HOUSTON – Alzheimer’s is a disease that starts with forgetfulness and declines to the point where your loved ones don’t know who you are.
Families around the U.S. were hopeful some new drugs that were recently approved by the FDA would help preserve the memories of their loved ones.
One of the drugs is Aduhelm, also known as the generic name Aducanumab.
A Houston family was one of the first to receive the treatment in June. It was hoped to be a way to reduce the progression of the disease, almost preserving it to where the patients were when they first start treatment.
Now, the Centers for Medicare and Medicaid (CMS) are drastically cutting down on who can get it, limiting it only to people enrolled in clinical trials. Meaning, the majority of Americans won’t have a chance to try it. At least, not yet.
Why the limitation?
The drug has come with some controversy. In November 2020, a review panel spoke out against the approval of the drug because of some side effects, but eventually, the FDA determined there was more benefit than risk.
However, those side effects came up again when CMS decided to limit access to these types of drugs.
A group called the Right Care Alliance said Aduhelm is dangerous. Reasons for concern include side effects like brain swelling and bleeding.
Can that really happen?
Professor of neurology with McGovern Medical School at UT Health, Dr. Paul Schultz, said brain swelling has happened in some of his own patients, and he’s still willing to prescribe it.
“About half the people don’t have any side effects and half have some side effects, but most of them don’t even know they have it. We just see it on imaging and take care of it and move along,” explained Dr. Schulz. “Even the people that have had the worst swelling in their brain as a side effect, we see them over a couple of months and it goes away and they get back to where they were.”
In fact, Dr. Shulz questions whether the swelling may be an indication the drug is working.
One of his patients, Rolfe Johnson, has been part of the trial with Aduhelm and has not experienced any side effects. He wishes to continue the use of the drug.
“I am with others who have the same Alzheimer’s disease or have had it longer or have had it not as long as I, and who do not seem to be getting along as well as I am, and I am amazed by that. I thank God for that, but I also thank the medicine,” Johnson said.
“Aduhelm was such a hope, it’s like the death of hope for so many people that were looking forward to this,” said Carol Johnson.
CMS final decision still to come
There’s an important decision still to come that will determine whether or not families like the Johnsons can gain access to the drugs.
CMS is waiting to hear from the public and physicians about their opinions and experience with drugs like Aduhelm.
Go to their website and fill out this form. CMS will review comments and decide whether to leave their draft in place, limiting access to only clinical trials, or change it based on input by physicians and the public. The deadline to comment is this Friday.