Current Position of the Mesulam Center on Aduhelm-Aducanumab
ADUHELM was approved by the FDA based on the manufacturer’s claim that it slows progression of Alzheimer’s disease by removing amyloid from the brain. The scientific evidence shows that ADUHELM does remove amyloid but there is no convincing proof yet that it has a clinical effect on symptoms or their progression. It should be noted that the FDA decision has been controversial, that the Scientific Advisory Panel had advised against it, that 3 members of the Panel resigned after the decision, and that the FDA acting commissioner launched an investigation into the process of the approval.
Here at Northwestern, the Pharmacy & Therapeutics Committee declined to place ADUHELM on the formulary so the drug will need to be obtained from third party pharmacies. Until there is better proof that it has a beneficial clinical effect, we are not enthusiastic about the use of ADUHELM but will not rule it out either. We will give you the facts and involve you in decision making.
Here are the facts:
To be eligible, you will need to meet two conditions. First, to have progressive weakness of memory or thinking that is mild as determined by quantitative testing. Second, to have a spinal tap or PET scan to show that you have amyloid in the brain. ADUHELM has not been tried yet in moderate or advanced disease.
The drug is administered by monthly intravenous infusions that last about 1 hour. Harmful side effects include brain swelling and pinpoint areas of blood seepage into the brain. These brain abnormalities are usually asymptomatic. Occasionally the ADUHELM-related brain abnormalities will cause symptoms. The most common are headache, dizziness, confusion. To monitor these potentially dangerous side effects, you will need to have brain scans before infusions #7 and #12 and additional ones if and when significant symptoms arise. The ADUHELM-related brain abnormalities and related symptoms are expected to be temporary. Your neurologist may decide to interrupt the infusions until symptoms resolve.
There is no claim that ADUHELM will reverse or stop the disease. You are not expected to experience improvement, but the drug may still be slowing progression. The problem is that the detection of slowing can be inferred but never proven or disproven. So, once you start treatment there are no guidelines for when to stop. The treatment is likely to be hugely expensive ($130,000/yr if paid out of pocket). Medicare coverage is unclear at this time and the decision will be announced within the next few months.