CMS: Get it through your head. This decision is final and clinical study requirement stays

[anonymous]

Decision was decisive and aside from a few very low potential tweaks, a clinical trial will always be required. This will not change over the comment period.

 

[anonymous]

How is this ok. Michel needs to be fired immediately and punitively. He has been an overpaid idiot who destroyed value and opportunity.

"“We need to be incentivised and rewarded"

In the drug world, you have to be successful to be rewarded. Biogen was not (terminating their pivotal trial as designed by them). End of conversation.

Whiney ceos paid 18M. Just sad. Needs to be fired right now. This is not ok.

Biogen hints at jobs cuts unless government pays up

 

[anonymous]

Biogen gets an ACCELERATED approval with CONDITIONS given that Aduhell has NOT demonstrated clinical efficacy. Then they try to soak the system with ridiculous pricing and a conscious slow pace to efficacy confirmation. It was Biogen's choice to move forward with failed Phase 3 of their own design, Biogen's choice on pricing, and Biogen's strategy of marketing ("Its time we know"). Maybe they are the problem in the system rather than the CMS. Let's also take that the EU/Japan/etc have said NO so I guess all those countries are racist, discriminatory, ageist, etc. Overall, Biogen has many nos (with more to come) and one sordof kindof approval with conditions (If anything, the FDA is the one way out of the norm)

Now, they want to say that of course the CMS should have to pay for an FDA approved drug at their ridiculous price (which they lowered out of desperation knowing they would likely get limited). And again, a sordof approval. Perhaps, the CMS should not make value driven coverage decisions on FDA approved drugs. However, most other markets consider value in the approval decision (so Biogen consciously tried to soak the system with an approval in hand knowing that Medicare is handcuffed and 80 percent of the market. Again, Biogen caused the severity of the problem). And again it is a sordof approval (with other major markets at no). So Biogen chose to exacerbate the problem to maximize their gain.

Biogen tried to soak the system. And they can't believe they got called out. Even if the NCD draft became the policy for all huge patient population, no demonstration of efficacy, accelerated approval drugs that really isn't a change in access to throw a hissy fit against. Medicare saw a 10% premium increase just based on Aduhelm and combined with the sordof approval this provides a reason to evaluate value and benefit. And none of it is discriminatory (any more than clinical trials from woke signaling companies are). Maybe, Biogen trying to take money from patients who don't know any better on the promise of likely false hope is more predatory and discriminatory (the same populations that they say they are advocating for in their current hyperbole are the ones who can often least afford this particularly with no likely benefit). So really limiting reimbursement to overpriced (which every exUS major market ties to approval. Guess they are discriminatory too), no efficacy demonstration, accelerated approval drugs is going to disrupt the system. Seriously? Biogen is just embarrassing to the industry. Stop woke hyperventilating and demonstrate your drugs work (not sordof under accelerated approval). Then you get paid for your science and risks that you choose (you don't get paid because you had an "expectation" to get compensated, Michel).

The CMS guidance has some kinks to work through but should be final. And Michel should shut up. since he simply appears as an overpaid toddler with only incompetence as a core competency. Biogen's stance has moved from incoherent and unjustified to just offensive.

 

[anonymous]

Biogen's Aduhelm reckoning
The Centers for Medicare and Medicaid Services dealt a heavy blow to Biogen by releasing a draft national coverage decision on its controversial Alzheimer’s drug Aduhelm, saying it will only pay for Aduhelm and other FDA-approved anti-amyloid monoclonal antibodies under CMS-approved randomized controlled trials. The news sent top leaders into panic mode, with US president Alisha Alaimo pledging to flood the agency with comments, CEO Michel Vounatsos vowing to fight the draft decision and sales leaders warning their staff about a dire situation where only 2,000 patients may get access to the drug, according to investors calls and an internal email and recording obtained by Endpoints FDA+ editor Zachary Brennan. For those who need to catch up on the context and implications, Zach walked through all potential scenarios in this preview and what they would’ve each entailed.

 

[anonymous]

How is this ok. Michel needs to be fired immediately and punitively. He has been an overpaid idiot who destroyed value and opportunity.

"“We need to be incentivised and rewarded"

In the drug world, you have to be successful to be rewarded. Biogen was not (terminating their pivotal trial as designed by them). End of conversation.

Whiney ceos paid 18M. Just sad. Needs to be fired right now. This is not ok.

Biogen hints at jobs cuts unless government pays up

Extortion much? Is Michel’s real name Corleone?

 

[anonymous]

Extortion much? Is Michel’s real name Corleone?

Billy be Dunn calls him Capo Michelos

 

[anonymous]

Who cares anymore, Blah Blah Blah...Time to move on!!! Get a life everyone. We are done!

 

[anonymous]

There is already a shred of truth on Cafepharma and that is why I read it. These earlier posts fully predicted the outcome.

 

[anonymous]

There is already a shred of truth on Cafepharma and that is why I read it. These earlier posts fully predicted the outcome.

oh, please. It’s not like anyone on here knew anything for certain. Educated guesses that anyone could have made.

 

[anonymous]

oh, please. It’s not like anyone on here knew anything for certain. Educated guesses that anyone could have made.

Go away you unhappy freak!

 

[anonymous]

Go away you unhappy freak!

What a pathetic come back. Lol

 

[anonymous]

What a pathetic come back. Lol

Dude. There is no comeback. You simply are a loser. Most people just find you completely nauseating. Congratulaions.

 

[anonymous]

Dude. There is no comeback. You simply are a loser. Most people just find you completely nauseating. Congratulaions.

Wow, your responses just get more and more pathetic. Please let us know how you managed to survey the vast majority of people who read this thread and how you managed to discern which posts came from which person. By all means, continue on with your childish little tantrum if it makes you feel better, DUDE.

 

[anonymous]

Never. Getting. Reimbursed.

 

[BIIB Room 4207]

Agreed that Cafe Pharma always ends up being a good forecast to the future. You have to get through the bullshit like some of the idiots that posted above. How do we get so many immature idiots in this industry? Seriously, like High School maturity level that it is scary!
But getting back to the forecasting. I know for a fact a lot of home office employees tend to come on here, especially when they feel like the company is treating people unfairly etc. In one previous company, we had access to an internal mole that knew a lot and eventually shared they were in meetings that discussed the future of certain employees and she felt they were absolutely trashy when it came to their "future" plans for the employees. Something like what is happening now here at Biogen.
If you go back to many of the posts, there were accurate announcements of FDA approval, congressional hearings, CED with clinical trial etc. well before any announcements were made.
So what happens now this week?
You will begin to hear more reports from commercial payers that they will not cover this drug and many more independent infusion sites will announce their detachment from infusing this drug. This will essentially lead to no places for patients to get infused, even with free drug.
Biogen will still let the world assume they are proceeding with a clinical trial for the earnings call, but in the next three months, will back away. MSL's will stay in place with patient services, but that will be it. Deb will be "transferred out" and reassigned a temporary role, being unfortunately and undeservingly promised the leadership role for zuranolone. Other leaders like Chris B will be gone, however we all know they have been working with executive recruiters for sometime now. In fact, Chris B, has scheduled a "Town Hall" call for his region I am being told for this afternoon at 4pmEST. He will do the standard fake messaging as always, with false promises, only offering his Joker-like fake smile from his ear to ear.

 

[anonymous]

Agreed that Cafe Pharma always ends up being a good forecast to the future. You have to get through the bullshit like some of the idiots that posted above. How do we get so many immature idiots in this industry? Seriously, like High School maturity level that it is scary!
But getting back to the forecasting. I know for a fact a lot of home office employees tend to come on here, especially when they feel like the company is treating people unfairly etc. In one previous company, we had access to an internal mole that knew a lot and eventually shared they were in meetings that discussed the future of certain employees and she felt they were absolutely trashy when it came to their "future" plans for the employees. Something like what is happening now here at Biogen.
If you go back to many of the posts, there were accurate announcements of FDA approval, congressional hearings, CED with clinical trial etc. well before any announcements were made.
So what happens now this week?
You will begin to hear more reports from commercial payers that they will not cover this drug and many more independent infusion sites will announce their detachment from infusing this drug. This will essentially lead to no places for patients to get infused, even with free drug.
Biogen will still let the world assume they are proceeding with a clinical trial for the earnings call, but in the next three months, will back away. MSL's will stay in place with patient services, but that will be it. Deb will be "transferred out" and reassigned a temporary role, being unfortunately and undeservingly promised the leadership role for zuranolone. Other leaders like Chris B will be gone, however we all know they have been working with executive recruiters for sometime now. In fact, Chris B, has scheduled a "Town Hall" call for his region I am being told for this afternoon at 4pmEST. He will do the standard fake messaging as always, with false promises, only offering his Joker-like fake smile from his ear to ear.

Basically there was a prediction on here for most outcomes. If I flip a coin and guess correctly if it’s heads or tails, it doesn’t mean that I knew it what it was going to be.

 

[anonymous]

Basically there was a prediction on here for most outcomes. If I flip a coin and guess correctly if it’s heads or tails, it doesn’t mean that I knew it what it was going to be.

Disagree. It was the naysayers that would say "Oh Aduhelm will be great!!!"

 

[anonymous]

Disagree. It was the naysayers that would say "Oh Aduhelm will be great!!!"

That proves nothing in terms of anyone on here having any inside information beyond what was approved to shared with the masses. Nothing but educated guesses at best. No one on here even correctly predicted when layoffs would be announced, who would be laid off, or what the packaged would be.
May 3 is the earnings call and the calendar invite for the May 5 USO call says they will e discussing the impact of the NCD. I predict that the official lay off announcement will be made by then. Educated guess.