You may have heard the noise about a new drug for treating Alzheimer’s disease and other dementias. It would make sense that there would be some noise, because we’re talking about a new treatment with a new target and new data on how well it works (or doesn’t). A lot of the noise, however, was not fanfare about a new drug as much as the red flags that Medicare (CMS) was raising about covering the new therapy’s use. That, and it’s been since my book was released in 2017 that any new way to address the devastating effects of Alzheimer’s has come on line…and that’s just about six years!
I won’t go into the details of those “older drugs,” except to say they didn’t have anything close to the dramatic results that consumers or physicians wanted:
- Cholinesterase Inhibitors (Donepezil, Galantamine and Rivastigmine); and
- NMDA antagonists (Memantine, Memantine and Donepezil combination).
You can read more in Chapter Seven of the book if you want to understand their mechanisms of action as well as other healthy lifestyle habits that can make a difference in addressing both the progression of Alzheimer’s and how the medications work.
I had mentioned the “noise” about a more recent addition to the inventory of FDA-approved treatments for Alzheimer’s. The new drug, Leqembi, was approved for treating AD, but there were a number of caveats imposed by the Food and Drug Administration from the get-go. When FDA gave its initial approval of Leqembi as “safe and effective,” the Centers for Medicare and Medicaid Services (CMS) placed some rather onerous restrictions on the use of this therapy. What restrictions? Patients can of course be prescribed Leqembi, but it will be “covered” by CMS only if their prescribing provider is part of a registry to monitor the use of the drug. This position has been a bit relaxed from their earlier restriction that patients could be prescribed this therapy only if they were involved in an extended clinical trial. And this is a first for CMS to require this sort of data-collection after FDA approval.
FDA’s approval was based, it seems, on the therapy’s ability to reduce amyloid beta plaque in patients’ brains in a 79 week trial among 856 patients. The manufacturers of Leqembi had completed the trial with up to 93 percent reduction in plaque at Leqemi’s highest dose. CMS has made restrictions for drugs yet to complete an approved clinical trial, but Leqembi was already done with that. What’s missing in this picture? Since this is going to take a bit more space to unpack, I’ll leave with you a question to be answered in “part 2:” What about maybe judging a therapy based on measures of Cognitive Decline?
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.