Biogen’s controversial Alzheimer’s drug generated just $300,000 in the first full quarter since its approval, far short of Wall Street predictions, as the Cambridge drug maker struggles to market the medicine to hospitals and persuade insurers to cover it.
Analysts had estimated that Aduhelm, the first new treatment for the deadly memory-ravaging disease in 18 years, would produce about $10.79 million in sales between July and September, according to Refinitiv data reported by Reuters.
But acceptance of the medicine has been slow due to uncertainty about whether the US Centers for Medicare & Medicaid Services will cover Aduhelm, which has a list price of $56,000 a year. The agency is expected to give its preliminary opinion in January and make a final decision in April.
Biogen executives said only about 120 sites in the United States have treated at least one patient with Aduhelm. In June, the company had estimated that 900 hospitals and clinics would soon be ready to provide monthly infusions.
“We are obviously disappointed,” Biogen chief executive Michel Vounatsos said of the slow rollout of the drug, which analysts had expected would be a blockbuster, or generating more than $1 billion in annual sales. Nonetheless, he said during an earnings call with analysts that “we continue to believe in Aduhelm’s long-term potential.” Vounatsos predicted that doctors will prescribe it more widely to patients with mild cognitive impairment if CMS decides in favor of Biogen.
An estimated 1 million to 2 million Americans with mild impairment would be eligible for the drug, under FDA guidance for prescribers. The vast majority of people with Alzheimer’s in the US are 65 and older and thus covered by the federal Medicare program.
In response to questions from analysts, Vounatsos said the company has no plans to lower the price of the drug, although he kept open the possibility of “fine-tuning” it at some point. And he said Biogen has no plans to reduce its marketing and manufacturing operations before the CMS decision.
“We stay the course,” he said.
Overall, Biogen’s revenue fell to $2.78 billion in the third quarter, from $3.38 billion in the same period in 2020. The company said it expects full-year sales to total $10.8 billion to $10.9 billion, with a per-share profit of $18.85 to $19.35. That was an increase from the forecast that company provided in July. Most of Biogen’s revenue comes from drugs for multiple sclerosis and spinal muscular atrophy, a rare disease that kills more infants than any other inherited disorder.
Dr. Stephen Salloway, director of neurology and the Memory and Aging Program at Butler Hospital in Providence, said Tuesday that his clinic has given monthly infusions of Aduhelm to 15 patients since the drug was approved in June, adding about two patients a week. That would appear to make his clinic among the biggest prescribers. But Salloway said it is far less than he had hoped to dispense by now. “Hundreds” of patients have expressed interest in the drug, he said.
The problem, Salloway said, is the uncertainty about whether public and private insurers will cover the cost of the drug and infusions. Some patients’ costs have been picked up by a regional Medicare office, private insurers, or Biogen itself, he said. Other patients are paying out of pocket.
“I didn’t expect this degree of controversy about the rollout,” said Salloway, a paid consultant for Biogen who tested the drug when Butler was one of the clinical trial sites. “I was hoping this wasn’t going to happen.”
He said it’s too soon to judge whether Aduhelm is helping patients. At best, he said, the drug will delay their cognitive decline. Salloway told the Globe in the spring that he treated 17 patients during clinical trials and that 10 didn’t decline while on it.
The two biggest private insurers in Massachusetts, Blue Cross Blue Shield and Point32Health, have said they will not cover the drug. Blue Cross, which has 2.8 million members in Massachusetts, said recently that it reviewed clinical studies and talked to specialists before concluding that Aduhelm is “investigational,” or unproven.
“The clinical evidence for Aduhelm, though promising, does not clearly demonstrate that the potential benefits of the drug outweigh the known risks,” company officials said in a statement. They said members and physicians can request individual consideration — but noted that no one, so far, has requested coverage for the drug. Several Blue Cross plans in other states have also rejected the drug.
In September, Mass General Brigham, the largest health care provider in Massachusetts, said it would not offer the treatment to patients because of concerns about safety and effectiveness. The Cleveland Clinic, Mount Sinai Health System in New York, and Providence in Renton, Wash., made similar decisions in July.
One of the most closely watched experimental drugs in recent history, the medicine from Biogen and its Japanese partner Eisai, is a monoclonal antibody made from the immune cells of older people with no or uncommonly slow cognitive decline.
The drug reduces a sticky protein called amyloid that clumps into plaques in the brains of people with Alzheimer’s. Some doctors believe amyloid buildup causes cognitive impairment, although that’s unproven and fiercely contested.
Aduhelm generated contradictory results in two late-stage clinical trials. In one study, Biogen said, a high dose could delay cognitive decline by 22 percent, or about four months over 18 months, an encouraging result. The other trial failed to prove the drug was effective.
Critics have also noted that the drug caused side effects in some patients, including brain swelling, although that didn’t usually result in serious symptoms.
Based on the conflicting trial results and potential side effects, an FDA scientific advisory committee in November voted 10-0, with one panelist voting “uncertain,” that the agency shouldn’t approve the drug. But the FDA cleared it anyway to the surprise of some experts, prompting three members of the committee to quit in protest.
The agency’s ruling has spurred investigations by Congress and the Department of Health and Human Services’ independent Office of the Inspector General.
Jonathan Saltzman can be reached at email@example.com.