Eli Lilly is expecting CMS to reverse course on its Medicare coverage policies around new Alzheimer's drugs as more evidence shows they are capable of reducing amyloid plaques in the brain, Reuters exclusively reported April 21.
"We believe that they (Medicare) will provide what we would call outright coverage like they do for every other FDA-approved medication," Derek Asay, Eli Lilly's senior vice president of government strategy and federal accounts, told the outlet.
The trial results from Eli Lilly's own Alzeimer's drug, donanemab, are expected to be released before the end of June. More data is expected in the coming months on Leqembi, a competing drug from Eisai and Biogen, according to the report.
The FDA approved Leqembi (lecanemab) on Jan. 6 — its third Alzheimer's drug approval in 30 years. A full approval is expected in July. Its predecessor, Biogen's Aduhelm, became a blunder.
Aduhelm was swept into controversy amid questions of its overall efficacy and wide-label approval, which preceded the resignation of the drugmaker's CEO and a congressional report blaming Biogen and the FDA.
CMS said in April 2022 that it would limit Aduhelm coverage to clinical trials only, which partly blocked the drugmaker's efforts to sell the drug it once deemed a blockbuster. Leqembi was subject to the same coverage plan, and CMS reaffirmed its position in February.
At the time, CMS said it may reconsider its coverage decision if "any new evidence" becomes available or an amyloid-targeting Alzheimer's drug receives traditional approval.
Since June, most UnitedHealthcare plans have covered Aduhelm only for patients in clinical trials who have received prior authorization. In September, Aetna said it would cover the drug if certain criteria are met, including obtaining prior authorization and receiving a prescription from a gerontologist, neurologist, psychiatrist or neuropsychiatrist.