ModifiedUnitedHealthcarePolicy CSOH2O25D01O8.D

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease (for Ohio Only)

This UnitedHealthcare Medical Benefit Drug Policy governs coverage and medical necessity criteria for the monoclonal antibody therapies Leqembi (lecanemab-irmb) and Kisunla (donanemab-azbt) for treatment of Alzheimer disease in Ohio members.

Policy Summary

PayerUnitedHealthcare

PolicyMonoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease (for Ohio Only)

Policy CodePolicy CSOH2O25D01O8.D

Change TypeMaterial operational updates and code removals

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, cognitive scores, and positive amyloid PET for Kisunla requests.

SourceLink

POLICY UPDATE CHANGES

Removed content addressing Aduhelm (aducanumab-avwa) because the drug product is no longer available for use.

Removed HCPCS code J0172 from Applicable Codes.

Archived previous policy version CSOH2O25D0108.C.

2drugs named in policy

J0174, J0175, G30.xexample codes listed

≤6m initial; ≤12m reauthauth durations (Kisunla)

Amyloid PET requiredbiomarker requirement

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1pivotal phase 3 trial

Coverage and Medical Necessity Criteria

Initial Therapy (Kisunla)

Kisunla (donanemab-azbt) may be covered when ALL of the following initial and continuation criteria are met.

ALL of the following

Diagnosis of one of the following based on National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria: mild cognitive impairment (MCI) due to Alzheimer’s disease; or mild dementia due to Alzheimer’s disease.
Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0.
- CDR Memory Box score of 0.5 or greater.
- Mini-Mental State Examination (MMSE) score of 20 or greater.
- One of the following: Montreal Cognitive Assessment (MoCA) score of 17 or greater; or Saint Louis University Mental Status (SLUMS) score of 17 or greater.
Documentation of presence of beta-amyloid protein deposition as evidenced by a positive amyloid PET brain scan (visual read).
Other primary causes of cognitive impairment have been reasonably excluded (e.g., dementia with Lewy bodies, frontotemporal dementia, vascular dementia, pseudodementia due to mood disorder, vitamin B12 deficiency, encephalopathy).
- Counseling provided that combined use of Kisunla with anticoagulant drugs may increase risk of cerebral macrohemorrhage and prescriber attests shared decision-making to initiate Kisunla therapy.
- 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 the patient is aware to monitor for headache, dizziness, visual disturbances, nausea, and vomiting.
Testing for ApoE e4 status has been offered to the patient and prescriber attests that the patient has shared in decision-making to initiate Kisunla therapy.
A baseline brain magnetic resonance imaging (MRI) has been completed within 12 months prior to initiating treatment.
Kisunla is not used in combination with other anti-amyloid monoclonal antibodies for Alzheimer’s disease (e.g., Leqembi).
Kisunla dosing is in accordance with the United States Food and Drug Administration approved labeling.
Initial authorization
- Initial authorization will be for no more than 6 months.

Continuation Therapy (Kisunla)

Kisunla continuation and reauthorization are covered when ALL of the following criteria are met.

ALL of the following

Patient continues to have one of the following diagnoses based on NIA-AA criteria: mild dementia due to Alzheimer’s disease; or mild cognitive impairment (MCI) due to Alzheimer’s disease.
Global Clinical Dementia Rating (CDR) score of 0.5 or 1.0.
- CDR Memory Box score of 0.5 or greater.
- Mini-Mental State Examination (MMSE) score of 20 or greater.
- One of the following: MoCA score of 17 or greater; or SLUMS score of 17 or greater.

Coverage criteria - Initial treatment (Leqembi)

Leqembi (lecanemab) may be covered when ALL of the following trial-aligned criteria are met.

ALL of the following

Diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s disease dementia consistent with the population studied in pivotal trials (treatment initiated in early-stage disease).
Confirmation of brain amyloid pathology prior to initiation by a positive amyloid PET scan (visual read) or equivalent validated biomarker evidence of amyloid deposition.
Baseline cognitive assessment consistent with trial entry: MMSE score ≥ 20 and < 28 and documented progressive change in memory function for at least 6 months.
Baseline tau assessment consistent with trial enrollment when available (e.g., tau PET visual read or SUVR categorization) per prescriber discretion.

Kisunla (donanemab-azbt) is unproven and not medically necessary for any indication other than mild cognitive impairment due to Alzheimer\u2019s disease and mild Alzheimer\u2019s disease dementia. Use outside these populations (for example, in moderate to severe Alzheimer\u2019s disease or in patients without demonstrated amyloid pathology) is not covered.

Many investigational anti-amyloid therapies have failed due to lack of target engagement, inclusion of patients without amyloid pathology, inadequate dosing or brain penetration, and enrollment of patients at later stages of Alzheimer\u2019s disease when irreversible neurodegeneration is more advanced. TRAILBLAZER-ALZ 2 supported efficacy of donanemab in patients with confirmed amyloid pathology and early-stage disease (MCI or mild dementia), and FDA labeling reflects initiation in these populations. Therefore, use without evidence of amyloid pathology or in later-stage disease is considered not medically necessary.

Applicable Codes and Coding Notes

Applicable HCPCS codesHCPCS

J0174	Injection; lecanemab-irmb, 1 mg.
J0175	Injection, donanemab-azbt; 2 mg

Applicable ICD-10 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

Removed/Archived HCPCS codesHCPCSNot Covered

J0172

Previously listed HCPCS code (removed from Applicable Codes)

inv-11: Amyloid PET Centiloid stopping threshold

Centiloid stopping ruleSwitch to placebo if amyloid PET ≤ 11 Centiloids on a single scan or 11 to <25 Centiloids on 2 consecutive PET scans.

Assessment timepointsAmyloid PET assessed at Weeks 24, 52, and 76 to determine eligibility for switch to placebo based on Centiloid thresholds.

Impact on treatment durationPercent eligible for switch to placebo at Weeks 24 / 52 / 76 were 17% / 47% / 69% in TRAILBLAZER-ALZ 2.

inv-12: MMSE inclusion range

MMSE inclusion rangeMMSE ≥ 20 and < 28 (eligibility criterion in TRAILBLAZER-ALZ 2).

Associated enrollment requirement

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Kisunla (donanemab-azbt). Initial authorization will be for no more than 6 months; reauthorization (continuation) approvals are for no more than 12 months. Prescribers must confirm the patient matches the trial‑aligned population (mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's disease dementia) and that treatment is being initiated in the mild cognitive impairment or mild dementia stage consistent with the clinical trials.

Initial authorization: ≤ 6 months
Reauthorization/continuation: ≤ 12 months
Treatment must be for MCI due to AD or mild AD dementia (trial-aligned population)

Documentation Required

Required Clinical Documentation

Submit medical records documenting baseline and follow-up clinical and biomarker assessments required to determine medical necessity and support both initial and continuation requests. For initial requests provide documentation completed no earlier than 12 months prior to initiation unless otherwise noted; for continuation requests updated assessments must be measured no earlier than 4 weeks prior to the continuation request.

Clinical Background

Alzheimer disease is characterized by progressive accumulation of extracellular amyloid‑beta plaques and intracellular neurofibrillary tangles composed of tau protein; amyloid accumulation typically begins decades before clinical symptoms emerge. Biomarker confirmation of abnormal amyloid (for example, by amyloid PET or validated CSF testing) is used to identify the target population for anti‑amyloid therapies. Donanemab (Kisunla) is a monoclonal IgG1 antibody directed at an N‑truncated, pyroglutamate form of amyloid‑beta and reduces plaque burden; clinical trial evidence supporting benefit was generated in patients with confirmed amyloid pathology and early-stage disease (mild cognitive impairment or mild dementia).

Key Definitions and Test Descriptions

inv-24: Amyloid PET — definition

DefinitionPositron emission tomography (PET) imaging using radiotracers to detect abnormal amyloid-beta (Aβ) plaque deposition in the brain.

Alternate biomarkerAbnormal Aβ may also be detected indirectly by measuring Aβ levels in cerebrospinal fluid (CSF).

Role in policyPositive amyloid PET is required documentation of beta-amyloid deposition for initial and continuation therapy with donanemab per the policy.

inv-25: MMSE / MoCA / CDR-SB — definitions and score ranges

MMSEMini-Mental State Examination (MMSE): 0–30 scale; lower scores reflect greater cognitive impairment.

MoCAMontreal Cognitive Assessment (MoCA): 0–30 scale; more sensitive than MMSE for detecting mild cognitive impairment.

Policy Changes and Version History

2025-07-01operational_removalLatest

References to Aduhelm (aducanumab-avwa) were removed from the coverage rationale because the drug product is no longer available.

2025-07-01code_removal

HCPCS code J0172 was removed from the policy's Applicable Codes list.

2025-07-01archival

Policy Summary

PayerUnitedHealthcare

PolicyMonoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimers Disease (for Ohio Only)

Policy CodePolicy CSOH2O25D01O8.D

Change TypeMaterial operational updates and code removals

Effective DateJul 1, 2025

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, cognitive scores, and positive amyloid PET for Kisunla requests.

SourceLink

On This Page

If patient has received Kisunla therapy for less than or equal to 6 months
- Prescriber attests that amyloid PET imaging will be performed prior to 18 months of total treatment to assess effect of Kisunla on amyloid plaque; OR a post-treatment amyloid PET brain scan performed < 1 month prior to the request for continued treatment is positive for amyloid based on visual read.
If patient has received Kisunla therapy for greater than 6 months
- A post-treatment amyloid PET brain scan obtained between 12 and 18 months of total treatment is positive for amyloid based on visual read.

For treatment beyond 18 months, a post-treatment amyloid PET brain scan must be performed at least once per 12 months and be positive for amyloid based on visual read.

Prescriber attests that continuation of therapy is appropriate based on the severity of the patient’s clinical symptoms, and follow-up MRI demonstrates radiographic resolution and/or stabilization.
OR prescriber attests that continuation of therapy is appropriate based on the radiographic severity of ARIA.

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

Kisunla dosing is in accordance with the U.S. FDA approved labeling.

Prescribed by a neurologist; geriatric psychiatrist; or geriatrician who specializes in treating dementia.

Reauthorization is for no more than 12 months.

Prescriber documents discussion of risks including amyloid-related imaging abnormalities (ARIA), and offers ApoE e4 testing to inform ARIA risk; patient shared decision-making is attested by the prescriber.

Baseline brain MRI completed prior to initiating therapy to assess for contraindications (e.g., recent intracerebral hemorrhage) and to allow ARIA monitoring during treatment.

Not used in combination with other anti-amyloid monoclonal antibodies (e.g., Kisunla).

Treatment follows dosing and monitoring per U.S. FDA-approved labeling and trial-derived safety monitoring (including periodic MRI for ARIA surveillance).

Progressive change in memory function for at least 6 months required for trial entry.

Trial contextRange reflects the mild cognitive impairment to mild dementia population enrolled in the pivotal trial supporting donanemab approval.

Baseline cognitive and functional assessments: Global CDR score (0.5 or 1.0), CDR Memory Box ≥ 0.5, MMSE ≥ 20, and one of: MoCA ≥ 17 or SLUMS ≥ 17
Documentation of amyloid pathology: positive amyloid PET scan OR other medical records demonstrating beta‑amyloid deposition
Baseline brain MRI within 12 months prior to initiating therapy and submission of follow-up MRI results after treatment initiation documenting ARIA status (ARIA not observed or documented ARIA with radiographic resolution/stabilization as applicable)
Documentation that ApoE ε4 testing was offered and prescriber attests patient shared in decision‑making regarding Kisunla therapy
For continuation: documentation that patient continues to meet cognitive thresholds (CDR Memory Box, MMSE, MoCA/SLUMS) and evidence of amyloid positivity on post‑treatment amyloid PET per timing requirements (see policy)

Denial Risk

Concomitant Therapy Restriction and Coding Disclaimer

Kisunla must not be used in combination with other anti‑amyloid (AB) monoclonal antibodies (e.g., Leqembi/lecanemab). Listing of procedure or diagnosis codes in this policy is for reference only and does not imply coverage or a guarantee of payment — member plan benefits and applicable law determine coverage and reimbursement.

Do not coadminister Kisunla with other anti‑amyloid mAbs for Alzheimer's disease (e.g., Leqembi)
Code listing disclaimer: inclusion of codes does not establish coverage or reimbursement rights

CDR-SBClinical Dementia Rating – Sum of Boxes (CDR-SB): 0–18 scale; higher scores indicate greater disease severity and map to global CDR stages (e.g., 0.5–4.0 corresponds to CDR‑G 0.5).

inv-26: iADRS — definition and score directionality

DefinitionIntegrated Alzheimer's Disease Rating Scale (iADRS): composite of ADAS‑Cog13 and ADCS‑iADL; total score ranges 0–144 with lower scores indicating worse cognitive and functional performance.

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

DirectionalityLower iADRS scores reflect greater impairment (worse cognitive/functional performance).

inv-27: Tau PET populations — SUVR thresholds

Low/medium tau populationDefined by visual assessment and flortaucipir SUVR ≥ 1.10 and < 1.46 (used as a primary analysis population in TRAILBLAZER‑ALZ 2).

High tau populationDefined by visual assessment and flortaucipir SUVR ≥ 1.46 (included in combined population analyses).

Trial relevanceEfficacy analyses reported outcomes for both the low/medium tau subgroup and the combined low/medium plus high tau population.

Previous policy version CSOH2O25D0108.C was archived.