aduhelm update

Crushed

With federal payment for Biogen’s controversial Alzheimer’s disease drug, Aduhelm, restricted to clinical trials only, neurologists don’t even want to use the therapy in this limited setting.

 

In a survey of 81 U.S.-based neurologists, 52% said they were “not likely” to allow their patients to go into a trial to access Aduhelm via Medicare, while 46% said they were “somewhat likely,” according to a new report out by consultants at Spherix.

And only 12% of respondents have Alzheimer’s patients who have received at least one Aduhelm infusion. Concerns about safety (60%) and efficacy (57%) were the top reasons respondents didn’t want to use the drug.

  May 16, 2022 08:23am

https://www.fiercepharma.com/marketing/neurologists-turning-their-backs-aduhelm-trials-cms-decision-has-not-killed-hope-all-anti

Michael Ellenbogen

https://www.specialtypharmacycontinuum.com/FDA-Approvals/Article/05-22/Aducanumab-Coverage-With-Evidence-Development-Decision-a-‘Unique’-NCD-CMS-Leaders-Say/66946

Crushed

 

https://www.specialtypharmacycontinuum.com/FDA-Approvals/Article/05-22/Aducanumab-Coverage-With-Evidence-Development-Decision-a-%E2%80%98Unique%E2%80%99-NCD-CMS-Leaders-Say/66946

I  made Michael's post into a hotlink He is quoted

  the  CMS official stated
“It is not our intention to do many NCDs [National Coverage Determinations] like this, if any, with other drugs,” she said.

 This is of course describing an off-hand telephone comment Not any kind of agency position
Nor is the speaker Tamara Syrek Jensen  at a policy making level

   

“This NCD supports innovation and certainty of coverage by creating a long-term coverage pathway without requiring a new NCD for future agents,” said Lee Fleisher, MD, the chief medical officer and director of the CMS Center for Clinical Standards and Quality. “While aducanumab is known to reduce amyloid plaques in the brain, there is not currently evidence that this reduction leads to clinical benefit in the form of cognition or function. There are, at the same time, known risks including potentially fatal brain bleeds, and we understand that investigations are under way of four patient deaths. Taken together, there is not currently sufficient evidence to support full Medicare coverage of this drug under the statutory ‘reasonable and necessary’ standard.


IMHO what he is saying is the FDA  Screwed the pooch badly on  aducanumab  and is unlikely to repeat the error. 

Michael Ellenbogen

TThanks for fixing that.

Michael Ellenbogen

https://www.dovepress.com/role-of-aducanumab-in-the-treatment-of-alzheimers-disease-challenges-a-peer-reviewed-fulltext-article-CIA