CurrentUnitedHealthcarePolicy IEXDO130.01

Kisunla (Donanemab-Azbt)

This policy governs medical benefit drug coverage for Kisunla (donanemab-azbt) for Individual Exchange members (excludes MA, NV, NY) and defines clinical criteria for initial and continuation authorization.

Policy Summary

PayerUnitedHealthcare

PolicyKisunla (Donanemab-Azbt) coverage criteria

Policy CodePolicy IEXDO130.01

Change TypeNo material clinical or coverage changes

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit required documentation including positive amyloid PET, CDR and cognitive test scores, baseline brain MRI, and prescriber attestation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J0175HCPCS

Excludes MA/NV/NYGeographic scope

≤6 mo / ≤12 moAuth durations

Positive amyloid PETBiomarker requirement

CDR 0.5/1.0; MMSE ≥20Cognitive thresholds

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Coverage Criteria for Kisunla (donanemab-azbt)

Initial Therapy

Covered when ALL of the following are met

Diagnosis per NIA-AA criteria of either mild cognitive impairment (MCI) due to Alzheimer's disease or mild dementia due to Alzheimer's disease

Cognitive staging: Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0 and CDR Memory Box score of 0.5 or greater

Cognitive test thresholds: MMSE score \u2265 20 OR MoCA score \u2265 17 OR SLUMS score \u2265 17

Updated assessments must be measured no earlier than 4 weeks prior to request when applicable

Biomarker confirmation: Documentation of beta-amyloid deposition evidenced by a positive amyloid PET brain scan

Baseline imaging and safety: Baseline brain MRI completed within 12 months prior to initiating treatment; no history of intracerebral hemorrhage within prior year; if taking an anticoagulant, counseling provided and prescriber attests shared decision-making

ApoE counseling: Testing for ApoE-ε4 status has been offered and prescriber attests that the patient participated in shared decision-making

Specialist prescriber: Prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia

Dosing: Kisunla dosing consistent with U.S. FDA approved labeling

Continuation Therapy

Continuation covered when ALL of the following are met

Prior authorization duration: Initial authorization for no more than 6 months; reauthorization for no more than 12 months

Ongoing diagnosis: Patient continues to have MCI due to AD or mild dementia due to AD and Global CDR score remains 0.5 or 1.0

Updated assessments: Submission of current medical records documenting CDR Memory Box score \u2265 0.5 and MMSE \u2265 20 OR MoCA/SLUMS \u2265 17 (updated assessments measured no earlier than 4 weeks prior to continuation request)

Amyloid PET during treatment: For total treatment <= 6 months: prescriber attests amyloid PET will be performed prior to 18 months OR a post-treatment amyloid PET performed < (time unspecified) prior to request is positive by visual read; For >6 months and <=18 months: post-treatment amyloid PET obtained between 12 and 18 months is positive by visual read; For treatment beyond 18 months: post-treatment amyloid PET at least once per 12 months and positive by visual read

Initial and monitoring criteria (trial-based)

Coverage considerations align with clinical trial populations and amyloid imaging-based dosing decisions.

Patient selection: Patient has diagnosis of Alzheimer's disease with mild cognitive impairment or mild dementia consistent with the population enrolled in TRAILBLAZER-ALZ 2

FDA indication supports initiation in MCI or mild dementia

Biomarker confirmation: Presence of amyloid pathology determined by PET imaging or accepted biomarkers consistent with trial inclusion; amyloid PET used to guide dosing decisions

Trial required amyloid positivity

Dosing and monitoring: Initial dosing used in trial: 700 mg every 4 weeks for first 3 doses, then 1400 mg thereafter; dosing continued or stopped based on amyloid PET Centiloid thresholds at Weeks 24, 52, and 76Centiloid <11 on a single PET OR 11 to <25 on two consecutive PETs to switch to placebo

Amyloid PET values may increase after stopping therapy

Not Medically Necessary / Unproven Uses

Not medically necessary: Use of Kisunla outside of mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's disease dementia is considered unproven and not medically necessary

Kisunla must not be used concurrently with other amyloid‑beta monoclonal antibodies for Alzheimer’s disease. The policy explicitly excludes combination therapy with other AB mAbs (for example, Aduhelm or Leqembi) for both initiation and continuation of Kisunla treatment.

FDA approval of Kisunla is informational only and is not by itself a basis for coverage. Coverage decisions depend on the member’s specific benefit plan document and any applicable federal or state mandates; in the event of conflict, the member‑specific benefit plan governs. Providers must verify member coverage and any plan‑level requirements before initiating therapy.

Use of Kisunla outside the studied populations is considered unproven and not medically necessary. Specifically, Kisunla is unproven and not medically necessary for any indication other than mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s disease dementia.

Longer‑term clinical benefit beyond the trial timepoints has not been demonstrated. Clinical trial data show statistically significant reductions in decline through Week 76 in primary analyses, but the policy notes that there is no data demonstrating longer‑term clinical benefit, and amyloid PET values may rise after stopping treatment—factors that may influence coverage decisions in some plans.

Coding and Clinical Thresholds

HCPCSHCPCSCovered

J0175

Injection, donanemab-azbt; 2 mg

Relevant ICD-10 Diagnosis CodesICD-10

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

inv-11: MMSE — numeric threshold

MMSE thresholdMini-Mental State Examination (MMSE) score ≥ 20

ContextRequired at baseline and for continuation; updated assessments must be measured no earlier than 4 weeks prior to a continuation request

Use in documentationSubmit medical records/chart notes documenting MMSE score as part of required documentation

inv-12: MoCA or SLUMS — numeric threshold

MoCA thresholdMontreal Cognitive Assessment (MoCA) score ≥ 17

SLUMS thresholdSaint Louis University Mental Status (SLUMS) score ≥ 17

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization and Plan Verification

Prior authorization is required per UnitedHealthcare Medical Benefit Drug Policy processes. Initial approvals will be for no more than 6 months; reauthorization (continuation) approvals will be for no more than 12 months. Coverage is subject to member-specific benefit plan terms and applicable state or federal mandates.

Initial authorization duration: ≤ 6 months
Reauthorization/continuation duration: ≤ 12 months
Coverage depends on member-specific benefit plan and applicable mandates

Documentation Required

Required Clinical Documentation

Requests must include documentation that supports the diagnosis and ongoing appropriateness of therapy. Insufficient or missing documentation may result in denial or delay of the request.

Background

Alzheimer’s disease is a progressive neurodegenerative disorder characterized by extracellular amyloid‑beta plaque deposition and intracellular tau pathology that begin years before clinical symptoms. Donanemab‑azbt (Kisunla) is an IgG1 monoclonal antibody targeting N‑truncated pyroglutamate amyloid‑beta to reduce amyloid plaques; pivotal trials enrolled patients with confirmed amyloid pathology in early symptomatic stages (mild cognitive impairment or mild dementia), and dosing and monitoring in the trials incorporated amyloid PET–guided decisions.

Definitions and Scales

inv-24: Clinical Dementia Rating - Sum of Boxes (CDR-SB) — scale ranges and mapping to CDR global

CDR-SB scale rangeCDR-SB scores range from 0 to 18; higher scores indicate greater severity

Mapping to CDR global 0.5CDR-SB range ~0.5 to 4.0 corresponds to CDR global 0.5 (questionable to very mild impairment)

Mapping to CDR global 1.0CDR-SB range ~4.5 to 9.0 corresponds to CDR global 1.0 (suggests mild dementia)

inv-25: Integrated Alzheimer's Disease Rating Scale (iADRS) — description and scoring

iADRS descriptionIntegrated Alzheimer's Disease Rating Scale (iADRS) is a linear combination of ADAS-Cog13 and ADCS-iADL; lower scores indicate greater impairment

Score range

Policy Summary

PayerUnitedHealthcare

PolicyKisunla (Donanemab-Azbt) coverage criteria

Policy CodePolicy IEXDO130.01

Change TypeNo material clinical or coverage changes

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit required documentation including positive amyloid PET, CDR and cognitive test scores, baseline brain MRI, and prescriber attestation.

SourceLink

On This Page

ARIA follow-up: Submission of follow-up brain MRI after initiation showing either no ARIA observed OR if ARIA observed, prescriber attests continuation is appropriate and follow-up MRI demonstrates resolution or stabilization (or attests continuation appropriate based on radiographic severity)

No combination therapy: Not used in combination with other amyloid-beta monoclonal antibodies for Alzheimer's disease (e.g., Aduhelm, Leqembi)

Specialist prescriber and dosing: Prescribed by appropriate dementia specialist and dosing per U.S. FDA labeling

Substitution ruleMoCA or SLUMS may be submitted as an alternative to MMSE for meeting cognitive test thresholds

inv-13: CDR global — values for eligibility

Eligible CDR global scoresGlobal Clinical Dementia Rating (CDR) score of 0.5 or 1.0

Associated requirementCDR Memory Box score ≥ 0.5 required at baseline and for continuation (updated measures within 4 weeks for continuation)

Role in criteriaCDR global used to stage patient as MCI (0.5) or mild dementia (1.0) consistent with policy inclusion

inv-14: Amyloid PET Centiloid thresholds — single or consecutive scan thresholds

Single-scan threshold (switch to placebo)Centiloid < 11 on a single PET scan

Consecutive-scan threshold (switch to placebo)11 to < 25 Centiloids on two consecutive PET scans

Use in trial-based monitoringCentiloid thresholds applied at Weeks 24, 52, and 76 to determine eligibility to switch to placebo

Medical records / chart notes and laboratory values documenting diagnosis per NIA‑AA criteria

Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0 and CDR Memory Box score ≥ 0.5

Cognitive testing: MMSE ≥ 20 OR MoCA ≥ 17 OR SLUMS ≥ 17

Documentation of beta-amyloid deposition (positive amyloid PET) for initial therapy; for continuation, post-treatment amyloid PET per policy requirements

Baseline brain MRI within 12 months prior to initiating treatment

ApoE ε4 testing has been offered and shared decision-making attestation provided

Prescriber specialty documented (neurologist, geriatric psychiatrist, or geriatrician who specializes in dementia)

Note

Concomitant Standard Alzheimer's Therapies

Treatment in clinical trials and routine care may include concomitant use of approved Alzheimer's therapies. The policy allows use of cholinesterase inhibitors and memantine concurrently with Kisunla; Kisunla must not be used in combination with other anti‑amyloid monoclonal antibodies for Alzheimer's disease (e.g., aducanumab, lecanemab).

Concomitant cholinesterase inhibitors and memantine are permitted
Not to be used concurrently with other anti‑amyloid mAbs (Aduhelm, Leqembi, etc.)

Note

Provider Note

Not all potential provider actions are specified in this section. Refer to the full policy and member specific benefit plan for additional operational requirements and to UnitedHealthcare Medical Benefit Drug Policy processes for submission details.

Check member specific benefit document for coverage determination
Follow UnitedHealthcare PA submission instructions and supporting documentation requirements

Denial Risk

Documentation Insufficiency May Trigger Denial

Requests lacking required documentation (for example, absence of positive amyloid PET, missing cognitive scores, missing MRI, or lack of prescriber specialty attestation) may be denied.

Denial risk if positive amyloid evidence is not provided for initial therapy
Denial risk if required cognitive assessments (CDR, MMSE or alternatives) are not documented
Denial risk if baseline MRI or prescriber specialty is not documented

Total iADRS score ranges from 0 to 144

Interpretation guidanceiADRS combines cognitive (ADAS-Cog13) and functional (ADCS-iADL) components; minimal clinically important differences suggested as ~5 points for MCI and ~9 points for mild AD

inv-26: iADRS — integrated scale details (duplicate/related to inv-25)

ComponentsiADRS is derived from ADAS-Cog13 and ADCS-iADL; ADAS-Cog13 score is multiplied by -1 when calculating iADRS so that lower iADRS indicates greater impairment

Range and directionScore range 0-144; lower scores reflect worse cognitive and functional performance

Use in trialsPrimary efficacy endpoint in TRAILBLAZER-ALZ 2 measured change in iADRS from baseline to 76 weeks

inv-27: Centiloid — PET amyloid quantitative measure and trial thresholds

What Centiloid measuresCentiloid is a quantitative PET amyloid measure used to assess amyloid plaque burden on PET imaging

Trial thresholdsTrial rules used Centiloid <11 on a single scan or 11 to <25 on two consecutive scans to permit switching to placebo

Monitoring timepointsCentiloid values were assessed at Weeks 24, 52, and 76 in TRAILBLAZER-ALZ 2; amyloid PET values may increase after stopping therapy