Clinical, Not Real-World, Data is Still The Key To On- And Off-Label Reimbursement (Part 2)
This article was originally published in The Pink Sheet Daily
While payers have ever-more sophisticated datasets for observing drug use in the clinic, such information generally is “inconclusive” for reimbursement decisions, a managed care executive cautions.
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Plans are acquiring the tools to monitor and assess the risk/benefit of drug use outside of the approved indication. Smart companies are working with payers to understand their concerns around off-label use and the data requirements in support of it.
Three major drug makers inked broad alliances with the research departments of major US payors in 2011. The alliances signal that even as pharma drug makers reorients its R&D engines to be more flexible and externally focused in the hopes of shedding risk and cost, such moves are not enough.
Third-party payers are looking for greater transparency in the processes that are used to generate compendia that list off-label uses of pharmaceuticals