FDA Approves Alzheimer’s Drug: Aduhelm
On June 7, 2021, the FDA approved Aduhelm for the treatment of Alzheimer’s disease. Aduhelm is the first medication approved to treat Alzheimer’s in nearly 20 years. The approval of Aduhelm has garnered significant interest and excitement for the Alzheimer’s community due to the number of patients living with this devastating disease.
The Alzheimer’s Association recently reported that more than 6 million Americans live with Alzheimer’s disease, with a projected 3-fold increase by 2050. In addition, over 11 million Americans provide unpaid care for people with Alzheimer’s or other dementias.
Medications previously approved for the treatment of Alzheimer’s only target the associated symptoms. Aduhelm offers the first approved treatment to address the disease process. While the approval of Aduhelm may provide a new treatment option, the FDA’s independent advisory committee and other experts have questioned the clinical benefit of this medication.
Aduhelm’s initial two clinical trials reported conflicting results related to the clinical benefit. The FDA recognizes that clinical trials of the drug have provided incomplete evidence to demonstrate effectiveness. Still, they proceeded with the approval for the drug to be used with an additional requirement that Biogen conduct a new clinical trial. The FDA reserves the right but is not required to rescind approval if the new trial fails to demonstrate efficacy.
In addition to the FDA Advisory Committee unanimously recommending that it NOT be approved, the Institute for Clinical and Economic Review (ICER, a well-respected authority on cost-effectiveness of drugs) stated that in approving Aduhelm, the FDA has “has failed in its responsibility to protect patients and families from unproven treatments with known harms.” However, the FDA defends its position, citing the reduction in the underlying cause of Alzheimer’s and the fact that the disease is prevalent and devastating with no current disease-modifying treatments available.
Biogen, the manufacturer of Aduhelm, stated the list price would be $56,000 annually, exceeding ICER’s cost-effectiveness threshold of $2,500-$8,300. In addition, there will most likely be significant costs for diagnostic testing and brain imaging. Because Alzheimer’s primarily affects the elderly, most costs are expected to fall under Medicare’s Part B program; CMS has not indicated how it would cover the drug and its associated costs.
Given FDA’s unlimited approval, the widespread nature of this disease also introduces the potential to overwhelm critical resources such as infusion sites, diagnostic imaging centers, and specialist care.
Confidio is working closely with our PBM partners to understand their plans for coverage of this product. As your most trusted consulting partner, Confidio will communicate with clients as information is available.
1. Belluck, P. and Robbins, R. F.D.A. Approves Alzheimer’s Drug Despite Fierce Debate Over Whether It Works. NY Times. June 7, 2021
2. Alzheimer’s Association. (2020, March 10). 2020 Alzheimer’s disease facts and figures. Retrieved from alz-journals: https://alz-journals.onlinelibrary.wiley.com/doi/full/10.1002/alz.12068
3. Institute for Clinical and Economic Review. ICER Issues Statement on the FDA’s Approval of Aducanumab for Alzheimer’s Disease. Boston: June 7, 2021. https://myemail.constantcontact.com/ICER-Issues-Statement-on-the-FDA-s-Approval-of-Aducanumab-for-Alzheimer-s-Disease.html?soid=1115682120931&aid=2vOhd8l4Mrw accessed 6/8/2021.
4. Cavazzoni, P. (2021). FDA’s Decision to Approve New Treatment for Alzheimer’s Disease. Beltsville MD: FDA Center for Drug Evaluation and Research.
5. Joseph A. An extra twist in the FDA Alzheimer’s decision: no limits on which patients can get the drug. STAT News, 6/7/2021. Statnews.com/2021/06/07/twist-fda-alzheimers-decision-no-limits-on-patients/, accessed 6/7/2021.