Aduhelm approval - why I have no faith in the FDA

[SpursforSix]

Surprised there's not a thread on this. The FDA advisory committee gave the Alzheimer's drug a pretty strong thumbs down but it gets approved anyway.
No significant benefits with potential fatal side effects.

Yet Biogen is going to charge $56,000 per year. Estimate cost to Medicare is over $57 billion.

It's criminal.

https://www.cnbc.com/2021/06/10/biogens-alzheimers-drug-could-cost-medicare-billions-of-dollars-a-year-report-finds.html

[CosmicCowboy]

It's not a done deal yet. It still has to go through phase 4 trial to actually prove clinical benefit. Proving it reduces the growth of plaque doesn't prove it actually benefits symptoms.

One really fucked up way that Medicare works, however is that it pays doctors 6% of the drug cost to prescribe it. That means they pay doctors $3,360 per year to prescribe it on top of the $56,000 cost.

[ElNono]

This is why Medicare needs to be empowered to negotiate drug prices, seeing they're by and large the largest customer.

[spurraider21]

This is why Medicare needs to be empowered to negotiate drug prices, seeing they're by and large the largest customer.
but thats communist

and also fascist at the same time

[ElNono]

but thats communist

and also fascist at the same time

Good ole American exceptionalism at work... lining up the pockets of the rich and powerful... in before CC's 'envy' post...

[Will Hunting]

Good ole American exceptionalism at work... lining up the pockets of the rich and powerful... in before CC's 'envy' post...
Those lazy ass dementia patients need to just pull themselves up by their bootstraps and come up with the $50k needed for that experimental dementia treatment!

[ElNono]

Those lazy ass dementia patients need to just pull themselves up by their bootstraps and come up with the $50k needed for that experimental dementia treatment!

Welfare queens!

[spurraider21]

Welfare queens! Thread is an expert on this subject

[Thread]

Thread (https://www.spurstalk.com/forums/member.php?u=19320) is an expert on this subject

He offered it, 21. Then lied like a cheap rug from the Wal-Mart. Twixt me and the wife I'm out $1200. I'm grudgin' it, ever more.

[cdcast]

Dale def needs this aduhelm asap.

[pgardn]

Bad move.
Since 2006 there have been a number of drugs that have shown degradation of plaque and none showed improvement in symptoms. But there are some people who have seen significant improvement in symptoms as always in these types of drugs that get pushed. There is a really hard push on this one because the US has a large population of old people. People flat out live longer and this disease is mostly age related.

And there are doctors who do NOT want to prescribe it (giving false hope) but what can they say now... lets give er a go for ~50K

[Winehole23]

how much is too much to pay for a marginally effective Alzheimer's drug with serious side effects?


Before and after approval, there was speculation that this “potentially zillion-dollar moneymaker” (as Sharon Begley called it (https://www.statnews.com/2019/10/23/7-burning-questions-biogen-alzheimers-drug/) in October 2019) might be the most lucrative drug ever (https://www.statnews.com/2021/06/07/why-biogen-may-be-sitting-on-the-most-lucrative-product-in-pharmaceutical-history/). Last November it was noted (https://www.reuters.com/article/us-biogen-aducanumab-breakingviews/breakingviews-biogen-gets-17-bln-jolt-of-alzheimers-hope-idUKKBN27L2PG) that if it brought in even a fraction of potential patients, it could still realistically be a $60 billion/year drug, changing Biogen’s revenue picture dramatically.


Taking a high-side estimate of $110 billion/year, Nicholas Bagley and Rachel Sachs speculated in The Atlantic (https://www.theatlantic.com/ideas/archive/2021/06/aduhelm-drug-alzheimers-cost-medicare/619169/) that Aduhelm could be the drug that breaks Medicare, given that that cost exceeds total current Part D medication expenses of $90 billion dollars.


Even at a much lower total, Aduhelm’s costs would still balloon Medicare costs and would exceed the total NASA budget of $23 billion (https://www.nytimes.com/2021/06/22/upshot/alzheimers-aduhelm-medicare-cost.html). Regardless of the exact total, the hit to Medicare would be big (https://www.statnews.com/pharmalot/2021/06/12/alzheimers-association-biogen-fda-aduhelm-price/).
https://hcrenewal.blogspot.com/2021/07/money-and-aducanumab.html

[Winehole23]

from Scientific American in 2016

one might well wonder how commonly journalists trade their integrity for access


It was a faustian bargain—and it certainly made editors at National Public Radio squirm. The deal was this: NPR, along with a select group of media outlets, would get a briefing about an upcoming announcement by the U.S. Food and Drug Administration a day before anyone else. But in exchange for the scoop, NPR would have to abandon its reportorial independence. The FDA would dictate whom NPR’s reporter could and couldn’t interview….. NPR took the deal. “I’ll be at the briefing,” [NPR reporter Rob Stein] wrote… Later that day in April 2014, Stein—along with reporters from more than a dozen other top-tier media organizations, including CBS, NBC, CNN, the Washington Post, the Wall Street Journal and the New York Times—showed up at a federal building to get his reward. Every single journalist present had agreed not to ask any questions of sources not approved by the government until given the go-ahead. https://www.scientificamerican.com/article/how-the-fda-manipulates-the-media/

[Winehole23]

how much is too much to pay for a marginally effective Alzheimer's drug with serious side effects?

https://hcrenewal.blogspot.com/2021/07/money-and-aducanumab.htmlOregon balks



Oregon is gearing up to ask the Biden administration if its Medicaid program can avoid paying for drugs approved through a fast-track approval pathway — like Biogen’s pricey, controversial new Alzheimer’s drug

https://www.statnews.com/2021/12/14/oregon-wants-to-get-out-of-covering-drugs-like-aduhelm-in-medicaid/

[Winehole23]

Charging too much for marginally effective medicine with strong side effects can apparently backfire.


Biogen Slashes Price of Alzheimer’s Drug Aduhelm, as It Faces Obstacles

A group of Alzheimer’s experts and health advocates called on the F.D.A. to withdraw its approval of the drug, the latest of several setbacks for the treatment.
https://www.nytimes.com/2021/12/20/health/alzheimers-aduhelm-price.html

[Winehole23]

Tangentially related:

1473123533601402883


1473123541218258945


https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786295

[SpursforSix]

Tangentially related:

1473123533601402883


1473123541218258945


https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2786295

Imo, that's not tangentially related. It's the crux of the situation.

[SpursforSix]

Biogen Alzheimer’s Medicare Setback Shocks Industry, Patients
https://www.bloomberg.com/news/articles/2022-01-12/biogen-alzheimer-s-smackdown-sends-shock-to-industry-patients?srnd=premium (https://www.bloomberg.com/news/articles/2022-01-12/biogen-alzheimer-s-smackdown-sends-shock-to-industry-patients?srnd=premium)

[SnakeBoy]

It's not a done deal yet. It still has to go through phase 4 trial to actually prove clinical benefit. Proving it reduces the growth of plaque doesn't prove it actually benefits symptoms.

One really fucked up way that Medicare works, however is that it pays doctors 6% of the drug cost to prescribe it. That means they pay doctors $3,360 per year to prescribe it on top of the $56,000 cost.

Dubya rule. Obama said he'd change it but folded like a cheap suit. Trump got rid of that rule. Biden brought it back.

[ElNono]

Biogen Alzheimer’s Medicare Setback Shocks Industry, Patients
https://www.bloomberg.com/news/articles/2022-01-12/biogen-alzheimer-s-smackdown-sends-shock-to-industry-patients?srnd=premium (https://www.bloomberg.com/news/articles/2022-01-12/biogen-alzheimer-s-smackdown-sends-shock-to-industry-patients?srnd=premium)

1481052988647030789

Bernie

[SnakeBoy]

Nobody cares what Bernie the cuck says

[Winehole23]

Biden Administration helpless to do anything this year for Alzheimer's patients seeking a marginally effective, grotesquely expensive drug with strong side effects. Really looking puny right now.


The Biden administration on Friday said it will not lower Medicare premiums for adults 65 and over this year, even though their costs spiked based on inflated financial projections for the beleaguered Alzheimer’s drug, Aduhelm.

Health and Human Services Secretary Xavier Becerra in January publicly announced he was ordering Medicare to consider dropping older adults’ premiums in the middle of this year, which would have been an unprecedented move (https://www.statnews.com/2022/01/10/becerra-medicare-aduhelm-reconsider-price/). But the administration decided against a change due to “legal and operational hurdles,” the department said Friday afternoon.

The overpayments will instead be factored into next year’s premiums.
https://www.statnews.com/2022/05/27/biden-administration-wont-lower-medicare-premiums-aduhelm

[Winehole23]

Just pitiful


The timeline of Biden’s Medicare moves, then, is this:



[*=1]In June 2021, Biden’s FDA approved (https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug) the drug Aduhelm for treatment of Alzheimer’s, despite controversy involving alleged scientific disputes inside the agency over the drug’s efficacy and industry pressure on the internal review process.
[*=1]In November 2021, the Centers for Medicare and Medicaid Services (CMS), which administers and oversees Medicare, approved the historic 14.5 percent (https://www.cms.gov/newsroom/press-releases/cms-announces-2022-medicare-part-b-premiums) premium increase for all Medicare beneficiaries. The announcement noted that among other reasons, the hike “reflects the need to maintain a contingency reserve for unanticipated increases in health care spending, particularly certain drug costs,” and specifically mentioned covering Aduhelm.
[*=1]A few days later, in response to questions from CNN, CMS revealed (https://edition.cnn.com/2021/11/16/politics/aduhelm-alzheimer-medicare-increase/index.html) that the projected cost of Aduhelm was alone responsible for half of the premium increase.
[*=1]The resulting outcry led Aduhelm’s manufacturer, Biogen, to halve (https://www.fiercepharma.com/pharma/biogen-halves-aduhelm-price-layoffs-ahead-medicare-decision-controversial-alzheimer-s-drug#:~:text=In%20an%20unusual%20move%2C%20Biogen, be%20%2428%2C200%20after%20the%20adjustment.) the drug’s price the following month.
[*=1]In January 2022, Health and Human Services Secretary Xavier Becerra called on (https://www.hhs.gov/about/news/2022/01/10/hhs-secretary-xavier-becerra-instructs-cms-reassess-recommendation-2022-medicare-part-b-premium.html) CMS to reassess those premium hikes this year.
[*=1]In April 2022, Medicare instituted strict rules (https://www.statnews.com/2022/04/07/medicare-final-decision-alzheimers-coverage-biogen-aduhelm/) regarding who could receive the Aduhelm under its plans — but kept the higher premiums in place.
[*=1]Around this same time, CMS announced a massive 8.5 percent (https://www.risehealth.org/insights-articles/cms-final-rate-notice-medicare-advantage-plans-to-see-an-85-pay-increase-in-2023/) increase in the rates paid to for-profit Medicare Advantage plans — despite the official body overseeing Medicare payments, the Medicare Payment Advisory Commission, concluding (https://www.medicarerights.org/medicare-watch/2022/03/17/medpac-demonstrates-medicare-advantage-overpayment-and-inadequate-quality-metrics) that Medicare Advantage is more costly than traditional Medicare.
[*=1]On May 27, the Biden administration announced (https://www.statnews.com/2022/05/27/biden-administration-wont-lower-medicare-premiums-aduhelm/) that despite the extraordinary premium hikes that stemmed from inaccurate price assumptions, they would not be lowering the monthly premium deducted from social security checks, instead saying any overcharges will be factored into next year’s Medicare premium calculations.

https://www.levernews.com/biden-hikes-medicare-prices-and-funnels-profits-to-private-insurers/

[DMC]

"nothing we can do"

[Winehole23]

DMC with no take

[ElNono]

Just pitiful

https://www.levernews.com/biden-hikes-medicare-prices-and-funnels-profits-to-private-insurers/

Truly terrible, considering they're the only party even trying here...

[Winehole23]

The FDA’s and Biogen’s joint preparation of a briefing document and a presentation for the FDA advisory committee meeting in November 2020 was unusual. It’s an approach that the FDA had previously used only nine times, investigators wrote, and never before in the neuroscience office. Generally, the agency’s and drug manufacturers’ analyses and briefing documents are separate and independent. By contrast, Biogen worked so closely with the FDA on the briefing document that it was difficult to distinguish between who wrote what, congressional investigators found.https://www.statnews.com/2022/12/29/8-key-takeaways-from-investigation-of-alzheimers-drug-aduhelm-approval/

[Winehole23]

The financial burden for Aduhelm would largely fall on Medicare, Biogen acknowledged in an internal projection. Roughly 85% of potential patients would be Medicare beneficiaries. Even if just 250,000 patients were to receive the drug, it would cost Medicare more than $12 billion a year, which would be 26% of the program’s annual budget for medicines administered in a physician’s office and nearly five times as much as the next costliest drug. The company knew many patients would struggle to afford Aduhelm, the documents show. Biogen’s analysis estimated some Medicare patients would face out-of-pocket costs of up to 20% of their income

[Winehole23]

The congressional investigation revealed for the first time that the FDA had initially recommended an unusually broad label for Aduhelm. The original label made all patients with Alzheimer’s eligible to receive the drug, even though it had been tested only on patients with early-stage disease. Despite internal misgivings, Biogen didn’t push back on the broad label, documents showed. After a month of intense backlash, Biogen made a request to narrow the label to the population studied in clinical trials.

[boutons_deux]

yawn

Like all Federal agencies, FDA/CDC are corrupted by lobbyists, staffed by industry execs and functionaries

[SpursforSix]

yawn

Like all Federal agencies, FDA/CDC are corrupted by lobbyists, staffed by industry execs and functionaries

That shouldn't be a yawn. It should be another wtf moment.

[boutons_deux]

FDA scientists disapproved of aspartame, but ...

Donald Rumsfeld and the Strange History of Aspartame

https://www.huffpost.com/entry/donald-rumsfeld-and-the-s_b_805581

that chemical shit aint harmless

search "aspartame side effects"

[SpursforSix]

FDA scientists disapproved of aspartame, but ...

Donald Rumsfeld and the Strange History of Aspartame

https://www.huffpost.com/entry/donald-rumsfeld-and-the-s_b_805581

that chemical shit aint harmless

search "aspartame side effects"

I don't even have to read the link. This was in the news about 30 years ago.

[SnakeBoy]

1681510193874575360

[ElNono]

1681510193874575360

They can still pass the legislation...