Coverage is subject to the specific terms of the member’s benefit plan.
The use of aducanumab-avwa (Aduhelm) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber must be, 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
- > 4 brain microhemorrhages; or
- Any areas of superficial siderosis; and
- Prescriber has assessed and documented baseline disease severity utilizing one of the following scores (within the past 6 months):
- Mini-Mental Status Exam (MMSE) score ≥ 21; or
- Clinical Dementia Rating - Global Score (CDR-GS) ≤ 1.0; or
- Montreal Cognitive Assessment (MoCA) ≥ 17.
Initial Authorization: 6 months
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 6 months):
- CDR-GS of ≤ 1.0; or
- MMSE score ≥ 21; or
- MoCA ≥ 17; and
- Prior to the 5th, 7th, 12th infusion, documentation of recent (within the previous month) brain MRI showing one of the following:
- ≤ 4 new incident microhemorrhages and 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)).
Continuation Authorization: 12 months
The use of aducanumab-avwa (Aduhelm) for any other indication than listed above is considered experimental/investigational and therefore, not covered.