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Off-Label Compendia Weaknesses Illustrated By Tarceva Evidence Gaps

 
• By Cathy Kelly

Compendia are often critical to reimbursement for oncology sponsors, but University of North Carolina researchers argue in JAMA the system needs to be revamped.

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Limitations in the evidence used by widely-consulted reference compendia to support off-label use of Roche/Astellas Pharma Inc.’s oncology drug Tarceva (erlotinib) demonstrate the weaknesses in the current system, researchers with the University of North Carolina Lineberger Comprehensive Cancer Center argue in an opinion piece published in the Journal of the American Medical Association Oct. 18.

The Medicare program and private payers have used third-party compendia to inform coverage decisions for off-label cancer drugs in the...

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