"Meanwhile, Biogen had set the list price at $56,000 per year. Media analyses suggested that at that price, the drug could cost Medicare up to $334.5 billion per year, which is nearly half of the budget for the Department of Defense[...]In November 2020, a committee of independent advisers for the Food and Drug Administration voted nearly unanimously against FDA approval for Aduhelm. The data did not indicate the drug is effective, the committee concluded. Ten of 11 committee members voted against approval while one voted "uncertain." But in June of this year, the FDA approved the drug anyway"
That's almost twice of the entire NHS healthcare spending for one drug that probably doesn't do anything for Alzheimer patients? This isn't actually going through at the end of the day right? The US healthcare, drug and regulatory system has lost the plot, that's just nuts.
And what on earth is going on at the FDA to approve this? Even if I was a literal pharma lobbyist I would probably skip that one because it just sounds too wrong
FDA doesn’t approve based on the projected costs to the system. That’s the underlying problem. There is no political mechanism to say “no, this treatment won’t be covered by medicare.” Further, such a mechanism would be wildly unpopular with your average voter. Nobody wants to deny their grandmas coverage to anything, and it’s a huge burden on the system and contributor to inflation.
It would not be under the FDA’s purview (nor should it be) to do a cost benefit analysis anyway. Their job is to vet medical claims, regardless of price.
Whether or not taxpayers should pay for a certain treatment for a certain population is a political excercise, usually implemented via CMS, but also state Medicaid departments.
True, with one caveat, state medicaid departments have like no incentive to not cover procedures or medications because they are 90%+ funded through the fed anyway. But most alz patients probably fall under medicare anyway.
Biogen had 'only' ~$13 billion in revenue in 2020, and won't do much better in 2021. If this one drug is really going to 25x their top line, why has the stock barely budged?
That sounds like a bad bet. Pharma ads are allowed to target patients directly, so people will ask their doctor for it, and pharma reps are cozy with doctors, so at least some doctors will go for it themselves.
This really requires some fix at the FDA or somewhere in the government or it's going to be a disaster.
Yeah, but there is so much publicity around the efficacy of the drug, people might not ask for it, and doctors might advise against it, or just refuse to write a script, particularly at that price.
And yet to voice concern around the current worldwide covid vaccine rollout and effects is to be "anti-vax" and anti-science. People can be funny with logic.
That's almost twice of the entire NHS healthcare spending for one drug that probably doesn't do anything for Alzheimer patients? This isn't actually going through at the end of the day right? The US healthcare, drug and regulatory system has lost the plot, that's just nuts.
And what on earth is going on at the FDA to approve this? Even if I was a literal pharma lobbyist I would probably skip that one because it just sounds too wrong