CurrentEmblemHealthPolicy MG.MM.PH.361

Aduhelm (aducanumab) - MEDICAID ONLY

Defines EmblemHealth Medicaid coverage, dosing, authorization, and renewal criteria for Aduhelm (aducanumab) for treatment of mild cognitive impairment or mild Alzheimer disease. Affects providers seeking preauthorization or renewal for Medicaid members.

Policy Summary

PayerEmblemHealth

PolicyAduhelm (aducanumab) - MEDICAID ONLY

Policy CodePolicy MG.MM.PH.361

Change TypeAnnual reviewadded renewal attestation

Effective DateAug 2, 2022

Next Review DateApr 29, 2024

Key ActionSubmit prior authorization with clinical evidence and attest at renewal that the patient's cognitive score is stable or improved versus baseline.

SourceLink

POLICY UPDATE CHANGES

Added Renewal Criteria- Provider must attest that the patient's score remained stable or improved using the same baseline assessment used for initial approval.

Annual Review: Manufacturer discontinuing in 2024, no criteria changes.

12 monthsLength of authorization

10 mg/kgMaintenance dose

MMSE 24-30Required severity scores

J0172Procedure code

64406-0101-01

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Coverage and Medical Necessity Criteria

Initial Therapy

Covered when ALL of the following are met

Initial Criteria for Aduhelm

A: Evidence of mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia as indicated by Clinical Dementia Rating (CDR)-Global score 0.5–1, Mini-Mental State Examination (MMSE) score 24–30, and/or Montreal Cognitive Assessment (MoCA) score ≥18CDR 0.5-1; MMSE 24-30; MoCA ≥18
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B: Apolipoprotein E (APOE) ε4 carrier status has been evaluated
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C: Positive amyloid status demonstrated by a PET scan or cerebrospinal fluid (CSF) analysis positive for amyloid beta deposits
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D: No evidence of another medical or neurological condition that could contribute to cognitive impairment (examples include stroke/vascular dementia, tumor, dementia with Lewy bodies, frontotemporal dementia)
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E: No history of a clotting disorder and not taking antiplatelet or anticoagulant medications other than aspirin ≤325 mg/dayaspirin ≤325 mg/day allowed
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F: Use of aducanumab is consistent with the FDA-approved product information
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Continuation Therapy / Renewal

Renewal covered when ALL of the following are met

Renewal Criteria for Aduhelm: Provider attests that the patient's score remained stable or improved using the same baseline assessment utilized for initial approval (CDR-Global, MMSE, and/or MoCA)stable or improved compared to baseline

Added renewal requirement (11/17/2022); see revision history

Coverage for Aduhelm is limited to patients who meet the policy's specified diagnostic, biomarker, and safety requirements. Specifically, patients with other medical or neurological conditions that could explain cognitive impairment (for example, stroke/vascular dementia, tumor, dementia with Lewy bodies, or frontotemporal dementia) are excluded from approval under the initial criteria. Additionally, individuals with a history of a clotting disorder or who are taking antiplatelet or anticoagulant medications (other than aspirin ≤325 mg/day) do not meet the safety requirements for initial coverage.

Use must also be consistent with the FDA-approved product information; failure to meet any of the listed items A–F in the initial criteria will render the request not approvable under this policy.

Use of Aduhelm outside the specified disease stage — i.e., not for mild cognitive impairment due to Alzheimer disease or mild Alzheimer dementia as defined by the policy thresholds — or without meeting the required diagnostic, biomarker, and safety conditions (items A–F) is not considered medically necessary under this coverage policy.

Applicable Codes and Score Ranges

Applicable Procedure CodesHCPCS

J0172

Injection, aducanumab-avwa, 2 mg

Applicable NDCsNDC

64406-0101-01	170 mg/1.7mL (100 mg/mL) single-dose vial
64406-0102-02	300 mg/3 mL (100 mg/mL) single-dose vial

Applicable ICD-10 DiagnosesICD-10

G30.1	Alzheimer's disease with late onset
G30.8	Other Alzheimer's disease
G30.9	Alzheimer's disease, unspecified

Cognitive assessment score ranges

Clinical Dementia Rating (CDR) — Global0.5 to 1 (CDR-Global)

Mini-Mental State Examination (MMSE)Score between 24 and 30

Montreal Cognitive Assessment (MoCA)Score ≥ 18

Authorization, Documentation, and Billing Actions

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Initial approval is required before initiation of therapy. Providers must obtain prior authorization from EmblemHealth; approval for renewal/continuation is contingent on the initial authorization and meeting the renewal criteria.

Prior authorization required for initial therapy and must be obtained prior to treatment initiation.

Step Therapy

Step therapy is not required. However, coverage (both initial and renewal) is contingent on meeting all applicable clinical criteria in the policy.

No step therapy required.
Approval contingent on meeting the Initial Criteria (I) and Renewal Criteria (II) as applicable.

Background and Clinical Context

Aduhelm (aducanumab) is a recombinant human IgG1 monoclonal antibody designed to promote clearance of amyloid aggregates and insoluble amyloid beta (Aβ) in the brain. It received FDA approval under the accelerated approval pathway based on its effect in reducing amyloid‑beta plaques in patients with mild cognitive impairment or mild Alzheimer disease. Aduhelm is administered by intravenous infusion with weight‑based dosing escalation to a 10 mg/kg maintenance dose, and use must align with the FDA‑approved product information.

Definitions

Aduhelm (aducanumab) — definition & mechanism

Generic name / termAduhelm (aducanumab)

Drug class / typeRecombinant human IgG1 monoclonal antibody

Mechanism summaryDesigned to promote clearance of amyloid aggregates and insoluble amyloid‑beta (Aβ) in the brain

Regulatory statusFDA approved under accelerated approval for treatment of MCI or mild dementia due to Alzheimer disease based on reduction of Aβ plaques

Policy Revision History

2024-04-29annual_reviewLatest

Annual review noted manufacturer discontinuing in 2024; no changes to coverage criteria.

2023-08-11annual_review

Annual review conducted with no changes to coverage criteria.

2022-11-17policy_change

Added renewal requirement: provider must attest that the patient’s score remained stable or improved using the same baseline assessment as for initial approval (CDR‑Global, MMSE, and/or MoCA).

Policy Summary

PayerEmblemHealth

PolicyAduhelm (aducanumab) - MEDICAID ONLY

Policy CodePolicy MG.MM.PH.361

Change TypeAnnual reviewadded renewal attestation

Effective DateAug 2, 2022

Next Review DateApr 29, 2024

Key ActionSubmit prior authorization with clinical evidence and attest at renewal that the patient's cognitive score is stable or improved versus baseline.

SourceLink

On This Page

Documentation Required

Required Clinical Documentation

Documentation required for clinical review: submit complete clinical evidence demonstrating the member meets all criteria. Incomplete documentation may delay or prevent approval.

Cognitive assessment scores used for approval: CDR‑Global Score, MMSE score, and/or MoCA score (include baseline and most recent scores).
Evidence of APOE ε4 evaluation (documentation of carrier status or statement that testing was performed).
Positive amyloid biomarker evidence: PET amyloid scan report or CSF analysis showing amyloid beta positivity.
Clinical history and exam notes demonstrating absence of alternative medical or neurological causes of cognitive impairment (e.g., stroke, tumor, Lewy body dementia, frontotemporal dementia).
For renewals: provider attestation that the patient’s score remained stable or improved using the same baseline assessment tool as used for initial approval.

Denial Risk

Missing Clinical Documentation — Denial Risk

Missing Clinical Documentation — Denial Risk: Failure to submit the required documentation (including baseline cognitive scores, APOE ε4 evaluation results, and amyloid biomarker evidence) will place the request at high risk for denial. EmblemHealth will not be able to properly review preauthorization or post-payment without these materials.

Omissions that may cause denial: missing baseline or follow-up cognitive scores; no documentation of APOE ε4 evaluation; absent PET or CSF amyloid positivity report; insufficient clinical history excluding other causes of cognitive impairment.
If documentation is not provided, the request may be denied and/or returned for additional information; prior authorization cannot be issued without required evidence.

2022-08-02policy_creation

Policy created as a new Medicaid-only coverage policy for aducanumab (Aduhelm).