Aduhelm, Biogen’s new drug for Alzheimer’s disease, which was approved by FDA contentiously last month, continues to face criticism since then. The FDA now says it should be investigated independently. Out of this criticism, some insurers have refused to pay for the drug, some hospitals have denied its administration and hence, more experts are of the view that the drug has no proven benefit and the cost of it is too high to be $56,000 for yearly supply.
Institute for Clinical and Economic Review (ICER), a non-profit organization, called in a meeting of medical experts. The panel disapproved by 15 to 0 votes, saying that the drug doesn’t seem to provide any clinical benefit to the patients.
The persistence of the viewpoint regarding Aduhelm was seen among the members of discussion panel for FDA, consisting of expert advisors, who also voted unanimously against FDA approval, last November. Ten out of eleven advisors voted against it, with the remaining one as “uncertain”.
The FDA, regardless of the negative feedback given by the panelists, approved the drug on June 7, igniting the fire of criticism. In an exception, FDA revised its recommendations for the recipients of the drug, narrowing the pool from all Alzheimer’s patients to patients with mild symptoms, which was an unusual step taken by the agency.
Things got odd when Janet Woodcock, acting Commissioner FDA, declared that she was going to call for the Office of Inspector General, to look into the matter. The ongoing concern over FDA’s compassion with Biogen could “undermine public’s confidence in the FDA’s decision,” she wrote to acting IG Christi Grimm.
The doctors, hospitals and the insurers, who already had refused paying for the drug or to administer it, are no longer interested in knowing the outcome of the investigation. Mount Sinai’s Health System and Cleveland Clinic have both refused to administer the drug, as reported by New York Times. Furthermore, six affiliates of Blue Cross and Blue Shield in Pennsylvania, North Carolina, Florida, New York and Michigan refused to cover the drug saying that it was “experimental” or “investigational”, Boston Globe said.
According to the ICER’s last month report, the latest cost-effectiveness analysis for Aduhelm computed the yearly price to be $3,000 to $8,400 at max, reducing the current cost up to 85-95%.
Biogen’s top medical officer, Maha Radhakrishnan, told the panel at the ICER meeting that the company “regrets that the ICER assessment missed the mark” for the drug evaluation. Radhakrishnan asserted that to assess the drug “innovative thinking” and a new framework are required.
Is Biogen’s Alzheimer’s drug worth $56K? Experts say $8400 and raise questions about efficacy
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