CurrentUnitedHealthcarePolicy N/A

Aduhelm (aducanumab) prior authorization requirements

Form and clinical criteria for prior authorization of Aduhelm (aducanumab) for treatment of patients with mild cognitive impairment due to Alzheimer's disease or mild Alzheimer's dementia; used by prescribing providers and pharmacy PA staff. Document appears specific to UnitedHealthcare pharmacy prior approval process (North Carolina variant noted).

Policy Summary

PayerUnitedHealthcare

PolicyAduhelm (aducanumab) prior authorization requirements

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form certifying all required clinical criteria and submit it to the Pharmacy PA Call Center.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=50minimum patient age required

MMSE 24-30acceptable cognitive screening score range

Baseline & serial MRIsrequired neuroimaging monitoring

≥1 cholinesterase inhibitorprior therapy requirement

Medical necessity / Prior authorization criteria for Aduhelm

Policy Summary

PayerUnitedHealthcare

PolicyAduhelm (aducanumab) prior authorization requirements

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionPrescriber must complete and sign the prior authorization form certifying all required clinical criteria and submit it to the Pharmacy PA Call Center.

SourceLink

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Medical necessity / Prior authorization criteria for Aduhelm

Treatment with Aduhelm will be considered when ALL of the following are met:

ALL of the following

Diagnosis of mild cognitive impairment due to Alzheimer’s disease or mild Alzheimer’s dementia
Age 50 years or older>= 50 years
ALL of the following
- acceptable tools
  - Mini-Mental Status Exam (MMSE) score between 24 and 30 (inclusive)MMSE 24-30
  - Equivalent cognitive assessment tool indicating MCI or mild dementia
Clinical Dementia Rating (CDR) Global Score of 0.5
Objective evidence of cognitive impairment at screening
ANY of the following
- Positive amyloid PET
- Positive CSF amyloid test (lumbar puncture)
Testing to rule out reversible causes of cognitive decline completed
Assessment including medication review to exclude medication-induced cognitive decline completed
Recent brain MRI within one year prior to initiationMRI within 12 months
Prescriber has assessed and documented baseline disease severity using an objective measure/tool
No history or increased risk of amyloid-related imaging abnormalities (ARIA-E or ARIA-H)
ARIA-E includes brain edema or sulcal effusions; ARIA-H includes microhemorrhage and superficial siderosis
Failure of or inability to tolerate at least one preferred cholinesterase inhibitor Alzheimer therapy for at least four months>= 4 months on cholinesterase inhibitor
Prescriber attests to obtain MRIs prior to the 7th infusion (first dose of 10 mg/kg) and 12th infusion (sixth dose of 10 mg/kg)
No hypersensitivity to components of Aduhelm
Aduhelm is prescribed by or in consultation with a neurologist, geriatrician, or geriatric psychiatrist

Required actions, documentation, and risks

Prior Authorization

Submit completed prior authorization form

Prescriber must complete and sign the prior approval form certifying all required clinical criteria and submit the signed form to the Pharmacy PA Call Center at 1-855-258-1593.

Documentation Required

Document baseline assessments and biomarker confirmation

Document and retain: CDR Global Score of 0.5; objective evidence of cognitive impairment at screening; MMSE score between 24–30 (or equivalent cognitive assessment); positive amyloid PET OR positive CSF amyloid test; assessment including medication review; testing to exclude reversible causes of cognitive decline; and documentation of baseline disease severity using an objective measure/tool.

CDR Global Score = 0.5
Objective cognitive impairment at screening
MMSE 24–30 (inclusive) or equivalent assessment
Positive amyloid PET OR positive CSF amyloid test
Medication review to exclude medication-induced cognitive decline
Testing to rule out reversible causes of cognitive decline
Baseline disease severity documented with an objective tool

Documentation Required

MRI monitoring

Obtain and document a brain MRI within one year prior to initiation and attest to obtain additional MRIs prior to the 7th infusion (first 10 mg/kg) and the 12th infusion (sixth 10 mg/kg dose) for ARIA monitoring.

Baseline MRI within 12 months prior to treatment start
MRI prior to 7th infusion (first 10 mg/kg)
MRI prior to 12th infusion (sixth 10 mg/kg)

Documentation Required

Specialist involvement

Aduhelm must be prescribed by or in consultation with a neurologist, geriatrician, or geriatric psychiatrist, and the prescriber’s signature is mandatory on the prior authorization form.

Denial Risk

Risk of denial if criteria not met

Authorization may be denied if any required clinical criteria are not met or are not documented on the form.

Age < 50 years
Absent or undocumented CDR = 0.5, objective impairment, or MMSE/equivalent in required range
No documented positive amyloid PET or CSF test
No baseline MRI within one year or missing MRI attestations for infusion monitoring
No documentation of prior cholinesterase inhibitor trial ≥4 months
No prescriber signature or lack of specialist prescriber/consultation

Clinical and administrative background

Aduhelm (aducanumab) is a monoclonal antibody that targets amyloid beta and is intended for treatment of early Alzheimer’s disease. Use is specified for patients with mild cognitive impairment (MCI) due to Alzheimer’s disease or mild Alzheimer’s dementia who have biomarker-confirmed amyloid pathology (positive amyloid PET scan or positive cerebrospinal fluid test). Prior to and during treatment, patients must be evaluated and monitored for amyloid-related imaging abnormalities (ARIA); ARIA-E refers to brain edema or sulcal effusions and ARIA-H refers to hemosiderin deposition such as microhemorrhage and superficial siderosis. The prior authorization form requires documentation of baseline cognitive testing, age criteria, recent brain MRI, and ongoing MRI monitoring around specified infusions to detect ARIA.

G31.84	Mild cognitive impairment, so labeled (example ICD-10 that may apply; form does not list codes explicitly)
G30.0	Alzheimer's disease with early onset (example)

OpenPayer

Aduhelm (aducanumab) prior authorization requirements

Medical necessity / Prior authorization criteria for Aduhelm

Numeric and timing thresholds to note

Required actions, documentation, and risks

Relevant coding groups

Clinical and administrative background

Defined terms

Policy updates

Aduhelm (aducanumab) prior authorization requirements

Medical necessity / Prior authorization criteria for Aduhelm

Numeric and timing thresholds to note

Required actions, documentation, and risks

Relevant coding groups

Clinical and administrative background

Defined terms

Policy updates

See also