CMS Input On Pivotal Trials Could Anticipate Medicare Coverage Issues – Brooks-LaSure
Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure responds to US Congressional concerns about the proposed Medicare coverage policy for Alzheimer’s drugs.
You may also be interested in...
FDA-CMS communications are expected to evolve as both agencies look to improve their relationship.
Eisai/Biogen’s promising Phase III data fueling the companies’ hopes that Medicare will relax coverage restrictions for their Alzheimer’s treatment candidate. If the sponsors fail to change the NCD, lecanemab will need to rely on a registry for reimbursement after full approval.
FDA commissioner Robert Califf wants to develop a postapproval evidence generation system through ongoing collaboration with CMS. Public health experts say efforts by FDA and CMS to work more closely could result in greater clarity on trial designs early in development programs.