Aduhelm (aducanumab-avwa) prior authorization - Coverage Criteria
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This document defines Alaska Medicaid prior authorization requirements, clinical criteria, and utilization limits for Aduhelm (aducanumab-avwa) infusions for treatment of Alzheimer's disease.
No material clinical or coverage changes in this revision.
Coverage Criteria for Aduhelm (aducanumab-avwa)
Initial approval criteria
Covered when ALL of the following are met
Reauthorization criteria
Reauthorization covered when ALL of the following are met
Prior authorization for Aduhelm is not recommended for patients receiving systemic anticoagulation other than aspirin ≤81 mg. Patients who have had a brain hemorrhage, a diagnosed bleeding disorder, or significant cerebrovascular abnormalities within the prior 6 months are excluded from approval. Additionally, recent significant systemic illness or infection within the past 30 days or a history of unstable cardiac events (including unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities) within the past 1 year are grounds for denial.
Use of Aduhelm is considered not approvable when the specified approval criteria are not met. Explicit denial triggers include failure to meet the approval criteria or the presence of any exclusionary condition listed (for example, use of disallowed anticoagulants or recent brain hemorrhage).
Provider Requirements, Prior Authorization, and Denial Triggers
Prior authorization required; time-limited approvals and dosing
Prior authorization is required. Initial approval is granted for up to 3 months. Reauthorization may be approved for up to 6 months only if MRI monitoring prior to doses 7 and 12 shows no increase in size or number of ARIA‑H and there is documented evidence of clinical benefit with no adverse reactions. Dosing follows the titration schedule up to a maximum of 10 mg/kg every 4 weeks from infusion 7 onward.
- Initial Approval: up to 3 months
- Reauthorization Approval: up to 6 months if MRI obtained prior to 7th and 12th doses shows no increase in ARIA‑H and patient demonstrates clinical benefit
- Dose escalation per schedule with maximum 10 mg/kg every 4 weeks from infusion 7
Step therapy not required
No step therapy requirements are specified in this policy.
Required documentation for initial request and reauthorization
Providers must supply documentation at initial request and for reauthorization that demonstrates the approval criteria and monitoring requirements are met.
- Patient age ≥ 50
- Prescribed by or in consultation with a neurologist
- Diagnosis of Alzheimer’s disease and presence of beta‑amyloid plaques verified by PET or CSF
- Baseline brain MRI within the last year showing no localized superficial siderosis, <10 brain microhemorrhages, and no brain hemorrhage >1 cm in the past year
- Objective evidence of cognitive impairment at screening, CDR global score 0.5, and MMSE ≥ 24
- For reauthorization: MRIs obtained prior to the 7th and 12th doses showing no increase in size or number of ARIA‑H, plus documented clinical benefit and absence of adverse reactions
Triggers for denial and high-risk exclusions
Denial will be issued when approval criteria are not met or when safety exclusions apply.
- Failure to meet the stated approval criteria
- Use of any blood thinners other than aspirin 81 mg or less
- Brain hemorrhage, bleeding disorder, or cerebrovascular abnormalities within the last 6 months
- Significant systemic illness or infection in the past 30 days
- History of unstable angina, myocardial infarction, advanced chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to screening
Definitions and Key Terms
Background
Aduhelm (aducanumab-avwa) is an amyloid beta-directed monoclonal antibody indicated for treatment of Alzheimer’s disease under an accelerated approval pathway. The accelerated approval is based on reduction of amyloid beta plaques as a surrogate endpoint; because safety and clinical benefit must be confirmed in ongoing studies, careful patient selection and monitoring are required, and use is subject to prior authorization and the policy’s specific exclusion criteria.
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