Preparing For Off-Label Drug Use In The Real World (Part 1 Of 2)
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
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.
Mesenchymal cell specialist Mesoblast came back from a near-death experience in 2016 when Teva returned a key asset. But recent success in a Phase III trial in acute GVHD has brought it some attention. Now it needs to repeat the achievement in advanced heart failure and find a partner for its burgeoning pipeline.