With the finalization of a controversial draft policy, one federal agency dashed the hopes of millions of people living with Alzheimer’s and related dementias.
The Centers for Medicare and Medicaid Services opted to severely limit access to aducanumab, the first FDA-approved treatment for Alzheimer’s disease in nearly two decades. But the agency didn’t stop there. CMS’ coverage decision also applies to future medications in the same class.
The Alzheimer’s community had implored the agency to ensure greater access, but their voices were largely ignored. CMS’ final policy stipulates that Medicare will cover aducanumab and future same class therapies only for people enrolled in a qualifying clinical trial. The decision will likely limit access to a few thousand patients.
Halting Access to an Approved Drug
“The national coverage determination denies patients the opportunity to weigh the risk and benefits of this new FDA-approved medication with their doctor and see if it’s right for them,” points out Stephen Salloway, MD, who helped develop the safety protocols for the drug. “Medicare beneficiaries made these treatments and diagnostic advances possible, and they deserve access to them.”
Aducanumab was approved in 2021 through the Food and Drug Administration’s accelerated approval pathway. The streamlined process is intended to bring innovative treatments to more patients sooner. In an ironic turn of events, CMS’ coverage decision will actually limit access – not only to aducanumab, but also to all similar drugs approved via the accelerated process.
Forcing additional clinical trials for an approved drug creates significant obstacles for patients and caregivers. There are few, if any, active trials since the drug is already approved. When new trials do open, patients’ proximity to a site, logistics and costs associated with participation are all barriers. And the very nature of being in a trial means some participants will receive a placebo in lieu of the approved medication – a grave concern to many advocates.
The access burden will be especially significant for communities of color, who historically are less likely to participate in clinical trials but are disproportionately more likely to have Alzheimer’s and other dementias.
With no other approach to access the treatment, the coverage decision also leaves patients currently receiving aducanumab in limbo.
A Concerning Precedent
By limiting access to only those patients enrolled in clinical trials, CMS has expanded its role in an unprecedented way. And by doing so, it is publicly calling into question the credibility of the FDA’s accelerated approval pathway – a process that was created by Congress 20 years ago and one that has been successfully used to get 67 other CMS-covered drugs to patients faster.
It also generates new questions for companies with sights set on an accelerated approval pathway – including therapies in development for rare diseases, which, like Alzheimer’s and dementia, have few treatment options.
CMS’ final coverage decision pulls the rug out from under Alzheimer’s patients and caregivers who were optimistic about a groundbreaking treatment – that now will be nearly impossible to access.