THOUGHT PIECE PREVIEW: Pricing Without Consequence: Taunting a Sleeping Giant

The United States is considered to be one of the last bastions of pricing freedom for new, innovative therapies.  The realities of the US pricing and market access environment contradict this belief, both at the net-price levels and increasingly may hold true at the list-price level.  Recent events regarding SOVALDI’s price as a breakthrough therapy for use among HCV patients have raised the profile of pharmaceutical pricing once again.  This example is just the latest in a series of launches since the turn of the century that have gradually moved the US market closer to price regulation.  Key questions remain as to whether all of these products deserve the same degree of public outcry that appears to manifest with each clinical advancement.  For precisely these reasons, it seems ever more likely that the US healthcare system is a runaway train on a track for HTA.  Some important milestones remain, but, but once they occur, benefit evaluation and resulting price controls may not be as remote as many currently believe.  It is up to the innovative industry to work directly with payers and policy-makers to inform them of how irrational or unplanned cost-containment interventions can actually lead to poorer patient access, poorer outcomes, and the ultimate decline of life sciences innovation in the US.