Medicare Coverage For Leqembi: Timeline For Reconsideration Of Restrictions
After getting a formal request for Medicare to reconsider coverage for Eisai’s new drug and other mAbs, CMS must decide by mid February whether to undertake the process. The formal timeline for reconsideration runs six to 12 months; past reviews have taken around nine months.
You may also be interested in...
Eisai has spent 25 years looking for a breakthrough in Alzheimer’s and warns that healthcare systems need to undergo a major shift to accommodate its breakthrough drug.
More long-term data for donanemab needed, FDA says. Lilly plans to seek traditional approval for its amyloid-clearing antibody after the Phase III TRAILBLAZER-ALZ 2 trial reads out in Q2, but it loses important ground in reimbursement negotiations.
FDA-approved language recommending ongoing patient monitoring through a registry is unusual but not unprecedented to address potential safety concerns.