alzheimers news-my comments to cms about medicare approval of aduhelm

ALZHEIMERS NEWS-MY COMMENTS TO CMS ABOUT MEDICARE APPROVAL OF ADUHELM

my drug aduhelm or aducanumab was approved by the fda for use in alzheimers disease
this was modified some to be only used in early alzheimers or mild cognitive impairment due to alzheimers

in 2022 you can definitely diagnose alzheimers disease so you can be as sure as you can in medicine on any diagnosis that the diagnosis is correct

the controversy is the way its approval was rushed through
i would argue they should have waited another 2-5 years before making a decision

they didnt
they the fda approved it
they let the cat out of the bag and they cant put it back in

also the results they were basing the approval on was not definite
they needed more time and more studies to really verify if it did slow down memory loss significantly

at best it probably does slow things down
but is it enough

so now its approved 
anyone with those diagnoses of early alzheimers disease or mci due to alzheimers can receive the medication now
the problem is no insurance or medicare will pay for it

to get your diagnosis you need a neurology exam memory testing labs mri scan and either a spinal tap for amyloid and tau and or a amyloid pet scan of the brain
when you are being treated along the way you also need a mri or two of the brain to be sure no aria or microbleeds have occurred

the cost of just the drug is now around $25,000+
plus
all these other tests and exams are expensive

who pays for that

so
if you got the money you can get the infusion now without any problem 
you just have to have the correct diagnosis and find a center that will give it to you

or
do like i have done get the infusions as part of a clinical trial
i am in the embark study where i get monthly infusions of aduhelm for at least 24 months
i also got 18 placebo infusions and 7 aduhelm infusions prior to the pandemic
again at no cost to me

so now 
medicare or cms has a proposal that will be voted on in april 2022 such that medicare will only pay for aduhelm if its in a clinical trial

something doesnt seem right about all this

that will limit its use to 

only those who can afford to pay for it themselves
or
only those really limited folks who can get in a clinical trial

as someone who has been in alzheimers clinical trials now for 10 years
it takes work and determination to be in these studies
they are commonly inaccessible to where most folks live

the rest of those of you or your loved ones with those diagnoses of early alzheimers disease or mci due to alzheimers disase will be shut out from this potentially but not proven treatment that may slow down alzheimers

another bad thing about all this is there are 3 drugs that soon will ask for approval that work similarly to aduhelm but probably will work much better
they will now be forced down this same pathway that the fda and cms has forced aduhelm to travel

if the diagnosis was terminal cancer and treatment would slow down the cancer to prolong life
would it be that this drug for treating this cancer be handled the same way

i doubt it

alzheimers is as terminal as cancer 
it just sometimes takes longer

as i told the nytimes writer who interviewed me about all this 
something doesnt smell right about all of this 

what i think they should do is
approve to pay for it with very strict criteria for who can get it

yes pay for it
then later if it does show in the studies not to work then pull the plug on its use for everyone

there is too much potential in this drug and the others like it not to do otherwise

so
this is what i would say to the medicare or cms folks

just do it or get off the pot

we in the alzheimers world had been anxiously awaiting these new drugs
thanks to you guys ie biogen fda cms for screwing this all up


the organicgreen doctor