Putting all your “weight” into regulatory approval can be a costly mistake. In our 20+ years of experience, we’ve seen many market access pathways come toppling down by companies relying on regulatory approval to get to market and disregarding reimbursement pathways and/or value propositions. What’s to be learned from these companies?
Make early health economics a priority!
Three essential legs – FDA approval, reimbursement, and value (established through health economics) – must work together to support market access, and health economics can provide a significant segue into each.