Biogen on Wednesday reported its new Alzheimer's drug, Aduhelm, brought in just $300,000 in revenue during the third quarter—falling far below the forecasted $12 million in sales for the drug's first full period of availability.
Biogen originally sought FDA approval for Aduhelm in 2019, after a company analysis of clinical trial data found a high dose of the medication provided a small benefit in slowing cognitive decline and that the drug was effective at removing the beta-amyloid proteins associated with Alzheimer's disease.
In 2020, a panel of independent experts convened by FDA reviewed the clinical trial data, determined there was not enough evidence to suggest the treatment had significant benefit for patients, and recommended against approval. However, some patient groups advocated strongly for approval, especially because Alzheimer's patients have few other medical options to slow their cognitive decline.
Ultimately, FDA on June 7 announced its decision to approve Aduhelm on a conditional basis. The drug costs the average patient around $56,000 annually, with each monthly infusion costing $4,300.
In August, HHS' Office of Inspector General (OIG) announced it would investigate the approval process used to initially approve the Alzheimer's drug after receiving a request from acting FDA Commissioner Janet Woodcock. OIG's review is not expected to be complete until 2023.
Meanwhile, CMS is in the process of a National Coverage Determination (NCD) analysis to determine if it should standardize coverage of the drug—a decision that could limit who receives it. A draft decision is expected in January, and a final decision is expected by April.
According to the Times, health insurers will likely remain hesitant to cover the drug until CMS' final decision is made next year. For instance, multiple Blue Cross Blue Shield health plans have said they won't cover the drug, and the Department of Veterans Affairs in August decided not to include the drug in its formulary of available medicines, the Times reports. Similarly, in separate statements, the Cleveland Clinic and Mount Sinai Health System said they will not administer the drug to patients.
Aduhelm falls short of sales expectations
On Wednesday, Biogen released its financial report for the third quarter, which marks Aduhelm's first full quarter of market availability. The report stated that the drug had garnered $300,000 in revenue, falling short of the forecasted $12 million expected by Biogen and Wall Street analysts.
Many experts credited the shortfall to concerns about the high annual cost of Aduhelm, as well as the controversial approval process, the Times reports.
However, Biogen CEO Michel Vounatsos told Wall Street analysts on Wednesday that the company was "not panicking" about the low sales, adding that the primary cause behind Aduhelm's slow uptake is the "lack of clarity on reimbursement," which he said CMS will clarify by 2022. He said the company continues "to believe in Aduhelm's long-term potential."