CurrentAvMedPolicy N/A

Aduhelm (aducanumab) prior authorization — medical necessity and monitoring criteria

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.

Policy Summary

PayerAvMed

PolicyAduhelm (aducanumab) prior authorization — medical necessity and monitoring criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Aduhelm (J0172); initial approvals are for 6 months (6 infusions).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsInitial auth duration

6 monthsContinuation auth

10 mg/kgMax maintenance dose

pre-5/7/9/12MRI monitoring

≤4ARIA-H mild threshold

Coverage Criteria for Aduhelm (aducanumab)

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.

inv-01: Initial Authorization

Covered when ALL of the following are met

Prescriber and age: Prescribed by or in consultation with a neurologist AND member is 50 years of age or older

See initial authorization requirements

Diagnosis severity: Confirmed diagnosis of mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia based on ONE of the following with baseline documentation: CDR-GS 0.5; MMSE 24-30; RBANS delayed memory index ≤85; MoCA 19.0-25; OR chart-documented signs of MCI

Submit baseline dementia rating scale results and chart notes ruling out alternate diagnoses

Amyloid confirmation: Provider must submit documentation of beta-amyloid protein deposition demonstrated by a positive amyloid PET scan

Amyloid PET required

MRI and hemorrhage limits: Recent brain MRI within the last year demonstrating all of: no brain hemorrhage >1 cm in past year; fewer than 10 brain microhemorrhages; no localized superficial siderosis; and no relevant brain hemorrhage, bleeding disorder, cerebrovascular abnormalities, or recent (within prior year) unstable cardiovascular condition

Submit MRI results

No recent major events/medications: No stroke, TIA, or unexplained loss of consciousness in past 12 months AND not currently receiving antiplatelet agents (except prophylactic aspirin), anticoagulants (e.g., Factor Xa inhibitors), or antithrombins (e.g., heparin)

Medication and event history required

Organ function and psychiatric stability: No impaired renal or liver function AND no clinically significant unstable psychiatric illness in the past 6 months

Clinical assessment required

Risk counseling: Provider attests that counseling was provided on the risk of amyloid-related imaging abnormalities (ARIA-E and ARIA-H) and member/caregiver are aware to monitor for headache, dizziness, visual disturbances, nausea, and vomiting

Documentation of counseling required

inv-02: Continuation of Therapy

Covered when ALL of the following are met (continuation of therapy)

Prior exposure and authorization cadence: Continuation approvals are for 6 months; infusion counts and approval limits follow specified rules based on total prior infusions (rules for <5, <6, <8, <12, >12 total infusions). Infusions administered every 4 weeks (at least 21 days apart). If an infusion is missed, resume at same dose as soon as possible.

See continuation scheduling details

Ongoing benefit: Member continues to meet initial authorization criteria AND demonstrates response to therapy or has not had clinically meaningful cognitive deterioration compared to pretreatment baseline as measured by one of the specified assessments (CDR-GS or CDR-SB, MMSE, RBANS, MoCA) OR has not progressed to moderate or severe dementia

Submit follow-up assessment results

MRI monitoring schedule: Member has received follow-up MRIs for ARIA monitoring at pre-5th, pre-7th, pre-9th, pre-12th infusions and every 6 months thereafter; MRI results must be submitted and meet specified acceptability/stability criteria

Submit MRIs at specified timepoints

inv-03: Dosing and ARIA management

Dosing schedule: Titration schedule: Infusions 1–2: 1 mg/kg; Infusions 3–4: 3 mg/kg; Infusions 5–6: 6 mg/kg; Infusion 7 and beyond: 10 mg/kg (maximum 10 mg/kg). Infusions administered IV over ~1 hour every 4 weeks (maximum dose every 21 days).10 mg/kg maximum

Follow recommended dosing schedule and vial information

ARIA dosing interruptions: Follow label-based ARIA management: suspend dosing for specified ARIA severities until radiographic resolution or stabilization and symptom resolution as guided by MRI and clinical judgment. If dosing is resumed after temporary suspension, it may resume at the same dose and titration schedule prior to suspension; consider benefit of reaching/maintaining 10 mg/kg when evaluating suspension. Specific suspension/continuation rules vary by ARIA-E and ARIA-H severity and symptom status per label tables.

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

Covered HCPCS Codes (drug requested)HCPCSCovered

J0172

Aduhelm (aducanumab) injection, intravenous

inv-07: ARIA-H microhemorrhage thresholds

Mild≤4 new microhemorrhages

Moderate5–9 new microhemorrhages

Severe≥10 new microhemorrhages

inv-08: ARIA-E size thresholds

MildSingle site FLAIR <5 cm

Moderate5–10 cm OR multiple sites each <10 cm

Severe>10 cm or extensive involvement (significant subcortical white matter and/or sulcal involvement)

Provider Requirements and Prior Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization required — A prior authorization is required for Aduhelm (aducanumab) IV (J0172); initial approvals are for 6 months (6 infusions).

Step Therapy

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.

Documentation Required

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.

Denial Risk

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

inv-14: Accelerated approval

Approval pathwayApproved under the FDA Accelerated Approval Pathway based on reduction in amyloid beta plaques

StatusHas not received traditional (full) FDA approval

Condition for continued approvalContinued approval contingent on verification of clinical benefit in a confirmatory trial

inv-15: ARIA classifications

ARIA categoriesIncludes ARIA-E (edema/effusion) and ARIA-H (microhemorrhage and superficial siderosis)

ARIA-E radiographic severityMild: FLAIR hyperintensity confined to sulcus and/or cortex/subcortical white matter in one location <5 cm; Moderate: 5–10 cm or >1 site each <10 cm; Severe: >10 cm or extensive involvement

ARIA-H radiographic severityMicrohemorrhage Mild: ≤4 new; Moderate: 5–9 new; Severe: ≥10 new; Superficial siderosis Mild: 1 focal area; Moderate: 2 focal areas; Severe: >2 focal areas

Policy Summary

PayerAvMed

PolicyAduhelm (aducanumab) prior authorization — medical necessity and monitoring criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for Aduhelm (J0172); initial approvals are for 6 months (6 infusions).

SourceLink

On This Page

ARIA MRI outcome criteria: MRI results must meet ONE of the specified ARIA criteria: for ARIA-E — no new ARIA-E OR mild asymptomatic ARIA-E; moderate or severe ARIA-E may be acceptable if asymptomatic and stable or if symptomatic but stable (conditions apply). For ARIA-H microhemorrhage — 1–4 new microhemorrhages (asymptomatic), 5–9 new if asymptomatic and stabilized, or 1–9 new if symptomatic and stabilized. For superficial siderosis — no new areas OR 1 (asymptomatic) OR 2 (asymptomatic and stabilized) OR 1–2 that resulted in symptoms if stabilized.

See ARIA MRI Classification Criteria and stability requirements