Price of Aducanumab Treatment for Early Alzheimer Disease Cut in Half 

The price of the first potentially disease-modifying treatment for Alzheimer disease (AD), aducanumab (Aduhelm; Biogen, Cambridge, MA and Eisai, Woodcliff Lake, NJ), has been reduced by 50%—from $56,000 to $28,000 annually. Aducanumab was approved via the accelerated pathway for treatment of early AD (mild cognitive impairment due to AD and mild AD dementia with amyloid positron emission tomography [PET] confirmation of brain amyloid). 

Upon initial price of aducanumab, multiple stakeholders, including the American Academy of Neurology (AAN) and the Alzheimer's Association. The Institute for Clinical and Economic Review (ICER) has suggested that an appropriate price would be under $10,000 annually. These costs do not include the cost of brain imaging, infusion, or safety monitoring. A press release issued by Biogen announcing the price reduction states the company's goal is to lower out-of-pocket expenses for patients and reduce potential financial implications for the US healthcare system. 

Aducanumab has been proven to lower levels of AD biomarkers, including brain amyloid and phosphorylated tau. Positive effects on reducing cognitive decline, however, were seen in only 1 of 2 pivotal trials and post hoc analysis of a subgroup in the other. The accelerated approval by the Food and Drug Administration (FDA) requires additional phase 4 studies to further explore clinical efficacy; these are underway or planned to begin in 2022.

Michel Vounatsos, chief executive officer at Biogen stated, "we have listened to the feedback of our stakeholders, and we are now taking important actions to improve patient access to Aduhelm. He continued ". . .patients not offered the choice of Aduhelm due to financial considerations are progressing beyond the point of benefitting from the first treatment to address an underlying pathology of AD. We recognize this challenge must be addressed in a way perceived to be sustainable for the US healthcare system. It is a critical time for the AD community as the Centers for Medicare and Medicaid Services (CMS) is considering the possibility of coverage of not only Aduhelm, but also this entire new class of AD therapies. We hope our actions today will facilitate patient access to these innovative AD treatments.”

Serious side effects can occur with aducanumab treatment, including amyloid-related imaging abnormalities (ARIA), which often does not cause symptoms, but can be serious if brain swelling (edema) and microbleeds occur as a result of ARIA. Brain MRI before initiation and during treatment with aducanumab is required to monitor for ARIA.