New Alzheimer’s Treatment Must Be Affordable and Accessible; with Faster and More Inclusive Phase 4 Confirmatory Trial
Washington, D.C. (June 21, 2021) - The FDA’s approval of Aduhelm is a breakthrough in the fight to treat Alzheimer's and offers a new option and new hope to many patients and families. But FDA approval of the first Alzheimer’s treatment in nearly 20 years will be a hollow victory unless this drug is accessible and affordable to the patients that could benefit from it the most.
UsAgainstAlzheimer’s calls on Biogen, the FDA and insurers to come together to solve four key issues that are critical for patients: affordability, equity, the length and diversity of the Phase 4 confirmatory trial, and who is most likely to benefit from the drug.
Making the drug accessible and affordable: The announced price for Aduhelm of $56,000 a year—plus the cost of office visits, diagnostics, and other tests—will limit the availability of this first-in-class treatment to only the wealthiest Americans unless the company and insurers work together to keep patients’ out-of-pocket costs low.
We are especially concerned about access for patients enrolled in Medicare fee-for-service without supplemental insurance, who would be expected to pay more than $11,000 a year for the drug alone—plus the costs of doctors, several MRIs, and initial diagnostic tests. Medicare must change its policy and cover an initial PET scan, the most common test used to detect Alzheimer’s plaques in the brain, which can cost a patient $5,000.
Together, we must do more. UsAgainstAlzheimer’s calls on Biogen and insurers to make access to this drug and related tests affordable for American families at every income level.
Ensuring equity: Black Americans and Latinos were woefully underrepresented in the clinical trials to date on Aduhelm, even though these communities are more likely than non-Hispanic Whites to develop Alzheimer’s. We demand that Biogen’s post-approval Phase 4 clinical trial set and meet inclusion and equity targets to ensure that diverse populations are represented at levels equal to their proportion of the Alzheimer’s population.
Speeding the timing of the confirmatory trial: It is critically important to learn more about who will benefit from Aduhelm in real-world conditions, and the nine-year time period for completion of this Phase 4 trial is indefensible. Patients cannot wait nine years for this vital data. We call on Biogen and the FDA to do whatever it takes to deliver results from the Phase 4 trial in half of that time.
Clarifying for whom this drug is intended: Patients should not have to wonder whether Aduhelm might work for them. The earlier clinical trials focused on patients with mild cognitive impairment and early stage Alzheimer’s, but the approved label for the drug is broader. Biogen and the FDA should clearly state what subset of Alzheimer’s patients will get the most benefit.
For people living with a progressive neurological disease such as Alzheimer’s, every single day matters. These issues cannot wait.
Biogen, Medicare, private insurers, and the FDA must immediately address patient concerns about affordability, equity, effectiveness, and whether the drug is right for them. UsAgainstAlzheimer’s stands ready to help.
UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the disease. We will not rest until brain-span equals lifespan - for everyone.