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Re: Doc328 post# 396548

Saturday, 01/07/2023 11:13:47 PM

Saturday, January 07, 2023 11:13:47 PM

Post# of 470336
Doc238,

As ususal, you raised a good and valid point about infusions not being covered by the donut whole. I did not think that through when I quoted that part.

Your argument that Medicare will review and relax the rules set in place for Aduhelm is yet to be seen. I am not so sure they will be pursuaded to change the limitations imposed on coverage for amyloid plaque removers based on the PH3 results obtained for Lecanemab, but you could be right since there appears to be some efficacy in slowing progression.

However, even if Medicare gives the go ahead, I still don't think you doctors will be overwhelming pushing Lecanemab. The FDA approval was limited to early stage AD patients, so there is that to think about, which greatly cuts back on FDA endorsed eligibility. How many doctors will ignore that guidance?

Also, it is infusion every two weeks, and how many patients will go for that? Quite inconvenient.

Also, there is limited effectiveness, so may doctors and their patients may choose to pass on this one even if it is covered, especially since it has side effects.

But, undoubtedly it will be tried by a group, estimated by BIIB to be on the order of 100,000, and that is really the point. BIIB will make sure of that.

The FDA wants to allow doctors to test this drug in a population that will not overwhelm the healthcare system, but provide new information not obtainable any other way, about amyloid placque removal and its medical and economic justifications.

How will it work beyond 18 months; what are the long term outcomes for keeping mild AD in check this way; can drug combinations improve on Lecanemab's operation; and will it work better in earlier cases of AD?

We need to get this information, and the FDA is opening the door so the medical community can make greater progress because the problem is enormous, and advancement has not come in the traditional clinical trial methodology.

I don't know if you work with any AD patients, but what are your thoughts about which types of patients you would and would not prescribe it for AD symptoms?

I assume you would be very discriminating? Am I right on that?
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