Biogen has two Alzheimer's disease medicines approved in the U.S. The first, Aduhelm, had a disastrous launch following its approval in the summer of 2021. Commercial insurers as well as the Centers for Medicare and Medicare Services weren't convinced the drug was effective enough to warrant an annual price tag set initially set at $56,000.
Aduhelm — at one point considered a blockbuster-to-be by many analysts — has since been shelved.
But Biogen has had a better experience with its second drug, Leqembi. Getting insurers to pay for Leqembi "has not been an issue," according to the company's CEO Christopher Viehbacher, who spoke Monday at the J.P. Morgan Healthcare Conference.
Viehbacher joined Biogen about a year ago, just before Leqembi received conditional clearance from the Food and Drug Administration. The medicine has since secured full approval, opening the door to broader coverage from CMS, which insures the majority of patients eligible to receive Alzheimer's therapies like Leqembi. CMS initially set a restrictive policy that made full approval necessary to unlock coverage.
Biogen's development partner Eisai leads Leqembi's commercial rollout, and in November reported that around 800 patients in the U.S. were on the drug by the end of October. The companies have said they hope to increase that number to 10,000 before April.
Viehbacher noted that despite the insurance progress, Leqembi's launch remains challenging. An estimated 6 million people live with Alzheimer's in the U.S., meaning that if only a fraction seek out Leqembi treatment, it can overwhelm the number of available neurologists. Viehbacher pointed to a "lengthy sales cycle" of two to three months from when Alzheimer's patients request an appointment with a neurologist to when they actually receive Leqembi.
"Up until now, there hasn't really been any disease-modifying treatments for Alzheimer's ... so now there's kind of a rush," he said. "I think the primary care physicians will play a role at some point, because patients coming in [are having trouble finding] an appointment for a neurologist."
Whether Biogen and Eisai will hit their patient goal isn't clear. Like with Aduhelm, the partners initially targeted treatment centers that see high volumes of Alzheimer's patients. Viehbacher claims they've been "broadening out" their reach, and that the number of centers ordering Leqembi has increased 37% since the third quarter.
But on Monday he played down the 10,000 target as a step toward a larger goal.
"Remember that the 10,000 was really designed to try to give people some sort of milestone, because there are no real analogs for this launch," he said. Currently, that figure "isn't really what we're interested in anymore. It’s: how do we now get to the 100,000? That's where we're focused.”
Viehbacher pointed to January sales numbers, when they come, as an important barometer, noting how December can be a “funny month” with the holiday schedule.
Soon, though, Biogen and Eisai could have a new competitor. Eli Lilly is awaiting an FDA decision on its rival Alzheimer’s drug donanemab, and expects a verdict early this year.
For Biogen, a strong launch is needed from Leqembi as it works to return to growth. The company had been counting on FDA approval of a partnered Sage Therapeutics drug for clinical depression, but the agency only granted a narrow label for postpartum depression.