CurrentAetnaPolicy N/A

Aduhelm ® (aducanumab-avwa) Medication Precertification Request

Precertification request form for Aduhelm (aducanumab-avwa) used by Aetna to collect patient, prescriber, clinical, diagnostic, and administration information required to evaluate coverage/authorization for initiation or continuation of therapy.

Policy Summary

PayerAetna

PolicyAduhelm ® (aducanumab-avwa) Medication Precertification Request

Policy CodePolicy N/A

Change TypeAdministrative form (no material change)

Effective Date

Next Review Date

Key ActionSubmit the completed precertification form with all required clinical documentation to Aetna Precertification Notification (phone or fax) for initiation or continuation of Aduhelm; all fields must be completed and legible.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes identified in this brief; the document is an administrative precertification request form to collect required information for Aduhelm initiation and continuation.

FormDocument Type

AduhelmProduct

ARIA monitoringKey Safety Checks

Policy / Form Summary

This is Aetna’s precertification form to collect information to evaluate medical necessity and safety monitoring for Aduhelm (aducanumab-avwa). The form requests baseline cognitive status (e.g., CDR‑GS, MMSE, MoCA or 'Score unknown'), confirmatory biomarker evidence of amyloid pathology (positive amyloid PET or CSF findings such as elevated P‑tau/T‑tau with reduced AB42 or low AB42/AB40 or elevated P‑Tau/AB42 or T‑Tau/AB42), MRI within one year prior to initiating treatment to assess for ARIA, and ongoing response assessment and MRI/ARIA monitoring at specified dose milestones for reauthorization.

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General Submission Requirements

General submission requirements

All fields must be completed and legible for precertification review. Clinical documentation required for all precertification requests.

A. Patient Information: Complete patient demographic and contact information (A. Patient Information).
B. Insurance Information: Complete insurance information including Member ID, Group #, other coverage and Medicare/Medicaid flags (B. Insurance Information).
C. Prescriber Information: Complete prescriber information including license numbers, NPI, specialty and check one of prescriber types (C. Prescriber Information).
D. Dispensing Provider/Administration Information: Complete dispensing provider/administration information including place of administration and administration CPT codes if applicable (D. Dispensing Provider/Administration Information).
E. Product Information: Provide product information including requested product (Aduhelm) dose and directions for use (E. Product Information).
F. Diagnosis Information: Provide primary ICD diagnosis code and other applicable ICD codes (F. Diagnosis Information).
G. Clinical Information: Provide required clinical information addressing infusion setting, adverse events, venous access issues, behavioral or cognitive impairments, medical instability (G. Clinical Information - For All Requests).

Initiation (New Start) Submission Fields

Initiation (New Start) specific criteria fields

Clinical documentation required for initiation requests.

Initiation (New Start) criteria

Trial enrollment: Indicate whether patient is enrolled in an IND or NIH-supported randomized controlled trial.
Rule-out other etiologies: Confirmation that other neurodegenerative etiologies (e.g., FTLD, Lewy body disease) have been ruled out.
Anticoagulation: Indicate whether patient is receiving therapeutic anticoagulation (except aspirin <=325 mg daily).<= 325 mg aspirin allowed
Recent TIA/stroke/seizure: Indicate history of TIA, stroke, or seizures within past 12 months.
Bleeding disorder thresholds: Indicate bleeding disorders not under adequate control (including platelet count <50,000 or INR >1.5).Platelets <50,000; INR >1.5
Combination therapy: Indicate whether medication will be used in combination with other amyloid beta-directed antibodies (e.g., lecanemab).
Prescriber specialty requirement: Indicate whether medication is prescribed by or in consultation with gerontologist, neurologist, psychiatrist, or neuropsychiatrist.
Genetic testing / Early onset AD: Indicate whether genetic testing confirmed APP, PSEN1, or PSEN2 mutation; and whether documentation supports early onset Alzheimer's disease.
Diagnosis severity: Indicate whether patient has mild cognitive impairment due to AD or mild AD and objective evidence of cognitive impairment at baseline.
Baseline cognitive assessments (one or more)
- CDR-GS: Clinical Dementia Rating Global Score (CDR-GS) - provide score or unknown.
- MMSE: Mini-Mental Status Examination (MMSE) - provide score or unknown.
- MoCA: Montreal Cognitive Assessment (MoCA) - provide score or unknown.
- None of the above.
Confirmatory biomarker: Indicate confirmatory biomarker: positive amyloid PET OR CSF findings (elevated P-tau and/or T-tau with reduced AB42, low AB42/AB40 ratio, elevated P-Tau/AB42 ratio, or elevated T-Tau/AB42 ratio).
Baseline MRI: Indicate whether a brain MRI within one year prior to initiating treatment has been obtained.within 1 year

Safety thresholds / lab criteria

Platelet count< 50,000 (criterion for bleeding disorder not under adequate control)

INR> 1.5 (criterion for bleeding disorder not under adequate control)

Aspirin dose allowance<= 325 mg daily (allowed prophylaxis dose exception)

Continuation / Reauthorization Requirements

Continuation / Reauthorization specific fields

Clinical documentation required for continuation requests and staged reauthorization checks.

Continuation / Reauthorization criteria

Trial enrollment (continuation): Indicate enrollment in IND/NIH-supported trial (for continuation requests).
Therapy duration: Provide how many months of therapy completed and therapy start date.
First reauthorization (after initial 6-month approval)
- MRI prior to 5th dose: Was patient evaluated for evidence of severe ARIA on MRI prior to the 5th dose (first dose of 6 mg/kg)?
- MRI prior to 7th dose: Was patient evaluated for evidence of severe ARIA on MRI prior to the 7th dose (first dose of 10 mg/kg)?
Second reauthorization (after 12-17 months)
- MRI prior to 9th dose: Was patient evaluated for evidence of severe ARIA on MRI prior to the 9th dose (third dose of 10 mg/kg)?
- MRI prior to 12th dose: Was patient been evaluated for evidence of severe ARIA on MRI prior to the 12th dose (sixth dose of 10 mg/kg)?
Continuation after >=17 months
- ARIA evidence details: Does the patient have evidence of ARIA? Provide radiographic ARIA-E and ARIA-H descriptors and symptom severity as applicable.
- Documented clinical response: Has patient had a positive clinical response as evidenced by stabilization on CDR-GS, MMSE, or MoCA? Provide scores or 'Score unknown'.

ARIA Monitoring & Documentation

ARIA (amyloid-related imaging abnormalities) documentation

For any ARIA evidence, specify radiographic severity and symptom presence.

ARIA documentation

ARIA-E severity and symptoms: ARIA-E options: mild asymptomatic or mild with mild/moderate/severe symptoms; moderate with any symptoms; severe with any symptoms.
ARIA-H severity and symptoms: ARIA-H options: mild asymptomatic; mild symptomatic; moderate asymptomatic or symptomatic; severe asymptomatic or symptomatic.

Documentation Required

ARIA monitoring and documentation for reauthorization

Document MRI evaluations for ARIA prior to specified dose milestones and report ARIA findings with radiographic severity and symptom status for reauthorization requests. Include MRI checks before the 5th dose (first 6 mg/kg), before the 7th dose (first 10 mg/kg), before the 9th dose (third 10 mg/kg), and before the 12th dose (sixth 10 mg/kg). For any ARIA, report radiographic descriptors for ARIA‑E and ARIA‑H and document symptom severity (asymptomatic; mild/moderate/severe as applicable).

MRI evaluations prior to dose milestones (5th, 7th, 9th, 12th doses)
Report ARIA findings with radiographic severity for ARIA‑E and ARIA‑H
Document symptom presence and severity (or state asymptomatic)

Documentation Required

ARIA monitoring and documentation for reauthorization — radiographic severity and symptoms

Provide radiographic severity and symptom status when documenting ARIA. When reporting ARIA-E and ARIA-H findings, indicate the radiographic descriptor (mild/moderate/severe) and whether the patient is asymptomatic or has mild/moderate/severe clinical symptoms.

Include radiographic descriptor for ARIA‑E and ARIA‑H
Specify symptom status (asymptomatic, mild, moderate, severe)

Required Provider Actions

Prior Authorization

Precertification required — submit completed form to Aetna

Submit the completed precertification form with all required clinical documentation to Aetna Precertification Notification by phone or fax to initiate or continue Aduhelm. All fields must be completed and legible.

Phone: 1-866-752-7021 (TTY: 711)
Fax: 1-888-267-3277
All fields must be completed and legible for precertification review

Documentation Required

Baseline and ongoing clinical documentation

Provide baseline cognitive assessments and confirmatory biomarker evidence and MRI prior to initiating treatment. At baseline, document CDR‑GS, MMSE, and/or MoCA scores (or indicate 'Score unknown'); confirm amyloid pathology by positive amyloid PET or CSF biomarkers (elevated P‑tau and/or T‑tau with reduced AB42, low AB42/AB40 ratio, elevated P‑Tau/AB42 or T‑Tau/AB42 ratios); and include a brain MRI performed within one year before starting treatment.

Document baseline CDR‑GS, MMSE, and/or MoCA scores or 'Score unknown'
Provide confirmatory amyloid PET or CSF biomarker results
Include brain MRI within one year prior to treatment start

Documentation Required

Continuation response assessment — documentation required

For continuation after 17 months of therapy, document a positive clinical response by showing stabilization on CDR‑GS, MMSE, or MoCA. Provide the specific scores for the instrument(s) used or indicate 'Score unknown' if unavailable.

Document stabilization on CDR‑GS, MMSE, or MoCA for continuation after ≥17 months
Provide scores for each measure reported or state 'Score unknown'

Documentation Required

Safety exclusions/contraindications documentation

Document the following safety exclusions/contraindications: any history of TIA, stroke, or seizures within the past 12 months; current therapeutic anticoagulation use (other than aspirin ≤325 mg daily); bleeding disorders not under adequate control (including platelet count <50,000 or INR >1.5); and use of the requested drug in combination with other amyloid beta‑directed antibodies.

History of TIA, stroke, or seizures within past 12 months
Therapeutic anticoagulation use (except aspirin ≤325 mg daily)
Bleeding disorders not under adequate control (platelets <50,000 or INR >1.5)
Combination therapy with other amyloid beta‑directed antibodies

Documentation Required

Prescriber specialty requirement

Indicate that the medication must be prescribed by or in consultation with a gerontologist, neurologist, psychiatrist, or neuropsychiatrist.

Prescriber specialty: gerontologist, neurologist, psychiatrist, or neuropsychiatrist (or consult with one)

Billing Rule

Medicare Advantage Part B instruction

For Medicare Advantage Part B members, use the Medicare Request Form instead of this precertification form.

Do not use this form for Medicare Advantage Part B — use the Medicare Request Form

Policy Summary

PayerAetna

PolicyAduhelm ® (aducanumab-avwa) Medication Precertification Request

Policy CodePolicy N/A

Change TypeAdministrative form (no material change)

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Aduhelm ® (aducanumab-avwa) Medication Precertification Request

Policy / Form Summary

General Submission Requirements

Initiation (New Start) Submission Fields

Continuation / Reauthorization Requirements

ARIA Monitoring & Documentation

Required Provider Actions

Codes / Billing

Definitions

Revision History