Nyah Phengsitthy, Bloomberg Law, June 29, 2023
Medicare’s insistence on using a patient registry as a condition of its coverage of a new Alzheimer’s drug is raising concerns as the FDA nears approval of the drug.
The Centers for Medicare & Medicaid Services pledged to cover Eisai Co. and Biogen Inc.’s Leqembi once the Food and Drug Administration grants full traditional approval of the pricey treatment, which is expected by July 6. But many stakeholders have questions about the CMS registry that the agency is requiring patients and clinicians to participate in before it will cover the drug.
The CMS recently spelled out new details about its patient registry and data collection, but the information outlined is still unclear for some Alzheimer’s care advocates.
“It’s a potentially positive step forward, but there’s still a lot that we don’t know that can impact how much access patients will have to Alzheimer’s treatments,” Michael Ward, vice president of public policy and government affairs for the Alliance for Aging Research, said in an interview.
Why the Registry?
The main idea behind the patient registry is to “make sure that drugs that are being developed really work for people,” Meena Seshamani, CMS deputy administrator and the director of the Center for Medicare, said in a June 28 webinar hosted by advocacy group Protect Our Care Michigan.
“We will continue to monitor and make sure we’re doing everything we can to make sure that people have access to medications, that they’re improving health,” she said, adding that the agency is also “looking at patient safety and quality.”
Leqembi, priced at $26,500 a year without insurance, was initially granted accelerated approval and is covered by Medicare for clinical trial use only. If the FDA grants traditional approval, Medicare patients eligible for coverage must participate in the registry, which will require information such as their clinical diagnosis, results from amyloid tests, and evidence of adverse events such as brain swelling or hemorrhage, among other facts.
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Despite concerns about accessing and navigating the registry, the CMS said in a release that the data submission portal is an “easy-to-use format” and is “collecting information that will help to evaluate the appropriateness of the treatment for the Medicare population.”
More Information to Consider
The expanded drug access can help Medicare patients in need, but clinical trials of Leqembi have found that patients who carry two copies of the APOE4 gene, a genetic variant linked to Alzheimer’s risk, experienced severe symptoms like brain swelling and bleeding.
The registry does not require physicians to enter information about patients’ genetic makeup, but some patient advocates say such information should be considered for inclusion.
“The more information we have, the better position patients are in to make an informed decision about whether to try this,” Diana Zuckerman, president of the National Center for Health Research, said in an interview.
Zuckerman said the CMS’ new details about the registry cover the basic information needed for now, along with the benefits it will bring for Medicare patients.
“This is a good idea because it gives access to a lot of patients for coverage because these are expensive drugs, and it’s not just the drugs that are expensive,” Zuckerman said. “It’s the PET scans and other brain scans that are necessary to make sure patients are benefiting and are staying safe.”
The CMS said it’s working with multiple organizations to open their own registries. Clinicians will be able to choose which registry to participate in.
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