Aduhelm Approved and Nothing But Controversy Since

On June 7, the FDA announced the approval Aduhelm (aducanumab), the first new treatment for Alzheimer’s disease in almost 20 years and the first that addresses what many believe is the underlying pathology of the disease.

Pretty much nothing but controversy has ensued.

Three members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee — Aaron Kesselheim, David Knopman and Joel Perlmutter — resigned in protest after the June 7 approval.

The Alzheimer’s Association applauded the approval the day it was announced but a few days later called the estimated annual price (based on the wholesale acquisition cost) of $56,000 as “simply unacceptable.”

Last Friday, Acting FDA Commissioner Janet Woodcock posted a letter asking the Office of Inspector General to investigate interactions between the FDA staff and Biogen officials prior to the approval. Stat, among other outlets, has reported that FDA staffers worked unusually closely with Biogen officials.

Numerous insurers have announced that they won’t cover the drug or will require prior authorization before paying for it. On Monday, CMS announced that it was beginning the process to make a national coverage determination for Aduhelm. The agency has scheduled two “listening” sessions as part of that process, one on July 22 from 9 a.m. to 11 a.m. EDT and the another on July 27 from 2 p.m. to 4 p.m. EDT.

Institute for Clinical and Economic Review (ICER) has also entered the fray. The Boston-based drug pricing group was unstinting in its criticism of the approval and the price. ICER pounced on the day of the approval, issuing a statement that criticized the agency for choosing to “move the goalposts and approve aducanumab based on the surrogate outcome of removing amyloid from the brain rather than the patient-centered outcome of clinical benefit.” Only a drug that halts dementia entirely would merit Biogen’s $56,000-a-year price, said the group’s strongly worded prepared statement. Before the FDA approval, ICER had issued a cost-effectiveness report on Aduhelm that concluded that the most optimistic appraisal of the drug’s efficacy would justify a price of $11,100 to $23,1000. On June 30, ICER issued a revised report that pegged the cost-effectiveness price range between $2,950 and $8,360.

ICER has scheduled a virtual public meeting about Aduhelm and the group’s cost-effectiveness report on the drug for tomorrow, starting at 12 p.m. EDT.