Sucks to be Biogen

And this is a good thing.

As I  noted earlier Biogen managed to get FDA approval of their Alzheimer's Aduhelm treatment which is (at best) barely effective, and prices at $56,000 a year, (now on sale for only $28,000 a year) sparking huge outrage.

Well, now Medicare has ruled that it will only cover the drug for patients in clinical trials, meaning that the potential market will be a fraction of what was initially anticipated, saving Medicare tens of billions of dollars.

I like the way that they split the baby here:

Medicare officials on Tuesday proposed covering a pricey, controversial Alzheimer’s drug but, in a highly unusual step, restricted it to people enrolled in approved clinical trials, sharply limiting the number of eligible patients.

The draft decision from the Centers for Medicare and Medicaid Services (CMS) means the program would cover Aduhelm and similar drugs in development — monoclonal antibodies that target beta amyloid, a sticky substance in the brain — only in studies approved by CMS or supported by the National Institutes of Health. CMS almost never demands such trials for a drug already approved by the Food and Drug Administration.

………

The drug had been viewed as a potential blockbuster and budget buster. Biogen originally priced Aduhelm at $56,000 a year per patient, later cutting that to $28,200.

The only people who thought that this was a potential blockbuster were Biogen's accountants, everyone else thought that it was a disaster.

………

CMS officials, in a call with reporters explaining the tentative ruling, acknowledged the decision was unusual, but said it was appropriate.

“It’s important to recognize the FDA approved the drug under an accelerated approval program,” said Lee A. Fleisher, director of CMS’s center for clinical standards and quality. While the FDA found the drug safe, it based its conclusion about whether the drug worked not on its effect on patients but on its ability to reduce amyloid — something the FDA said had a reasonable likelihood of benefiting patients.

Fleisher noted that while the treatment might be promising, it also has the potential of seriously harming patients. Side effects include headaches, dizziness, falls and brain bleeds. He added that CMS believes “any appropriate assessment of patient outcomes must weigh both harm and benefits before arriving at a final decision.”

You know, if they had charged something like $5,600 a year, Biogen would be in fat city, at least until further studies showed that it has little or no effect, but they got greedy, and people noticed, and they got were made an example of.

We need more of this.