The second option for coverage is in CMS-approved clinical trials with goals to develop better AD treatment or prevention strategies or to identify subpopulations at risk for AD. Amyvid received FDA clearance in April 2012 and was approved by the European Commission in January 2013. Prior to the draft coverage decision, Wei-Li Shao, senior director of Eli Lilly's Alzheimer's Business Division said in a conference call that clinical trials could take years, blocking patient access to Amyvid's diagnostic ability and negatively influencing patient diagnosis and treatment. More than 5 million Americans have AD, though half are undiagnosed, according to the Alzheimer's Association. Early diagnosis is thought to lead to better outcomes and better quality of life for both the patient and the family. In a statement released this week, Eli Lilly said that the final decision was contrary to expert opinion and the appropriate use criteria.