When the Centers for Medicare and Medicaid Services (CMS) decided how it would cover new Alzheimer’s disease drugs awarded accelerated FDA approval, it required that more safety and efficacy data be generated from clinical trials it authorized. CMS now says Medicare will cover Alzheimer’s drugs that receive traditional FDA approval, but the agency isn’t budging from its data collection stance. Instead of collecting evidence from a clinical trial, CMS will require evidence from physicians who will provide real-world information about how these therapies are working.
The CMS announcement on Thursday centers on registries, a tool for collecting patient data in a clinical setting. The agency said clinicians will be able to submit this information through a nationwide portal that it described as having an “easy-to-use format.” More details are coming, but CMS said that this portal will have safeguards to protect patient privacy. It will also allow access for researchers who can use the data in studies that advance the knowledge of these drugs.
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There’s precedent for using registries to gather more information about new treatments. CMS points to the traditional approval of a medical device, the transcatheter aortic valve replacement (TAVR). Clinicians and hospitals were required to contribute to registries that enabled CMS to track patient outcomes. CMS said that this information informed Medicare coverage determinations while also helping patients and their doctors decide whether TAVR was appropriate for them.
The new CMS policy for Alzheimer’s drugs comes as two of them move forward under the traditional approval pathway. Eisai aims to convert the accelerated approval of Leqembi into a full approval. Its application is currently under FDA review. The second drug is from Eli Lilly. After that antibody, donanemab, met the goals of its Phase 3 study, the drugmaker said it planned to file an application by the end of June seeking traditional FDA approval.
An FDA advisory committee is scheduled to meet on June 9 to discuss the application for traditional approval of Leqembi; a regulatory decision on the therapy is expected by July 6. CMS said broader Medicare coverage of Leqembi would begin on the same day the FDA grants traditional approval. The agency added that if other drugs in the same class of medicines receive traditional approval, they would be eligible for the same broader coverage.
CMS says the registry requirement is consistent with its coverage determination last year for Biogen’s Aduhelm. The decision called for the coverage of that drug and others in its class only for Medicare beneficiaries who are enrolled in a CMS-approved clinical trial. For Medicare coverage of Alzheimer’s drugs granted traditional approval, beneficiaries must be enrolled in Medicare Part B; be diagnosed with mild cognitive impairment or early dementia caused by Alzheimer’s; and have a qualified physician who participates in a registry.
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The registry requirement is encountering some resistance. The Alzheimer’s Association issued a statement calling registries an “unnecessary barrier.” While the group acknowledged that registries can be important for gathering real-world evidence, it contends they “should not be a requirement for coverage of a FDA-approved treatment.”
Drugmakers are also sounding caution on the registries. In a statement, Eisai said it’s difficult to understand how a registry will affect patient access to Leqembi. But the company added that historically, registries have not equally served patients, particularly those in underserved communities and geographic regions that have barriers to medical care. Lilly took a stronger position against registries.
“CMS should revise its National Coverage Determination to provide full Medicare coverage for FDA-approved Alzheimer’s medicines,” the Indianapolis-based company said in an emailed statement. “We strongly believe that mandating patient enrollment in registries will continue to pose unnecessary barriers and contradicts CMS’s promise of broad coverage to all Medicare beneficiaries. Establishing a precedent where the agency can restrict coverage for new medicines, singling out groups of patients and exacerbating health disparities, is not in the best interest of patients.”
Some see the registries as less of a hurdle. William Blair analyst Myles Minter wrote in a Thursday research note that those receiving anti-amyloid therapies will already be “high touch” patients requiring regular monitoring for the brain inflammation and bleeding complication that is a known side effect of these treatments. Clinicians will want to track cognitive outcomes in the real world given safety risks of the drug class.
“Details of the registry will be important and statements can change, but we believe this actually sets up Leqembi’s [advisory committee] and full approval as the key catalysts given that CMS reimbursement appears to be secured,” Minter said.
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