Aduhelm and Medicare
science.org
science.org
People bitch when the FDA says “no” and then turn around and bitch when the FDA says “yes”.
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.
This is not entirely correct. There is relatively recent FDA guidance addressing the balance of pre market and post market data collection.[1] I am aware the title of the guidance says devices, but note that the center for biologics evaluation and research (CBER) is on the guidance.
That being said, my opinion is that this decision by FDA is an abomination — the second extremely questionable approval on Woodcock’s watch — and never should have happened.
[1] https://www.fda.gov/regulatory-information/search-fda-guidan...
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.
To be clear, it's possible that the blowback around the FDA decision led to CMS's decision, so I'm not critiquing the critiques. Just keeping in mind that this seems like a pretty ideal outcome.
> Have there been any studies that show that plaque-reducing drugs don't ameliorate Alzheimer's?
There are, I believe, about a dozen drugs that tried to reduce plaques that have all failed to ameliorate Alzheimer's. And several of them despite actually demonstrating reduction of plaques.
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.
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?
https://www.reuters.com/business/healthcare-pharmaceuticals/...
Keep in mind that the total number of patients treated is quite low.
https://www.cnbc.com/2022/01/10/government-may-scale-back-me...
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.
Basically an obfuscated tax, especially for higher earners.
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.
Payers determine if it’s worth the money.
Not sure your point?
The goal is to give patients access to potentially effective medications. They do this because people bitch when the FDA says "no".
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.
This outcome was entirely predictable based on Medicare’s NCD process.
Here they approve a costly drug with almost no track record. FOLLOW THE MONEY!