Medicare Coverage for Leqembi via Michael Ellenbogen

Lane Simonian

https://www.cms.gov/newsroom/press-releases/statement-broader-medicare-coverage-leqembi-available-following-fda-traditional-approval

Kraft44

Lane:

Since they removed the Clinical Trials Discussion Board, I feel we are missing information of new trials and advances in drug technology.

What is your opinion of Leqembi. And thoughts generally with new advances in drug therapies.

Lane Simonian

Thank you. I feel exactly the same way.

Leqembi has little effect on ApoE4 non-carriers because they have much less amyloid in their brains than carriers. Some consider the drug's effects on carriers to be borderline clinically significant, but others dispute this. And pulling the amyloid out of blood vessels can cause brain swelling and brain bleeds that can be fatal.

There is another anti-amyloid drug-Alzheon's ALZ-801, that produces similar results as Leqembi, but without brain swelling and brain bleeds because it inhibits the buildup of amyloid rather than removes it. It may be a couple of years away from possible FDA approval.

I try to keep my eye out for antioxidant drugs and natural products for the treatment of Alzheimer's disease. One of these may be Anavex 2-73/blarcamesine. This drug acts similarly to Aricept but may act like a direct antioxidant thus extending the time where at least mild Alzheimer's disease is kept relatively stable. But in its trial quite a few people dropped out or were down-titrated due to dizziness and confusion. The company thinks that by giving the drug at bedtime it may be able to reduce dizziness. They seem to be talking with the FDA about accelerated approval where the drug could be sold but a larger phase four clinical trial would be run.

There are many more drugs in phase 2 clinical trials and some in phase 3 clinical trials, but the chances for success of many of them are not good.