- The Centers for Medicare and Medicaid Services will retain its tight restrictions on paying for new Alzheimer’s drugs, stating that it hasn’t yet seen enough data to demonstrate Eisai and Biogen’s Leqembi meets its standards for coverage. Following an accelerated approval of Biogen’s Aduhelm last year, the agency said it would cover only patients who are enrolled in clinical trials.
- CMS, whose programs cover the vast majority of people with Alzheimer’s, reiterated it would broaden coverage “on the same day” the Food and Drug Administration converts the accelerated approvals granted to the Alzheimer’s drugs to full approval.
- Unlike Aduhelm, Leqembi has consistent data indicating it slows the cognitive decline of Alzheimer’s patients in addition to removing deposits of a toxic protein called amyloid from their brains. The FDA granted accelerated approval based on the amyloid effects as it reviews the data on cognitive decline for full approval.
The CMS issued its statement late Wednesday following a request from the Alzheimer’s Association to reconsider its coverage policy on amyloid-clearing antibody drugs. The agency said its standards for coverage, that a drug is “reasonable and necessary,” differ from the FDA’s “safe and effective” requirements for approval, and the data its top officials have seen so far haven’t changed their views.
“We are aware that additional publications may be forthcoming that include information relevant to the questions included in the current [policy],” the statement said. “CMS will expeditiously review any new evidence that becomes available that could lead to a reconsideration.”
The Alzheimer’s Association said it was “appalled” at the CMS announcement. “CMS' role is to provide health care coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate,” the group’s CEO, Joanne Pike, said in a statement.
Full FDA approval and CMS coverage could come as soon as early July based on Eisai’s Jan. 6 submission of data from the CLARITY-AD trial, if it receives priority review, Evercore ISI analyst Umer Raffat wrote in a Feb. 23 note to clients.
That CMS coverage could come with some strings attached, however. The statement emphasizes that it would be under a policy called “coverage with evidence development” that would require further data gathering to understand how well Leqembi works in real-world settings.
So-called “registry” studies, which follow patients taking a drug but don't compare how the drug works against another treatment or a placebo, would help answer lingering questions about Leqembi and “fill evidence gaps for patients who were vastly underrepresented in initial trials,” CMS said.
Stifel analyst Paul Matteis said the announcement that CMS won’t yet give full coverage to Leqembi may look negative, but the message in its statement “is a favorable step for Biogen/Eisai” because it points to broader coverage in the near future. “It sounds like this probably won't represent a major impediment to use,” Matteis wrote.