I had left you last week with what may have seemed to be an optimistic note regarding the latest Alzheimer’s therapy to gain FDA approval. I am going to hand this second part over to one of my senior team members, Steven Steiber, Ph.D. Steve has his doctorate in behavioral science and nearly 40 years in clinical and market research in biopharma. Please read what he has to say:
“I’d like to start with some of the reaction to the Centers for Medicare and Medicaid Services (CMS) current unenthusiastic opinion on whether they will cover Lecanemab.
When FDA approves a medication, it’s on the simple premise that the drug is first “safe” and second is “effective.” That sounds pretty rigorous, and yes, there’s a good deal of statistical testing with relatively large samples of patients in double-blinded (neither the patients nor the clinicians know if they’re using the new medication or a placebo) clinical trials. CMS takes this a step beyond what the numbers say and asks if the therapy is both “reasonable” and “necessary?” I believe they’ll announce their final decision in early July.
I’ve had the good fortune to have attended a webinar this past week sponsored by the International Alzheimer’s Institute. They had a panel of professors, physicians and even a biostatistician discussing the “data” on Lecanemab. The first important point raised was simply to lay out that the amyloid plaque that lecanemab helps remove isn’t the source of Alzheimer’s. It’s the result of what Alzheimer’s does to the brain. It’s like rheumatoid arthritis in that the inflammation which swells joints is not the disease, but a result of the disease.
And how much amyloid does Lecanemab eliminate? The 18-point scale used to measure the effect against placebo showed those who had received the Lecanemab injections had .45 units less amyloid at the end of the trial…2.5 percent less amyloid. The trial also used a cognition scale that could show no statistically significant difference between the experimental group and the placebo group.
Clinical trials are also required to track any side effects reported by participants during the trial as well as after the trial is closed. The Mayo Clinic has a list of more than 30 side effects associated with Lecanemab, and one of the panelists on my webinar, a neurologist at Northwestern University Hospital, reported a macrohemorrhage in an otherwise healthy patient. She subsequently died.
I won’t pass judgment on a new medication…above my pay grade…but I will continue to look for treatments that actually address cognition or can work upstream from the plaque accumulation that Alzheimer’s leaves in the brain. I would rather hire a contractor who can build a great house that the critics call brilliant than one whose only claim to fame is how tidy they leave the site when their work is done. I would encourage you all to follow other trials for a way to address Alzheimer’s as well as those therapies that target other neurodegenerative conditions like Parkinson’s or Huntington’s. I’ve got a number of start-up companies that I am following, and we’ll updte you when new information becomes available. Meantime, let’s see what the final word from CMS on lecanemab is.”
Charlotte Bishop is an Aging Life Care Advisor, Geriatric Care Manager and founder of, certified professionals who are geriatric advocates, resources, counselors and friends to older adults and their families in metropolitan Chicago. She also is the co-author of How Do I Know You? A Caregiver’s Lifesaver for Dealing with Dementia.