Aduhelm and Medicare

https://www.science.org/content/blog-post/aduhelm-and-medicare

by nceqs3 • 5 years ago

40 34 5 years ago

https://news.ycombinator.com/item?id=29907819

axg112• 5 years ago

Free-market folks could argue: what's the point of the FDA here? The organizations that bear the cost of the medicine have decided that there isn't enough evidence of benefit from Aduhelm and further clinical evidence is required.

Perhaps the FDA's involvement should stop at Phase 2? Allow the free market to decide whether the clinical trial and efficacy results are sufficiently positive. The current setup encourages Pharma companies to design trials for the purpose of gaming the FDA.

refurb4• 5 years ago

The FDA decides if it’s safe and effective.

Payers determine if it’s worth the money.

Not sure your point?

axg112• 5 years ago

My point (a view shared by the article and many others) is that the FDA decided Aduhelm is safe but did a terrible job of deciding that it is effective. Safety is also not absolute. All medicines have adverse effects, safety is then relative to the benefits of the medicine.

clcaev• 5 years ago

Payers determine if it's worth the money.

As I understand, Medicare (Part B) pays "market rate" for this drug and cannot act as an independent payer and negotiate, yet, they seem as the primary market? This market price would be set by the secondary, and much smaller, market of private payers.

fabian2k2• 5 years ago

Just looking from the outside the Aduhelm approval just seems kinda insane. Approving a drug that failed its primary trials based on a biomarker that is under serious doubt just doesn't make any sense. And it's not like this is a harmless drug, it does have quite serious potential side effects.

refurb4• 5 years ago

It wasn’t a full approval but an “accelerated approval” based on “promise”.

People bitch when the FDA says “no” and then turn around and bitch when the FDA says “yes”.

fabian2k2• 5 years ago

Approving drugs based on wishful thinking isn't how the process is supposed to work, but that is what happened here. It is still pretty unclear whether the amyloid hypothesis is true and whether reducing amyloid would actually treat the cause of Alzheimers.

The trials for this drug failed, they were stopped because it didn't work. And then they picked some data out of that and decided it reduced amyloids, so we just approve it based on that even without a clear signals that patients actually benefit.

lotsofpulp2• 5 years ago

People bitch when the FDA says “no” and then turn around and bitch when the FDA says “yes”.

The FDA’s purpose is to vet medical claims, and if the data does not support the claim, then the FDA should not give it a stamp of approval. Whether or not nebulous people complain about approval or denial is irrelevant, only the reasons for approving or denying are relevant.

InvisibleCities• 5 years ago

Ever think those might not be the same people?

spaetzleesser2• 5 years ago

"People bitch when the FDA says “no” and then turn around and bitch when the FDA says “yes”."

that's true for most preventative professions. You get either criticized if you spend money and nothing happens or you get criticized when something happens. People have trouble with risks that may or may not materialize.

einpoklum• 5 years ago

People bitch when the FDA says “no”

Do they, though? I mean, I don't live in the US, but when some regulatory body forbids the sale of something medicinal my tendency is to have a sigh of relief about being spared something dangerous - and that's based on the assumption that regulation is too lax.

Of course there are exceptions to this rule, e.g. how governments have mostly prevented the use of cannabis for medicinal purposes because of the plant's psychoactive effects, but still... who actually bitches about FDA disapprovals?

jklein114• 5 years ago

What are the serious potential side effects?

_qua• 5 years ago

Swelling and bleeding in the brain.

refurb4• 5 years ago

Remember the stories by reporters saying this drug would bankrupt the US because it would cost $500B per year?

This outcome was entirely predictable based on Medicare’s NCD process.

PopAlongKid• 5 years ago

This drug was largely responsible for the giant increase in Medicare Part B premiums for 2022, which is now being considered for a partial rollback.

https://www.cnbc.com/2022/01/10/government-may-scale-back-me...

peter3032• 5 years ago

15% increase, way over inflation.

Pre-medicare people have the impression medicare is cheap. But I pay $615 a month because I make more than $91,000 a year, which triggers an income surcharge. My premiums increased $784 (whole year) since last year.

lotsofpulp2• 5 years ago

I assume official inflation figures will always be lower than the growth in my expenses. It is the only possibility due to demographic changes causing greater demand for labor relative to supply, and will allow the government to fulfill its debt obligations (at least nominally).

Basically an obfuscated tax, especially for higher earners.

hprotagonist2• 5 years ago

“this is safe and doesn’t work” is batshit insane; aduhelm never should have been approved, but at least a fail-safe worked and it’ll never be widely used.

peter3032• 5 years ago

A sad thing is the FDA dragged its feet on approving the covid vaccine for all age groups, taking 14 months. And vaccine makers/CDC had hard data vaccination would cut the 10,000 weekly death toll by 85%.

Here they approve a costly drug with almost no track record. FOLLOW THE MONEY!

Aduhelm and Medicare

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