The Centers for Medicare and Medicaid Services announced Thursday that it will cover a new class of highly anticipated drugs that treat Alzheimer’s, once they are granted the FDA's traditional approval.
The agency indicated that, in order for such drugs to be covered, patients with Medicare Part B must be enrolled in registries that collect real-world data on the treatments' effectiveness.
“I’m pleased to make this announcement today as part of CMS’ mission to help improve the lives of Americans we serve,” CMS Administrator Chiquita Brooks-LaSure said in the announcement. “I hope we see more private sector partners in this work making their own announcements soon.”
Eisai’s Leqembi is slated to be the first drug in line to receive coverage, as the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee is scheduled to discuss trial results on June 9, with a possible approval to follow soon after.
CMS indicated that coverage of qualified drugs will begin on the day the FDA grants its full traditional approval. Currently, Leqembi and Biogen’s Aduhelm have both received accelerated approval, but neither have been given traditional approval yet.
Under the current CMS coverage policy, this class of drugs also would be eligible for broader coverage once granted traditional FDA approval.
Read the full announcement here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She joined Innovate Healthcare in 2021 and has since put her unique expertise to use in her editorial role with Health Imaging.