CurrentUnitedHealthcarePolicy N/A

Aduhelm (aducanumab) prior authorization — coverage criteria and documentation

Prior authorization form and clinical criteria for Aduhelm (aducanumab) prescribing, documentation, and imaging requirements for beneficiaries with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia. Applies to UnitedHealthcare beneficiaries and prescribers completing the PA form.

Policy Summary

PayerUnitedHealthcare

PolicyAduhelm (aducanumab) prior authorization — coverage criteria and documentation

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionComplete the prior authorization form with documentation of amyloid positivity, CDR global score 0.5, MMSE 24–30 (or equivalent), age ≥50, recent MRI, and prescriber specialty or consultation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≥50minimum beneficiary age required

24–30MMSE score range

prior to 7th & 12thMRI monitoring

failed ≥1 cholinesteraseTherapy failure

Coverage Criteria for Aduhelm (aducanumab)

Initial Authorization Criteria

Covered when ALL of the following are met:

Aduhelm coverage criteria: Patient has mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementiarequired

Documented on PA form via clinician attestation; see clinical assessment items 1 and 7 in the form.

Disease severity measures

Clinical Dementia Rating (CDR) global score of 0.5
CDR documented on form (item 2a).
Objective evidence of cognitive impairment at screening
Documented on form (item 2b).

Policy Summary

PayerUnitedHealthcare

PolicyAduhelm (aducanumab) prior authorization — coverage criteria and documentation

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

SourceLink

On This Page

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The form requires assessment of risk for amyloid-related imaging abnormalities (ARIA) before initiating therapy. Specifically, providers must confirm the beneficiary does NOT have a history of or increased risk for ARIA-E (brain edema or sulcal effusions) or ARIA-H (microhemorrhage or superficial siderosis). This attestation is listed as a required item on the clinical information portion of the form and is used to exclude patients at elevated ARIA risk from treatment consideration.

In addition, the form asks whether the prescriber will obtain scheduled MRIs for ARIA monitoring: a baseline MRI within one year prior to treatment and attestations to obtain MRIs prior to the 7th infusion (first 10 mg/kg dose) and the 12th infusion (sixth 10 mg/kg dose). These imaging requirements support early detection of ARIA. Finally, the form asks whether the beneficiary has any hypersensitivity to components of Aduhelm™; a positive hypersensitivity history is an exclusionary caution noted on the form.

The form defines several exclusion and non-coverage triggers that can prevent approval. A key requirement is documented amyloid positivity — either a positive amyloid PET scan or a positive cerebrospinal fluid test; lack of this documentation is listed as a grounds for not meeting the form's criteria.

Objective cognitive impairment and specific severity thresholds are also required. The form requires a Clinical Dementia Rating (CDR) global score of 0.5 and a Mini-Mental State Examination (MMSE) score between 24 and 30 (inclusive) or an equivalent tool indicating mild cognitive impairment or mild dementia; if the CDR is not 0.5 or the MMSE falls outside the 24–30 range without documented justification, the form indicates the therapy would not be supported. The form also requires ruling out reversible causes of cognitive decline and completion of a medication review; failure to document these items can render the request unsupported.

Prior Authorization & Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: A completed prior authorization (PA) form must be submitted and include clinical confirmation that the beneficiary meets all clinical entry criteria. Ensure the PA contains prescriber contact information, NPI, and requester contact details so the request can be processed.

Completed PA form with prescriber NPI and fax number
Requester contact name and phone/extension

Documentation Required

Required Documentation

Required Documentation: Include objective disease severity measures and baseline testing. The PA must document CDR global score, objective cognitive impairment at screening, MMSE (or equivalent) score, amyloid positivity (PET or CSF), age, and evaluation for reversible causes. Also include attestation that baseline MRI within one year was obtained and that a specialist (neurologist, geriatrician, or geriatric psychiatrist) is prescribing or consulting.

CDR global score (e.g., 0.5)
Objective evidence of cognitive impairment at screening
MMSE score 24–30 or equivalent tool result
Positive amyloid PET or positive CSF amyloid test
Documentation of age ≥50
Documentation ruling out reversible causes of dementia
Baseline MRI within 1 year noted
Prescriber specialty or consultation documented

Step Therapy

Therapy Failure / Prior Treatment

Therapy Failure Requirement: Document that the beneficiary failed or could not tolerate at least one other preferred cholinesterase inhibitor for at least four months prior to this request.

Name of prior cholinesterase inhibitor
Duration of trial (≥4 months) or reason for intolerance

Denial Risk

Documentation Triggers for Denial

Documentation Triggers for Denial: Requests lacking objective cognitive impairment evidence, missing amyloid positivity proof (PET or CSF), absent CDR global score, missing baseline disease severity assessment, or incomplete prescriber information may be denied.

No documented amyloid-positive PET or CSF test
No objective cognitive impairment documented at screening
Missing CDR global score or baseline disease severity measure
Incomplete prescriber NPI or contact information

Denial Risk

Imaging Noncompliance — MRI Requirements

Imaging Noncompliance Risk: The provider must attest to obtaining MRIs prior to the 7th infusion (first 10 mg/kg dose) and 12th infusion (sixth 10 mg/kg dose). Failure to obtain or document these follow-up MRIs, or lack of a recent baseline MRI within one year prior to treatment start, may lead to denial or interruption of authorization.

Attestation that MRIs will be obtained prior to 7th and 12th infusions
Baseline brain MRI within one year prior to initiation

Background

This prior authorization form is intended for beneficiaries with mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia who are being considered for Aduhelm (aducanumab). The form documents required baseline elements: confirmation of the diagnosis, baseline disease severity measures (including CDR global score of 0.5 and objective evidence of cognitive impairment), and a baseline brain MRI performed within one year prior to initiating therapy.

The form also captures eligibility thresholds such as age ≥ 50 years, documentation of amyloid positivity (positive amyloid PET or CSF), and confirmation that the prescriber is a neurologist, geriatrician, or geriatric psychiatrist or is consulting with one. These items together define the patient population for whom the form supports prior authorization.

Definitions and Monitoring

Amyloid positivity

DefinitionPositive amyloid PET scan OR positive cerebrospinal fluid (CSF) test collected via lumbar puncture indicating presence of amyloid beta plaque

Acceptable testsAmyloid PET imaging or CSF amyloid assay documented on the prior authorization form

Denial triggerLack of documented amyloid positivity (PET or CSF) may render therapy not supported by criteria

Disease severity measures

CDR global scoreClinical Dementia Rating (CDR) global score of 0.5

MMSE rangeMMSE score between 24 and 30 (inclusive) or equivalent tool indicating MCI or mild dementia

Objective impairmentObjective evidence of cognitive impairment at screening must be documented

ARIA monitoring MRIs

Required MRI timingMRI prior to the 7th infusion (first 10 mg/kg dose) and prior to the 12th infusion (sixth 10 mg/kg dose)

Baseline MRIRecent baseline brain MRI within one year prior to beginning treatment is required

Provider attestationProvider must attest on the form to obtain MRIs prior to the 7th and 12th infusions

OpenPayer

Aduhelm (aducanumab) prior authorization — coverage criteria and documentation

Coverage Criteria for Aduhelm (aducanumab)

Key Scores, Age, and Definitions

Prior Authorization & Documentation Requirements

Background

Definitions and Monitoring