ModifiedUnitedHealthcarePolicy CS2026D0108O

Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease

Defines UnitedHealthcare Community Plan medical benefit drug coverage criteria for lecanemab (Leqembi) and donanemab (Kisunla) for treatment of mild cognitive impairment or mild dementia due to Alzheimer's disease, including initial and continuation authorization requirements and required testing.

Policy Summary

PayerUnitedHealthcare

PolicyMonoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease

Policy CodePolicy CS2026D0108O

Change TypeCoding updatestate applicability editarchival

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation including baseline cognitive scores and evidence of amyloid pathology (PET or CSF) and baseline brain MRI within 12 months.

SourceLink

POLICY UPDATE CHANGES

Updated list of applicable HCPCS codes to reflect quarterly edits; revised description for J0174.

Removed content/language pertaining to the state of Louisiana.

Archived previous policy version CS2026D0108N.

2drugs referenced

12 monthsinitial auth period

MMSE 20-30baseline cognitive ranges

J0174, J0175

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12.5%ARIA-E incidence (lecanemab)

Coverage Criteria for Leqembi and Kisunla

Kisunla (donanemab-azbt) Continuation Therapy

Covered for continuation when ALL of the following are met:

Kisunla continuation therapy: Either: (A) Patient has received Kisunla therapy for less than or equal to 18 months AND either post-treatment amyloid PET brain imaging is positive for amyloid based on visual read OR the prescriber attests that amyloid PET will be performed prior to 18 months to assess treatment effect; OR (B) Patient has received Kisunla therapy for greater than 18 months AND post-treatment amyloid PET brain imaging is performed at least once per 12 months and is positive for amyloid based on visual read. AND submission of medical records confirming follow-up brain MRI has been completed after initiation of therapy; AND either ARIA has not been observed on MRI OR if ARIA has been observed then the 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 continuation is appropriate based on radiographic severity; AND Kisunla is not used in combination with other Aβ monoclonal antibodies; AND prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia; AND dosing is in accordance with FDA-approved labeling; AND reauthorization is for no more than 12 months.

Complex conditional logic with time-based branches (≤18 months vs >18 months) and ARIA management requirements.

Leqembi (lecanemab-irmb) Continuation Therapy

Covered for continuation when ALL of the following are met:

Leqembi continuation therapy: Submission of medical records confirming follow-up brain MRI has been completed after initiation of therapy; AND either ARIA has not been observed on MRI OR if ARIA has been observed then the prescriber attests that continuation of therapy with Leqembi is appropriate based on the severity of the patient’s clinical symptoms; AND either follow-up MRI demonstrates radiographic resolution and/or stabilization OR the prescriber attests continuation is appropriate based on the radiographic severity of ARIA; AND Leqembi is not used in combination with other Aβ monoclonal antibodies; AND prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in treating dementia; AND dosing is in accordance with FDA-approved labeling; AND reauthorization is for no more than 12 months.

Documented prescriber attestation required when ARIA observed.

Unproven/Not Medically Necessary Indications

Other indications: Kisunla (donanemab-azbt) and Leqembi (lecanemab-irmb) are unproven and not medically necessary for any indication other than Alzheimer’s disease.

Initial coverage criteria

Covered when ALL of the following mirror clinical trial populations and diagnostic confirmation:

Therapy-specific dosing and monitoring: Therapy is administered at dosing regimens studied in clinical trials (e.g., lecanemab 10 mg/kg IV every 2 weeks; donanemab initial dosing then 1,400 mg every 4 weeks) with monitoring for ARIA via MRI and for infusion-related reactions; dosing continued or stopped in response to observed effects on amyloid imaging per trial protocols (donanemab PET-guided switch rules).

ARIA rates, dosing schedules, and PET-guided switching described in trials

Concurrent administration of more than one anti-amyloid (Aβ) monoclonal antibody for Alzheimer's disease is prohibited. The policy explicitly states that Kisunla (donanemab-azbt) and Leqembi (lecanemab-irmb) must not be used in combination and coverage will not be provided when two Aβ mAbs are given concurrently.

Coverage is limited to patients with early Alzheimer's disease populations consistent with the clinical trials (mild cognitive impairment due to AD or mild dementia due to AD). Members without evidence of amyloid pathology by PET or cerebrospinal fluid biomarkers are excluded from coverage, as are patients outside the trial populations (for example, later-stage dementia). Documentation of biomarker-confirmed amyloid pathology is required to align treatment with the populations studied.

Kisunla (donanemab-azbt) and Leqembi (lecanemab-irmb) are considered unproven and not medically necessary for any indication other than Alzheimer's disease. The policy therefore does not cover use of these agents for other neurologic or non‑neurologic indications outside the labeled/trial AD populations.

Anti-amyloid antibody therapy is not covered when patients lack confirmation of amyloid pathology or when treatment is initiated at later, irreversible stages of Alzheimer's disease. The clinical evidence section notes that many prior anti-Aβ trials failed due to inclusion of patients without Aβ pathology or those at advanced stages where irreversible neurodegeneration had already occurred; therefore, treatment without biomarker confirmation or for advanced dementia is not supported by the trials and is considered not medically necessary.

Applicable Codes and Test Thresholds

Applicable Codes (reference)mixed

J0174	Lecanemab-irmb, for intravenous injection, 1mg
J0175	Injection, donanemab-azbt, 2mg
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

Applicable HCPCS codes (updated quarterly)HCPCS

J0174

Description revised per policy history (specific updated description not included in this extract)

Cognitive test eligibility ranges (baseline)

MMSE20–30

MoCA17–30

SLUMS17–30

Baseline brain MRI timing and use

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

PurposeAssess for ARIA baseline findings and exclude other structural causes of cognitive impairment

Continuation requirement

Prior Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior authorization timeframe and imaging requirements

Prior authorization required. Initial authorizations will be limited to no more than 12 months; reauthorization (continuation) requests are limited to no more than 12 months per authorization period and require updated imaging and clinical documentation to demonstrate ongoing appropriateness.

Initial authorization duration: ≤ 12 months
Reauthorization duration: ≤ 12 months; requires post-treatment imaging and documentation

Prior Authorization

Prior authorization for lecanemab and donanemab

Prior authorization will only be approved when documentation confirms treatment is being initiated in patients with mild cognitive impairment (MCI) due to Alzheimer's disease or mild dementia due to Alzheimer's disease, and when diagnostic confirmation of amyloid pathology is provided as required by the specific agent.

Lecanemab: diagnostic confirmation of amyloid pathology required (positive amyloid PET or qualifying CSF biomarkers).

Background and Rationale

Alzheimer's disease (AD) is characterized by accumulation of amyloid‑beta plaques and neurofibrillary tangles that lead to synaptic dysfunction and neurodegeneration. Amyloid accumulation often predates clinical symptoms by years and is detectable using amyloid PET imaging or cerebrospinal fluid biomarkers. Anti-amyloid monoclonal antibodies such as Leqembi (lecanemab-irmb) and Kisunla (donanemab-azbt) target aggregated forms of Aβ with the intent of reducing plaque burden; their development and clinical trial results emphasize the need for biomarker confirmation and early-stage treatment to show clinical benefit.

Definitions and Clinical Measures

Amyloid-related imaging abnormalities (ARIA): definitions and counseling

ARIA-EAmyloid-related imaging abnormality with edema (ARIA-E): MRI finding characterized by edema or sulcal effusion; requires counseling on risk and symptom monitoring

ARIA-HAmyloid-related imaging abnormality with hemosiderin/hemorrhage (ARIA-H): MRI finding indicating microhemorrhage or superficial siderosis

Counseling pointsProvide counseling on ARIA risk prior to initiation and instruct patients to monitor for headache, dizziness, visual disturbances, nausea, and vomiting

Cognitive scales and specified score use

MMSEUsed as a baseline cognitive assessment; acceptable score range for eligibility: 20–30

MoCA

Policy Summary

PayerUnitedHealthcare

PolicyMonoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease

Policy CodePolicy CS2026D0108O

Change TypeCoding updatestate applicability editarchival

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization with required documentation including baseline cognitive scores and evidence of amyloid pathology (PET or CSF) and baseline brain MRI within 12 months.

SourceLink

On This Page

Follow-up brain MRI must be completed after initiation for continuation documentation

Donanemab amyloid PET switch-to-placebo thresholds (centiloids)

Donanemab PET switch threshold (single scan)< 11 centiloids

Donanemab PET switch threshold (consecutive scans)11 to < 25 centiloids on two consecutive PET scans

Operational consequencePatients meeting these centiloid thresholds were eligible to be switched to placebo in TRAILBLAZER-ALZ 2

Donanemab: diagnostic confirmation per labeling and trial populations (treatment initiated in MCI or mild dementia).

Prescriber specialty requirement: neurologist, geriatric psychiatrist, or geriatrician who specializes in dementia.

Documentation Required

Documentation and diagnostic confirmation required

Providers must submit medical records to support the diagnosis, baseline cognitive status, and biomarker confirmation. Lack of required documentation may result in denial of the request.

Required initial documentation: chart notes, laboratory values, baseline cognitive testing scores (MMSE 20–30, MoCA 17–30, or SLUMS 17–30).
Required diagnostic confirmation: positive amyloid PET; or for lecanemab, alternatively CSF biomarker results documenting beta-amyloid pathology (e.g., Aβ42/40 ratio, p-tau181/Aβ42, t-tau/Aβ42).
Prescriber attestation that dosing follows FDA labeling.

Note

Coverage not guaranteed by FDA approval

FDA approval does not by itself guarantee coverage. Coverage decisions require member-specific clinical documentation that meets the policy criteria.

Do not rely on FDA approval alone as the basis for coverage.
Submit member-specific documentation to demonstrate criteria are met.

Documentation Required

Required documentation for initial therapy

For initial therapy, submit medical records documenting diagnosis, baseline cognitive testing, baseline brain MRI within 12 months prior to initiation, prescriber specialty, and evidence of amyloid pathology (as applicable to the agent).

Baseline MRI completed within 12 months prior to treatment start.
Cognitive testing: MMSE, MoCA, or SLUMS scores in allowable ranges.
Amyloid confirmation: positive amyloid PET or CSF biomarker (per agent requirements).
Prescriber specialty: neurologist, geriatric psychiatrist, or geriatrician experienced in dementia.

Documentation Required

Required documentation for continuation

For continuation (reauthorization), submit post-treatment amyloid PET results (visual read) and follow-up brain MRI reports; document ARIA monitoring and clinical status. Continuation decisions depend on imaging results, ARIA findings, and prescriber attestation of clinical appropriateness.

Post-treatment amyloid PET: positive for amyloid by visual read when required for continuation (timing varies by agent and duration of therapy).
Follow-up MRI after therapy initiation; document presence/absence of ARIA and any radiographic resolution/stabilization.
Prescriber attestation that continuation is appropriate in the setting of ARIA when observed.

Documentation Required

Required clinical documentation

Clinical documentation must support early Alzheimer's disease staging (MCI or mild dementia) using NIA-AA criteria and include baseline cognitive scores, biomarker evidence of amyloid, prescriber specialty, and adherence to FDA dosing.

Diagnosis per NIA-AA criteria: MCI due to AD or mild dementia due to AD.
Baseline cognitive scores within specified ranges (MMSE, MoCA, SLUMS).
Amyloid pathology evidence (PET or CSF where applicable).
Prescriber specialty: neurologist, geriatric psychiatrist, or geriatrician specializing in dementia.

Denial Risk

Concurrent Aβ mAb use restriction

Concurrent use of more than one anti–amyloid-β monoclonal antibody is prohibited. Do not combine lecanemab and donanemab or other Aβ mAbs for Alzheimer's disease.

Concurrent administration of Kisunla (donanemab) with Leqembi (lecanemab) or other Aβ mAbs is not allowed.

Prior Authorization

Imaging-guided dosing continuation (operational)

Operational imaging-guided dosing for donanemab: dosing may be continued or switched to placebo based on amyloid PET centiloid thresholds measured at scheduled timepoints (e.g., Week 24, Week 52, Week 76). Providers must submit PET results used to guide dosing decisions.

Donanemab PET-guided rules: eligible to switch to placebo if < 11 Centiloids on a single PET or 11 to < 25 Centiloids on two consecutive PETs (per trial operational rules).
Providers must submit amyloid PET values and the dates of PET scans used for dosing decisions.
Be aware PET values may change after treatment is stopped; document PET-based decisions in the medical record.

Used to detect subtle cognitive deficits; acceptable score range for eligibility: 17–30

SLUMSAlternative baseline cognitive assessment; acceptable score range for eligibility: 17–30

Other scalesCDR‑SB, ADAS‑Cog13, and iADRS referenced for staging and outcome assessment in trials

Alzheimer's numeric clinical stages (selected descriptions)

Numeric Clinical StagingStages 2–6 described in NIA‑AA numeric clinical staging; Stage 3 = cognitive impairment with early functional impact; Stage 4 = dementia with mild functional impairment; Stage 5–6 = moderate to severe functional impairment

Stage 2Transitional decline: mild detectable change with minimal impact on daily function

Stage 3Performance in impaired range with early functional impact; corresponds to early symptomatic AD relevant to trial populations

Leqembi (lecanemab-irmb): definition and mechanism

DefinitionLeqembi (lecanemab-irmb) is a humanized IgG1 monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta

MechanismBinds aggregated soluble and insoluble Aβ to reduce amyloid plaque burden

Indication contextReferenced as therapy for early Alzheimer’s disease (MCI or mild dementia) when trial-based criteria met

Kisunla (donanemab-azbt): definition and mechanism

DefinitionKisunla (donanemab-azbt) is a humanized IgG1 monoclonal antibody directed against N‑truncated pyroglutamate amyloid beta

MechanismTargets N‑truncated pyroglutamate Aβ and reduces amyloid beta plaques as demonstrated in TRAILBLAZER‑ALZ 2

Operational monitoringDosing and continuation in trials were guided by serial amyloid PET centiloid thresholds and MRI monitoring for ARIA