Biogen writes off Aduhelm inventory as Worthless

Crushed

Biogen is trying to escape the dark Aduhelm cloud hanging over its Alzheimer's disease drug launch. So far, the launch has triggered layoffs, a CEO switch and much more.Now, Biogen has quietly unveiled a sizable inventory write-off. In a recent Securities and Exchange Commission (SEC) filing, the company said its Aduhlem inventories as of June 30 were "de minimis," or functionally worthless. That was $233 million lower than at the end of 2021, meaning the company wrote off the remaining value of its Aduhlem inventories in the first half of this year.
  https://www.fiercepharma.com/pharma/biogen-files-233-million-aduhelm-write-wake-aduhelm-overhaul

The Aduhelm fiasco is being studied by policy analysts all over the world.  
 Everything about the drug launch was extreme
The patients were extremely desperate
Medicare is extremely vulnerable to ineffective medications.  
The scientific data was extremely poor 
The FDA approval process was extremely sloppy 
The success criteria  was extremely vague 
Enlisting the  public to pressure the regulators was extremely questionable.  
Ignoring the outside expert panel was extremely dangerous 

Drug pricing was extremely high

 The image of corporate greed counting on a flood of Federal  medicare money  to treat desperate families  with a questionable drug was unshakeable.

 

Joydean

Crushed for once I agree with you.

Newbernian

I'm not sure about my memory but I think the rates for Medicare were raised significantly a year ago.  The reason given was an expected rise in costs for this drug.  If I am correct, can we also expect a decrease in rates this year be-cause of last year's premature increase???

Quilting brings calm

The word is that next year’s Medicare increase will take the reduced  costs and amount of use of this drug in consideration when planning the premium to be charged. In other words, a smaller increase than otherwise planned. 

As the spouse of a diabetic on a once a day long acting insulin, I wish Medicare had approved continuous glucose monitors for people like him rather than this drug.  I’ve heard that dementia  is sometimes referred to as type 3 diabetes.  Currently you have to be on insulin three times a day to qualify.  Anything that we can do to try to prevent  dementia would be helpful since the dementia numbers are expected to soar by 2050’

ImMaggieMae

I thought drugs were covered by Medicare part D. This drug was treated differently?

Crushed

ImMaggieMae wrote:

I thought drugs were covered by Medicare part D. This drug was treated differently?

FDA has two ways of approving drugs  there is the traditional "science based approval" showing "clinical effectiveness and  the "alternate pathway" , which no evidence of clinical effectiveness. Aduhelm was approved without evidence of clinical effectiveness  Which triggered a medicare evaluation as to whether "it is reasonable and necessary" 


  

for drugs that FDA has not determined to have shown a clinical benefit (or that receive an accelerated FDA approval), Medicare will cover in the case of FDA or National Institutes of Health (NIH) approved trials. Under this NCD, CMS will support the FDA by covering the drug and any related services (including, in some cases, PET scans if required by trial protocol) for people with Medicare who are participating in these trials.  

There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,”