Medicare And Alzheimer’s Drugs: Pressure To Relax Coverage Restrictions Rising Wtih Donanemab Data
Lilly's donanemab may be the second amyloid-targeting drug for Alzheimer’s headed toward a traditional US Food and Drug Administration approval this year, setting up a showdown with Medicare over its coverage with evidence development requirements.
You may also be interested in...
FDA’s Califf Speaks Of Tailoring Trials For CMS Evidence Amid Spotlight On Alzheimer’s Drugs
FDA Commissioner Robert Califf spoke of the need for a better hand-off to CMS, including tailoring trials to generate evidence relevant for Medicare coverage. He also weighed in on the possibility of accelerated approval for chronic disease drugs, among other topics.
Lilly’s Dosing Scheme For Donanemab In Alzheimer’s And Treatment Cost Effectiveness
Firm’s aggressive approach to amyloid plaque removal means a shorter duration of treatment and potentially lower costs.
US Medicare Agency Clarifies View Of Accelerated Approval
CMS says it has not changed its historical policy towards drugs granted Accelerated Approval. The agency does, however, appear to be suggesting grounds for skepticism towards novel uses of the regulatory pathway.