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Reimbursement for Alzheimer's medicines still will occur only with the completion of studies to support full FDA approval.
Confusion recently arose over whether and how Medicare will cover new Alzheimer’s treatments, but the fine print indicates that reimbursement for such medicines still will occur only with the completion of studies to support full FDA approval. And even with that imprimatur from FDA, the Centers for Medicare and Medicaid Services (CMS) will limit reimbursement to patients who enroll in physicians’ registries. While one treatment for this widespread condition may gain full approval next month, accelerated approval status remains insufficient to support reimbursement by the federal government.
The issue made headlines when CMS announced on June 1, 2023 that Medicare will cover drugs in this new class of Alzheimer’s treatment that receive “traditional approval” from FDA. However, the fine print stipulated that coverage will only apply to those who participate in a registry to collect real-world data that can further assess the usefulness of these drugs for elderly patients. CMS ignited controversy in 2022 when it decided to only pay for treatment of those few patients participating in confirmatory studies, under its coverage-with-evidence-development program.
The first drug likely to qualify for full approval is Leqembi from Eisai, which is scheduled for an FDA advisory committee review of its confirmatory studies on June 9. FDA granted accelerated approval for the treatment in January, but CMS limited coverage to those patients enrolled in confirmatory trials, as it did earlier with Biogen’s Aduhelm. In addition, Eli Lilly hopes to provide sufficient data to gain full approval for its Alzheimer’s therapy by year-end.
The Alzheimer’s Association protested CMS’ requirement for registry enrollment as erecting “an unnecessary barrier” to coverage. While patient registries are “important tools for gathering much needed real-world evidence” to improve patient care, they should not be used to limit access to an FDA-approved treatment, the patient advocates stated.
Similarly, the Biotechnology Innovation Organization (BIO) described CMS’ policy as reinforcing criticism of FDA accelerated approval and raised concerns that these challenges to accelerated approval will limit patient access to treatment and curb future innovation.Some members of Congress and patient groups agree with FDA on the importance of permitting broad access to potentially beneficial treatments, especially for severe conditions affecting small patient populations.
It really all comes down to money: the high cost of new Alzheimer’s treatments and potentially millions of patients likely to seek treatment would run up Medicare prescription drug budget exponentially.
Jill Wechsler is Washington report for Pharmaceutical Technology.