ModifiedUnitedHealthcarePolicy CS2026D0108N

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

Medical benefit drug policy covering donanemab (Kisunla) and lecanemab (Leqembi) for MCI or mild dementia due to Alzheimer's disease; defines initial and continuation authorization criteria, imaging and documentation requirements, and provider responsibilities for UnitedHealthcare Community Plan members.

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS2026D0108N

Change TypeRevised continuation and authorization durations

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit medical records documenting cognitive scores and evidence of amyloid pathology and a baseline brain MRI within 12 months when requesting initiation or continuation authorization.

SourceLink

POLICY UPDATE CHANGES

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

Revised Kisunla continuation criteria: removed requirement that patient must have MCI or mild dementia or have progressed to moderate/severe with shared decision-making; extended treatment period thresholds and modified post-treatment amyloid PET timing requirements.

Revised Leqembi continuation criteria: removed requirement that patient must have MCI or mild dementia (criterion removed).

Revised continuation therapy criteria for Kisunla: removed requirement that the patient be in MCI or mild dementia or that a prescriber attest shared decision-making if progressed to moderate/severe; extended the time thresholds related to treatment duration and post-treatment amyloid PET imaging (replaced <=6 months with <=18 months for one criterion and modified PET timing language for >18 months).

For Leqembi continuation after >18 months, post-treatment amyloid PET imaging is to be performed at least once per 12 months and be positive on visual read.

Archived previous policy version CS2025D0108M.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Donanemab (Kisunla) and Lecanemab (Leqembi)

Initial Therapy — Kisunla (donanemab-azbt) initial therapy criteria (ALL required)

Kisunla (donanemab-azbt) is medically necessary when ALL of the following are met for initial therapy:

Kisunla initial: Diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease OR mild dementia due to Alzheimer’s disease per NIA-AA criteria; documented cognitive testing with one of: MMSE 20-30 OR MoCA 17-30 OR SLUMS 17-30; evidence of amyloid beta pathology via positive amyloid PET brain imaging; other causes of cognitive impairment have been reasonably excluded (e.g., DLB, FTD, vascular dementia, reversible causes); no history of intracerebral hemorrhage within the prior year; anticoagulation status addressed (patient not on anticoagulant OR if on anticoagulant, counseling provided and prescriber attests shared decision-making); counseling provided on ARIA risks and ApoE ε4 testing offered with prescriber attestation of shared decision-making when testing performed; baseline brain MRI completed within 12 months prior to initiation; not used in combination with other anti-amyloid monoclonal antibodies; prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in dementia; dosing per FDA-approved labeling; initial authorization for no more than 12 months.

From Coverage Rationale

Continuation Therapy — Kisunla continuation criteria (ALL required)

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

Continuation timing and imaging: Either: (1) 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 by visual read OR prescriber attests that amyloid PET will be performed prior to 18 months of total treatment to assess effect on amyloid; OR (2) 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 by visual read.<=18 months OR >18 months with annual positive PET

Imaging-based persistence of amyloid required as specified

Continuation safety and prescriber requirements: Submission of medical records confirming follow-up brain MRI after initiation; either no ARIA observed on MRI OR if ARIA observed then prescriber attests continuation is appropriate based on clinical severity AND either follow-up MRI demonstrates radiographic resolution/stabilization OR prescriber attests continuation appropriate based on radiographic severity; not used in combination with other anti-amyloid mAbs; prescribed by a dementia specialist (neurologist, geriatric psychiatrist, or geriatrician); dosing per FDA labeling; reauthorization for no more than 12 months.

Safety monitoring for ARIA and specialist prescriber required

Initial Therapy — Leqembi (lecanemab-irmb) initial therapy criteria (ALL required)

Leqembi (lecanemab-irmb) is medically necessary when ALL of the following are met for initial therapy:

Leqembi initial: Diagnosis of mild cognitive impairment (MCI) due to Alzheimer’s disease OR mild dementia due to Alzheimer’s disease per NIA-AA criteria; documented cognitive testing with one of: MMSE 20-30 OR MoCA 17-30 OR SLUMS 17-30; evidence of amyloid beta pathology demonstrated by positive amyloid PET OR by CSF biomarker abnormalities suggestive of beta-amyloid accumulation (e.g., Aβ42/40 ratio, ptau181/Aβ42, ttau/Aβ42); other causes of cognitive impairment have been reasonably excluded; no history of intracerebral hemorrhage within the prior year; counseling provided on ARIA risk and ApoE ε4 testing offered with prescriber attestation of shared decision-making when testing performed; baseline brain MRI completed within 12 months prior to initiation; not used in combination with other anti-amyloid monoclonal antibodies; prescribed by a neurologist, geriatric psychiatrist, or geriatrician who specializes in dementia; dosing per FDA-approved labeling; initial authorization for no more than 12 months.

From Coverage Rationale

Continuation Therapy — Leqembi continuation criteria (ALL required, excerpted)

For continuation of Leqembi, ALL of the following are required (excerpted):

Leqembi continuation safety: Prescriber attests that continuation of therapy is appropriate based on the radiographic severity of ARIA; submission of medical records confirming follow-up brain MRI after initiation; either no ARIA observed on MRI OR if ARIA observed then prescriber attests continuation is appropriate based on clinical severity AND either follow-up MRI demonstrates radiographic resolution/stabilization OR prescriber attests continuation appropriate based on radiographic severity; not used in combination with other anti-amyloid mAbs; prescribed by a dementia specialist; dosing per FDA labeling; reauthorization for no more than 12 months.

Continuation criteria focused on ARIA monitoring and prescriber attestations

Covered with criteria (summary) — Coverage aligned with trial populations and imaging-confirmed amyloid pathology

Coverage aligns with clinical trial populations and requires imaging-confirmed amyloid pathology; continuation criteria revised as noted below:

Clinical trial populations: Trials enrolled adults approximately 50–90 years with early Alzheimer’s disease (MCI or mild dementia) and required evidence of amyloid pathology on PET or CSF; cognitive and functional scales used in trials (e.g., CDR-SB, ADAS-Cog13, iADRS) inform expected patient selection and baseline ranges.

Supports coverage eligibility for initiation

Lecanemab efficacy/safety summary: CLARITY AD (n=1,795) demonstrated a statistically significant but modest slowing of clinical decline at 18 months (CDR-SB difference -0.45) with substantial amyloid PET reduction; ARIA-E incidence ~12.5% (symptomatic 2.8%).

Informs risk-benefit and monitoring

Donanemab efficacy/safety summary: TRAILBLAZER-ALZ 2 (n=1,736 randomized) showed statistically significant reductions in iADRS and CDR-SB at 76 weeks; donanemab dosing and continuation in trials were guided by serial amyloid PET centiloid thresholds with protocol-defined stopping/switch-to-placebo rules.

Continuation Therapy (Kisunla and Leqembi) - Revised — summary of revisions to continuation criteria

Revised continuation criteria for Kisunla and Leqembi (summary of changes):

Continuation Criteria (summary)

Duration-related conditions: Patient has received therapy for less than or equal to 18 months OR has received therapy for greater than 18 months with periodic post-treatment amyloid PET imaging performed at least once per 12 months that is positive on visual read.<=18 months; >18 months with annual positive PET
Kisunla language explicitly changed from <=6 months to <=18 months; PET timing for >18 months standardized to at least once per 12 months.
Removed conditions: The following continuation conditions were removed from both Kisunla and Leqembi continuation criteria: requirement that the patient has MCI due to AD; requirement that the patient has mild dementia due to AD; requirement that the patient progressed to moderate or severe dementia and the prescriber attests shared decision-making to continue therapy.
These conditions were explicitly removed from continuation criteria.

This policy specifies that anti-amyloid monoclonal antibodies must not be used concurrently. Specifically, Kisunla (donanemab-azbt) and Leqembi (lecanemab-irmb) are not to be used in combination with other Aβ monoclonal antibodies for Alzheimer’s disease, per the coverage criteria requiring monotherapy with a single Aβ‑directed mAb during treatment.

FDA approval and the labeled indications for Kisunla and Leqembi are provided for informational context only. FDA approval alone is not a basis for coverage; coverage decisions require the patient to meet the payer’s specified clinical and documentation criteria (e.g., disease stage, cognitive scores, evidence of amyloid pathology, baseline MRI).

The policy history documents that the previous policy version CS2025D0108M has been archived; prior content from that version is superseded by the current revisions reflected here.

Review of the policy history chunks shows procedural and administrative entries but no explicit coverage exclusions are listed within these specific history sections.

Multiple policy history entries reference continuing Leqembi therapy and note supporting information and prescriber attestation; these history lines document continuation but do not themselves establish additional coverage exclusions beyond the main criteria.

Within the documented policy history segments, there are no discrete coverage or exclusion criteria presented; the entries largely record revision notes such as continuing Leqembi therapy and references to supporting information rather than operational exclusions.

This portion of the policy history contains administrative revision text and supporting information placeholders but does not include explicit coverage, exclusion, or medical necessity statements in the cited chunks.

The referenced policy history section contains summaries and supporting information placeholders; there are no explicit coverage exclusions specified within these particular history entries.

The policy history text in this segment is administrative and summarizes revisions; it contains no coverage criteria, exclusions, or medical necessity statements in the cited material.

Across these revision-history chunks, no specific coverage exclusions are documented; the entries act as policy history placeholders rather than operational exclusion rules.

The policy clarifies the scope of appropriate use: Kisunla and Leqembi are considered unproven and not medically necessary for any indication other than Alzheimer’s disease. Use outside the Alzheimer’s disease indication is not supported by the coverage rationale in these sections.

The document cautions against initiating anti-amyloid therapy without evidence of amyloid pathology or in later-stage disease. Prior clinical trial failures were attributed in part to enrolling patients without documented Aβ pathology and to treating patients at later stages when irreversible neurodegeneration exists; therefore, treatment should be limited to patients with demonstrated amyloid pathology and stages studied in trials (mild cognitive impairment or mild dementia).

In the provided policy history sections there are no explicit statements designating additional interventions or scenarios as 'not medically necessary'; the chunks cited are administrative placeholders and supporting information without such determinations.

Coding and Key Values

Drug HCPCS CodesHCPCS

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

Diagnosis 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

Cognitive test score ranges for initiation (MMSE/MoCA/SLUMS)

MMSE range20 to 30

MoCA range17 to 30

SLUMS range17 to 30

Initial authorization duration (Kisunla) — new limit

Kisunla initial authorization limitNo more than 12 months

Reauthorization periodReauthorization for Kisunla is for no more than 12 months

Operational change note

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization and reauthorization are required for initial and continuation therapy for Kisunla and Leqembi. Initial authorizations are limited to no more than 12 months; reauthorizations (continuation) are limited to no more than 12 months. Requests must include submission of medical records documenting diagnosis, cognitive testing results (MMSE, MoCA, or SLUMS scores in the specified ranges), evidence of amyloid pathology (positive amyloid PET or qualifying CSF biomarkers for Leqembi), and baseline brain MRI performed within 12 months prior to initiation. Follow-up brain MRI after therapy initiation must be submitted for continuation requests. Prescriber attestation may be required for planned PET imaging or to support continuation in certain ARIA scenarios.

Initial authorization duration: <= 12 months
Reauthorization/continuation duration: <= 12 months
Baseline brain MRI within 12 months prior to initiation required
Follow-up brain MRI after initiation required for continuation
Required documentation: cognitive test scores (MMSE 20–30; MoCA 17–30; SLUMS 17–30)
Required documentation for amyloid evidence: positive amyloid PET (visual read) or CSF biomarker abnormalities (Leqembi)
Not used in combination with other Aβ monoclonal antibodies (e.g., Kisunla not combined with Leqembi)

Background on Alzheimer's Disease and Anti-amyloid Therapies

Alzheimer’s disease is characterized by progressive accumulation of amyloid‑beta (Aβ) plaques and tau neurofibrillary tangles, which contribute to neuronal injury and cognitive decline. Amyloid pathology often precedes symptoms by years and can be detected by amyloid PET imaging or CSF Aβ biomarkers, approaches used to select patients in the pivotal clinical trials and reflected in the policy’s requirement for documented amyloid positivity prior to initiating anti‑Aβ monoclonal antibody therapy.

Definitions and Key Terms

Amyloid beta (Aβ) pathology definition

DefinitionDeposition of Aβ plaques in the brain detectable by PET imaging or indirectly via CSF Aβ biomarkers

Pathophysiology noteAβ deposition generally begins decades before symptoms and precedes tau accumulation and neurodegeneration

Detection methodsDetected directly via PET tracers or indirectly by measuring long-form Aβ in CSF

Definition of Mild cognitive impairment (MCI) or mild dementia due to AD and related score ranges

Clinical definitionMild cognitive impairment (MCI) due to AD or mild dementia due to AD as defined by NIA-AA numeric clinical staging

MMSE support rangeMMSE 20 to 30 (used to document cognitive stage)

Policy History and Revision Information

(multiple entries)archival

Archived previous policy version CS2025D0108M (administrative archival noted across multiple history entries).

(various history entries)revision_note

Policy history contains multiple entries labeled 'Supporting Information' and summary lines referencing continuation of Leqembi therapy and prescriber attestation; these entries document prior supporting-information updates rather than standalone clinical criteria changes.

2026-02-01

Policy Summary

PayerUnitedHealthcare

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

Policy CodePolicy CS2026D0108N

Change TypeRevised continuation and authorization durations

Effective DateFeb 1, 2026

Next Review Date

Key ActionSubmit medical records documenting cognitive scores and evidence of amyloid pathology and a baseline brain MRI within 12 months when requesting initiation or continuation authorization.

SourceLink

On This Page

Denial Risk

Denial Risk for Insufficient Authorization or Continuation Documentation

Continuation requests may be denied if they do not meet post-treatment documentation requirements. Denial triggers include absence of required follow-up imaging or amyloid confirmation as specified for continuation (for example, missing post-treatment amyloid PET when required for treatment beyond specified durations), requests exceeding the authorized duration, or incomplete medical record submission documenting diagnosis, cognitive testing, MRI results, or amyloid evidence. Specifically, continuation beyond 18 months for Kisunla requires periodic post-treatment amyloid PET (at least once per 12 months) that is positive on visual read; missing this may lead to denial.

Denial triggers: missing required post-treatment amyloid PET or follow-up MRI documentation
Denial triggers: requests exceeding the allowed authorization duration
Denial triggers: insufficient documentation of diagnosis, cognitive scores, MRI, or amyloid evidence
Denial risk highlighted for continuation requests that lack post-treatment amyloid PET for therapies >18 months (Kisunla)

Documentation Required

Documentation Requirements and Policy History Notes

Provider should submit supporting medical records (chart notes, labs, imaging reports) that confirm: diagnosis per NIA-AA criteria, cognitive assessment scores within required ranges, baseline and follow-up brain MRI reports, and amyloid pathology evidence (amyloid PET visual read or CSF biomarker results). Prescriber attestation statements (e.g., that amyloid PET will be performed prior to 18 months, or that continuation is appropriate despite ARIA based on clinical severity) are included in the policy as acceptable supporting information. The policy history contains multiple entries labeled 'Supporting Information' and 'Summary of Changes' that reference continuation of Leqembi therapy, but these history lines do not replace the operational prior authorization criteria and should not be interpreted as standalone authorization instructions.

Submit: baseline MRI (within 12 months), follow-up MRI after initiation, amyloid PET or CSF results, cognitive test scores, prescriber notes/attestations
Policy history contains multiple 'Supporting Information' and 'Summary of Changes' entries mentioning continuation of Leqembi therapy, but those entries do not substitute for required documentation

Note

Policy History / Revision Information (Informational)

This section contains policy history and multiple 'Summary of Changes' and 'Supporting Information' placeholders. Many revision-history entries repeat 'Supporting Information' or note archival of a previous policy version (CS2025D0108M). Several history lines state 'continue Leqembi therapy' as a summary but do not present formal prior authorization criteria. Providers must rely on the operational coverage rationale and documentation criteria (initial and continuation requirements) for authorization decisions rather than the policy history placeholders.

Policy history includes multiple 'Summary of Changes = Supporting Information' entries
Policy history includes entries stating 'continue Leqembi therapy' but these do not establish prior authorization operational criteria
Archived previous policy version: CS2025D0108M noted in history