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Lilly Disappointed in Draft Medicare Coverage Decision for Beta-Amyloid Imaging Agents
Date:7/7/2013

e are still evidentiary gaps necessary to reconcile prior to reevaluating coverage. CMS would require additional trial(s) to address these gaps, and only those patients taking part in the trials would be eligible for coverage.3 Once those studies are complete, CMS can conduct another national analysis and render a decision on coverage.

"Lilly remains steadfast in our request for Medicare coverage of beta-amyloid imaging agents for the appropriate patient population without Coverage with Evidence Development, as recommended by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging," said Wei-Li Shao, senior director, Alzheimer's Business Division, Eli Lilly and Company.  

A task force of experts organized by the Alzheimer's Association and the Society of Nuclear Medicine and Molecular Imaging has developed the Appropriate Use Criteria, which outline the appropriate and inappropriate use of amyloid PET imaging.4

The decision is currently in draft form and is subject to change before the final decision is expected in October. For now, there is a 30-day comment period in which interested parties can post their reactions to the decision at http://www.cms.gov/medicare-coverage-database/indexes/nca-open-and-closed-index.aspx.

Alzheimer's Disease is one of many possible causes of cognitive impairment, which can make diagnosis challenging.5,6 In fact, it is estimated that up to one in five patients clinically diagnosed with probable Alzheimer's Disease during life do not exhibit Alzheimer's Disease pathology upon autopsy.7,8 If determined through clinical assessment and scan results that Alzheimer's Disease is not the cause of a patient's cognitive impairment, their physician can avoid or discontinue unnecessary or potentially harmful treatm
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SOURCE Eli Lilly and Company
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