ModifiedColorado Rocky Mountain Health PlansPolicy IEXD0130.03

Kisunla (donanemab-azbt) — Coverage Criteria

Defines medical necessity criteria, authorization, and coding for Kisunla (donanemab-azbt) for treatment of Alzheimer’s disease for Individual Exchange plans (excludes MA, NV, NY). Applies to prescribers and providers requesting drug benefit coverage.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKisunla (donanemab-azbt) — Coverage Criteria

Policy CodePolicy IEXD0130.03

Change TypeOperational revisions to authorization durations and continuation imaging/timing

Effective DateFeb 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization with documentation of diagnosis, baseline cognitive scores, positive amyloid PET, baseline MRI, and specialist prescriber; initial authorization limited to ≤ 12 months.

SourceLink

POLICY UPDATE CHANGES

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

Revised continuation criteria to remove requirement that the patient be in MCI or mild dementia or attest to shared decision-making if progressed to moderate/severe dementia.

Extended allowable prior treatment window from <=6 months to <=18 months for continuation criteria.

Clarified post-treatment amyloid PET imaging requirement for patients treated >18 months to be performed at least once per 12 months and positive by visual read.

J0175HCPCS code listed

≤12moAuthorization durations

MMSE 20–30

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Baseline cognitive ranges

1,736Patients randomized

≤12moNew initial auth

Coverage Criteria for Kisunla (donanemab-azbt)

Initial Therapy

Covered when ALL of the following are met for 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.

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

Amyloid pathology: Submission of medical records documenting presence of amyloid beta pathology evidenced by positive amyloid PET brain imaging.

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

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

ARIA counseling and ApoE: Counseling provided on ARIA risks and on how ApoE ε4 status informs ARIA risk; ApoE ε4 testing has been offered and prescriber attests to shared decision-making regarding testing.

Baseline MRI: Baseline brain MRI completed within 12 months prior to initiating treatment.

Monotherapy: Not used in combination with other amyloid-beta 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 and authorization duration: Kisunla dosing is in accordance with FDA-approved labeling.

Initial authorization will be for no more than 12 months.

Continuation Therapy

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

Amyloid PET timing and treatment duration option A: Both: patient has received Kisunla therapy for less than or equal to 18 months AND either post-treatment amyloid PET is positive based on visual read OR prescriber attests that amyloid PET will be performed prior to 18 months to assess effect.

Revised continuation window allows ≤18 months prior treatment before required PET.

Amyloid PET timing and treatment duration option B: Both: patient has received Kisunla therapy for greater than 18 months AND post-treatment amyloid PET is performed at least once per 12 months and is positive for amyloid based on visual read.

Annual PET required for patients treated >18 months.

Follow-up MRI and ARIA: Submission of records confirming follow-up brain MRI after initiation AND either ARIA not observed OR (ARIA observed AND prescriber attests continuation appropriate based on clinical severity AND either follow-up MRI shows radiographic resolution/stabilization OR prescriber attests continuation appropriate based on radiographic severity).

Other Indications

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

Coverage criteria (initial and continuation)

Covered when ALL of the following are met (reflecting trial entry and policy revision):

Population and diagnosis: Patient has mild cognitive impairment or mild dementia stage of Alzheimer's disease consistent with the TRAILBLAZER-ALZ 2 trial population and documented progressive memory decline for ≥6 months.MMSE ≥20 and ≤28

Trial enrollment criteria; policy aligns initiation to this population.

Biomarker confirmation: Evidence of brain amyloid pathology confirmed by amyloid PET (visual read/centiloid thresholds) or validated CSF/biomarker testing prior to initiation.Amyloid PET visual read/centiloid thresholds used for in-trial dosing decisions (switch to placebo if <11 Centiloids on single PET or 11–<25 on two consecutive PETs)

Policy requires amyloid confirmation per trial and imaging-guided treatment continuation.

Dosing and imaging plan:

This policy applies to Individual Exchange benefit plans in all states except for Massachusetts (MA), Nevada (NV), and New York (NY). Requests for coverage under those state-specific Individual Exchange plans are not governed by this document.

Information about U.S. Food and Drug Administration action is provided for reference only. FDA approval alone is not a basis for coverage; coverage decisions are determined by the member’s specific benefit plan and the medical necessity criteria in this policy.

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

Kisunla is not indicated for use in patients who do not have confirmed amyloid pathology; initiation without biomarker confirmation is unsupported by trial evidence and may be denied. The therapy is also not appropriate for patients with later-stage dementia where significant, irreversible neurodegeneration has already occurred, as prior trials excluded such patients and outcomes are unlikely to be altered. Additionally, continuation or long‑term use beyond the evidence base (beyond the 76‑week trial data) lacks supporting data, and post‑treatment amyloid dynamics are uncertain; the policy requires imaging-based confirmation and adherence to the specified monitoring schedule to support continued treatment.

Coding and Test Ranges

HCPCS CodesHCPCSCovered

J0175

Injection, donanemab-azbt, 2mg

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

Affected codesmixed

affected codes

Placeholder codes referenced in prior authorization section of policy

Baseline cognitive test acceptable ranges — MMSE / MoCA / SLUMS

MMSEScore range 20 to 30 documented in medical records as baseline eligibility

MoCAScore range 17 to 30 documented in medical records as baseline eligibility

SLUMSScore range 17 to 30 documented in medical records as baseline eligibility

MMSE — trial-specified range / threshold

MMSE trial entry rangePatients enrolled with MMSE ≥ 20 and ≤ 28 (TRAILBLAZER-ALZ 2)

Clinical requirement linkPolicy aligns initiation to trial enrollment MMSE threshold for the covered population

Prior Authorization, Documentation, and Monitoring

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kisunla (donanemab — donanemab‑azbt). Providers must request prior authorization before initiating therapy and for reauthorization. Initial authorizations will be for no more than 12 months; reauthorizations may be granted for no more than 12 months at a time.

Affected product: Kisunla (donanemab‑azbt)
Initial authorization: ≤ 12 months
Reauthorization: ≤ 12 months

Prior Authorization

Prior Authorization — Kisunla (donanemab) Specifics

Kisunla prior authorization must document that the patient meets the trial- and FDA-aligned population: diagnosis of MCI due to Alzheimer disease or mild dementia due to Alzheimer disease, confirmation of amyloid pathology, baseline cognitive scores in specified ranges, and treatment prescribed by an appropriate dementia specialist. Dosing must follow FDA labeling.

Diagnoses required: MCI due to AD or mild dementia due to AD (NIA‑AA criteria)
Baseline cognitive testing: MMSE 20–30, or MoCA 17–30, or SLUMS 17–30

Background

Alzheimer disease is characterized by progressive accumulation of amyloid‑beta (Aβ) plaques and pathologic tau, which together contribute to synaptic dysfunction and neurodegeneration. Aβ deposition typically begins decades before clinical symptoms, and therapeutic approaches targeting aggregated Aβ aim to remove plaques or limit further accumulation. Clinical trials of anti‑Aβ antibodies have often failed when patients lacked documented Aβ pathology or when treatment was initiated in later stages with established irreversible neurodegeneration. The donanemab program (TRAILBLAZER‑ALZ 2) enrolled patients in early symptomatic stages (mild cognitive impairment or mild dementia due to AD) and used serial amyloid PET and cognitive/functional endpoints to assess treatment effect over the trial timeframe.

Definitions and Clinical Terms

Kisunla (donanemab-azbt) — drug description

Generic descriptionKisunla (donanemab-azbt) is a humanized IgG1 monoclonal antibody directed against insoluble N‑truncated pyroglutamate amyloid beta that reduces amyloid beta plaques.

Therapeutic targetTargets aggregated/insoluble N‑truncated pyroglutamate Aβ plaques in Alzheimer’s disease

Drug classMonoclonal antibody (IgG1) for amyloid-beta plaque reduction

Eligible clinical stage — MCI due to AD or mild dementia due to AD per NIA-AA criteria

Eligible diagnosesMild cognitive impairment (MCI) due to Alzheimer’s disease OR mild dementia due to Alzheimer’s disease per NIA-AA criteria

Corresponding trial stagesPopulation consistent with numeric clinical stages 3-4 (early symptomatic) as used in TRAILBLAZER-ALZ 2

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyKisunla (donanemab-azbt) — Coverage Criteria

Policy CodePolicy IEXD0130.03

Change TypeOperational revisions to authorization durations and continuation imaging/timing

Effective DateFeb 1, 2026

Next Review DateN/A

SourceLink

On This Page

Monotherapy and prescriber/dosing: Not used in combination with other amyloid-beta monoclonal antibodies; prescribed by appropriate dementia specialist; dosing per FDA labeling.

Reauthorization is for no more than 12 months.

Planned dosing per trial (700 mg x3 then 1400 mg every 4 weeks) with scheduled amyloid PET assessments to guide continuation or stopping; dose adjustments permitted for ARIA findings on MRI.

Amyloid PET assessments at approximately Weeks 24, 52, and 76 in-trial; switch criteria: <11 centiloids on single PET or 11–<25 on two consecutive PETs

Documented PET results required to support continuation.

Authorization duration: Initial authorization limited to no more than 12 months; continuation requires meeting ongoing imaging and treatment-duration criteria as specified in policy revisions.Continuation windows include allowances up to and beyond 18 months with annual PET if treated >18 months

Reflects recent policy changes (initial auth extended to 12 months; continuation timing revised).

Progressive memory declinePatients had progressive change in memory function for ≥ 6 months at enrollment

iADRS — primary efficacy endpoint measured at 76 weeks

iADRS endpointPrimary efficacy endpoint: change in iADRS from baseline to 76 weeks

iADRS compositionComposite of ADAS-Cog13 and ADCS-iADL; total score range 0–144 with lower scores indicating worse function

Statistical result at 76 weeksDonanemab showed statistically significant reduction in clinical decline on iADRS versus placebo at Week 76

Amyloid PET Centiloid rules — switch to placebo thresholds

Single-PET switch ruleIf amyloid plaque level is < 11 Centiloids on a single PET scan, patient eligible to be switched to placebo

Two-consecutive-PET switch ruleIf amyloid plaque level is 11 to < 25 Centiloids on two consecutive PET scans, patient eligible to be switched to placebo

In-trial PET timepointsAmyloid PET assessments performed at approximately Weeks 24, 52, and 76 to guide switching decisions

Amyloid confirmation: positive amyloid PET brain imaging (visual read)

Prescriber: neurologist, geriatric psychiatrist, or geriatrician specializing in dementia

Dosing: per FDA approved labeling

Documentation Required

Required Clinical Documentation for Authorization

Required clinical documentation must be submitted with the prior authorization request. Incomplete documentation is a frequent cause of denial.

Medical records/chart notes documenting diagnosis and differential diagnoses ruled out
Baseline and follow‑up cognitive test scores (MMSE, MoCA, or SLUMS) with dates
Baseline amyloid PET result (positive) and any post‑treatment amyloid PET results (visual read) with dates
Baseline brain MRI within 12 months prior to initiation and follow‑up MRIs after initiation with reports documenting presence/absence and course of ARIA
ApoE ε4 testing offered and prescriber attestation of shared decision‑making regarding testing and ARIA risk counseling
Dates and doses of Kisunla administered, and prescriber specialty

Documentation Required

Reauthorization Monitoring and Continuation Criteria

Reauthorization requires documentation of ongoing appropriateness and monitoring per policy timing. Continuation criteria differ by total duration of prior therapy and require evidence related to post‑treatment amyloid PET and MRI/ARIA monitoring.

If total Kisunla therapy ≤ 18 months: documentation that treatment duration is ≤ 18 months AND either (a) a post‑treatment amyloid PET is positive on visual read, or (b) prescriber attests that amyloid PET imaging will be performed prior to reaching 18 months of total treatment to assess treatment effect
If total Kisunla therapy > 18 months: post‑treatment amyloid PET must be performed at least once every 12 months and be positive on visual read
Submission of follow‑up brain MRI after therapy initiation is required; if ARIA observed, provide MRI reports and prescriber attestation that continuation is appropriate based on clinical severity and/or radiographic resolution/stability

Step Therapy

Step Therapy / Concomitant Therapy

Step therapy and concomitant therapy rules: no formal step‑therapy requirement with other anti‑amyloid mAbs is allowed; Kisunla must not be used in combination with other Aβ monoclonal antibodies. Concomitant use of approved symptomatic AD therapies is permitted.

Not used in combination with other Aβ mAbs (e.g., Leqembi) — combination usage is contraindicated by policy
Concomitant cholinesterase inhibitors and memantine are permitted (no step requirement to try/stop these agents)
If patient is on anticoagulants, either: patient is not taking an anticoagulant OR if taking an anticoagulant, counseling provided and prescriber attests shared decision‑making regarding increased hemorrhage risk

Denial Risk

Denial Triggers — Initial Authorization

Denials or non‑coverage may occur if required diagnostic, biomarker, imaging, safety, specialist, dosing, or monitoring criteria are not met or adequately documented.

Missing or non‑confirmatory amyloid PET (must be positive by visual read)
Diagnosis not consistent with MCI due to AD or mild dementia due to AD per NIA‑AA criteria
Baseline cognitive scores outside required ranges or not documented
No baseline MRI within 12 months prior to initiation or missing required follow‑up MRIs
Prescriber is not a dementia specialist as required
Dosing not consistent with FDA approved labeling
Failure to provide documentation of counseling for ARIA and ApoE ε4 testing offer

Denial Risk

Denial Triggers — Continuation/Reauthorization

Denials for continuation may follow failure to meet the revised continuation criteria, insufficient post‑treatment imaging evidence, inadequate ARIA monitoring or documentation, or lack of prescriber attestation where required.

For therapy ≤ 18 months: absence of documentation that post‑treatment amyloid PET is planned prior to 18 months when required, or lack of positive post‑treatment amyloid PET when requested
For therapy > 18 months: absence of annual post‑treatment amyloid PET or negative amyloid PET on visual read
Lack of required follow‑up MRI reports or unresolved/untreated ARIA without prescriber justification
Prescriber fails to attest shared decision‑making for anticoagulant or ApoE ε4 considerations

Requirement for progressive declinePatients had progressive change in memory function for at least 6 months at trial enrollment

iADRS — integrated AD Rating Scale definition and scoring context

DefinitionIntegrated Alzheimer’s Disease Rating Scale (iADRS) is a composite of ADAS-Cog13 and ADCS-iADL

Scoring rangeTotal iADRS score ranges from 0 to 144, with lower scores indicating worse cognitive and functional performance

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

Tau PET classification — low/medium/high SUVR thresholds

Low/medium tauDefined by flortaucipir visual assessment and SUVR ≥ 1.10 and ≤ 1.46

High tauDefined by flortaucipir visual assessment and SUVR > 1.46

Trial population splitIn TRAILBLAZER-ALZ 2, 68% had low/medium tau and 32% had high tau based on these thresholds