Aduhelm (aducanumab) prior authorization — medical necessity and monitoring criteria
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Medical prior authorization criteria and dosing/monitoring requirements for Aduhelm (aducanumab) IV for AvMed members; applies to prescribers and administering facilities seeking coverage for Aduhelm infusions.
No material clinical or coverage changes in this revision.
Coverage Criteria for Aduhelm (aducanumab)
inv-01: Initial Authorization
Covered when ALL of the following are met
See initial authorization requirements
Submit baseline dementia rating scale results and chart notes ruling out alternate diagnoses
Amyloid PET required
Submit MRI results
Medication and event history required
Clinical assessment required
Documentation of counseling required
inv-02: Continuation of Therapy
Covered when ALL of the following are met (continuation of therapy)
See continuation scheduling details
Submit follow-up assessment results
Submit MRIs at specified timepoints
See ARIA MRI Classification Criteria and stability requirements
inv-03: Dosing and ARIA management
Follow recommended dosing schedule and vial information
See label recommendations for ARIA-E and ARIA-H dosing decisions
AvMed limits Aduhelm use to patients with mild cognitive impairment (MCI) due to Alzheimer's disease or mild Alzheimer's dementia. The policy states there is insufficient evidence to support Aduhelm for moderate or severe Alzheimer's disease, and all listed clinical criteria must be met and documented for coverage consideration.
AvMed considers the current evidence insufficient to determine that Aduhelm improves health outcomes. Coverage is available only when the member satisfies the policy’s specified medical necessity criteria and all required supporting documentation (labs, diagnostics, chart notes) is submitted; incomplete documentation may lead to denial.
Coding and ARIA Thresholds
| J0172 | Aduhelm (aducanumab) injection, intravenous |
Provider Requirements and Prior Authorization Actions
Prior Authorization Required
Prior authorization required — A prior authorization is required for Aduhelm (aducanumab) IV (J0172); initial approvals are for 6 months (6 infusions).
Samples and Prior Therapy Verification
Samples and prior therapy verification — Use of drug samples to initiate therapy does not meet step edit/preauthorization criteria. Previous therapies will be verified through pharmacy paid claims or submitted chart notes; samples cannot be used to satisfy step-therapy or prior-authorization requirements.
- Use of samples to initiate therapy does not meet step edit/preauthorization criteria.
- Previous therapies will be verified through pharmacy paid claims or submitted chart notes.
Required Clinical Documentation
Required clinical documentation — Submit baseline dementia rating scale results (e.g., CDR-GS, MMSE, RBANS, MoCA), positive amyloid PET documentation, recent brain MRI results, and follow-up MRIs as specified for ARIA monitoring. Provider must also submit chart notes ruling out alternative diagnoses and documenting signs/symptoms of mild cognitive impairment when applicable.
Incomplete Documentation Risk
Incomplete documentation risk — Authorization can be delayed or denied if request information is incomplete, incorrect, or illegible. Ensure all supporting documentation (labs, diagnostic reports, MRI and PET results, baseline and follow-up cognitive testing, provider chart notes, prescriber signature and contact information) is included with the request to avoid processing delays.
- Authorization can be delayed or denied if information is incomplete, incorrect, or illegible.
- Include prescriber signature (no preprinted stamps), phone and fax numbers, MRI/PET reports, baseline and follow-up cognitive test results, and relevant chart notes.
Background
Aduhelm is a monoclonal antibody targeting beta-amyloid that received FDA approval through the Accelerated Approval Pathway based on reduction in amyloid plaques. Continued approval is contingent on confirmatory trials; until clinical benefit is verified, AvMed requires adherence to the policy’s detailed eligibility, dosing, monitoring, and documentation requirements for any authorization.
Definitions and Classifications
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