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