Eisai and Biogen’s new Alzheimer’s disease drug Leqembi won’t receive any special treatment under Medicare’s restrictive coverage rules for anti-amyloid medicines—at least for now.
The Centers for Medicare & Medicaid Services (CMS) on Wednesday rejected a petition to provide wider coverage for Leqembi on Medicare, keeping in place a restrictive policy for the entire class of Alzheimer’s drugs.
That means Leqembi, just like Aduhelm before it, will only be reimbursed in clinical trial settings under what’s known as the “coverage with evidence development” pathway.
The agency made the decision in response to a request by the Alzheimer’s Association to change its policy for Leqembi. It also comes shortly after the American Academy of Neurology threw its support behind Leqembi, and after lawmakers sent letters urging Department of Health and Human Services and CMS to reconsider the coverage plan.
For its part, CMS on Wednesday said there isn’t “evidence meeting the criteria for reconsideration.” That conclusion comes despite new phase 3 data showing Leqembi’s ability to improve cognitive decline.
CMS will “expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the [national coverage determination],” the agency said. “We are aware that additional publications may be forthcoming” that include relevant clinical information, CMS said.
These include details about the characteristics of the trial patients and trial sites which have not yet been made public, according to the agency’s response letter to the Alzheimer’s Association.
In a Wednesday statement, the Alzheimer’s Association said it’s “appalled that the Biden Administration is extending its unjust decision to deny access to FDA-approved treatments for people living with Alzheimer’s.” In a separate statement, patient advocacy group UsAgainstAlzheimer’s called CMS’s argument “simply empty and erroneous rhetoric.”
Eisai wasn’t surprised by the CMS rejection. Eisai “anticipated that CMS would wait for the traditional FDA approval of Leqembi to make a public statement about any coverage change,” the company said in a statement.
The drugmaker is “actively working with CMS to determine the most efficient path to appropriate access,” a spokesperson said, noting that the company “has not received any details of deficits in the data set at this time.”
CMS installed the restrictive policy last year after Leqembi's predecessor, Aduhelm, won a controversial FDA accelerated approval. In its coverage decision, CMS painted all anti-amyloid antibodies cleared under the FDA’s accelerated approval pathway with the same brush.
CMS’ restrictions for the class stemmed in part from seemingly contradictory findings from two phase 3 trials for Aduhelm. The FDA granted Aduhelm an accelerated approval based on the drug’s ability to clear amyloid plaques in the brain as Biogen runs a phase 4 trial to determine whether Aduhelm can slow cognitive deterioration.
In forming the coverage criteria, CMS sought to answer whether the drug class can improve health outcomes in a broad community setting, whether treatment benefits and harms depend on various factors, and how the drugs’ effects change over time.
Eisai's supporters argue that data from the phase 3 Clarity AD for Leqembi trial meet CMS' requirements. As published in The New England Journal of Medicine, Leqembi’s phase 3 study showed that the drug led to “moderately less decline” on cognition and function measures, versus placebo, at 18 months.
The American Academy of Neurology, in a letter (PDF) to CMS, said it believes data from Clarity AD provide “persuasive evidence that indicates meaningful direct clinical benefit,” and that “these findings support the need for broader access to [Leqembi] than currently permitted” by the CMS. But instead of a Medicare policy change right now, the medical association advocated for a reconsideration “upon traditional [FDA] approval.”
CMS responded that it will reconsider its policy when provided with evidence that answers its research questions or upon a full FDA approval.
Meanwhile, Eisai in January used the Clarity AD findings to file for a traditional approval with the FDA. But even after a potential full FDA nod, CMS is recommending coverage strictly under real-world registry-based studies rather than a straightforward policy with no limitations.
Without Medicare coverage, Eisai is providing Leqembi to cash-paying patients or through a patient assistance program. The company said it recorded the first sales of Leqembi on Jan. 18, and the first prescription was written Jan. 23.