Medicare announces coverage expansion for Alzheimer’s drugs pending full FDA approval, subject to certain limitations.
TWC – In a groundbreaking move, Medicare is set to broaden its coverage to include a new class of Alzheimer’s drugs, provided they receive complete approval from the U.S. Food and Drug Administration (FDA), albeit with certain restrictions. The U.S. Centers for Medicare and Medicaid Services (CMS) revealed on Thursday that drug manufacturers must obtain full FDA approval and maintain a comprehensive data registry showcasing the drugs’ real-world efficacy.
CMS Administrator Chiquita Brooks-LaSure emphasized the significance of this decision, stating, “Alzheimer’s disease exacts a toll not only on the individuals afflicted but also on their loved ones and caregivers in a manner unlike any other illness. CMS has consistently demonstrated its commitment to facilitating timely access to innovative treatments that genuinely enhance care and outcomes for this disease.” She further assured that if the FDA grants formal approval, CMS stands ready to ensure coverage under Medicare Part B for all eligible individuals.
The drugs at the center of this development, namely Lecanemab (Leqembi) and Aduhelm, have already received accelerated approval to address an unmet medical need. At the same time, further research is conducted to assess their effectiveness and safety. However, neither drug has yet achieved complete, conventional approval.
Nevertheless, the requirement to collect real-world data in a registry has been met with mixed reactions. The Alzheimer’s Association expressed discontent, referring to the registry mandate as “an unnecessary barrier” and asserting that coverage of FDA-approved treatments should not be contingent upon such a requirement.
Contrarily, the CMS argued that employing registries has a “strong precedent.” Given that approximately 6 million Americans live with Alzheimer’s disease, which detrimentally impacts memory and cognitive abilities, this move by Medicare can potentially enhance the lives of those affected significantly. While there is currently no known cure for Alzheimer’s, expanding coverage for these promising treatments brings hope to individuals and families grappling with the devastating effects of this illness.