Aducanumab

[MoJames 8257]

So approximately 2 years ago the drug company Biogen put into stage III trials their new monoclonal antibody focused on plaque build up of a certain type in Alzheimer's. Their hope obviously was to augment plaque production to change the progression of Alzheimer's Dementia. Well about a year ago, they all but abandoned the drug as the clinical findings were that there was no significant change in the progression of the awful disease.

Well apparently the data was reviewed and secondary endpoints were closely evaluated as the primary goal had failed. Well turns out someone was able to find in the data some statistical differences in the outcome of independence. As such, the FDA started moving towards approval of the drug. Well the drug is an infusion that one would do once a month. For those who aren't in medicine, adding an infusion cost to a medication increases cost substantially. On top of that the secondary endpoint that showed benefits was that is potentially prolonged patients' independence by several months. 

Several Neurologists stepped up to show dismay on the decision of the FDA to approve the medication that showed little to any benefits. As such, the FDA put together a commission of independent Neurologists to review the data. 10 of the 11 did not recommend approval of the drug with the final sitting firmly on the fence. On Friday the NYT put out this article on the process thus far and today in my neurology clinic the drug rep showed up to determine how we would respond to the medication.

Link

I'm curious from the general population, how they feel about this keeping in mind that one year of the drug is around $60,000. This is not including the cost of the infusion clinic. Currently 5.8 million patients in the USA are noted to have Alzheimer's dementia. The benefit of the drug is to potentially prolong independence by several months.

[bernorange 8377]

Death panels!

[Deej 77298]

Aducanumab

-What I recited to the cop when asked to say the alphabet. 

[elfenix 34396]

 

[bernorange 8377]

Aducanumab

also my favorite Genesis album

[UT_OB1 2229]

I would agree that it wouldn’t meet the cost/benefit ratio. However, as with most scientific and research programs, I would hope that something is learned from it.  Maybe they’ve started down the right path, but just need to refine it?  Maybe one breakthrough is lacking for it to be effective and we’ll revisit it in 10 years?  Or maybe it will lead to an unexpected breakthrough in a completely unrelated area?   L

[miguelito 11347]

Go home, Macanudo, you're drunk. 

[pacman 7441]

High cost but there may be quite a few who consider the extra m9nths of independence well worth it. Personally, I would pass at that price point.

[pacman 7441]

13 minutes ago, miguelito said:

Go home, Macanudo, you're drunk. 

You joke but I did see Macanudo somehow.

[Anastasis 23520]

1 hour ago, MoJames said:

I'm curious from the general population, how they feel about this keeping in mind that one year of the drug is around $60,000. This is not including the cost of the infusion clinic. Currently 5.8 million patients in the USA are noted to have Alzheimer's dementia.

Medicare spending was ~$650B in 2019. Assume ~25% of those AD patients will be treated with this drug, ~$90B annually, most of which will hit Medicare. So let's just project that this single drug has potential to add 10-15% to federal Medicare expenditures as a conservative estimate. That math don't work, and that doesn't count any of the ancillary resource use that may be involved, e.g. infusion costs, amyloid tests, etc. And that is just back of the envelope stuff before you layer in aging population structure resulting in accelerated growth of AD, expanding to other indications like MCI, etc. The resource would be better spent on non-drug and caregiving support, imo. 

Edited November 10, 2020 by Anastasis

[TwiceHorn 31705]

In the most practical of senses, this is a disaster.

People and their families will clamor for this drug, Medicare and private insurers will wind up eating some of it, and prices will go up for everyone.

[Deej 77298]

But free healthcare.

[Liquor and Poker 3659]

1 minute ago, Deej said:

But free healthcare.

I almost wrote a long diatribe about false equivalence, but what's the point?

 

 

[immortal13 4059]

16 minutes ago, Deej said:

But free healthcare.

It's a human right!

[TwiceHorn 31705]

Does anyone know how these high-cost drugs are handled in healthcare systems outside the US?

One partial answer is that the price may be controlled.

But I also suspect that these types of drugs with marginal cost/benefit are not readily available in those systems.

[Deej 77298]

"Ask your doctor if Aducanumab is right for you."

[Armybrat 41043]

1 hour ago, Deej said:

Aducanumab

-What I recited to the cop when asked to say the alphabet. 

And he probably let you go?

[Deej 77298]

7 minutes ago, Armybrat said:

And he probably let you go?

"Call Art!" - Jeff Ward

[Willfully Horn 8104]

Fuck Alzheimer’s.

Kill it until it is dead.

Edited November 10, 2020 by Willfully Horn
Not funny

[MoJames 8257]

23 minutes ago, TwiceHorn said:

Does anyone know how these high-cost drugs are handled in healthcare systems outside the US?

One partial answer is that the price may be controlled.

But I also suspect that these types of drugs with marginal cost/benefit are not readily available in those systems.

Here is a old article that describes the process that occurs in the UK.

https://www.bbc.com/news/health-28983924

[staboner 5017]

huh I thought we were talking about the dude we just crowd sourced in the CR

this is some ummagumma next level shit

[Captainant 28005]

3 hours ago, MoJames said:

So approximately 2 years ago the drug company Biogen put into stage III trials their new monoclonal antibody focused on plaque build up of a certain type in Alzheimer's. Their hope obviously was to augment plaque production to change the progression of Alzheimer's Dementia. Well about a year ago, they all but abandoned the drug as the clinical findings were that there was no significant change in the progression of the awful disease.

Well apparently the data was reviewed and secondary endpoints were closely evaluated as the primary goal had failed. Well turns out someone was able to find in the data some statistical differences in the outcome of independence. As such, the FDA started moving towards approval of the drug. Well the drug is an infusion that one would do once a month. For those who aren't in medicine, adding an infusion cost to a medication increases cost substantially. On top of that the secondary endpoint that showed benefits was that is potentially prolonged patients' independence by several months. 

Several Neurologists stepped up to show dismay on the decision of the FDA to approve the medication that showed little to any benefits. As such, the FDA put together a commission of independent Neurologists to review the data. 10 of the 11 did not recommend approval of the drug with the final sitting firmly on the fence. On Friday the NYT put out this article on the process thus far and today in my neurology clinic the drug rep showed up to determine how we would respond to the medication.

Link

I'm curious from the general population, how they feel about this keeping in mind that one year of the drug is around $60,000. This is not including the cost of the infusion clinic. Currently 5.8 million patients in the USA are noted to have Alzheimer's dementia. The benefit of the drug is to potentially prolong independence by several months.

My dad with advance Parkinson's was nearly killed by a similar anti-hallucination drug. Same story, rushed FDA approval. Bad shit, rushing science rarely leads to good things

[wd40 1976]

had a related conversation, the other night.  I wondered if you can tell when your mind is going.  like, at what point do you lose consciousness of your consciousness.  because just before that point, I'm out.

fuck wasting away.

[Armybrat 41043]

Sometimes I think I’m getting there, and can notice some progression.

[Shoxthemonkey 1983]

5 minutes ago, wd40 said:

had a related conversation, the other night.  I wondered if you can tell when your mind is going.  like, at what point do you lose consciousness of your consciousness.  because just before that point, I'm out.

fuck wasting away.

My Mother had Alzheimer's and was very much aware that she was declining. She became unable to communicate and spent her last 10 years as a shell in a living facility. Nice term for a warehouse. She had good care, of course, but the quality of life was something that I will not go through if I have the awareness to stop it. I will not spend the thousands for this drug that will only extend life for a few months. A cure or nothing for me, please.

[sdm 895]

17 minutes ago, Armybrat said:

Sometimes I think I’m getting there, and can notice some progression.

Don't beat yourself up Brat, after several centuries you're bound to experience a little deterioration. 

[strangulation! 1716]

36 minutes ago, Armybrat said:

Sometimes I think I’m getting there, and can notice some progression.

Have Mrs Brat take you to a neurologist. There are drugs that can slow the progression way down

[XYZ 2154]

12 hours ago, MoJames said:

I'm curious from the general population, how they feel about this keeping in mind that one year of the drug is around $60,000. This is not including the cost of the infusion clinic. Currently 5.8 million patients in the USA are noted to have Alzheimer's dementia. The benefit of the drug is to potentially prolong independence by several months.

You are asking how we feel about a drug that is extremely expensive and provides almost no benefit? Well, considering that the healthcare system in the USA is clearly, CLEARLY designed to maximize profits to hospitals/doctors/pharma/medical supplies/whatever, I consider it a great success!

[CooterBrown 18118]

9 hours ago, staboner said:

huh I thought we were talking about the dude we just crowd sourced in the CR

this is some ummagumma next level shit

Me too. I had to reread the OP just to figure out what I was reading.

[BabaYaga 15419]

11 hours ago, TwiceHorn said:

Does anyone know how these high-cost drugs are handled in healthcare systems outside the US?

Portfolio pricing...ie., formulary tiering.  Assuming of course they even have access at all, which is far more likely

[MoJames 8257]

1 hour ago, XYZ said:

You are asking how we feel about a drug that is extremely expensive and provides almost no benefit? Well, considering that the healthcare system in the USA is clearly, CLEARLY designed to maximize profits to hospitals/doctors/pharma/medical supplies/whatever, I consider it a great success!

I honestly am hoping that the FDA doesn't approve the medication. From a provider standpoint it only offers a new obstacle to providing care for these situations that are already futile. If this medication made a substantial difference in the magnitude of years, or somehow arrested progression, I'm all in. But the data was so bad that it was all but abandoned.

13 hours ago, Anastasis said:

Medicare spending was ~$650B in 2019. Assume ~25% of those AD patients will be treated with this drug, ~$90B annually, most of which will hit Medicare. So let's just project that this single drug has potential to add 10-15% to federal Medicare expenditures as a conservative estimate. That math don't work, and that doesn't count any of the ancillary resource use that may be involved, e.g. infusion costs, amyloid tests, etc. And that is just back of the envelope stuff before you layer in aging population structure resulting in accelerated growth of AD, expanding to other indications like MCI, etc. The resource would be better spent on non-drug and caregiving support, imo. 

This is what will most likely happen unfortunately if it is approved by the FDA and if so...

Edited November 10, 2020 by MoJames

[MoJames 8257]

Well just met with the rep again and we will find out June 6th if this gets approved by the FDA.

[Anastasis 23520]

FDA just approved it. 

[MoJames 8257]

We fucked.

[Pato del Muerto 52977]

Bullets are cheaper (at present) and more humane. 

[AUS-97HORN 11894]

i look forward to the ad blast we are about to get.

[bernorange 8377]

On 11/9/2020 at 7:09 PM, MoJames said:

So approximately 2 years ago the drug company Biogen put into stage III trials their new monoclonal antibody ...

I see ads on TV frequently telling people to ask their doctor about monoclonal antibodies as a treatment for c19.  Is this related?

[Homercles 10206]

3 minutes ago, bernorange said:

I see ads on TV frequently telling people to ask their doctor about monoclonal antibodies as a treatment for c19.  Is this related?

On a side diatribe, it’s fucking ridiculous that prescription drugs can be advertised on tv.  

[Heme Doc 417]

Stupid ass FDA

[sidis 9875]

On 11/10/2020 at 6:43 AM, Armybrat said:

Sometimes I think I’m getting there, and can notice some progression.

i have wondered before if your inevitable deterioration of cognitive skills is being slowed in any material way by your significant engagement and participation here.  i have to think so relative to other olds who just sit around and watch shitty news channels all day.

[Armybrat 41043]

11 minutes ago, sidis said:

i have wondered before if your inevitable deterioration of cognitive skills is being slowed in any material way by your significant engagement and participation here.  i have to think so relative to other olds who just sit around and watch shitty news channels all day.

The wife & I stopped watching 95% of the news stuff a decade ago. It has done wonders for the blood pressure.

in spite of the cataract & retina surgery that greatly improved my eyesight last year, it is getting much more difficult to read the smaller print things. That is probably due to eyestrain while surfing nsaa.

[sidis 9875]

3 minutes ago, Armybrat said:

The wife & I stopped watching 95% of the news stuff a decade ago. It has done wonders for the blood pressure.

in spite of the cataract & retina surgery that greatly improved my eyesight last year, it is getting much more difficult to read the smaller print things. That is probably due to eyestrain while surfing nsaa.

while on your browser, hold down ctrl and roll your mouse wheel (or whatever your comparable setup is) up. 

that will allow you to see deep into your fellow posters' wives' buttholes a little better.

[Anastasis 23520]

How dumb is this?

Approval based on a surrogate endpoint, and post-hoc reanalysis of the data. So now, they get to market it, generate the revenues, and essentially use paying customers to actually test the product for effectiveness on someone else's dime.  What a fucking world.  Doesn't look like FDA has posted the post-marketing study requirements, but that will be interesting to see what the exact requirements are. 

 

https://www.statnews.com/2021/06/07/fda-grants-historic-approval-to-alzheimers-drug-designed-to-slow-cognitive-decline/

FDA grants historic approval to Alzheimer’s drug designed to slow cognitive decline

The Food and Drug Administration on Monday approved the first new treatment for Alzheimer’s disease in nearly two decades, a landmark decision that has been eagerly awaited by millions of Americans diagnosed with the condition but that will be hotly contested by some in the scientific community who doubt the drug’s effectiveness.

While other drugs treat symptoms of Alzheimer’s, the new medicine, called Aduhelm, is the first to attack what some believe is an underlying cause of the disease and slow cognitive decline, albeit marginally. It does so by eliminating clumps of a toxic protein believed to destroy neurons and cause dementia. Aduhelm is not a cure for Alzheimer’s, and it doesn’t reverse the disease’s progression.

The drug — which just two years ago was declared a stunning failure — is now expected to generate billions of dollars in revenue for its maker, Biogen.

...

But the approval of Aduhelm, also known by its scientific name aducanumab, is all but sure to become one of the most controversial and disputed decisions on a drug application in recent years. The FDA granted marketing clearance to the drug over the strong objections of a panel of independent experts it convened in November. Those advisers reviewed Biogen’s clinical data and concluded overwhelmingly that there was insufficient evidence that the treatment had significant benefits for patients. They argued the drug should not be approved, as have many outside experts. Others saw enough evidence of efficacy — and a desperate need for new treatments.

Instead of judging Biogen’s treatment solely on its effects on cognition, the FDA granted a conditional approval based on Aduhelm’s ability to clear the toxic proteins, called beta-amyloid. In order to continue marketing the drug, Biogen will need to complete a large clinical trial to confirm that removing the plaque has cognitive benefits, the FDA said. If that study fails, the FDA has the authority to rescind its approval.

In approving the drug on a conditional basis, the agency departed from decades of regulatory precedent, setting a new bar for treatments with considerable potential but unproven benefits — a standard that could also be applied to other devastating diseases.

[bernorange 8377]

1 hour ago, Homercles said:

On a side diatribe, it’s fucking ridiculous that prescription drugs can be advertised on tv.  

The weird thing about these ads is that they don't mention a brand name.

[Bevo 13660]

I don't think much of the drug, but I don't think they have the mechanism of the disease understood well enough. Is beta amyloid a precursor or a sequela? If it truly is a precursor maybe a two treatment cocktail with the monoclonal will be effective. My biggest problem is that insurance will be paying for it and it will contribute to rising healthcare costs and worse coverage for everyone.

[CooterBrown 18118]

Wouldn’t insurance have to approve the drug as treatment before paying for it? I can’t imagine many companies are going to approve it.

[MoJames 8257]

In this instance there is only one insurance that really matters, Medicare. CMS is looking over it but due to limited options in the treatment of AD, it will likely get approved in some fashion.

[MaybeACoordinator 8350]

Aducanumab: One out of every 11 leading neurologists doesn't totally hate it

[Incredulity 11734]

I just learned Alzheimers is the #6 cause of death in the country.  According to Sheperd  Smith.  That is shocking to me.

[MoJames 8257]

5 minutes ago, Incredulity said:

I just learned Alzheimers is the #6 cause of death in the country.  According to Sheperd  Smith.  That is shocking to me.

Something has to kill people.