Biogen is waiting with bated breath for a key reimbursement decision on Aduhelm from Medicare this week. With pushback mounting against the controversial Alzheimer’s disease therapy, the biotech isn’t picky for any potential coverage.
“Anything that starts to provide access in this country—the No. 1 market in the world—is very good news,” Biogen CEO Michel Vounatsos said during the annual J.P. Morgan healthcare conference. “It means the door is open, and then it’s a matter of time” before more data, better documentation on the product, more use and infrastructure adjustment put Aduhelm on track, the CEO said.
The Biogen chief made his comments as industry watchers await an Aduhelm coverage decision from the Centers for Medicare & Medicaid Services (CMS). For Biogen, the company is hoping a positive decision can save Aduhelm from a disastrous launch that only produced $300,000 in sales in the third quarter.
Rather than writing Aduhelm off Biogen’s business, like some investors are doing, Vounatsos is labeling the drug as experiencing a “delayed uptake.” As the CEO sees it, the launch only starts when reimbursement is in place.
A CMS ruling could go five different ways, including no coverage whatsoever. Among the possible options, Biogen is advocating for coverage that aligns with Aduhelm’s clinical trial population from the phase 3 EMERGE and ENGAGE trials, Alisha Alaimo, Biogen’s U.S. chief, said during the JPM event.
That would mean more restrictions than Aduhlem’s current FDA label, which only asks the drug to be used in mild Alzheimer’s patients. The Aduhelm clinical trials, however, were much more exclusive. For example, people who had any contraindications on brain scans were excluded from the studies. Patients who were taking blood thinners were also not included unless they were only on aspirin at a preventive dose or less.
The CMS is expected to deliver a draft guidance by Wednesday. But the final verdict, which likely won’t come out until April, could be very different from the draft, Alaimo cautioned, pointing to prior experiences with CAR-T cancer therapies.
Ahead of the Medicare ruling, Biogen surprisingly cut Aduhelm’s list price in half. CMS doesn’t take pricing into consideration when making coverage decisions, Alaimo noted. Still, Biogen has received feedback from payers and patients that the move significantly lowered patients’ out-of-pocket costs, she added.
Lower price or not, many doctors simply don’t view Aduhelm as a drug with any clear efficacy but with dangerous side effects. They argue that beta amyloid, the biomarker Aduhelm targets and that serves as the basis for FDA’s accelerated approval, wasn’t enough to reasonably predict the drug’s clinical benefits. Several major health systems have reportedly declined to list the drug on their formularies and don’t plan to change them even with potential CMS coverage.
Meanwhile, Biogen is accelerating Aduhelm's phase 3 trial dubbed EMBARK. Biogen and Eisai plan to file the final protocol of the trial for FDA review by next March and screen the first patient in May.