In an analysis for CNN, columnist Zachary B. Wolf writes, “The new Alzheimer’s drug Aduhelm [aducanumab] costs $56,000 per person, per year – so much that it would affect the economics of Medicare.” However, Wolf says that “the sheer cost of the drug is enough to raise questions.” He adds that is “not clear exactly how many patients would be eligible for the drug under the narrower FDA approval limiting use to those with only mild impairment or dementia,” but “at $56,000 a person, the cost to treat 500,000 patients – a fraction of the estimated 6 million or so Americans who are estimated to have Alzheimer’s – would reach $29 billion in a single year.”
Outcry over Alzheimer’s drug reportedly may lead to conversation about FDA approval process.Modern Healthcare reports that “while heightened controversy and discussion is rare for” FDA-approved “drugs, outcry over the Alzheimer’s drug Aduhelm [aducanumab] could lead to a broader conversation about the approval process and what patients and providers are looking for with value-based care.” The reaction from the medical community “to Aduhelm has been especially uncommon with independent review boards stating that they wouldn’t have approved the drug and providers declining to administer it, said Rick Kes, healthcare partner at RSM.” Even though “the Center for Drug Evaluation and Research’s accelerated approval process was put in place to quickly get drugs to patients with life-threatening diseases, it can incentivize speed over quality, [Andrew Hertler, an oncologist and chief medical officer at New Century Health,] said.”
Former FDA adviser says HHS IG’s probe into Biogen Alzheimer’s drug approval should consider lack of evidence for treatment. Reuters (7/20, Steenhuysen, Beasley) reports an HHS Office of the Inspector General probe of the FDA’s “approval of a controversial new Alzheimer’s disease drug should look into why that decision was made without clear evidence of patient benefit, a former adviser to the agency said on Tuesday.” Acting FDA Commissioner Janet Woodcock earlier this month called for the federal investigation into “whether FDA representatives’ interactions with drugmaker Biogen Inc were inconsistent with agency policies.” However, speaking at a live event, “Dr. Aaron Kesselheim of Harvard-affiliated Brigham and Women’s Hospital, who resigned as a member of the FDA advisory panel that reviewed and voted against approval of Biogen’s drug prior to the FDA” approval, “said more information is needed on FDA’s role in Biogen’s evaluation of clinical trial data, as well as why the agency decided to base its approval on a ‘surrogate’ biomarker rather than the drug’s impact on cognitive function.”
From the news release of the American Association for Justice.
