AMDA: Aducanumab Trials Did Not Adequately Demonstrate Safety or Efficacy in PALTC
Drug was not tested in frail older adults before approval was given
Columbia, MD – After studying the recent trials of Biogen’s controversial Alzheimer’s Dementia (AD) medication, aducanumab (Aduhelm), AMDA – The Society for Post-Acute and Long-Term Care Medicine has concluded that the trials did not adequately demonstrate safety and efficacy. In addition, the drug needs to be tested in a population representative of nursing home residents before it is prescribed in post-acute and long-term care (PALTC) facilities. AMDA’s statement noted that:
- The lack of evidence of benefit, along with the significant potential for dangerous side effects, is likely to have negative consequences for the 6 million people living with dementia in this country, along with their caregivers
- The high cost and need for sophisticated neuroimaging can be expected to widen inequitable care gaps
- There should be a Coverage with Evidence Program, where CMS can negotiate prices linked only to appropriate populations and actual evidence of efficacy
“We understand that there is a high concentration of people living with dementia in long-term care, which puts an enormous burden on our PALTC workforce and on our residents’ families,” says AMDA Executive Director Christopher E. Laxton. “However, we have a responsibility to ensure that the safety and benefit of any new medication is properly understood within our population before it is approved as a potential treatment. In the case of aducanumab, that has not yet happened.”
AMDA’s complete statement can be found here.
AMDA – The Society for Post-Acute and Long-Term Care Medicine is the only medical specialty society representing the community of over 50,000 medical directors, physicians, nurse practitioners, physician assistants, and other practitioners working in the various post-acute and long-term care (PALTC) settings. Dedicated to defining and improving quality, we advance our mission through timely professional development, evidence-based clinical guidance, and tireless advocacy on behalf of members, patients, families, and staff. Visit www.paltc.org for more information.