U.S. Centers for Medicare & Medicaid Services (CMS) Administrator Chiquita Brooks-LaSure made her first appearance April 26 before the House Energy and Commerce’s Subcommittee on Health, ostensibly to discuss legislative solutions to increase transparency and competition in health care. But member after member, regardless of political party, demanded answers about why CMS continues to severely restrict access to Eisai Co. Ltd.’s Alzheimer’s drug, Leqembi (lecanemab), especially since another government agency is covering it for all veterans that meet the labeling requirements.
The U.S. Veterans Health Administration (VA) is being applauded for doing what Medicare has refused to do – provide coverage for Leqembi (lecanemab) in the early stages of Alzheimer’s disease. Under the March 13 VA decision, the Eisai Co. Ltd. drug, which was partnered with Biogen Inc. and granted accelerated approval in January, will be listed as a nonformulary therapy that must be prescribed by a VA-board certified neurologist, geriatric psychiatrist or geriatrician who specializes in treating dementia.
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies approved to treat Alzheimer’s.
Now that the U.S. FDA has granted accelerated approval for Biogen Inc./Eisai Co. Ltd.’s early Alzheimer’s drug, Leqembi (lecanemab), the Centers for Medicare & Medicaid Services (CMS) is being pressured to rethink its coverage of amyloid-targeting monoclonal antibodies.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.
As expected, the U.S. FDA gave its go-ahead to lecanemab, an amyloid-beta binder for mild cognitive impairment caused by Alzheimer’s disease (AD) and mild AD – together known as early AD – from Biogen Inc. and Eisai Co. Ltd, which have assigned to the compound the brand name Leqembi.