ModifiedColorado Rocky Mountain Health PlansPolicy 2026D0130D

Kisunla (donanemab-azbt) — Coverage Criteria for Alzheimer’s Disease

Clinical criteria and coverage policy for use of Kisunla (donanemab-azbt) for treatment of Alzheimer’s disease, including initial and continuation authorization requirements and applicable billing codes; applies to Colorado Rocky Mountain Health Plans members under UnitedHealthcare Commercial Medical Benefit Drug Policy.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKisunla (donanemab-azbt) — Coverage Criteria for Alzheimer’s Disease

Policy CodePolicy 2026D0130D

Change TypeMaterial updates to authorization durations and continuation imaging/criteria

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of positive amyloid PET and baseline cognitive testing (e.g., MMSE 20-30) and request authorizations for no more than 12 months.

SourceLink

POLICY UPDATE CHANGES

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

Replaced continuation criterion limiting prior therapy duration of ≤ 6 months with ≤ 18 months and modified post-treatment amyloid PET imaging timing and requirements for treatment beyond 18 months.

Removed requirement that patient must have MCI due to Alzheimer's disease or mild dementia due to Alzheimer's disease (or progressed to moderate/severe with shared decision-making) as a continuation criterion.

12 monthsAuthorization duration

MMSE 20-30Baseline cognitive requirement

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Amyloid PET required

Biomarker requirement

Specialist onlyPrescriber specialty

Coverage Criteria for Kisunla (donanemab-azbt)

Initial Therapy

Covered when ALL of the following are met for initial therapy:

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

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

Baseline MRI: Baseline brain magnetic resonance imaging (MRI) completed within 12 months prior to initiating treatment.

Baseline cognitive testing: Submission of medical records documenting one of the following: MMSE 20–30 OR MoCA 17–30 OR SLUMS 17–30.

Anticoagulant status: Either the patient is not currently taking an anticoagulant OR the patient is taking an anticoagulant and counseling provided about increased hemorrhage risk and prescriber attests shared decision-making.

ARIA and ApoE counseling: Counseling provided on the risk of amyloid-related imaging abnormalities (ARIA) and on how ApoE ε4 status informs ARIA risk; testing for ApoE ε4 has been offered and prescriber attests shared decision-making.

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

No combination anti-Aβ mAbs: Not used in combination with other amyloid-β monoclonal antibodies for Alzheimer’s disease (e.g., Leqembi).

Prescriber specialty: Prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia.

Dosing per FDA labeling: Kisunla dosing is in accordance with United States FDA–approved labeling.

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

Continuation Therapy

Covered when ALL of the following are met for continuation of therapy:

Diagnosis of Alzheimer’s disease.

Follow-up MRI and ARIA management: Follow-up brain MRI completed after initiation of therapy; no ARIA observed on MRI OR if ARIA observed the prescriber attests continuation is appropriate based on clinical severity and follow-up MRI demonstrates radiographic resolution and/or stabilization.

Post-treatment amyloid PET schedule: If total treatment duration is ≤ 18 months: either post-treatment amyloid PET is positive for amyloid by visual read OR prescriber attests amyloid PET will be performed prior to 18 months. If total treatment duration is > 18 months: post-treatment amyloid PET is performed at least once per 12 months and is positive for amyloid by visual read.

No combination anti-Aβ mAbs: Not used in combination with other amyloid-β monoclonal antibodies for Alzheimer’s disease.

Initial and continuation therapy

Covered when ALL of the following are met (summary of content present in this document portion):

Treated population consistent with trials: Patient has confirmed amyloid pathology and is in the mild cognitive impairment or mild dementia stage of Alzheimer’s disease (trial population); trial entry MMSE range was ≥20 and ≤28 and progressive memory change for ≥6 months.MMSE ≥20 and ≤28; progressive memory change ≥6 months

Treatment should be initiated in the population studied in TRAILBLAZER-ALZ 2.

Dosing, monitoring, and PET-guided stopping rules: Donanemab dosing per study: 700 mg for first 3 doses then 1400 mg every 4 weeks; treatment may be switched to placebo/stopped based on amyloid PET at Weeks 24, 52, and 76 using Centiloid thresholds (eligible to stop if single PET <11 Centiloids or two consecutive PETs 11 to <25 Centiloids); dose adjustments permitted for ARIA events.PET at Weeks 24/52/76; stop if single PET <11 CL or two consecutive 11–<25 CL

No data beyond 76 weeks to guide additional dosing.

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

FDA approval alone is not a basis for coverage. Coverage determinations for Kisunla are made in the context of this policy and must be applied together with the member’s specific benefit documents and any applicable mandates.

Any use of Kisunla outside the specific Alzheimer’s disease indications and the clinical criteria described in this policy is considered unproven and not medically necessary.

Use of anti-amyloid therapies in patients without evidence of amyloid pathology or in later stages of Alzheimer’s disease characterized by significant, irreversible neurodegeneration is unlikely to be effective and is considered not medically necessary, reflecting trial evidence that benefit requires target pathology and earlier-stage disease.

Billing and Diagnosis Codes

Applicable HCPCS CodesHCPCS

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

No CPT/HCPCS/ICD-10 codes listed in this document portionmixed

No codes listed

MMSE inclusion in TRAILBLAZER-ALZ 2

MMSE range in TRAILBLAZER-ALZ 2MMSE ≥ 20 and ≤ 28 (enrollment criterion)

Clinical contextPatients had progressive memory change ≥ 6 months and were in mild cognitive impairment or mild dementia stages

Trial dosing related noteEntry MMSE range corresponds to population randomized to donanemab vs placebo (n=1,736)

Amyloid PET Centiloid thresholds for stopping treatment

Single PET stopping thresholdIf a single amyloid PET Centiloid value is < 11, patient eligible to be switched to placebo (stop treatment)

Two-consecutive PETs threshold

Prescriber Requirements, Authorization, and Documentation

Prior Authorization

Prior authorization required — initial and reauthorization

Prior authorization is required for initial and continuation requests. Initial and reauthorization requests are limited to no more than 12 months and must meet the clinical criteria outlined in the policy.

Initial and reauthorization duration: <= 12 months
Prescriber specialty requirement: neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia

Documentation Required

Required clinical documentation

Submission of complete clinical documentation is required to support both initial authorization and continuation requests. Incomplete documentation may result in denial.

Baseline cognitive testing: MMSE 20–30 OR MoCA 17–30 OR SLUMS 17–30 (medical records/chart notes must be submitted)

Background on Alzheimer's Disease and Treatment Context

Alzheimer's disease is characterized by accumulation of extracellular amyloid‑beta (Aβ) plaques and intracellular tau neurofibrillary tangles. Amyloid deposition typically begins decades before clinical symptoms, and progression to symptomatic disease involves spreading tau pathology and progressive neurodegeneration. This pathogenic sequence underlies the rationale for anti‑Aβ therapies that aim to reduce plaque burden early in the disease course.

Key Definitions and Clinical Measures

Donanemab (Kisunla) — description and mechanism

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

Drug classHumanized IgG1 monoclonal antibody

Target and mechanismDirected against insoluble N‑truncated pyroglutamate amyloid‑β; reduces amyloid‑β plaques in the brain

Indication contextDeveloped for treatment of Alzheimer’s disease by targeting amyloid plaque pathology

Cognitive assessments and scoring

MMSEMini‑Mental State Examination (MMSE): 0–30 score; lower scores indicate greater impairment; commonly used to assess global cognition

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKisunla (donanemab-azbt) — Coverage Criteria for Alzheimer’s Disease

Policy CodePolicy 2026D0130D

Change TypeMaterial updates to authorization durations and continuation imaging/criteria

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit prior authorization with documentation of positive amyloid PET and baseline cognitive testing (e.g., MMSE 20-30) and request authorizations for no more than 12 months.

SourceLink

On This Page

Dosing compliance: Kisunla dosing is in accordance with United States FDA–approved labeling.

Prescriber specialty: Prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia.

Reauthorization duration: Reauthorization is for no more than 12 months.

Continuation decision factors:

Continuation depends on prior duration of therapy and periodic positive amyloid PET results; policy updated continuation thresholds to allow prior therapy ≤18 months and to require annual post-treatment amyloid PET for >18 months of therapy.

Prior therapy threshold ≤18 months; annual PET for >18 months

Specific continuation documentation and timing must be provided for authorization.

If two consecutive amyloid PETs are 11 to < 25 Centiloids, patient eligible to be switched to placebo

Timing of PET assessmentsAmyloid PET measurements used at Weeks 24, 52, and 76 to determine eligibility to stop treatment

MMSE entry range (trial)

MMSE trial entry range>= 20 and <= 28

Associated enrollment criteriaProgressive memory change ≥ 6 months required for trial entry

Population stagePatients were in mild cognitive impairment or mild dementia stage (Stage 3–4)

Documentation confirming presence of amyloid beta pathology: positive amyloid PET brain imaging (visual read)

Baseline brain MRI completed within 12 months prior to initiating treatment and follow-up MRI after initiation (medical records/chart notes)

Documentation that other differential diagnoses have been ruled out

Documentation of counseling regarding ARIA risks and ApoE ε4 testing offered and shared decision-making attestation

Note

Imaging-guided therapy continuation

Continuation of therapy is contingent on imaging-guided monitoring and trial-based stopping rules derived from clinical evidence. Post-treatment amyloid PET imaging and serial MRI findings must be documented to support ongoing treatment.

For patients treated ≤ 18 months: post-treatment amyloid PET is positive for amyloid on visual read OR prescriber attests that amyloid PET will be performed prior to 18 months of total treatment
For patients treated > 18 months: post-treatment amyloid PET must be performed at least once per 12 months and be positive for amyloid on visual read
Follow-up brain MRI must be completed after initiation of therapy and submitted with reauthorization requests
ARIA on MRI: if ARIA has not been observed, continuation may proceed; if ARIA observed, prescriber must attest that continuation is appropriate based on severity of clinical symptoms and provide evidence of radiographic resolution and/or stabilization when applicable
Not used in combination with other Aβ monoclonal antibodies (e.g., Leqembi); dosing per FDA labeling

Montreal Cognitive Assessment (MoCA): 0–30 score; more sensitive than MMSE for detecting mild cognitive impairment

SLUMSSaint Louis University Mental Status (SLUMS): cognitive screening tool with scoring similar purpose to MMSE/MoCA (documented in policy as acceptable baseline tests)

iADRS — definition and interpretation

DefinitionIntegrated Alzheimer's Disease Rating Scale (iADRS): combination of ADAS‑Cog13 and ADCS‑iADL

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

Primary endpoint in trialiADRS change from baseline to 76 weeks was the primary efficacy endpoint in TRAILBLAZER‑ALZ 2

ARIA (amyloid‑related imaging abnormalities) — types and monitoring implications

ARIA typesAmyloid‑related imaging abnormalities include ARIA‑E (edema/effusion) and ARIA‑H (hemorrhage/hemosiderin deposition)

Implications for dosingDose adjustments were allowed for treatment‑emergent ARIA; ARIA findings may prompt treatment interruption or modification

Monitoring requirementBaseline MRI within 12 months prior to initiating treatment and follow‑up MRI after initiation to monitor for ARIA

Clinical decision contextIf ARIA is observed on MRI, prescriber must attest that continuation is appropriate based on clinical severity and radiographic resolution/stability