On the same day the White House announced Medicare beneficiaries will pay slightly less next year for Part B services in part because of the agency’s decision to limit coverage of a costly Alzheimer’s disease medication, the makers of that drug released results of studies they claim show their new Alzheimer’s medication to be effective and on track for approval.
“Complete coincidence,” Libby Holman, director of product communications at Eisai, told Fierce Healthcare. Eisai and Biogen developed the new Alzheimer’s drug—lecanemab—together. Biogen’s rollout of Aduhelm last year proved disastrous because of its exorbitant cost and questions about its efficacy.
Michael Carome, M.D., concurs with Holman. “I suspect that the two announcements occurring on the same day was a coincidence,” Carome, director of the health research group at Public Citizen, told Fierce Healthcare.
Carome adds, “I don’t know whether Biogen and Eisai knew about the White House announcement and moved forward its announcement about lecanemab [because of that].”
Randy Vogenberg, Ph.D., principal at the Institute for Integrated Healthcare, tells Fierce Healthcare:“I tend to view announcements this week as more coincidence than policy due to overall timing of events across stakeholders over the past two years along with general underutilization of healthcare during the pandemic.”
Vogenberg adds, however, that “there definitely appears to be a battle of wits occurring between policymakers like the White House and select pharmaceutical firms that is likely to continue into the presidential election cycle.”
Biogen and Eisai announced yesterday that lecanemab hit its primary and key secondary endpoints. Fierce Biotech reports that the “study randomized 1,795 people with early Alzheimer’s to receive lecanemab, an antibody designed to take out amyloid-beta aggregates, or placebo intravenously twice a month. After 18 months, the partners found lecanemab slowed cognitive decline by 27% compared to placebo, causing the trial to hit its primary endpoint with a p-value of 0.00005.” The Food and Drug Administration could approve lecanemab Jan. 6.
Some experts expressed skepticism that lecanamab will live up to its hype.
Lon Schneider, M.D., a physician and Alzheimer’s expert at the Keck School of Medicine of the University of Southern California, told Stat that “this is a statistically robust and positive study but the treatment effect is small.”
Michael Greicius, M.D., a neurologist at Stanford University who studies and treats Alzheimer’s, told Stat that he thinks “if anything this is going to be on the cusp of what’s considered minimally clinically significant, and it may be below that. That’s where we need to see more data.”
Neither Schneider nor Greicius were involved in the study.
Meanwhile, Biden announced that Medicare Part B’s cost will be $164.90 a month next year as opposed to the $170.10 beneficiaries paid this year, and the $5.20 in savings (about $60 a year) matters considering how people on fixed incomes find inflation particularly difficult to deal with.
“It’s going to be a godsend for many families,” Biden told healthcare advocates in a White House Rose Garden event Tuesday. “It’s going to take a little while for some of this to kick in, but it’s locked in.”
The decrease in Medicare Part B costs doesn’t seem that much year to year, but Medicare had to raise 2022 premiums by 14.5% compared to 2021, partly because of the cost of Aduhelm, which was priced at about $56,000 a dose. The Centers for Medicare & Medicaid Services (CMS) this year limited access to the drug, and Biogen cut the cost in half. Because it spent less on that drug and other services, CMS could reduce the cost for Part B in 2023. Part B’s annual deductible decreased by $7 to $226, as well.
A CMS report issued in May stated “potential Aduhelm costs resulted in roughly half of the 2022 premium increase due to the drug’s average price of $56,000 per year, uncertain utilization, and uncertain Medicare coverage, which were factored into the actuarial models used to calculate the adopted premium recommendation.”
The Alzheimer’s Association issued a statement last night saying that “for people in the earliest stages of Alzheimer’s, this treatment has the potential to change the course of the disease in a clinically meaningful way. These results indicate lecanamab may give people more time at or near their full abilities to participate in daily life, remain independent and make future health care decisions.”