https://safirsoft.com Expert panel says new $56,000 unproven Alzheimer's drug worth up to $8,400

A Biogen representative said that evaluating its own drugs requires "innovative thinking." Aduhelm's new drug, Aloeheimer Biogen, continues to face opposition after a controversial approval by the Food and Drug Administration last month — which the FDA now says should be considered independently. Some insurance companies say they won't pay for the drug, some hospitals say they won't prescribe it, yet most experts say the drug has no proven benefits and is expensive for $5,600 a year.

On Thursday, a panel of medical experts voted 0 to 0 by the Institute for Clinical and Economic Review (ICER), saying there is no evidence that Adohlm will provide patients with clinical benefits. The unanimous vote is another case of the FDA's Advisory Board of Experts, which voted with FDA approval last November. Eleven out of ten counselors voted that data collected in two Phase III clinical trials were not comparable to the evidence that the drug was effective, and the remaining counsel's vote was "not definitive."

However, the US Food and Drug Administration approved the drug on June 7, prompting criticism. Last week, the US Food and Drug Administration (FDA), in an unprecedented move, updated its recommendation for people who should receive the drug, dramatically limiting the Alzheimer's disease pool to only moderate patients. It is unusual for the FDA to make such changes after a decision Initial and without new data after the decision.

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When FDA Commissioner Janet Woodcock announced she wanted the office, it was odd for the inspector general to independently examine whether any of the FDA officials involved in the decision decided to get involved — much relied on with Biogen before adoption. "Ongoing concerns about the FDA's relationship with Biogen could 'undermine public confidence in the FDA's decision,'" he wrote in a letter to Inspector General Christie Grimm. The House Oversight and Reform Committee previously conducted similar investigations. But doctors, hospitals, and insurance companies aren't waiting Hear the results of any research. The Cleveland Clinic and Mount Sinai Health System in New York City earlier said they would not prescribe the drug, The New York Times reported. Six affiliates 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 "research" or "experimental," the Boston Globe reports.

Other insurance companies hold their decisions until they weigh Medicare.On Monday, Medicare launched its own national rating analysis to determine its coverage policy. Some preliminary analyzes estimate that even if a fraction of Alzheimer's patients eligible for Medicare eventually use the drug, Medicare could end up paying billions of dollars.

Last month, ICER reported that the latest A cost-effectiveness analysis of Aduhelm has been priced between $3,000 and $8,400 a year. This represents 85 to 95 percent of the current list of $56,000 per year. At the ICER meeting on Thursday, Biogen's chief medical officer Maha Radhakrishnan told the board that the company "regrets [according to FiercePharma] that the ICER evaluation was not evaluated 'in a drug evaluation.' Adulham's evaluation requires 'innovative thinking' and a new framework."

Expert panel says new $56,000 unproven Alzheimer's drug worth up to $8,400
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