capitol hill report: FDA APPROVES ADUCANUMAB FOR ALZHEIMER’S DISEASE

June 7, 2021

Latest Advocacy News

On May 19, 185 members from 46 states participated in the AAN’s first ever virtual Neurology on the Hill, meeting with a total of 246 congressional offices. Members advocated for AAN priority issues, including the permanent expansion of telehealth access, funding for neurological research recovery, and averting the upcoming “Medicare cliff” that will adversely affect reimbursements and cause a substantial negative impact on patient access to care. On social media, participants contributed over 1,300 tweets and nearly 900 retweets, totaling over 2 million impressions. Be sure to listen to last Thursday’s Neurology Minute^® podcast to learn about this year’s priority issues and the experience of Alejandro Vargas, MD.
As Congress continues to debate legislation to address infrastructure, the AAN joined 229 members of the Ad Hoc Group for Medical Research to send a letter to Congress urging to include investments in medical research in the final bill.
The AAN also joined nearly 60 members of the GME Advocacy Coalition to send a letter to Congress and the administration expressing support for including additional Medicare-supported GME positions in the bill.
On May 28, President Biden released his full proposed budget for Fiscal Year 2022, which includes a 23-percent increase for the Department of Health and Human Services. The president’s budget is one of the first steps in a lengthy appropriations process that is ultimately determined by Congress before the start of the new fiscal year on October 1. Learn more details about the AAN’s federal funding priorities. The proposed budget includes:
- $52 billion in funding for the National Institutes of Health
- The creation of a new agency called the Advanced Research Projects Agency for Health (ARPA-H)

Issue In Focus

The FDA announced today the approval of Alzheimer's drug Aduhelm (aducanumab). The drug was approved under the Accelerated Approval pathway, one of the alternative drug approval pathways detailed in a recent AAN policy brief. The AAN is reviewing the details of the FDA decision and will provide more details about the indication and labeling to members in the coming days. The AAN formed a work group of experts in health policy, science, and education in July 2020 to prepare for a potential release of aducanumab and its implications for neurologists and their patients. The group prepared recommendations for education and practice resources that the AAN can develop in the coming months to support members with treatment guidance, patient safety, practice workflow, coverage, and reimbursement. Our goal is to provide members with resources and education to know who should be receiving the drug, when to prescribe the drug, how to treat any side effects, and tools to help patients and families. While the AAN did not weigh in on whether the drug should be approved, we did submit comments last October for the FDA to consider around labeling.

What We're Reading

Senate confirms Brooks-LaSure to run health care programs (AP News)
Step therapy hurts America's sickest patients — reasonable parameters are needed now (The Hill)
AMA releases plan dedicated to embedding racial justice and advancing health equity (American Medical Association)