CurrentAnthemPolicy CC-0200

Medical Drug Clinical Criteria — Aduhelm (aducanumab)

Defines Anthem's clinical review and coverage stance for Aduhelm (aducanumab-avwa) under the medical benefit, including clinical background, safety concerns, coding, and prior authorization expectations for providers requesting Aduhelm.

Policy Summary

PayerAnthem

PolicyMedical Drug Clinical Criteria — Aduhelm (aducanumab)

Policy CodePolicy CC-0200

Change TypeCoverage stance clarifiedcoding update

Effective Date

Next Review Date

Key ActionSubmit prior authorization with applicable treatment/procedure codes and ICD-10 diagnoses for clinical review; requests for Aduhelm may not be approved for any diagnosis.

SourceLink

POLICY UPDATE CHANGES

Removed All diagnosis pend to clarify Aduhelm may not be approved for any diagnosis.

Coding Update: Note that HCPCS J0172 will be discontinued 1/1/26.

41.7%subjects with ARIA events on Aduhelm 10 mg/kg (EMERGE)

7.5%subjects with symptomatic ARIA on Aduhelm 10 mg/kg (EMERGE)

FDA accelerated approvalapproval pathway

Discontinuedmanufacturer status

Coverage determination and clinical rationale

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Coverage determination

Anthem's clinical criteria for Aduhelm

Coverage stance: Requests for Aduhelm are subject to clinical review and may not be approved for any diagnosis.

Document states requests may not be approved; FDA accelerated approval based on amyloid reduction with uncertain clinical benefit; CMS NCD limits coverage to CED and manufacturer has discontinued product; HCPCS J0172 will be discontinued 1/1/2026.

Requests for Aduhelm (aducanumab) for any diagnosis may not be approved. This document reflects Anthem's stance that prior authorization/clinical review is required and that coverage determinations for Aduhelm are subject to clinical review and potential denial regardless of the requested diagnosis.

There is no reliably verified clinical benefit for Aduhelm. FDA approval was granted under the accelerated approval pathway based on reduction in amyloid beta plaques, but it is uncertain whether plaque reduction translates to meaningful cognitive improvement and continued approval depends on confirmatory trials.

The pivotal phase 3 trials (EMERGE and ENGAGE) were stopped early for futility, produced conflicting results between studies, had high dropout rates and limited exposure to the high dose (10 mg/kg), and only a minority of participants were included in key analyses—factors that undermine confidence in demonstrated efficacy.

Safety concerns include a substantial incidence of amyloid-related imaging abnormalities (ARIA) in treated patients and uncertainty about the balance of benefits and harms; taken together the trial design, early termination, inconsistent efficacy findings, and safety signals support the conclusion that evidence is insufficient to reliably demonstrate clinically meaningful benefit.

Prior authorization, documentation, and provider-facing guidance

Prior Authorization

Prior Authorization Required

Prior authorization/clinical review is required. Requests for Aduhelm (aducanumab) for any diagnosis may not be approved.

Aduhelm (aducanumab): requests may not be approved for any diagnosis
Prior authorization/clinical review required for medical-benefit review

Documentation Required

Coding and Documentation

Providers should include applicable treatment/procedure and diagnosis codes when submitting requests for clinical review or prior authorization. Coding is provided for informational purposes and does not guarantee coverage or reimbursement; verify member contract benefits at time of service.

HCPCS: J0172 — Injection, aducanumab-avwa, 2 mg (Note: HCPCS J0172 will be discontinued 1/1/2026)
ICD-10: All diagnosis — requests for Aduhelm may not be approved for any diagnosis

Clinical background and drug information

Aduhelm (aducanumab-avwa) is a human monoclonal IgG1 anti-amyloid beta antibody indicated for treatment of Alzheimer's disease and was approved by the FDA under the accelerated approval pathway based on reduction in amyloid beta plaques observed in treated individuals.

The clinical development program included two identical 18-month phase 3 trials (EMERGE and ENGAGE) in patients with early Alzheimer’s disease (mild cognitive impairment or mild dementia) that were terminated early for futility. Post‑hoc and subgroup analyses yielded conflicting efficacy signals and only a small proportion of participants had evaluable high‑dose exposure and complete outcome data.

Use of Aduhelm is associated with notable safety concerns, including a substantial frequency of amyloid‑related imaging abnormalities (ARIA) observed in trial participants. Because clinical benefit remains unverified and safety risks exist, confirmatory trials were required as a condition of accelerated approval.

Key terms and safety concepts

Accelerated approval — definition

DefinitionFDA accelerated approval: a pathway where approval is based on a surrogate or intermediate clinical endpoint (here, reduction in amyloid beta plaques) with a requirement for confirmatory trials to verify clinical benefit.

Basis for Aduhelm approvalAduhelm was approved under accelerated approval based on observed reduction in amyloid beta plaques, not on demonstrated clinical benefit.

Confirmatory requirementContinued approval may be contingent on verification of clinical benefit in confirmatory trial(s); manufacturer has up to 9 years to submit results.

Uncertainty of clinical benefitThe relationship between amyloid beta plaque reduction and clinically meaningful cognitive benefit is uncertain; trials produced conflicting results and no replication of benefit.

ARIA — definition and safety

DefinitionAmyloid-related imaging abnormalities (ARIA): MRI findings that include edema or sulcal effusions (ARIA-E) and microhemorrhage or superficial siderosis (ARIA-H).

Frequency with high-dose AduhelmIn EMERGE (10 mg/kg), subjects with any ARIA events: 41.7% vs placebo 10.2%; ARIA-E 34.4% vs 2.4% placebo; ARIA-H (microhemorrhage) 19.7% vs 6.8% placebo.

Symptomatic ARIASubjects with symptomatic ARIA on Aduhelm 10 mg/kg: 7.5% (placebo 0.4%).

Timing and unknown long-term impactMost ARIA-E radiographic events occurred early in treatment (within the first 8 doses); the long-term effect of ARIA in individuals with dementia is unknown.