Alzheimer's Association CEO comments on new Alzheimer's treatment drug Aduhelm
The Alzheimer’s Association has advocated strongly for approval of aducanumab, now called Aduhelm, which received accelerated approval from the Food and Drug Administration (FDA) on June 7. This treatment, while not a cure, has the potential to give more time to those with Mild Cognitive Impairment (MCI) due to Alzheimer’s or those with early stage Alzheimer’s dementia. This is the first treatment ever to achieve such approval to address Alzheimer’s disease itself, not just the symptoms.
Since the approval, much has happened. The FDA has now clarified the people who would likely benefit from this new treatment. It is the same group I described above, those with Mild Cognitive Impairment (MCI) due to Alzheimer’s or those with early stage Alzheimer’s dementi, and the group that the Alzheimer’s Association has advocated to have access to this treatment throughout the approval process.
Achieving access to treatment for those who would likely benefit is now our focus.
Regrettably, Biogen, the company that developed Aduhelm, priced it at $56,000 annually. That is simply unacceptable. The Alzheimer’s Association continues to call on the company to change that price. To fail to do so would deny access for many who could benefit.
To achieve access for this treatment, and other treatments that will one day follow, the Alzheimer’s Association is committed to working with the Centers for Medicare & Medicaid Services (CMS), as well as health insurance companies and others in the private payer community, to expedite coverage and access.
You might have also heard that there have been multiple calls for investigation of the approval process for Aduhelm. The Alzheimer’s Association strongly supports such inquiries to reassure all of us that treatment approval processes work the way they should.
We firmly believe that the FDA’s accelerated approval was the right decision, given the publicly available science, especially for such a devastating and fatal disease - one that otherwise has no treatment to even slow it down. Having the availability of such an option and access to it are needs we’ve long heard from the patient and caregiver community that we serve. You can be assured that the Alzheimer’s Association will continue to advocate for coverage of this now approved treatment for everyone who is likely to benefit.