Mar 2, 2023 3 min read

The approval of new drugs to treat Alzheimer’s disease is welcome news to Sherry Yancosek of Washington.

“These new monoclonal antibody drugs are going to be awesome,” she said. “As we’ve seen them develop in the situation of other disease processes, they’ve been very, very successful. I think this has a lot of possibility and definitely brings hope.”

Yancosek is a member of the committee for the Alzheimer’s Association Walk to End Alzheimer’s in Washington. She became involved after her mother, Gloria Borkoswki, was diagnosed with dementia in 2018. Borkowski died from the disease in 2020 at the age of 97.

“(The drugs) could give somebody some extra weeks, months, who knows, of being present for their family, of doing their own thing, being able to do their everyday activities without assistance,” Yancosek said.

However, an obstacle remains. Access to the drugs is limited.

The Centers for Medicare and Medicaid Services (CMS) requires Medicare beneficiaries be enrolled in a clinical trial to receive coverage for the FDA-approved Alzheimer’s treatments.

In the past, Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, said while the drugs show promise, the potential for harm exists, such as headaches, dizziness, and falls, as well as other potentially serious complications such as brain bleeds.

The Alzheimer’s Association submitted a formal request to CMS to remove the clinical trial requirement.

In a statement released Feb. 22 by CMS, the federal agency said it is not reconsidering the national coverage determination for the antibodies.

“We are making this decision, because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration,” the statement reads. “If a monoclonal antibody directed against amyloid for the treatment of Alzheimer’s disease subsequently receives traditional FDA approval, CMS will provide broader coverage.”

The Alzheimer’s Association responded, saying it was “appalled” at the decision.

“CMS’ role is to provide health-care coverage,” said Joanne Pike, Alzheimer’s Association president and CEO. “Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate. Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary.”

Access to the treatments becomes limited to those who can pay out of pocket, which is pricey – about $26,500 a year.

More than 6.5 million Americans are living with Alzheimer’s, and Yancosek said research indicates about 14 million Americans are expected to be living with it in 2060.

“It’s unbelievable that that many more people will be added to those rosters,” she said. “If you have a drug that can slow that progress, to restrict access to it, shame on Big Pharma. Alzheimer’s patients deserve treatment as much as anybody with any other type of disease. It’s pretty crappy of CMS to say we’re only going to pay for these people in the clinical.”

Nonetheless, Yancosek remains optimistic that someday there will be a cure for Alzheimer’s.

“With these new drugs, they’re clearing out those plaques in the brains,” she said. “More research can make it cheaper. They can hone it a little better. There’s been a few drawbacks with these types of drugs, but they haven’t been anything horrid. I’m always hopeful.”