EYEWITNESS NEWS (WBRE/WYOU) — It’s been about one year since the first new drug to treat Alzheimer’s Disease, in nearly two decades, received FDA approval.

But now access to that drug is in danger of being severely limited to Alzheimer’s patients and the concern leaves the drug’s advocates scrambling.

Aduhelm is prescribed for early-onset Alzheimer’s patients as a first of its kind therapy to target the underlying disease process and slow Alzheimer’s progression. Before the FDA accelerated approval in June 2021, early Alzheimer’s patients like Kevin Bonham of Bear Creek Village participated in clinical trials.

“After you get the infusion, within a day or two you just. Everything clears out and you can understand things better. You can reason things better,” said Kevin Bonham, receives Aduhelm infusion therapy.

“He had a beautiful, robust response and remained independent and active,” said Kim Bonham, Kevin’s wife.

Bonham’s wife says in the months without treatment, between clinical trials and FDA approval, his cognition began to decline. She says he’s stable since resuming treatment. But now centers for Medicare and Medicaid Services or CMS are nearing a decision on whether to pull federal insurance funding for the drug unless patients are enrolled in a clinical trial of the medicine.

“They don’t really need to do that because they have paid very little towards Alzheimer’s disease. Families pay about 70 percent,” said Sue Peschin, President/CEO, Alliance for Aging Research.

Biogen cut its annual $56,000 price of Aduhelm in half this year. But besides cost, CMS is questioning the drug’s efficacy and potential side effects and wants more proof. Biogen submitted a final protocol Wednesday morning to the FDA to enroll about 1,500 patients in may for a final, four-year study.

The drugmaker revealed it aims to include at least 18 percent of U.S. Patients from the Black and Latino populations after cms requested more diversity in Aduhelm clinical trials. But African Americans against Alzheimer’s, which believe diversity should always be the goal, considers the demand at this stage too late.

“We actually have a drug that works and we’re then going to say we’re not going to let these people who frankly need it the most who were excluded from trials, we’re now not going to allow them to have access to the drug. That feels discriminatory,” said Stephanie Monroe, Executive Director of African Americans Against Alzheimer’s.

A final decision by cms is expected on April 11. Advocates of Aduhelm say if funding is pulled, it will also affect coverage of other potential treatments in the pipeline.

Head to this web page to learn more about the cms decision-making process and how you can make your voice heard one way or the other.