TAMPA, Fla. — The Centers for Medicare and Medicaid Services (CMS) announced its preliminary decision Tuesday to restrict the coverage of Aduhelm, the first FDA-approved treatment for Alzheimer’s Disease in nearly two decades. The FDA fast tracked approval back in June, but in what experts call an unusual move, the CMS proposed limiting Medicare coverage of the treatment to those participating in randomized clinical trials, citing the need for more evidence that it is safe and effective.

“I think at the end of the day, that’s Medicare’s concern, that there isn’t sufficient evidence to come down on one side or the other, in terms of this drugs and other ones like it,” said Juliette Cubanski, the deputy director of the program on Medicare policy for the Kaiser Family Foundation. “So these trials have to be designed in order to generate significant clinical evidence to suggest that this drug does or does not have a meaningful impact on cognitive function.”

Still, this is the only treatment out there that addresses Alzheimer’s Disease and its progression directly, rather than just the symptoms. Those who consider it their only hope say they are disappointed in the decision.

The family of 54-year-old Michele Hall, a Bradenton attorney who was diagnosed with early-onset Alzheimer’s, said they will now have to consider paying for the drug out of pocket. Hall, who already received one infusion of Aduhelm, said she didn’t hesitate to get the treatment, despite potentially dangerous side effects, like brain bleeding.

“This is an easy question because there’s nothing else around so what we thought is let’s start doing it,” Hall said. “And if something better comes, we jump ship and go to what’s next.”

Right now, the cost of Aduhelm is $28,000 annually.  Spectrum News reached out to the Alzheimer’s Association and received the following statement from the Alzheimer’s Association:

“(The) draft decision by the Centers for Medicare & Medicaid Services (CMS) is shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics. With this approach, access to treatment would now only be available to a privileged few, those with access to research institutions, exacerbating and creating further health inequities.”

Medicare’s final decision on this class of drugs is expected by April 11, after which officials say approved clinical trials can begin.