Latest on Aduhelm

Crushed

Medicare officials have decided that the federal health insurance program should only cover the controversial new Alzheimer’s drug Aduhelm for patients who are participating in approved clinical trials. If the preliminary decision is finalized later this year, it would significantly limit the number of patients who could use the expensive drug.

The decision, reached after lengthy deliberations, was released on Tuesday by the Center for Medicare and Medicaid Services, or C.M.S. It said that coverage should be provided for patients in “C.M.S. approved randomized controlled trials” and trials supported by the National Institutes of Health. “All trials,” it said, “must be conducted in a hospital-based outpatient setting,”
https://www.nytimes.com/2022/01/11/health/aduhelm-medicare-alzheimers.html
  https://www.nytimes.com/2022/01/11/health/aduhelm-medicare-alzheimers.html

Quilting brings calm

Crushed -  I knew you’d have the details on this. 

In addition, Medicare has been ordered to re-evaluate their rate increase for 2022 due to the price drop from $56,000 to $28,000 for this drug, The fact that it is now only covered  for a small number of people should also come into consideration in that evaluation.  

Crushed

As a regulatory person the rules require approved randomized controlled trials

 The rules are designed to prevent Biogen from just using a bogus trail to pump the drug out

the rules require a statistically significant and clinically meaningful difference in decline in cognition and function 

 WOW  THIS IS A REAL REBUKE TO FDA

Lane Simonian

I appreciate your months of work on this, Crushed.

The only question that seems to remain is will Medicaid have to cover the cost for Aduhelm?

A decision by Medicare not to cover Aduhelm will shift all of the costs entirely to the Medicaid program, which is required by federal law to cover all FDA-approved drugs, no matter how poorly they work.

But if Medicare is covering the drug in clinical trial settings does this let Medicaid off the hook and if not what are the chances of waivers being granted?

Crushed

Lane Simonian wrote:

I appreciate your months of work on this, Crushed.

The only question that seems to remain is will Medicaid have to cover the cost for Aduhelm?

A decision by Medicare not to cover Aduhelm will shift all of the costs entirely to the Medicaid program, which is required by federal law to cover all FDA-approved drugs, no matter how poorly they work.

But if Medicare is covering the drug in clinical trial settings does this let Medicaid off the hook and if not what are the chances of waivers being granted?

It will take some further administrative action   but CMS regulates both programs
 

Lane Simonian

Your response was helpful, Crushed.

That was really a rebuke to the FDA.  I hope that a thorough investigation is done to determine how the FDA reached its decision.

DJnAZ

So, now use of the Aduhelm is restricted to trials, which may be one of their better decisions. However, Medicare increased the Part B premium by 17% due to what they stated in the press will be the much higher cost of Aduhelm to Medicare covered AD patients. Is it just me or could there be another reason for the Medicare premium increase? 

Another article:

 https://www.statnews.com/2022/01/11/medicare-aduhelm-proposed-decision/

[Deleted User]

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Crushed

Already been super prompt action from the Administration 

on January 10 

"There’s a chance that your Medicare Part B premiums for 2022 could be reduced.

Health and Human Services Secretary Xavier Becerra on Monday announced that he is instructing the Centers for Medicare & Medicaid Services to reassess this year’s standard premium, which jumped to $170.10 from $148.50 in 2021.

About half of the larger-than-expected increase was attributed to the potential cost of covering Aduhelm — a drug that battles Alzheimer’s disease — despite not knowing yet to what extent the program would cover it. Either way, the manufacturer has since cut in half its estimated per-patient price tag to $28,000 annually from $56,000 — meaning Medicare’s cost estimate was based on now-dated information."  https://www.cnbc.com/2022/01/10/government-may-scale-back-medicare-part-b-premium-increase.html

  

Michael Ellenbogen

I would start to send your letters now to CMS. This is a very bad road we are heading down if they win this. In fact they have meeting on this today at 3 PM. How sneaky of them to not let most folks even know so they could prepare for it. I have now been involved with many trying too undue. If they win this this will restrict all future drugs for dementia. That is completely biased toward a certain dises and may people who need it will suffer. This is not about just this drug they have today but all future. They asl are not the FDA and should not have th right to make that decision.

M1

Unfortunately I saw in the Washington Post today that the Alzheimer's Asssociation is going to fight this CMS move.  Not a good decision by the AA in my mind.  

I work with our state Medicaid program, and medications that are administered intravenously  are not covered by pharmacy benefit managers but by guidelines from the managed care organizations that participate in the programs.  I feel sure they will formulate their guidelines to be the same as CMS/Medicare; that's what they do on most things.

Lane Simonian

Very interesting and important information, M1.  Thank you.

I like how there are people with all sorts of expertise on these boards.

I know there is an outcry that Medicare is denying access to a drug that may help.  But Aduhelm performs no better than placebo in non-ApoE4 carriers and on average only slightly slows down the progression of the disease in ApoE4 carriers (according to a review of the data by the FDA's own statistician).  In addition, ApoE4 carriers can experience brain bleeds and brain swelling from the drug.  Other anti-amyloid drugs currently working their way to the FDA produce very similar results.  It will be very interesting to see how the FDA and then possibly Medicare handles them.

Some other drugs currently going through phase 3 clinical trials in the next year or two will likely produce better results.  I am not too excited about simufilam since it seems like a little better version of Aricept, but I think that Anavex 2-73 (blarcamesine) has a real chance.

Michael Ellenbogen

CMS is holding a stakeholder informational meeting TODAY at 3pm ET. Register here.

Crushed

Michael Ellenbogen wrote:

I would start to send your letters now to CMS. This is a very bad road we are heading down if they win this. In fact they have meeting on this today at 3 PM. How sneaky of them to not let most folks even know so they could prepare for it. I have now been involved with many trying too undue. If they win this this will restrict all future drugs for dementia. That is completely biased toward a certain dises and may people who need it will suffer. This is not about just this drug they have today but all future. They asl are not the FDA and should not have th right to make that decision.

I have to disagree.  Aduhelm  was an appalling decision . Ive taught FDA regulation since teh 1980s and I have never seen such a travesty Most importantly the drug has NEVER shown clinical effectiveness

That gives CMS the power to not buy it 
You are simply incorrect on the law

By law, Medicare only covers products and services that are “reasonable and necessary” for diagnosis or treatment. CMS is able to use the NCD process to evaluate the evidence in support of a new product or service and determine whether this standard is met. Although most products that meet the FDA’s standard of “safe and effective” are likely to meet the “reasonable and necessary” bar, the two are in fact different. Yesterday’s NCD provides a strong, clear statement of CMS’ independence and willingness to enforce its own legal standards for its own agency priorities. 
 https://www.healthaffairs.org/do/10.1377/forefront.20220112.876687
NCD is national coverage determination 


  

"The monoclonal antibody’s accelerated approval marks the first new therapy for Alzheimer disease brought to market in nearly 2 decades, although progress in the field has been growing in recent years. The treatment functions by targeting the buildup of amyloid beta plaques in the brain, which are thought to be a pathophysiological driver of the neurodegenerative disease.  But little evidence exists proving reduction of amyloid actually helps patients by improving their memory and cognitive problems. Indeed, previous trials of drugs targeting this potential root cause have yielded numerous failures. For this reason, Aduhelm was granted accelerated approval, which is based on its “effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients.”In other words, the drug was approved to treat amyloid plaque buildup and not the actual disease, which constitutes an important distinction, said Aaron S. Kesselheim, MD, JD, MPH, a professor of medicine at Harvard Medical School and a faculty member in the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital, during a panel presented by The Hastings Center, a nonprofit bioethics research organization.

During the advisory committee meeting, the FDA “explicitly excluded discussion of amyloid plaque as a surrogate for clinical effect,” according to Kesselheim.  The fact the FDA “switched the premise on which they were evaluating the drug and then approved the drug on a totally different premise than they presented to the advisory committee made me concerned that they weren’t using the advisory committees as they should—as truly independent expert views on an important issue,” Kesselheim said. This conflict contributed to his decision to resign from the position.

https://www.ajmc.com/view/how-biogen-s-aduhelm-approval-marks-a-precipitous-turning-point-for-the-fda