- A Congressional investigation into Biogen's controversial Alzheimer's drug Aduhlem was just released.
- The 45-page report details an improper relationship between the company and the FDA.
Aduhelm, the first Alzheimer's drug to be approved by the Food and Drug Administration in 18 years, has already faced its share of controversy. On Thursday an 18-month congressional investigation into the drug's review process and launch plans was released.
Among other revelations, the investigation revealed inappropriate collaboration between the company developing the drug and the FDA, a high price tag despite knowing it would make the drug inaccessible to patients, and knowledge of a strain on the country's Medicare budget.
Despite mixed data on whether the drug actually worked in patients and guidance from experts that recommended against approval, the FDA gave Aduhelm the green light to come to market in June 2021. The treatment flopped commercially, however, when providers and insurers pushed back against prescribing it to patients, citing lack of evidence that it worked in clinical trials and concerns over the drug's safety.
Soon after Aduhelm's approval, several scientific advisors at the FDA resigned from their positions and interim FDA Commissioner Janet Woodcock called for a third-party investigation into whether the agency's staff had failed to act in accordance with FDA procedures.
Aduhelm was developed by Cambridge, Massachusetts-based biotech company Biogen and Japanese pharmaceutical company Eisai. The duo is currently developing another Alzheimer's drug, called lecanemab, which is expected to receive approval from the FDA in January and has shown more promising data in clinical trials.
The report concluded by saying that the investigation had raised "serious concerns about FDA's lapses in protocol and Biogen's disregard of efficacy and access in the approval process for Aduhelm."
The report's findings could have wide-reaching effects on not just the future of Aduhelm, but other drugs seeking approval for treatments that target debilitating illnesses with few treatment options.
In an emailed response to Insider on Thursday, a Biogen spokesperson said, "Biogen stands by the integrity of the actions we have taken. As stated in the congressional report, an FDA review concluded that, 'There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation.'"
In order to restore trust in the FDA's practices and to avoid public doubt moving forward, the report recommended that the agency should enact several policies, including ensuring proper documentation of meetings between the FDA and drug developers and updating its guidance for reviewing new Alzheimer's treatments before any new drugs are approved.
Insider reviewed the 45-page investigation into Biogen's Alzheimer's drug. Here are three of the most shocking takeaways:
Biogen gave Aduhelm a crazy price tag despite knowing it would become inaccessible to many patients
From the moment Biogen announced Aduhelm's $56,000 price tag, the company faced backlash. Biogen justified the price tag by saying that at the time of its approval, Aduhelm was the first Alzheimer's drug approved by the FDA in 18 years and it would "transform the treatment of patients living with Alzheimer's disease," according to CEO Michel Vounatsos.
But the new congressional report says that pushback on the high price tag wasn't a surprise to Biogen; in fact, the company was expecting it. In anticipation, the report says, "Biogen developed an external narrative about the drug's value to sell to patients and the public," paying third-party consultants to provide guidance on pricing strategies and communications. In an April 2020 draft presentation, Biogen acknowledged that setting a price for the drug over $40,000 would be the best way to maximize revenue, but would have negative impact on patient access and affordability.The plan to maximize revenue at all costs ended up backfiring — almost immediately after launch, investors said the pricing was too high, and the company said it was lowering the price to $28,200 in December 2021.
Biogen knew the high price could strain the Medicare system
Biogen was planning for Aduhlem to be covered by Medicare Part B, which provides insurance to millions of patients over the age of 65. In fact, the company estimated that 85% of the drug's target population would be covered by Medicare. But the company knew that a high price tag would stretch the Medicare budget thin, and could cost the agency $12 billion per year on Aduhelm alone. The investigation found that Biogen knew many Medicare patients would have a hard time affording Aduhlem even with insurance, and that some patients could face out-of-pocket costs of up to 20% of their income.
The company created a payment assistance program for some patients, but the programs would not help people on Medicare. The company estimated that Medicare beneficiaries would have to pay anywhere "from $0 to $9k, stressing fixed income budgets" for the medication, in addition to costs for scans and infusions, according to the report.
Aduhelm's launch hit the pockets of all Medicare Part B recipients, whether they were eligible for Aduhlem or not. In November 2021, The Centers for Medicare & Medicaid Services announced that monthly Medicare Part B premiums would increase $21.60 per person partially in anticipation of higher Aduhlem expenses.
The company planned to spend millions of dollars advertising to patients of color, despite not prioritizing them in clinical trials
The investigation showed that Biogen had an aggressive marketing strategy for Adhulem, targeting both doctors, journalists, and patients. In some plans, the document reports, the company anticipated spending $3.3 billion on sales and marketing for the drug — more than two and a half times the cost of developing the drug.One of the key populations that Biogen targeted for marketing included communities of color, developing promotional materials specifically targeted at Black and Latino patients and their health care providers. According to the investigation, in one presentation the company said it could spend more than $3 million on media advertising focusing on patients of color, including by buying advertising slots on Telemundo, Black Entertainment Television, and other networks.
The same focus on communities of color didn't happen when Biogen was developing the drug, however. The investigation points out that in Biogen's late stage clinical trials for Aduhelm, only 3 percent of participants were Hispanic, 0.6 percent of participants were Black, and 0.03 percent were American Indian or Alaska Native.