Although the drug – Aducanumab, marketed under the trade name “Aduhelm” – is FDA approved, the proposal from the Centers for Medicare & Medicaid Services would limit its availability to clinical trials.
on a recent draft proposal that would severely limit the availability of Aducanumab, marketed under the trade name “Aduhelm,” which is used to treat Alzheimer’s disease.Although the drug is approved by the FDA, the proposal from the Centers for Medicare & Medicaid Services would limit its availability to clinical trials.
Eric VanVlymen, regional leader for the Alzheimer’s Association in Ohio, views the draft decision as inherently discriminatory.According to VanVlymen, Blacks are roughly twice as likely to be afflicted with the disease, though they are severely underrepresented in clinical trials. In addition, many Alzheimer’s patients -- including Hispanics, women and the elderly -- may simply lack the financial wherewithal to access the drug.
Biogen later discovered that a certain subset from the clinical trials benefited from the drug, which led to further studies and FDA approval.“Yes, the drug is controversial,” admitted VanVlymen. “But this is the first drug ever to treat the underlying issue of Alzheimer’s.” “We’ve seen treatments like this covered for other severe diseases,” argued VanVlymen. “A lot of people think of Alzheimer’s as a memory problem, but it’s a fatal disease.”
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