Statement on Aducanumab

In concert with and endorsed by AMDA, I co-authored this statement and feel strongly that aducanumab has not demonstrated safety or efficacy for people living in nursing homes. 

AMDA – The Society for Post-Acute and Long-Term Care Medicine is compelled to comment on the recent approval of the controversial parenteral Alzheimer’s Dementia (AD) medication, aducanumab. After considering the evidence, we conclude that the aducanumab trials did not adequately demonstrate safety or efficacy. Moreover, aducanumab has only been studied in individuals with mild cognitive impairment or early stage dementia due to hyperamyloidosis (e.g., AD) and has never been tested in a population representative of nursing home residents. We therefore cannot endorse recommending or prescribing aducanumab to post-acute and long-term care (PALTC) residents and patients.

In alignment with other partner organizations and recognized experts, we believe that the lack of evidence of benefit, along with the significant potential for dangerous side effects (over 30% of study participants had brain swelling or bleeding), high medication delivery cost (initial pricing for the drug alone is projected at $56,000.00/year, and it requires intravenous infusion), and potential for providing false hope is likely to have extraordinarily negative consequences for the 6 million people and their caregivers living with dementia in this country. Additionally, the high cost and need for sophisticated neuroimaging can be expected to widen inequitable care gaps.  Lastly, the invasive workup and monitoring process would be overly burdensome to most nursing home residents. With respect to aducanumab, we advocate for a Coverage with Evidence Program, where CMS could negotiate prices linked only to appropriate populations and actual evidence of efficacy.

We understand and deeply appreciate the overwhelming suffering caused by AD and other dementias, and strongly support future trials of novel candidate drugs to prevent or slow AD. We also recognize that there are numerous types of dementia, many overlapping in nature, and that there will probably never be a single medication to cure dementia.  As such, AMDA supports public health efforts to mitigate modifiable risk factors, such as vascular disease, and strongly endorses initiatives and legislation to support both formal and informal caregivers and existing models of care that are known to improve outcomes of people living with dementia.

AMDA also acknowledges that our PALTC workforce bears a disproportionate burden because of the high concentration of people living with dementia in long-term care. We must answer to families and caregivers who are desperate to try “anything that might help”; however, it is our responsibility to resist the urge to prescribe a potentially dangerous and ineffective medication that is untested in our population, even if it has FDA approval.

Lea C. Watson, MD, MPH

Co-chair Behavioral Health Council, AMDA

Richard Juman, Psy.D.

Co-chair Behavioral Health Council, AMDA