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.
They 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.
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.
Accelerated 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".
Payers determine if it’s worth the money.
Not sure your point?