Pictured: Front of FDA headquarters/courtesy of Al Drago/CQ Roll Call/Getty Images
Thursday, the Centers for Medicare and Medicaid Services released information about how it will collect patient data from physicians prescribing Eisai and Biogen’s Leqembi, should it be approved by the FDA, as it will be a requirement for physicians who want their patients to be covered by Medicare.
On June 1, Medicare announced the data collection requirement, referred to as a patient registry, should the FDA grant Leqembi full traditional by July 6. Full approval is expected, as the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously in support of the drug on June 9.
According to the fact sheet released Thursday, CMS plans to create a free patient registry available for any monoclonal antibody treatment that is approved to treat Alzheimer’s, not just Leqembi.
Physicians will be required to submit information about patients’ demographics, diagnosis and medical history, as well as disclose if a patient is taking anything to prevent or treat blood clots. Doctors will also have to submit the results of any brain scans and any other tests that assess amyloid levels, and will be expected to report any side effects that occur after patients begin treatment with Leqembi.
CMS also stated it is working with several other organizations to prepare their own registries, and when they are available, physicians will be able to choose which one to use.
Update published June 1:
CMS Will Provide Coverage for Leqembi Upon Traditional Approval
Medicare elaborated on its intentions to broaden coverage for new Alzheimer’s drugs, such as Biogen and Eisai’s Leqembi, if they receive full approval from the FDA, according to a statement released by the Centers for Medicare & Medicaid Services (CMS) Thursday.
The agency is ready to provide coverage for anyone with Medicare Part B who meets the criteria upon traditional FDA approval.
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to discuss the results of a confirmatory trial for Leqembi on June 9. A decision on traditional approval could follow within weeks.
Once the FDA grants traditional approval, broader Medicare coverage for Leqembi would begin the same day. CMS’s current coverage policy dictates that if the FDA grants traditional approval to other drugs in the same class, they would also qualify for expanded coverage. Currently, only Leqembi and Aduhelm have FDA-accelerated approval status.
More registries for drugs that may slow the progression of Alzheimer’s disease are expected to become available soon.
Original article published April 11:
FDA Adcomm to Vote on Traditional Approval of Eisai and Biogen’s Lecanemab in June
The FDA announced Monday that its Peripheral and Central Nervous System Drugs Advisory Committee will meet on June 9 to discuss the marketing application for traditional approval of Eisai and Biogen’s Alzheimer’s disease drug Leqembi (lecanemab).
The FDA is not obligated to follow the recommendations of its advisory committees, but it usually does.
In April, the companies presented new data analyses from lecanemab’s trials at the International Conference on Alzheimer’s and Parkinson’s Diseases (AD/PD 2023). This included results from studies examining adverse effects associated with blood thinning medications, quality of life metrics for patients and their caregivers and projected long-term health outcomes.
Lecanemab is a monoclonal antibody that, when administered intravenously, travels to the brain to clear amyloid plaques, a hallmark of Alzheimer’s disease. Data from a Phase III trial (Clarity AD) including more than 1,900 early-stage Alzheimer’s patients showed that lecanemab slowed the rate of cognitive decline by 27% compared to a placebo over 18 months. The trial met its primary endpoint and all key secondary endpoints.
Those results, first published in The New England Journal of Medicine in November 2022, prompted the FDA to approve lecanemab on an accelerated basis in January.
An ARIA Quandary
Among the results presented at the conference were additional analyses from the Phase IIb trial (Study 201) and data from Clarity AD on the relationship between amyloid-related imaging abnormalities (ARIAs)—a common side effect of anti-amyloid antibodies—and antiplatelet and anticoagulant drugs.
Such blood thinners were implicated in the deaths of three patients during the extended period of Clarity AD. While Eisai has not commented widely on the deaths, experts have speculated that lecanemab might weaken blood vessels during treatment, leading to brain swelling and bleeding that could in turn be exacerbated by blood thinners.
The new data suggest, however, that such side effects are rare. In Clarity AD, ARIAs did not occur more frequently in participants receiving both lecanemab and antiplatelet or anticoagulant drugs compared to participants who received only lecanemab.
While Eisai representatives did not respond to BioSpace’s requests for comment prior to publication, Brian Skorney, a Baird senior research analyst covering biotechnology, said this finding was unexpected and will warrant further scrutiny. The prevailing view is that ARIAs often increase with the level of intervention, and that appeared to be the case in placebo groups that did not receive lecanemab but were on blood thinners.
“But in the treated group it went the opposite way—the greater the intervention, the lower the risk,” Skorney told BioSpace. “I think it is hard to make a clear judgment that this is an absolutely true finding . . . but the risk here appears to be lower than one would have prospectively thought.”
Improving Quality of Life
In addition, Eisai presented quality of life results in which researchers used the European Quality of Life–5 Dimensions (EQ-5D-5L) and Quality of Life in AD (QOL-AD) scales to assess patient wellness and the QOL-AD and Zarit Burden Interview to assess caregiver burden. After 18 months of treatment with lecanemab, scores across the three scales accounted for 23–56% less impact as the disease progressed compared to placebo.
Currently, only Europe and Japan consider such metrics when assessing drug approval or acceptance by insurance, prompting Norman Foster, director of the Center for Alzheimer’s Care, Imaging and Research at the University of Utah, to tell BioSpace that such findings are “positive” but “low impact.”
Foster added that collectively, the results shared at the conference “are all supportive of a positive effect of treatment” with lecanemab.
“[It’s] the story we already know, but it is always good to have consistency.”
On April 4, Eisai researchers also published a study in Neurology and Therapy modeling the long-term health outcomes for patients. Using updated results from Clarity AD, the team found that treatment with lecanemab resulted in a two to three year delay in the time it took patients to progress to more severe stages of the disease, as compared with patients who received only the standard of care. Five percent of patients were able to avoid institutional care altogether.
Lecanemab is only the second early Alzheimer’s drug to receive FDA approval in the past 20 years following the contentious approval of another Eisai/Biogen candidate, Aduhelm (aducanumab), in 2021. That drug moved forward over objections from an FDA advisory panel, and three members ultimately resigned. A subsequent review found that the FDA’s approval process had been “atypical,” and the U.S. Centers for Medicare and Medicaid Services (CMS) severely curtailed the circumstances under which it would cover the drug.
Early evidence suggests that lecanemab may fare better. Results from Clarity AD have shown the drug’s effects to be more robust while prompting fewer side effects than aducanumab. And while lecanemab received accelerated FDA approval based on data from the Phase II trial, Eisai has since applied for approval that will include Clarity AD results.
The FDA has set a decision date of July 6, 2023, and CMS has noted that while the agency currently only covers the drug for patients enrolled in clinical trials, it would consider extending coverage if lecanemab were to receive traditional FDA approval.
Eisai also announced at AD/PD that the company is establishing a dosing regimen for a subcutaneous form of lecanemab. Biogen CEO Chris Viehbacher previously said that a biweekly infusion could be particularly valuable for pre-symptomatic Alzheimer’s patients.
Amanda Heidt is a freelance science writer and editor based in Moab, Utah. To learn more, follow her on Twitter (@Scatter_Cushion) or visit www.amandaheidt.com.
