Biogen’s new Alzheimer’s drug Aduhelm continues to face opposition after its contentious approval by the Food and Drug Administration last month—which the FDA now says should be independently investigated. Some insurers say they won’t pay for the drug, some hospitals say they won’t administer it, and yet more experts say it has no proven benefit and is dramatically overpriced at $56,000 for a year’s supply.
On Thursday, a panel of medical experts convened by the nonprofit Institute for Clinical and Economic Review (ICER) voted 15 to 0 to say that there is no evidence that Aduhelm provides clinical benefit to patients. The unanimous vote echoes another one from a panel of expert advisors for the Food and Drug Administration who voted last November against FDA approval. Eleven of ten advisors voted that data collected in two identical Phase III clinical trials failed to show that the drug is effective, with the remaining advisor voting “uncertain.”
The FDA nevertheless approved the drug on June 7, sparking a firestorm of criticism. In an unprecedented move last week, the FDA updated its recommendation for who should receive the drug, significantly narrowing the pool from all Alzheimer’s patients to only those with mild disease. It’s unusual for the FDA to make such a modification so soon after an initial decision and without fresh data to back a change.
Things got weirder when Acting FDA Commissioner Janet Woodcock announced that she was calling for the Office of the Inspector General to independently investigate if any FDA officials involved in the decision got too cozy with Biogen prior to the approval. Ongoing concern over the FDA’s relationship with Biogen could “undermine the public’s confidence in the FDA’s decision,” she wrote in a letter to acting Inspector General Christi Grimm.
The House Committee on Oversight and Reform had already opened a similar investigation of its own.
But doctors, hospitals, and insurers aren’t waiting to hear the outcomes of any investigations. The Cleveland Clinic and Mount Sinai’s Health System in New York City have both already announced that they will not administer the drug, the New York Times reported. Six affiliates of Blue Cross and Blue Shield in Florida, New York, Michigan, North Carolina, and Pennsylvania have said they will not cover the drug because they consider it “investigational” or “experimental,” the Boston Globe reported.
Other insurers are holding off on decisions until Medicare weighs in. On Monday, Medicare opened a National Coverage Determination analysis to determine its coverage policy. Some early analyses have estimated that Medicare could end up paying billions of dollars if even a sliver of Medicare-eligible Alzheimer’s patients ends up taking the drug.
Last month, the ICER reported that its latest cost-effectiveness analysis for Aduhelm set its price at $3,000 to $8,400 per year. That would represent an 85 percent to 95 percent discount from its current list price of $56,000 per year.
At the ICER meeting Thursday, Biogen’s top medical officer, Maha Radhakrishnan, told the panel that the company “regret[s] that the ICER assessment missed the mark,” on evaluating the drug, according to FiercePharma. Radhakrishnan argued that assessing Aduhelm requires “innovative thinking” and a new framework.
https://arstechnica.com/?p=1781019