Biogen defends slow rollout of new Alzheimer's drug, criticizes negative media attention
As Biogen execs bemoaned the negative media coverage around Aduhelm’s approval a month ago, the biotech isn’t gaining much traction yet in using its new drug, largely due to a lack of insurance coverage, according to an earnings call Thursday.
Management indicated that of the nearly 900 sites that were prepped and ready following Aduhelm’s approval, 325 of those, or about 35%, have completed a positive pharmacy and therapeutics (P&T) review or won’t require one. The review is a step some hospitals or health systems take prior to using a new drug. Some major sites, however, have said they won’t participate.
Biogen’s top research chief Al Sandrock also said on the call that he welcomed a formal review into the interactions between FDA and Biogen, as “a better understanding is good for everyone involved.” He also offered an open letter on Thursday to “correct some of the misinformation” around the approval. For instance, Sandrock took issue with the idea that aducanumab’s trial results are “post hoc,” although the company did stop the trials due to futility. He also stressed that the accelerated approval pathway, while noting that collaboration between industry and regulatory agencies is common, appropriate and beneficial.
A former senior FDA official told Endpoints that any discussion at a conference between agency officials and a company on an application’s details or timing, is improper and should not happen. Both STAT News and NYT also confirmed separately that FDA’s neuroscience head Billy Dunn met privately at a conference to discuss Aduhelm’s application.
Sandrock also seemed to blame the controversy around the Aduhelm approval on negative media attention. Jay Olson, a research analyst at Oppenheimer, opened the call’s questioning with one about all of the “negative media” coverage, which CEO Michel Vounatsos thanked him for asking and said he agreed with.
Vounatsos said he does expect regional Medicare MAC/Advantage plans will provide coverage while Medicare’s NCD review is ongoing. But the NCD will override any of those local Medicare plan decisions that are instituted prior to the NCD, said Alisha Alaimo, president of Biogen’s US organization. That NCD decision from CMS isn’t expected for another 9 months.
But, according to one Biogen employee, that regional coverage has not happened yet, and commercial insurers have been hesitant to cover the new drug. The company said it brought in $2 million in quarterly Aduhelm sales, but Vounatsos said to assume that a “big chunk” of that $2 million is inventory and does not reveal how many patients have been treated.
Biogen expects “modest” sales in 2021 but did not provide any financial estimates.
“It’s still early days,” Vounatsos said. “Overall, it’s a bit slower than what we assumed, but we’re making progress.”
Alaimo said Biogen is making every effort to get in front of these local Medicare decision makers and there’s a “high level of interest” in Biogen’s program where it pays for a test that can identify beta amyloid in potential patients.
She noted that although no insurers have come out with a coverage policy yet, so there are no mandates on finding amyloid beta yet, “that’s the expectation.” There are several areas of the country where access to amyloid PET is not available, she said, noting that Biogen has requested PET and CSF tests, but the company is working on gaining PET reimbursement through CMS.
Vounatsos also promised that Biogen will publish its Phase III trial results for Aduhelm in a peer-reviewed journal. Those data are important as some experts are now raising questions about what the FDA released alongside the accelerated approval, and as three adcomm members have now resigned from the FDA panel.