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CMS Decision on Diagnostic Drug Highlights New Study Challenges

October 10, 2013
The Centers for Medicare & Medicaid Services’ (CMS) decision to limit coverage of a diagnostic imaging drug for Alzheimer’s disease not only threatens the development of such drugs, but illustrates how industry must rethink clinical trial design, stakeholders say. CMS last week said it would consider coverage for beta-amyloid imaging drugs such as Eli Lilly’s Amyvid (florbetapir F 18 injection) only in limited circumstances: for clinical trials that must be approved in advance by CMS.
Washington Drug Letter