6 ms·
Aduhelm and Medicare
- hprotagonist 5y agohttps://news.ycombinator.com/item?id=29907819 https://news.ycombinator.com/item?id=29907819
- axg11 5y agoFree-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.
- refurb 5y agoThe FDA decides if it’s safe and effective. Payers determine if it’s worth the money. Not sure your point?
- clcaev 5y 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.
- rayiner 5y agoThey aren’t the primary market. Except for drugs used in hospitalizations and certain other settings, Medicare itself doesn’t cover drugs. Drug coverage is under Part D plans offered through private insurers, who do negotiate prices. The goal is to have a many-to-many market. When you have a one buyer to many seller market, you open yourselves up to monopsony, which can drive prices below the efficient level.
- axg11 5y agoMy 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.
- refurb 5y agoAccelerated approvals are just that - accelerated and don't require the same standard of proof of efficacy. Just like Avastin for Breast Cancer - it got accelerated approval, turned out it didn't work, so approval was recinded. The goal is to give patients access to potentially effective medications. They do this because people bitch when the FDA says "no".
- fabian2k 5y agoJust 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.
- refurb 5y agoIt 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”.
- fabian2k 5y agoApproving 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.
- pfisherman 5y ago> Approving drugs based on wishful thinking isn't how the process is supposed to work… 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-guidance-documents/balancing-premarket-and-postmarket-data-collection-devices-subject-premarket-approval https://www.fda.gov/regulatory-information/search-fda-guidan...
- lotsofpulp 5y ago
- refurb 5y agoRemember 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 5y agoThis 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-medicare-part-b-premium-increase.html https://www.cnbc.com/2022/01/10/government-may-scale-back-me...
- peter303 5y ago15% 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.
- lotsofpulp 5y agoI 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.
- hprotagonist 5y 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.
- peter303 5y agoA 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!