If Biogen thought selling its first-to-market Alzheimer’s treatment Aduhelm would be an easy feat, it had another thing coming.
Biogen’s top brass on Thursday admitted that its Aduhelm rollout—a task some analysts have pegged as the biggest in biopharma history—has lagged behind its own expectations.
Unfortunately, Aduhelm is launching slowly just as Biogen's multiple sclerosis drug Tecfidera is losing sales to generics at top speed, helping to drag down overall sales to $2.7 billion from $3.7 billion a year ago.
But there are many reasons why FDA approval didn't immediately open the floodgates on Aduhlem prescriptions. For one, hospitals and insurers are sitting in a holding pattern as the Centers for Medicare and Medicaid Services (CMS) carries out its National Coverage Decision, which will ultimately decide which Alzheimer’s patients under the federal insurance programs will be covered, if any. Some clinical sites have outright refused to dose patients with the treatment in the meantime.
Then there are the less-than-favorable Aduhelm headlines. During an earnings call with analysts, CEO Michel Vounatsos blasted critics and the media for generating “controversy” and “background noise” over the hotly-debated treatment since it scored a historic FDA nod in June.
Vounatsos said Oppenheimer’s Jay Olson was “absolutely right” for categorizing Biogen’s media attention as “an assault” during the analysts’ question-and-answer period on the company's Q2 earnings call.
Those comments came after an emphatic defense from Biogen's chief of research and development, Alfred Sandrock, M.D., Ph.D. In a statement, Sandrock said Biogen welcomes a "formal review" into the company's reportedly cozy dealings with the agency ahead of Aduhelm's approval.
The Alzheimer's drug has been the subject of "extensive misinformation and misunderstanding," Sandrock argued, pointing out the more than 250 other drugs that have been awarded accelerated approvals since 1992.
Some experts have doubted the theory that removing amyloid plaque will actually benefit patients, but Sandrock said earlier anti-amyloid antibodies didn't effectively remove the protein from the brain. He also said the company didn't pick apart its late-stage trial data through a "post hoc" analysis, as some have suggested.
Despite its headwinds, Biogen is still finding instances of “tremendous progress,” Vounatsos added.
Of the 900 sites that Biogen had previously determined were ready and willing to administer Aduhelm, about 325 have issued favorable reviews of the treatment or aren’t requiring any review at all.
For those that have refused access, Biogen’s U.S. president Alisha Alaimo suggested doctors can still prescribe the treatment for infusion elsewhere.
The company said CMS’ decision to create a nationwide reimbursement policy should add “clarity” for healthcare providers in the coming months.
“Our teams are making every attempt to get in front of the decision-makers in order to help them better understand the science and data,” Alaimo said.
Right now, local Medicare contractors are responsible for coverage decisions. Based on recent precedent set under CAR-T treatments, Biogen predicts patients under the contractors and Medicare advantage plans will be covered, Alaimo said.
RELATED: A $57B drug? Medicare faces a massive bill for Biogen's Aduhelm—even if it limits coverage
Biogen is confident that it can get the ball rolling in the coming months. Physicians are working up protocols, scheduling amyloid beta plaque testing and discussing those findings with their patients, Biogen said.
Those tests, largely uncovered by insurance plans, could cost patients thousands, but Biogen is fielding costs for the bioassays used to screen for amyloid in patients who’ve undergone spinal taps, a top Biogen official told Endpoint News.
For months, the Cambridge, Massachusetts-based pharma has maintained that Aduhelm’s uptake would be gradual. A “big chunk” of the $2 million in Aduhelm sales Biogen reported on Thursday represents inventory working its way to clinical sites, but it’s still very early, executives said.
To Jefferies' analysts, Biogen's comments on Thursday suggest "good strong early demand," consistent with its own research, according to a note to clients on Thursday. While the company didn't disclose patient numbers, Jefferies was encouraged by the "very high" interest in the treatment and Biogen's efforts to expand access.
In all, Biogen’s second-quarter revenue fell to $2.7 billion, down from the $3.7 billion it reported during the same period last year.
Much of the drugmaker’s loss was pinned on an 80% year-over-year U.S. sales decline for its multiple sclerosis drug, Tecfidera, which has faced an ambush of copycat competition. The treatment raked in $178.4 million in U.S. sales during the quarter, down from $913 million last year.
