Medicare’s Registry Plans For Leqembi Prompt New Calls For Transparency, Rigor

Cathy Kelly, Pink Sheet, August 2, 2023

The Centers for Medicare and Medicaid Services should require registries maintained by outside organizations that are tracking patients taking Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi to include all “critical data” that could shed light on safety and outcomes and, importantly, ensure that at least CMS has access to the data, health care providers, patients, physician groups, researchers and policy experts are urging the agency.

In two recent letters to CMS and the Department of Health and Human Services, the experts call for transparency and consistency in the data collection and evaluation processes.

The letters follow CMS’ recent announcement that it will allow physicians to record minimal amounts of data in a Medicare-facilitated registry to satisfy its coverage with evidence development policy for Leqembi.  (Also see “Broader Medicare Coverage For Leqembi Begins As CMS-Backed Registry Opens For Business” – Pink Sheet, 6 Jul, 2023.)

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The message in the letters is something of a counterpoint to the intense public pressure that CMS has faced demanding that the agency should water down, or better yet drop, the registry requirement.

The groups behind them hope their input will be “helpful to CMS because they’ve been under tremendous pressure to not have a registry, to have as little information in the registry as possible, [and] to be as flexible as they can possibly be about letting different registries include whatever information they want,” National Center for Health Research president Diana Zuckerman told the Pink Sheet. Zuckerman is a signatory of one letter and the NCHR is among the groups that signed the other.

“We got together on the other side of this to say, ‘No, if you want useful information, you need some consistency among the registries and you need to have that important transparency where the data can be analyzed by other people,” she added.

Independent Analysis Of Private Registry Data

Both letters strongly emphasize the importance of allowing the data collected in the private registries to be available for analysis by researchers outside of their host organization, including at CMS and even outside the agency.

“The vast majority of registries that I’ve seen are owned and operated by the medical societies and they don’t make that information public,” Zuckerman explained. Agencies or outside researchers “can analyze the data in a way that might be different from the way the registry folks do” who might “have a vested interest in answering certain questions and answering them in a certain way.”

The signatories of a 27 July letter “support CMS’ plan for its Leqembi registry because the data from the registry will be available for CMS to analyze, and it is our understanding that [US Food and Drug Administration] and outside researchers will also have access to independently statistically analyze the data,” it says.

However, “we are very concerned that Leqembi registries developed by medical societies, medical centers, nonprofit organizations, or other non-governmental entities may limit access to their respective population-level data, potentially making it difficult for CMS and other researchers to conduct independent analysis of the data.”

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Both letters advise CMS to ensure the collection of key information that would inform questions around safety and outcomes. The letter from the Patient, Consumer and Public Health Coalition, dated 2 August, urges that the CMS registry and any other Alzheimer’s treatment registries “include information regarding patients who are at the greatest risk for adverse events from the drugs. This includes patients homozygous for APOE4 or who are taking anti-platelet or anti-coagulation blood thinners.”

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ALZ-NET Will Pay Providers To Participate

The letter also points out that data sharing requirements are particularly important because Leqembi’s label recommends enrollment in the ALZ-NET registry, but not the CMS one, which might lead more patients to participate in ALZ-NET than the agency’s registry.  Furthermore, “ALZ-NET has stated that they will pay providers to enroll and treat patients in their registry, which is likely to reduce the use of the CMS registry,” the letter points out.

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