Criteria
Coverage is subject to the specific terms of the member’s benefit plan.
Initial Criteria
The use of aducanumab-avwa (Aduhelm) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
- Aducanumab-avwa (Aduhelm) must be prescribed by, or in consult with, a specialist in neurology or gerontology; and
- The individual has mild cognitive impairment (MCI) or mild Alzheimer’s dementia due to Alzheimer’s disease (Stage 3 or 4) as evidenced by all the following with the past 6 months:
- Objective evidence of cognitive impairment at screening; and
- Positron Emission Tomography (PET) scan or Cerebral Spinal Fluid (CSF) is positive for amyloid beta plaques; and
- Other conditions of non-Alzheimer’s dementia etiology have been ruled out (e.g., vascular dementia, dementia with Lewy bodies [DLB], frontotemporal dementia [FTD], Parkinson’s Disease dementia); and
- The individual has received a baseline brain magnetic resonance imaging (MRI) within past year prior to initiating treatment verifying the individual does not have the following:
- acute or subacute hemorrhage; or
- Macrohemorrhage; or
- Greater than four (4) brain microhemorrhages; or
- Any areas of superficial siderosis; and
- Documentation has been submitted including baseline disease severity utilizing one of the following scores (within the past six (6) months):
- Mini-Mental Status Exam (MMSE) score greater than or equal to 21; or
- Clinical Dementia Rating - Global Score (CDR-GS) less than or equal to 1.0; or
- Montreal Cognitive Assessment (MoCA) greater than or equal to 17.
Reauthorization Criteria
Continuation of therapy with aducanumab-avwa (Aduhelm) may be considered medically necessary when ALL of the following are met:
- The individual must have experienced meaningful clinical benefit since starting treatment with aducanumab-avwa (Aduhelm), as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review) including one of the following scores and symptoms (within the past six (6) months):
- CDR-GS of less than or equal to 1.0; or
- MMSE score greater than or equal to 21; or
- MoCA greater than or equal to 17; and
- Prior to the 5th, 7th, 12th infusion, documentation of recent (within the previous month) brain MRI showing one of the following:
- Less than or equal to 4 new incident microhemorrhages and one (1) focal area of superficial siderosis; or
- Radiographic stabilization since baseline (i.e., no increase in size or number of amyloid-related imaging abnormalities – hemosiderin deposition (ARIA-H)).
The use of aducanumab-avwa (Aduhelm) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
