The Food and Drug Administration is changing its recent and controversial approval of a new drug for Alzheimer’s disease. The Agency now recommends that the called Aduhelm and developed by Biogen, is given only to humans in the earliest stages of the ultimately fatal neurodegenerative state. The decision will greatly affect the insurance coverage of the treatment, which is expected to cost $ 56,000 a year.
The move comes just under a month after the agency first approved the drug against the recommendations of an external panel that reviewed the evidence of the clinical trial. Since then, scientists and lawmakers have done so criticized FDA, where some call the approval the worst decision of its kind made in recent history.
Among other things, critics have pointed to the lack of data supporting Aduhelm’s benefits, as only one trial found statistically significant evidence of slower cognitive decline in patients, and only in those who took the highest dose (the second trial did not find a generally slower decrease but possibly a non-significant effect in high-dose patients).
Another major criticism of the FDA approval concerned the drug’s eligibility. Although they were only tested for people with mild cognitive impairment or early suspicion of Alzheimer’s, the FDA initially indicated that it would be recommended to any patient, no matter how far their disease was was. The language driven is concerned that widespread use of the potentially ineffective drug would overwhelm public payers like Medicare, which provides health coverage for the majority of the estimated 5 million Americans currently lzeal with Alzheimer’s. Now the FDA is withdrawing endorsement on carpet.
“Since the agency approved Aduhelm, prescribers and other stakeholders have expressed confusion regarding the intended population for treatment,” FDA spokesman Michael Felberbaum told New York Times.
In its now updated labeling on prescription of the drug, the FDA recommends that Aduhelm “be initiated in patients with mild cognitive impairment or mild dementia stage of the disease, the population in which treatment was initiated in clinical trials. ” According to NYTThe FDA sought the change, where Biogen agrees to submit revised language. Previously, the company claimed that it would only market the drug to patients with eaAlzheimer’s disease.
Doctors are allowed to prescribe drugs off-label, which means that patients with more advanced Alzheimer’s disease can still access Aduhelm. But the new label is almost certain to be widely adopted by insurance companies and payers like Medicare at the provision coverage for Aduhelm.
This decision does not resolve the controversy over drug approval, which some researchers fear discourage research into other, potentially more effective treatments. Recently, STAT News reported about a lengthy collaboration between certain FDA officials and Biogen before and during the approval process, which included discussions about submitting the drug through a less stringent route to approval. In response, legislators have as rep. Katie Porter (D-CA) it called for a formal FDA investigation conducted by the Inspector General, a government agency.