Aduhelm™
Drug - Aduhelm™ (aducanumab) [Biogen Inc.]
April 2022
Therapeutic area - Alzheimer’s Agents
Initial approval criteria
- Patient is at least 50 years of age AND
- Aduhelm must be prescribed by a neurologist AND
- Patient has a diagnosis of Alzheimer’s disease with mild cognitive impairment or mild dementia as demonstrated by 3 validated scales, one of which must be the MMSE (Mini Mental State Exam) AND
- Patient’s Alzheimer’s disease is of confirmed beta amyloid pathology as evidenced by ONE of the following:
- A positive amyloid PET scan interpreted by a radiologist or nuclear medicine specialist OR
- Amyloid is detected in CSF from a lumbar puncture AND
- Patient has had a brain MRI within the past 12 months that does NOT show ANY of the following:
- Pre-treatment localized superficial siderosis OR
- 10 or more brain microhemorrhages OR
- A brain hemorrhage greater than 1 cm AND
- Patient has undergone a complete physical and neurological exam to comprehensively rule out all other possible causes of neurocognitive decline including but not limited to:
- Any medication potentially causing cognitive impairment must have been stopped for at least 4 weeks with continued cognitive symptoms
- Currently uncontrolled psychiatric condition (including alcohol or substance abuse)
- Parkinson’s disease
- Lewy body dementia
- Vascular dementia (such as from a stroke) AND
- Patient is not taking any blood thinners (exception: low dose aspirin) AND
- Prescriber attests that the patient and/or caregiver understands the risks and benefits of Aduhelm therapy AND
- Prescriber attests that the patient and/or caregiver understands and is committed to receiving scheduled doses and enhanced clinical vigilance during the titration period
- The following documentation must be provided at time of requests:
- Healthcare facility’s written processes and procedures to support enhanced clinical vigilance during the titration period
- Patient’s educational materials to empower patient and caregiver during the enhanced clinical vigilance period and thereafter including ways to contact prescriber and other relevant clinical staff
- Initial approval is for 6 months
Renewal criteria
- Documentation of follow-up MRIs to evaluate for ARIA-E, ARIA-H, and other structural changes prior to the 7th and 12th infusions, then at least once annually AND
- Documentation of current disease severity as demonstrated by current MMSE score (at least every 6 months)
- Coverage authorization may be discontinued when Alzheimer’s disease progresses rapidly into moderate to severe Alzheimer’s disease unless the prescriber provides published peer-reviewed clinical research supporting its continued use
- Rapid decline is defined as a 4-point reduction in a 6-month period on the MMSE, with an additional 1-point reduction in the following 6 months
- Renewal approval is for 6 months
Quantity limits
- Patient’s weight (in kg) must be submitted at time of request
- Requested quantity must be rounded to the nearest vial size in order to minimize waste
- Requested quantity must reflect dosing schedule outlined in the FDA approved label
| IV infusion (every 4 weeks) |
Dosage (administered over approximately one hour) |
| Infusion 1 and 2 |
1 mg/kg |
| Infusion 3 and 4 |
3 mg/kg |
| Infusion 5 and 6 |
6 mg/kg |
| Infusion 7 and beyond |
10 mg/kg |
Billing for Aduhelm
- Aduhelm must be billed as a medical claim
Background
Aduhelm is an amyloid beta-directed antibody indicated for the treatment of Alzheimer's disease. Treatment with Aduhelm should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with Aduhelm. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
Questions?
MHCP Provider Resource Center 651-431-2700 or 800-366-5411
