Expert Panel Says New $ 56,000 Alzheimer’s Disease Drug Has Not Been Proven To Be Worth Up To $ 8,400

Biogen’s new Alzheimer’s drug Aduhelm continues to face opposition after controversial approval by the Food and Drug Administration last month, which the FDA said should be investigated independent. Some insurers say they won’t pay for the drug, some hospitals say they won’t administer it, and even more experts say it has no proven benefit and is considerably too expensive to pay. $ 56,000 for one year supply.

On Thursday, a panel of medical experts convened by the nonprofit Institute for Clinical and Economic Review (ICER) voted 15-0 to say that there is no evidence that Aduhelm offers a clinical benefit to patients. patients. The unanimous vote echoes another from a panel of Food and Drug Administration expert advisers who voted last November against FDA approval. Eleven of ten advisers voted that data collected in two identical Phase III clinical trials failed to show the drug is effective, with the advisor voting “uncertain.”

The FDA approved the drug on June 7, however, triggering a storm of criticism. In an unprecedented move last week, the FDA updated its recommendation about who should receive the drug, drastically reducing the group of all patients with Alzheimer’s disease to those with mild illness. It is unusual for the FDA to make such a change so soon after an initial decision and without new data to support a change.

Things got stranger when Acting FDA Commissioner Janet Woodcock announced she was asking the Office of the Inspector General to independently investigate whether any FDA officials involved in the decision were getting too close. comfortable with Biogen prior to approval. Continuing concerns about the FDA’s relationship with Biogen could “undermine public 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.

But doctors, hospitals and insurers are not waiting for the results of investigations. The Cleveland Clinic and Mount Sinai’s Health System in New York have both already announced that they will not administer the drug, The New York Times reported. Six subsidiaries of Blue Cross and Blue Shield in Florida, New York, Michigan, North Carolina and Pennsylvania said they would not cover the drug because they consider it “investigative” or “experimental”, reported the Boston Globe.

Other insurers are delaying their decisions until Medicare intervenes. Medicare opened a National Coverage Determination Analysis on Monday to determine its coverage policy. Some early analyzes have estimated that Medicare could end up paying billions of dollars if even a fraction of Medicare-eligible Alzheimer’s patients end up taking the drug.

Last month, the ICER reported that its latest cost-effectiveness analysis for Aduhelm priced it at $ 3,000 to $ 8,400 per year. This would represent an 85-95% discount from its current list price of $ 56,000 per year.

At the ICER meeting on Thursday, Biogen’s top medical official, Maha Radhakrishnan, told the panel that the company “regrets[s] that the ICER evaluation missed the mark, “on the drug’s evaluation, according to FiercePharma. Radhakrishnan argued that Aduhelm’s evaluation requires” innovative thinking “and a new framework.