We spoke about the Aduhelm fiasco about two weeks ago.
But, the furor is not abating. (FDA advisory committee members are complaining and resigning!)
While some patients are willing to swear by the drug and its utility, the proof of same is severely lacking.
We also have to consider that on three separate occasions the Peripheral and Central Nervous Systems Drug Advisory Committee voted to NOT approve the drug. Yet, the FDA overrode these advisory committees (which is a very atypical result). Moreover, the FDA initially provided NO logic or political reasoning as to why this drug was approved, despite the non-recommendations of the advisory committee. [We will have more about this tomorrow, when we present their response (and my editorial comments)!]
The FDA did not deny that the committee was correct in stating that the evidence that the drug lacked clinical proof of efficacy. It just used a special approval process that is normally reserved for cancer trials and drugs- the accelerated approval pathway- whereby drugs go to market before definitive proof exists of any clinical benefit.
The “logic” behind this approval process is not that the drug has a demonstrable effect on patient survival, well-being, or feeling. No, this process is employed when the drug effects changes in the body in ways that might predict such a benefit. (Aduhelm does bind to beta-amyloid structures, which are thought to create memory problems in Alzheimer’s patients when the amyloid binds to neurons in the patient’s brains.)
But, there’s yet another problem with this approval. Once a drug obtains FDA approval, Medicare is obliged to cover the cost of the medicine. Given that Biogen plans to charge some $ 56000 a year for the therapy, we are not talking about chicken feed.
Nor does it help that the Institute of Clinical and Economic Review (ICER) argues against the price that Biogen has developed for the drug. ICER believes the therapeutic value sets the price of the drug between $ 2500 and $ 8300 a year. If Aduhelm achieved significantly higher success rates in patients, is would alter its recommended price levels at $ 11,100 to $ 23,100. Those higher rates are still 1/3 to 1/6 what Biogen plans to charge.
Given that 1.2 -1.4 million patients are expected to be prescribed this drug, we are talking about a bonanza of some $ 73 billion for Biogen- all paid out at US Treasury expense.
So, it’s not just an FDA problem- it’s a Medicare problem. One that requires Medicare have the ability to negotiate the prices of drugs for which it pays- and to require any drug for which it pays to have all clinical trials completed.
So, a drug that has not been approved by the advisory committee and has not shown efficacy, has been approved by the FDA. At a minimal cost of $76 billion to taxpayers. Seriously, who are the people who approved it and have they been financially vetted?
Victoria Juster recently posted..Love Never Dies
The FDA is not responsible for monitoring costs- only the efficacy and safety of drugs. That’s a big enough mandate. One- that you will see as we read my blogs this week- they failed.
Medicare needs to be empowered to negotiate drug prices- they already can negotiate hospital fees. It’s time they get these additional rights.
You are so right, Roy!
Victoria Juster recently posted..Love Never Dies
I still don’t get this approval. Thanks for the visit, Victoria.
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