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More than a month has passed since the United States Food and Drug Administration (FDA) approved the first Alzheimer’s disease drug, Aduhelm, in more than 20 years, but critics over the approval and drugmaker Biogen (BIIB) continue to rise.
Among the many concerns are the price of $ 56,000 per year, much of it paid by taxpayers through Medicare, as well as unusual private meetings between the agency and company officials, and a study nine-year post-market confirmation period, the longest ever granted for a drug.
Medical doctor and Yale physician Dr Reshma Ramachandran told Yahoo Finance that the FDA made the wrong choice in approving the drug.
“For me, as a clinician, I see the agency as a protector of our patients, and now they have put us in the unfortunate situation of having to have these difficult discussions with our patients … that the FDA green light is maybe wasn’t a good idea, ”Ramachandran said.
Flashback for Biogen
Thursday was one of the biggest hits to Biogen’s stock in recent months, having climbed to over $ 410 a share in the days following approval on June 7. Since June 9, the stock has seen a steady decline.
On June 24, Biogen shares fell on news that the Senate was holding a hearing to consider how Medicare would handle the cost of the new drug, and again on Thursday after several Blue Cross Blue Shield insurers and health systems rejected the drug. . The Cleveland Clinic and Mount Sinai have said they will not use the drug, and insurers have said they consider the drug “experimental” or “investigative” and therefore will not cover it.
Ramachandran said the clinical and scientific community hailed the rejections, calling them “incredible moves,” saying the companies “have stepped in where the FDA has really let its responsibility or given up its responsibility for failing to protect patients and ditching its responsibility. ‘approve this drug without proven clinical benefit. “
But approval alone, by an accelerated route, is not the only problem. The drug’s price, initially estimated at $ 56,000 per year, based on monthly intravenous doses, has also been a source of criticism for Biogen.
In a virtual public meeting of the Institute for Clinical and Economic Review (ICER), an independent research entity, company officials defended the price tag based on the number of patients expected.
The company has estimated a conservative target population of between 1 million and 1.2 million individuals, according to Chris Leibman, senior vice president of Biogen.
“I can give you the actual number that we actually found, which is less than 1.5 (million). We think it will be a fraction of those who will ultimately benefit from it. We don’t think it will. there will be a large number of patients, ”he said.
Leibman cited other diseases for which drug absorption, even after years of marketing, averages between 11% and 16%.
And although he did not disclose how the company came up with the price, Leibman shared the company’s thoughts on the value the drug brings to society – a measure commonly used by drug companies to defend pricing. high.
“We have thought very carefully about the overall impact and the value this treatment can bring to patients, caregivers and society. It is a disease that is already costing society $ 355 billion per year. American, ”he said.
But the price does not include additional costs such as a higher price based on a person’s weight, as well as follow-up tests and analyzes to measure the impact of the drug on the patient, all of which lead to problems. additional charges and out-of-pocket expenses.
FDA under fire
The FDA, meanwhile, is also heavily criticized not only for the secret meetings before approval, but also for ignoring data from a separate but identical trial that showed no improvement in patients.
Three of the agency’s advisory board members resigned after the approval, citing the November 2020 meeting in which members voted almost unanimously against approving the drug.
Biogen maintained that the trial used to justify approval included a higher dosage, which is why approval for patients with early-stage Alzheimer’s disease was appropriate.
But ICER members were not convinced. The panel voted unanimously, 15-0, that Aduhelm’s data did not adequately demonstrate that it had a real impact compared to simply caring for a patient with D’s disease. Alzheimer’s without the drug.
In a separate virtual event Thursday, Yale University health expert Zachary Cooper told a Carnegie Mellon University panel that the drug was not working.
Like Ramachandran, he criticized the FDA, saying the country did not need an agency that “would endorse anything better than sugar pills.”
Acting Commissioner Janet Woodcock called for an investigation into the private meetings and defended the agency’s approval, which sought to give much-needed hope to Alzheimer’s patients and their families.
And while the company has nine years to conduct a post-market study, Biogen officials told ICER on Thursday that they hoped to see results sooner.
“Nine years is not our intention, we want to finish this much sooner,” said Leibman.
Dr Maha Radhakrishnan, Chief Medical Officer of Biogen, said the company operates with a “sense of urgency” and “works closely with regulators, physician groups, patient advocacy groups as well as CMS . Every effort is made to get it studied and running.
Additionally, the FDA said in its June 7 post-approval statement that “if the confirmatory trial does not verify the drug’s expected clinical benefit, the FDA has regulatory procedures in place that may lead to the withdrawal of the drug. market drug “.
But in the meantime, competitors are considering the same route Biogen uses for their Alzheimer’s disease drugs, although the Centers for Medicare and Medicaid Services, which oversee Medicare, likely won’t make the decision to cover the drug until. April 2022.
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