Alzheimer's Association Statement: Next Steps For New Alzheimer's Treatment
Alzheimer's Association's research experts and advisors are deeply familiar with the basic and regulatory science that led to the FDA's decision.
CHICAGO, June 12, 2021 /PRNewswire/ -- As the global nonprofit leader in Alzheimer's research and science we have extensively reviewed the clinical trial data for Aduhelm™ (aducanumab). Based on the trial data, the treatment demonstrated an efficacious result which has also been confirmed by leading scientists in the Alzheimer's and dementia scientific community and the Food and Drug Administration (FDA). Alzheimer's Association's research experts and advisors are deeply familiar with the basic and regulatory science that led to the FDA's decision. They were right to approve this treatment.
Additionally, the FDA appropriately took into account the vast unmet need of the Alzheimer's community. Aduhelm is certainly not a cure, but at long last it provides many with Alzheimer's disease and their families an effective treatment. The confirmatory trial should begin promptly.
Our focus has and will continue to be access to this treatment for all likely to benefit. Approval is the fundamental first step to access. The first drug in a category invigorates the field, increases investments in new treatments and encourages greater innovation.
Following approval, the manufacturer, Biogen, announced their intention to price Aduhelm at $56,000 per year. This price is simply unacceptable. For many, this price will pose an insurmountable barrier to access, it complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity. We call on Biogen to change this price.
Next, the path to access turns to the Centers for Medicare & Medicaid Services (CMS). Just as with the FDA, we have the utmost respect for CMS and how they will approach the key decisions ahead. We're committed to working with them — and with the private payer community — to expedite access for all of those who would likely benefit based on the successful clinical trial. CMS faces difficult policy decisions on how to best accomplish this within the context of the Medicare program, and we stand ready to fully support CMS and private payers in this work for all communities in need.
Alzheimer's Association
The Alzheimer's Association leads the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. For more information, visit www.alz.org or call the 24/7 Helpline at 800.272.3900.
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SOURCE Alzheimer’s Association
