeNew policy

Effective DateFebruary 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Kisunla infusion therapy with all required diagnosis, diagnostic testing, baseline MRI, safety, and monitoring documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J0175Kisunla procedure code

4Alzheimer's diagnosis codes

24 weeksARIA monitoring period

4Infusions requiring MRI monitoring

Mild only

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CurrentCommunity Health ChoicePolicy N/A

Prior Authorization Criteria for Kisunla

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Policy Summary

PayerCommunity Health Choice

PolicyPrior Authorization Criteria for Kisunla

Policy CodePolicy N/A

Change TypeNew policy

Effective DateFebruary 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Kisunla infusion therapy with all required diagnosis, diagnostic testing, baseline MRI, safety, and monitoring documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J0175Kisunla procedure code

4Alzheimer's diagnosis codes

24 weeksARIA monitoring period

4Infusions requiring MRI monitoring

Mild only

Eligible disease stage

Coverage Criteria

Initial Therapy

Initial prior authorization is considered when all of the following criteria are met.

Diagnosis and clinical confirmation: The client has a confirmed diagnosis of Alzheimer's disease; other forms of dementia, except Alzheimer's disease, have been ruled out by appropriate laboratory or other diagnostic testing; the presence of amyloid-beta plaques is confirmed; and clinical testing confirms mild cognitive impairment caused by Alzheimer's disease or mild Alzheimer's disease.ICD-10-CM G30.0, G30.1, G30.8, or G30.9

Baseline evaluation: Documentation confirms that the client received a baseline brain MRI before initiating treatment to evaluate for pre-existing amyloid-related imaging abnormalities.Within the past year before treatment initiation

ApoE evaluation: The prescriber attests that ApoE ε4 status will be tested before treatment initiation and that ApoE ε4 homozygous clients will be counseled regarding their higher incidence of developing amyloid-related imaging abnormalities.Before initiation of treatment

Safety and treatment monitoring

Safety eligibility: The client is not currently taking an anticoagulant, except aspirin at a prophylactic dose or less, and has no history of clotting disorder.
ARIA monitoring: The prescriber monitors the client for amyloid-related imaging abnormalities during treatment.First 24 weeks of treatment
Infusion MRI monitoring: The prescriber attests to obtaining an MRI to check for asymptomatic amyloid-related imaging abnormalities before the 2nd, 3rd, 4th, and 7th infusion.Before infusions 2, 3, 4, and 7

Renewal or Continuation Therapy

Renewal or continuation requires all of the following.

Continuation of Kisunla therapy

Initial criteria remain met: The client continues to meet all initial authorization approval criteria.
Disease stage remains eligible: The client has not progressed to moderate or severe dementia caused by Alzheimer's disease.Mild cognitive impairment or mild Alzheimer's disease
Positive clinical response: The client has experienced a positive clinical response to therapy, demonstrated by no increase in amyloid plaque or radiographic stabilization compared with baseline.No increase in amyloid plaque or radiographic stabilization compared with baseline

Severe ARIA-H Management

Severe ARIA-H does not automatically require discontinuation when the following condition is met.

Continuation after severe ARIA-H: Therapy may continue only after radiographic stabilization has been confirmed by a follow-up MRI and supported by clinical evaluation.Radiographic stabilization confirmed by follow-up MRI

A client is not eligible for Kisunla if currently taking an anticoagulant, except aspirin at a prophylactic dose or less, or if the client has a history of a clotting disorder.

Coding and Monitoring Requirements

Kisunla Procedure CodeHCPCSCovered

J0175

Kisunla

Covered Alzheimer's Disease 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

Baseline brain MRI

RequirementA baseline brain MRI must be obtained within the past year before initiating treatment.

PurposeThe MRI evaluates for pre-existing amyloid-related imaging abnormalities (ARIA).

Applies toInitial Kisunla (donanemab-azbt) treatment authorization.

ARIA monitoring period

Monitoring periodThe prescriber must monitor for amyloid-related imaging abnormalities (ARIA) during the first 24 weeks of treatment.

TreatmentKisunla (donanemab-azbt) infusion therapy.

Provider Actions and Coverage Risks

Prior Authorization

Initial Prior Authorization Required

Prior authorization is required for Kisunla (donanemab-azbt) infusion therapy under Medicaid and CHIP for dates of service on or after Feb. 1, 2025. Submit the required clinical documentation and prescriber attestations for initial approval.

Applicable drug/procedure: Kisunla (donanemab-azbt), procedure code J0175.
Initial approval requires all stated clinical, imaging, testing, and monitoring criteria to be met.

Prior Authorization

Renewal Prior Authorization

Renewal or continuation requires documentation that the client continues to meet the initial authorization criteria and remains eligible for treatment. Reauthorization should also demonstrate clinical benefit and absence of disease progression or unacceptable toxicity.

Client must not have progressed to moderate or severe Alzheimer's disease dementia.
Document positive clinical response, including no increase in amyloid plaque or radiographic stabilization compared with baseline.

Background

Kisunla (donanemab-azbt) is an amyloid-beta-directed antibody indicated for Alzheimer’s disease by reducing amyloid-beta plaques. This policy applies to clients with mild cognitive impairment caused by Alzheimer’s disease or mild Alzheimer’s dementia and requires prior authorization, baseline imaging, and safety monitoring for amyloid-related imaging abnormalities (ARIA).

Definitions

Amyloid-related imaging abnormalities (ARIA)

DefinitionAmyloid-related imaging abnormalities (ARIA), including ARIA-H, are imaging findings monitored during Kisunla treatment.

Severe ARIA-H managementTherapy may continue only after radiographic stabilization is confirmed by a follow-up MRI and supported by clinical evaluation.

Monitoring contextARIA monitoring is required during the first 24 weeks of treatment and before the 2nd, 3rd, 4th, and 7th infusion.

ARIA-H

DefinitionARIA-H refers to amyloid-related imaging abnormalities involving hemosiderin deposition.

Continuation after severe ARIA-HTherapy may continue only when radiographic stabilization has been confirmed by a follow-up MRI and supported by clinical evaluation.

Initial Therapy Criteria

Initial Therapy

Initial Kisunla infusion therapy requires all clinical, diagnostic, imaging, safety, and monitoring criteria specified in the policy.

Initial Kisunla therapy requirements

Diagnosis and disease stage: The client has confirmed Alzheimer's disease, confirmed amyloid-beta plaques, and mild cognitive impairment caused by Alzheimer's disease or mild Alzheimer's disease; other forms of dementia have been ruled out by appropriate laboratory or other diagnostic testing.ICD-10-CM G30.0, G30.1, G30.8, or G30.9; mild cognitive impairment or mild Alzheimer's disease
Baseline imaging: A baseline brain MRI was obtained before treatment initiation to evaluate for pre-existing amyloid-related imaging abnormalities.Within the past year before initiating treatment

Continuation Criteria

Continuation Therapy

For renewal or continuation, all of the following requirements must be met.

Kisunla continuation requirements

Initial criteria remain met: All initial authorization approval criteria continue to be satisfied.
Eligible disease stage: The client remains in the mild disease stage and has not progressed to moderate or severe Alzheimer's dementia.Mild cognitive impairment or mild Alzheimer's disease
Clinical response: The client has experienced a positive clinical response, demonstrated by no increase in amyloid plaque or radiographic stabilization compared with baseline.No increase in amyloid plaque or radiographic stabilization compared with baseline

Policy Summary

PayerCommunity Health Choice

PolicyPrior Authorization Criteria for Kisunla

Policy CodePolicy N/A

Change TypeNew policy

Effective DateFebruary 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization for Kisunla infusion therapy with all required diagnosis, diagnostic testing, baseline MRI, safety, and monitoring documentation.

SourceLink

On This Page

Required MRI monitoring: Documentation confirms MRI monitoring to check for amyloid-related imaging abnormalities during Kisunla treatment.Before infusions 2, 3, 4, and 7

Tolerability: The client has not experienced complications or unacceptable toxicities during treatment with Kisunla.

Monitoring focusAmyloid-related imaging abnormalities (ARIA).

Required infusion MRI monitoring

MRI timingBefore the 2nd, 3rd, 4th, and 7th infusion.

PurposeTo check for asymptomatic amyloid-related imaging abnormalities (ARIA).

DocumentationFor renewal or continuation, MRI documentation before the 2nd, 3rd, 4th, and 7th infusion is required.

Document that no complications or unacceptable toxicities occurred during treatment.

Documentation Required

Initial Clinical Documentation

For initial approval, document the qualifying Alzheimer's disease diagnosis, disease stage, confirmation of amyloid-beta plaques, and exclusion of other dementias. Clinical testing must support mild cognitive impairment caused by Alzheimer's disease or mild Alzheimer's disease.

Use an eligible Alzheimer's disease diagnosis: G30.0, G30.1, G30.8, or G30.9.
Prescriber must confirm the presence of amyloid-beta plaques.
Prescriber must attest that other forms of dementia, except Alzheimer's disease, were ruled out through appropriate laboratory or diagnostic testing.
The client must be in the mild cognitive impairment or mild dementia stage caused by Alzheimer's disease.

Documentation Required

Baseline MRI Required

Document a qualifying baseline brain MRI obtained before treatment initiation and within the past year. The MRI is required to evaluate for pre-existing amyloid-related imaging abnormalities (ARIA).

Retain the baseline MRI documentation in the authorization record.
The MRI must be performed before the first infusion and within one year before initiation.

Documentation Required

ApoE ε4 Testing and Counseling

Before treatment initiation, the prescriber must attest that ApoE ε4 status will be tested and that ApoE ε4 homozygotes will be counseled about their higher incidence of ARIA.

Document ApoE ε4 testing or the prescriber’s attestation to test.
Document counseling for clients who are ApoE ε4 homozygotes.

Documentation Required

Infusion-Related MRI Monitoring

During Kisunla treatment, document an MRI before the 2nd, 3rd, 4th, and 7th infusions to check for asymptomatic ARIA. The prescriber must also monitor for ARIA during the first 24 weeks and retain the required imaging documentation for continuation or renewal.

Obtain and document MRI results before infusions 2, 3, 4, and 7.
Monitor for ARIA throughout the first 24 weeks of treatment.
Renewal documentation must include the required infusion-related MRI monitoring.

Documentation Required

Severe ARIA-H Continuation Documentation

A client with severe ARIA-H may continue Kisunla only when a follow-up MRI confirms radiographic stabilization and clinical evaluation supports stabilization. Document both elements before resuming or continuing therapy.

Obtain a follow-up MRI confirming radiographic stabilization.
Document clinical evaluation supporting the client’s clinical stabilization.

Documentation Required

Renewal Documentation

For renewal, document that all initial authorization criteria remain satisfied and that the client has not progressed to moderate or severe dementia caused by Alzheimer's disease.

Confirm ongoing eligible Alzheimer's disease diagnosis and mild disease stage.
Document continued amyloid-beta plaque confirmation, dementia exclusion, and other initial criteria as applicable.
Document positive clinical response, including no increase in amyloid plaque or radiographic stabilization compared with baseline.

Denial Risk

Diagnosis or Disease-Stage Criteria Not Met

Coverage may be denied when the client does not have an eligible Alzheimer's disease diagnosis, confirmed amyloid-beta plaques, or mild cognitive impairment or mild Alzheimer's disease. Initial approval requires all of these disease-stage and diagnostic elements.

Diagnosis must be G30.0, G30.1, G30.8, or G30.9.
Amyloid-beta plaque presence must be confirmed.
Moderate or severe Alzheimer's disease dementia does not meet the initial mild-stage requirement.

Denial Risk

Alternative Dementia Not Ruled Out

Coverage may be denied when the prescriber has not documented that other forms of dementia, except Alzheimer's disease, were ruled out through appropriate laboratory or diagnostic testing.

Obtain and retain the prescriber attestation and supporting diagnostic documentation.
Alternative dementias must be excluded before initial treatment.

Denial Risk

Required Imaging or Monitoring Missing

Missing required imaging, ApoE ε4 counseling, or ARIA monitoring documentation creates a denial risk for initial, ongoing, or renewal coverage. Ensure each required record is available in the authorization submission and treatment file.

Baseline brain MRI must be completed before initiation and within the past year.
ApoE ε4 testing and counseling of homozygotes must be documented before initiation.
MRI must be documented before the 2nd, 3rd, 4th, and 7th infusions.
ARIA monitoring during the first 24 weeks must be documented.

Denial Risk

Continuation Criteria No Longer Met

Continued coverage is ineligible when the client no longer meets initial criteria, progresses to moderate or severe Alzheimer's disease dementia, fails to demonstrate a positive clinical response, or develops complications or unacceptable toxicity.

Do not continue or renew when disease has progressed beyond the mild stage.
Document no increase in amyloid plaque or radiographic stabilization compared with baseline.
Do not continue when complications or unacceptable toxicities occurred during treatment.
Required infusion-related MRI monitoring must remain documented.

Denial Risk

Anticoagulation or Clotting Disorder

Kisunla treatment requires that the client is not currently taking an anticoagulant, except aspirin at a prophylactic dose or less, and does not have a history of clotting disorder. Failure to meet this exclusion criterion creates a denial risk for treatment or continuation.

Document current medication review and anticoagulant status.
Aspirin at a prophylactic dose or less is the stated exception.
Document absence of a history of clotting disorder.

Treatment contextARIA-H is monitored during Kisunla treatment.

ApoE ε4 testing and counseling: The prescriber attests to testing ApoE ε4 status and counseling ApoE ε4 homozygous clients regarding their higher incidence of developing amyloid-related imaging abnormalities.Before initiation of treatment

Safety eligibility: The client is not currently taking an anticoagulant, except aspirin at a prophylactic dose or less, and has no history of clotting disorder.

ARIA monitoring: The prescriber monitors for amyloid-related imaging abnormalities during the treatment period and obtains MRI before the 2nd, 3rd, 4th, and 7th infusion to check for asymptomatic amyloid-related imaging abnormalities.ARIA monitoring during the first 24 weeks; MRI before infusions 2, 3, 4, and 7

Monitoring and tolerability: Required MRI monitoring is documented, and the client has had no complications or unacceptable toxicities during Kisunla treatment.MRI before infusions 2, 3, 4, and 7