0:00

Now, uh, I'd like to talk about

0:02

where these important regulatory updates.

0:04

This is a very exciting time, uh, for dementia.

0:07

Uh, following the FDA's decision on July 6th, 2023

0:11

to grant traditional approval of Le Kembe, the, uh,

0:14

generic name is Lecan.

0:16

CMS then immediately affirm that

0:18

that will cover this medication broadly.

0:20

So this is a very pivotal step that really is allowing

0:24

a means for drug access to the millions of Americans

0:28

that are suffering from Alzheimer's disease.

0:30

And the only criteria for CMS coverage is you have

0:33

to have Medicare, you have to have mild cognitive impairment

0:35

or mild Alzheimer's disease, which must be documented, uh,

0:39

as evidence of amyloid plaque.

0:41

And then, uh, you, you also have

0:43

to join a registry which your neurologist will, um,

0:45

help take care of for you.

0:47

It's on the CMS website

0:48

and it's a very simple registry

0:50

for your neurologist to sign you up in.

0:52

Uh, individuals with original Medicare will pay the standard

0:54

20% co-insurance of Medicare approved amount

0:58

of embi once they meet their part B deductible.

1:01

But Medicare will cover the other 80%

1:04

and actually the largest health system in the United States.

1:06

The va, uh, started covering this drug even

1:09

before C-M-S-C-M-S was waiting for the FDA, uh,

1:12

can traditional approval before they decided

1:13

to make the decision to cover.

1:16

So in the Clarity ad phase three trial,

1:18

which was published in the New England Journal

1:19

of Medicine on January 5th, 2023,

1:23

kinumab met the primary efficacy endpoint

1:25

by slowing the rate of cognitive decline

1:27

by 27% over an 18 month period based on

1:30

the clinical dementia rating.

1:31

Sum of boxes. This is looking at the primary endpoint

1:36

for the CLARITY trial.

1:37

And here you can see lecan here slowing the rate

1:40

of cognitive decline compared to the, uh, placebo.

1:43

And then if we look at the secondary endpoint,

1:45

which is clearance of the beta amyloid

1:47

plaque, there's just no comparison.

1:48

Here's placebo here. No change at slight increase in plaque.

1:51

Whereas look at

1:53

how well kinumab is doing in dropping the amount

1:56

of amyloid plaque in the brain.