A very good article on NCD Final Decision - Justifiably the end for Aduhelm

[anonymous]

Inside the tactical tug of war over the controversial Alzheimer's drug

CMS’ decision came under a policy called coverage with evidence development. Though the program began in 2005, Aduhelm is by far the most important product CMS has declined to reimburse without further study.

The agency’s decision “is a little inelegant” because it puts the brakes on an FDA approval, said former CMS chief medical officer Dr. Sean Tunis, now a consultant and senior fellow at Tufts Medical Center, but “it seems completely justifiable since the evidence of benefit is pretty weak and the evidence of harm is pretty strong.”

The remarks are roughly divided among pros and cons, and many appear to be organized by groups on the pro side of the debate (such as the Alzheimer’s Association) or those opposed (such as the nonprofit More Perfect Union). The agency could change or even reverse its decision, though experts believe the latter is unlikely.

 

[anonymous]

Inside the tactical tug of war over the controversial Alzheimer's drug

CMS’ decision came under a policy called coverage with evidence development. Though the program began in 2005, Aduhelm is by far the most important product CMS has declined to reimburse without further study.

The agency’s decision “is a little inelegant” because it puts the brakes on an FDA approval, said former CMS chief medical officer Dr. Sean Tunis, now a consultant and senior fellow at Tufts Medical Center, but “it seems completely justifiable since the evidence of benefit is pretty weak and the evidence of harm is pretty strong.”

The remarks are roughly divided among pros and cons, and many appear to be organized by groups on the pro side of the debate (such as the Alzheimer’s Association) or those opposed (such as the nonprofit More Perfect Union). The agency could change or even reverse its decision, though experts believe the latter is unlikely.

Agree with the article. Chances of any significant change is unlikely. It really comes to the safety of patients and beyond efficacy, there is question there. Over 40% aria is concerning. What now? CMS says "Oh yeah, we made a mistake and we will retract the clinical trial" Very doubtful when there were many supporters stating they did the right thing.
Also a possibility of a delay? No. CMS needs to play their hand now and they know it. They are under a magnifying glass and a delay would be bad.

 

[anonymous]

Is there a possibility that CMS will announce the NCD next week?

 

[anonymous]

Is there a possibility that CMS will announce the NCD next week?

no one on here knows, so quit asking. It will have to change to some extent as the proposal is not feasible. Good chance it does change significantly only because other pharmacies companies have pushed back because they don’t want to have a precedent where CMS contradicts the FDA…Right or wrong,

 

[anonymous]

no one on here knows, so quit asking. It will have to change to some extent as the proposal is not feasible. Good chance it does change significantly only because other pharmacies companies have pushed back because they don’t want to have a precedent where CMS contradicts the FDA…Right or wrong,

People can do whatever the F*ck they want, so mind your business. You clearly don't know shit so you shouldn't have responded to the poster.