Aduhelm Overkill: Broad Medicare Policy Is Unreasonable – And Unnecessary
Medicare has clearly won the battle when it comes to prevent the Alzheimer’s therapy Aduhelm from consuming billions in taxpayer spending based on data that the payor agency finds unconvincing. But in finalizing a policy that has broad implications for all FDA approved therapies, it may be starting a war that it cannot win.
You may also be interested in...
There is certainly some logic to directing the US FDA to create a council of top managers to assure that the Accelerated Approval pathway is used consistently. But it sure sounds like exactly what the agency did with Aduhelm.
Medicare Registry-Based Studies For Alzheimer’s Drugs Still ‘Challenging’ Prospect – Former CMS Official
Medicare coverage with evidence development requirements for Alzheimer’s drugs that obtain traditional approvals may be more involved than they appear.
CMS took pains in its final national coverage determination to try to mend fences with FDA; how the NCD will play with Medicare recipients remains an open question, especially since the Alzheimer’s-induced premium hikes remain in effect.