The “extraordinary” collaboration that resurrected Aduhelm three months after Biogen canceled clinical trials took place through at least 115 meetings, calls and email exchanges between the company and the FDA over a year, the Oversight and Reform Committees report said. and Energy and Commerce.
The joint effort culminated with agency staff helping Biogen draft a document used to inform an FDA advisory committee before it met in November to discuss Aduhelm. 6, 2020. While the FDA often follows the advisory committee’s recommendation, it did not this time. After no member of the advisory committee recommended Aduhelm, the FDA reversed course, allowing Biogen to move the drug into an accelerated approval process.
Under the FDA’s proposal, the drug was labeled for use by the nation’s more than 6 million Alzheimer’s patients, although it was only tested on people with early Alzheimer’s and mild symptoms.
“This is the worst decision the FDA has made in half a century,” said Sidney Wolfe, founder of the Public Citizen Health Research Group. “This was an unprecedented alliance between the company and the FDA.”
“We have cooperated fully with the Committees’ assessment and continue to review their findings and recommendations,” the FDA said in a statement responding to the report. “The agency’s job is to interact frequently with companies to ensure we have adequate information to inform our regulatory decision-making. We will continue to do this because it is in the best interest of patients. However, the agency has already started implementing changes in accordance with the Committee’s recommendations.
The agency previously conducted an internal investigation into its treatment of Aduhelm, concluding more than a year ago that while the cooperation “exceeded the norm in some respects,” there was “no evidence that the dealings between the company and the regulator were anything but one-upmanship.” appropriate.”
The internal report said the decision to work “proactively” with Biogen was “consistent with FDA policy” both in light of the “great unmet medical need” for Alzheimer’s treatment and an FDA official’s consideration that one of Aduhelm’s studies may represent “one.” a home run in terms of safety and efficacy”.
Reports from two House committees also faulted the company, saying Biogen knew its initial $56,000 price (reduced to $28,000 in January 2022) would burden patients. But the Cambridge, Mass.-based company estimated the treatment could earn Biogen $18 billion a year, and cheered in a slide presentation to the board: “Our ambition is to make history” and “build [the drug] as one of the best pharmaceutical releases of all time.
In fact, Aduhelm has proven to be a financial problem, bringing in $3 million for the entire year of 2021.
In a statement responding to the report, Biogen said it cooperated with the committees and “stands by the integrity of our actions.” Biogen’s statement also cited an internal FDA investigation that concluded there was no evidence of impropriety in dealings between the agency and the company.
Biogen has stuck to its original $56,000-a-year price tag, despite projections that the drug could cost Medicare $12 billion a year. Other Alzheimer’s treatments are available at lower prices. Annual supply Arisept Expenses of less than $8,000; Exelon, a drug from the same family, costs about $8,800 for a year’s supply; and Swimming less than $3,000 a year is spent.
The report includes recommendations that the FDA should follow to “help restore the confidence of the American people,” as well as actions that Biogen and other drug companies should take to “fulfill their responsibilities to patients and families.” Because the recommendations leave it up to the FDA and companies to change their policies, it’s unclear whether they will prevent future episodes like this.
The committees recommended that the FDA document all relationships with drug sponsors, establish a system of partnerships with companies to produce reports used to inform its advisory committees, and update its official guidance for the development and review of new Alzheimer’s drugs.
Drug sponsors recommended by the committees should be open and transparent in communicating any concerns about the safety and efficacy of treatments to the FDA, and should consider the opinions of outside experts when pricing new drugs.
Aduhelm, a lab-made protein that is administered directly into a patient’s vein, reduces the brain’s sticky substance called amyloid beta, which accumulates between neurons and disrupts their function. Some scientists have suggested that the accumulation of amyloid beta in the brain causes Alzheimer’s disease.
In September 2015, Biogen began enrolling patients in two Phase 3 clinical trials testing the drug’s safety and efficacy and comparing it to standard treatment. Three and a half years later, in March 2019, the company announced the end of both trials after receiving an independent report that the treatment did not slow memory loss, confusion and other symptoms of brain damage caused by Alzheimer’s disease.
But the death of the drug was short-lived.
Two months after the trials were stopped, Biogen and FDA representatives met at a neuroscience conference in Philadelphia and discussed the results of the studies, the report shows. An FDA official suggested the agency and the company set up a special meeting to discuss data from the trials.
FDA documents reviewed in the new report show that Biogen has begun informal talks with the agency to test whether data from the unfinished trials show some benefit to patients. A meeting between the FDA and Biogen in mid-June 2019 led to the two agreeing to form a joint “task force.”
The collaboration will allow the FDA and Biogen to move forward on the drug, although officials at both the agency and the company expressed reservations about some of the decisions being made.
For example, the FDA granted expedited approval for Aduhelm after failing to win the support of one member of its advisory committee and without bringing the idea to any internal or external agency for discussion.
In addition, the FDA’s approval contradicted its own guidelines for the early treatment of Alzheimer’s disease, which said there was “not enough reliable evidence” that a drug’s effect on amyloid beta would be enough to benefit patients. Scientists have conflicted opinions on whether amyloid beta is the cause of Alzheimer’s disease or just a consequence of the disease.
The report also found that a team of Biogen staff examined the financial impact of Aduhelm’s initial price on patients and concluded that “more than 65 percent of the country’s population will be affected.” [their] solvency.” The team estimated that two-thirds of Medicare patients at risk for Alzheimer’s disease would have to pay some of the costs themselves, even though more than half of Medicare patients had incomes of less than $50,000 a year and more than one-third had less than $5,000 in assets. .
While the report found the company had “developed financial assistance programs for eligible patients,” investigators wrote that “these programs would leave significant gaps in coverage.”
Despite the difficulty the price is expected to impose on patients, Biogen expects to spend “$500 million to $600 million to build the sales force” to bring the drug to market.
Five months after the drug hit the market, the Centers for Medicare and Medicaid Services announced that monthly premiums for Medicare Part B will increase 14.5 percent in 2022, half of that increase in anticipation of higher costs due to new Alzheimer’s treatments.
The rate increase translated into a $21.60 increase in monthly premiums for Medicare Part B beneficiaries, “the largest dollar increase in the program’s history,” the report said.
For its part, Biogen has moved forward with a broad label for Aduhelm, which is for “people with Alzheimer’s disease,” despite the employees’ reservations about the lack of evidence of clinical benefit for patients with more advanced stages of the disease than those participating in the clinic. trials Some insiders even expressed concern that pushing ahead with the labeling plan could “damage the company’s credibility,” the report said.
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