ModifiedUnitedHealthcarePolicy 2026D0130D

Kisunla (Donanemab-Azbt) — Medical Benefit Drug Policy; Coverage Criteria

Criteria and coverage stance for use of Kisunla (donanemab-azbt) to treat Alzheimer's disease in UnitedHealthcare Commercial members; includes initial and continuation authorization requirements and coding references.

Policy Summary

PayerUnitedHealthcare

PolicyKisunla (Donanemab-Azbt) — Coverage Criteria

Policy CodePolicy 2026D0130D

Change TypeMaterial coverage updates (authorization duration and imaging/continuation thresholds)

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, baseline cognitive testing, positive amyloid PET, baseline MRI within 12 months, and request reauthorization no more than every 12 months.

SourceLink

POLICY UPDATE CHANGES

Changed initial authorization duration from 'no more than 6 months' to 'no more than 12 months'.

Removed requirement that continuation therapy applicants must have specific staging language (MCI or mild dementia or prescriber attestation for progressed patients).

Extended the definition of short-duration treatment from ≤6 months to ≤18 months for continuation criteria.

Replaced prior imaging timing language for post-treatment amyloid PET with a requirement that for patients >18 months on therapy, post-treatment amyloid PET be performed at least once per 12 months and be positive on visual read.

12 monthsmaximum initial authorization duration

18 monthsshort vs long treatment threshold

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baseline cognitive score ranges

J0175drug HCPCS code listed

Prohibitedcombination therapy prohibition

Coverage Criteria for Kisunla (donanemab-azbt)

Initial Therapy

Kisunla is proven/medically necessary for initial therapy when ALL of the following are met:

Initial Therapy: Diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease OR mild dementia due to Alzheimer’s disease based on NIA-AA criteria.

Presence of amyloid beta pathology has been confirmed (e.g., positive amyloid PET).

A baseline brain magnetic resonance imaging (MRI) has been completed within 12 months prior to initiating treatment.

Other differential diagnoses (e.g., DLB, FTD, vascular dementia, pseudodementia due to mood disorder, vitamin B12 deficiency, encephalopathy) have been ruled out.

Patient is not currently taking an anticoagulant OR if on an anticoagulant the prescriber documents counseling about increased cerebral macrohemorrhage risk and attests shared decision-making regarding initiation of Kisunla.

No history of intracerebral hemorrhage within the previous year prior to initiating treatment.

Counseling has been provided on the risk of amyloid-related imaging abnormalities (ARIA-E and ARIA-H) and patient is aware to monitor for relevant symptoms (headache, dizziness, visual disturbances, nausea, vomiting).

Kisunla is prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia and dosing is in accordance with FDA-approved labeling.

Initial authorization will be for no more than 12 months.12 months

Continuation Therapy

For continuation of therapy, ALL of the following are required:

Continuation Therapy: Diagnosis of Alzheimer’s disease.

Follow-up brain MRI has been completed after initiation of therapy and submitted with reauthorization request.

Not used in combination with other Aβ monoclonal antibodies for Alzheimer’s disease (e.g., Leqembi).

Kisunla dosing is in accordance with FDA-approved labeling and prescriber is specialist in dementia (neurologist, geriatric psychiatrist, or geriatrician).

Reauthorization is for no more than 12 months.12 months

Amyloid PET and duration-based imaging requirements

Coverage and continuation overview

Coverage and continuation criteria reference the clinical trial population and imaging-based treatment management; initial authorization and continuation imaging intervals are specified.

Initial authorization duration changed to no more than 12 months.12 months

See Policy History for change.

Continuation therapy imaging frequency for long-term treatment: For patients who have received Kisunla therapy for greater than 18 months, post-treatment amyloid PET brain imaging is to be performed at least once per 12 months and must be positive for amyloid based on visual read to continue therapy.>18 months; PET at least annually

Replaces previous more complex timing language.

Operational notes for authorization: Prior authorization is expected with documentation supporting diagnosis, baseline cognitive testing, baseline MRI within 12 months, positive amyloid PET, prescriber specialization, planned dosing per FDA label, and adherence to combination therapy prohibition.

Unproven/Not Medically Necessary

Unproven/Not Medically Necessary: Kisunla is unproven and not medically necessary for any indication other than Alzheimer’s disease.

Kisunla (donanemab-azbt) is unproven and not medically necessary for any indication other than Alzheimer’s disease.

Coverage may be excluded when the member-specific benefit plan does not permit payment for experimental, investigational, or unproven treatments or for off‑label medication use; providers must consult the member’s benefit document and any applicable federal or state mandates because those terms govern coverage decisions.

Any use of Kisunla for diagnoses other than Alzheimer’s disease is considered not medically necessary/unproven and is not covered by this policy.

Coding and Test Thresholds

Drug HCPCS CodeHCPCS

J0175

Injection, donanemab-azbt, 2mg.

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

Cognitive test score thresholds — MMSE, MoCA, SLUMS

MMSE (Mini-Mental State Examination)Score range acceptable for initial therapy: 20 to 30.

MoCA (Montreal Cognitive Assessment)Score range acceptable for initial therapy: 17 to 30.

SLUMS (Saint Louis University Mental Status)Score range acceptable for initial therapy: 17 to 30.

Baseline MRI timing requirement — baseline brain MRI within specified timeframe

Required timingBaseline brain MRI must be completed within 12 months prior to initiating treatment.

PurposeEstablish baseline imaging to assess for ARIA risk and document pre-treatment brain status.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kisunla (donanemab-azbt). Initial authorizations will be for no more than 12 months. Providers must ensure prior authorization requests include all required clinical documentation described below and reference the member-specific benefit plan to determine coverage and any applicable mandates.

Initial authorization duration: no more than 12 months
Prescribers: neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia

Documentation Required

Documentation Required for Continuation Requests

When submitting a continuation (renewal) request, include documentation of post-treatment amyloid PET results and follow-up MRI as specified in the continuation criteria. For members treated ≤18 months, include either a positive post‑treatment amyloid PET based on visual read or an attestation that amyloid PET will be performed prior to 18 months of total treatment. For members treated >18 months, include post‑treatment amyloid PET performed at least once per 12 months and positive for amyloid on visual read. Also submit documentation confirming follow-up brain MRI after initiation of therapy and either that ARIA has not been observed or, if ARIA was observed, documentation that the prescriber attests continuation is appropriate with evidence of radiographic resolution and/or stabilization as applicable.

Background and Clinical Context

Alzheimer’s disease is a progressive neurodegenerative disorder characterized pathologically by accumulation of extracellular amyloid‑beta (Aβ) plaques and intracellular neurofibrillary tangles composed of hyperphosphorylated tau. Amyloid deposition often begins decades before clinical symptoms and is confirmed in practice with biomarkers such as amyloid PET or cerebrospinal fluid Aβ/p‑tau. Donanemab (Kisunla) is a humanized IgG1 monoclonal antibody directed against N‑truncated, pyroglutamate Aβ that reduces amyloid plaque burden; treatment and monitoring decisions use clinical staging (mild cognitive impairment or mild dementia) and biomarker imaging to align with the trial populations supporting efficacy.

Definitions and Trial Population

Kisunla (donanemab-azbt) — drug description and mechanism

Generic name and brandDonanemab (Kisunla, donanemab-azbt).

Molecule classHumanized IgG1 monoclonal antibody.

Mechanism of actionDirected against insoluble N‑truncated pyroglutamate amyloid‑beta to reduce amyloid beta plaques in the brain.

Indication contextUsed for treatment of Alzheimer's disease with confirmed amyloid pathology per policy criteria.

Cognitive testing (MMSE, MoCA, SLUMS) — definition and score ranges

MMSEMini-Mental State Examination; 0–30 scale. Policy accepts scores 20 to 30 for initial therapy; lower scores indicate greater impairment.

Policy Summary

PayerUnitedHealthcare

PolicyKisunla (Donanemab-Azbt) — Coverage Criteria

Policy CodePolicy 2026D0130D

Change TypeMaterial coverage updates (authorization duration and imaging/continuation thresholds)

Effective DateFeb 1, 2026

Next Review DateN/A

SourceLink

On This Page

If total therapy duration ≤ 18 months: Either post-treatment amyloid PET brain imaging is positive for amyloid based on visual read, OR prescriber attests that amyloid PET will be performed prior to 18 months of total treatment to assess effect on amyloid plaque.
If total therapy duration > 18 months: Post-treatment amyloid PET brain imaging is performed at least once per 12 months and is positive for amyloid based on visual read.>18 months; PET at least annually

ARIA management: If ARIA has not been observed on MRI, no ARIA-related limitation; if ARIA has been observed, prescriber attests continuation is appropriate based on severity and documents radiographic resolution and/or stabilization.

Initial and reauthorizations limited to no more than 12 months.

Reference in continuation criteriaFollow-up MRI must be completed after initiation and used to evaluate ARIA for continuation decisions.

Post-treatment amyloid PET brain imaging results (visual read)
Documentation of follow-up brain MRI after initiation of therapy
Prescriber attestation if ARIA observed and rationale for continuation

Billing Rule

Code Listing Disclaimer

Listing of a code in this policy does not imply that the service described by the code is a covered or non-covered health service. Benefit coverage is determined by the member-specific benefit plan document and applicable laws or mandates; inclusion of a code does not guarantee reimbursement or payment.

Example HCPCS: J0175 (Injection, donanemab-azbt, 2 mg)
Example diagnosis codes: G30.0, G30.1, G30.8, G30.9

Denial Risk

Member-Specific Benefit and Documentation Requirements

Reference the member-specific benefit plan document when requesting coverage; coverage decisions depend on plan terms and applicable federal or state mandates. Some certificates of coverage may exclude experimental/investigational/unproven treatments — in such cases coverage may be denied. Where state or federal mandates require coverage, those mandates supersede plan language. Ensure requests include member plan information and any required attestations to support coverage.

Confirm member-specific benefit plan and applicable mandates before submission
Coverage may be denied if the member's plan excludes experimental/investigational treatments

MoCAMontreal Cognitive Assessment; 0–30 scale used to detect milder deficits. Policy accepts scores 17 to 30 for initial therapy.

SLUMSSaint Louis University Mental Status exam; policy accepts scores 17 to 30 for initial therapy.

iADRS — definition of Integrated Alzheimer's Disease Rating Scale

Full nameIntegrated Alzheimer's Disease Rating Scale (iADRS).

ComponentsCombination of ADAS-Cog13 (cognitive) and ADCS-iADL (instrumental activities of daily living).

Scoring range and interpretationTotal score ranges 0 to 144; lower scores reflect worse cognitive and functional performance.

TRAILBLAZER‑ALZ 2 population — eligibility characteristics from pivotal trial

Enrollment MMSE rangePatients randomized in TRAILBLAZER‑ALZ 2 had MMSE ≥20 and ≤28.

Clinical stage and symptomsParticipants had mild cognitive impairment or mild dementia with progressive memory change for at least 6 months.

Trial size and randomizationTRAILBLAZER‑ALZ 2 randomized 1,736 patients 1:1 to donanemab versus placebo (860 treatment, 876 placebo).

Biomarker stratificationEnrollment used visual assessment of tau PET (flortaucipir) and included tau‑based low/medium and high groups; 68% low/medium, 32% high; 71% were ApoE ε4 carriers.