What the Centers for Medicare & Medicaid Services Denial for Eli Lilly and Company's Amyvid Means for Pharma

Published: Jul 12, 2013

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CMS is proposing to deny coverage of Lilly’s Alzheimer’s “rule-out” diagnostic Amyvid. The decision is the clearest demonstration yet that the agency really will refuse to pay for FDA approved drugs—if it sticks. The Centers for Medicare & Medicaid Services is proposing only very limited coverage for Lilly’s recently launched diagnostic agent Amyvid, concluding that the evidence does not support routine payment for use of the scan to rule out Alzheimer’s in patients with early signs of dementia. The proposed coverage decision, available here, limits payment for the scan solely to use in clinical trials that are intended to demonstrate the value of the test in some tangible measure of clinical utility – or to enrich a patient population for development of a potential therapeutic. (You can read more on the decision in The Pink Sheet DAILY, here.)

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