Statement of Dr. Diana Zuckerman Regarding the January 11, 2022 CMS Decision about Aduhelm

The National Center for Health Research fully supports the decision by the Centers for Medicare and Medicaid Services (CMS) to restrict payments for the Alzheimer’s drug Aduhelm to patients who are in well-designed clinical trials.  When the FDA approved Aduhelm despite evidence that it could be very harmful — and no clear evidence it helped patients – the agency put Medicare at risk for bankruptcy, patients and families at risk of financial ruin, and patients at risk of brain swelling that could cause great harm.  CMS has chosen a compromise strategy that will help ensure that patients and family members can make a decision about the drug based on unbiased information about the known risks and the lack of certainty about any benefit.  At the same time, it will gather urgently needed information about Aduhelm or any other Alzheimer’s Drug that FDA might approve based on its impact on amyloid plaques on the brain but not based on evidence that it improves memory or cognitive function.

Let’s be clear:  There is no evidence that Aduhelm helps delay the damage caused by Alzheimer’s Disease.  The CMS decision does not harm patients, it helps them. FDA should not have approved Aduhelm, and they should not approve any other Alzheimer’s drug based on such questionable data.  We thank CMS for making the best of a very bad situation, making a wise choice that will benefit all Americans.  Biogen’s recent price reduction to approximately $28,000/patient/year is still too expensive for an unproven treatment of a common condition.  Equally important, the use of Aduhelm requires numerous brain scans that are also very expensive for patients and for Medicare.  New, unbiased studies are urgently needed to find out if Aduhelm does more harm than good.  That will protect Alzheimer’s patients and their families from harm.  Of course, those studies should be funded by the companies, not by the American taxpayer through Medicare, so we will be carefully monitoring the situation to make sure that the studies are carefully conducted and Medicare’s financial health is not harmed by this government agency compromise.

Unfortunately, FDA’s approval of Aduhelm will put Medicaid at risk, since Medicaid needs to pay for drugs approved by FDA.  That is a serious problem that needs to be solved as soon as possible.