We have reported in the past about the controversial drug Aduhelm, whose benefits for Alzheimer’s sufferers have been widely questioned in the medical community.
In January, the Centers for Medicare and Medicaid Services (CMS) announced an interim policy that Medicare would severely restrict the number of seniors who can access the drug because it planned to only cover the drug for patients participating in rigorous, agency-approved clinical trials.
When Aduhelm came on the market it was announced as the first new Alzheimer’s medication in nearly two decades. Initially priced at a whopping $56,000 a year, it was expected to quickly become a blockbuster drug, generating billions for the drug company that developed it.
However, from the beginning, it has been controversial. The FDA approved the drug over the opposition of its own advisory panel. In fact, some members of the panel resigned in protest over the approval of the drug.
In addition, doctors have been hesitant to prescribe it, given weak evidence that the drug slows the progression of Alzheimer's and insurers have blocked or restricted coverage over the drug’s high price tag and uncertain benefit.
The drug company even cut the price of Aduhelm in half, to $28,000 per year, apparently with the hope that the lower price would encourage more sales.
Since the interim CMS decision in January, there has been a huge lobbying effort in Washington on the part of Alzheimer’s patient advocates in an attempt to persuade CMS to cover the cost of the drug for all Alzheimer patients. But the uncertainty over the effectiveness of the drug seems to have led to last week’s decision.
This final CMS decision means that for Medicare to pay for the drug, patients taking Aduhelm will have to be part of clinical trials to assess the drug’s safety and effectiveness in slowing the progression of early-stage dementia.