Ultimately, the Patient, Not the Payor, is the Customer

Implications: "He who pays the fiddler calls the tune."  Here's an example of the fiddler pro-actively asking the guy in the room with the deepest pocket what he'd like to hear.  If it's not something in the current repertoire, the fiddler seems willing to learn.  However, by the time he's got the new song by heart the guy with the deep pocket may have moved on to another venue.  Will the new tune please the crowd that remains?

Analysis: In today's regulatory environment it certainly makes sense for industry to speak early and often with government about the pathway to approval for a new drug or device.  It also makes sense for industry to communicate clearly with scientists and doctors about unmet needs.  However, seeking the opinion of payors about their therapeutic priorities is a risky proposition.

Ultimately, the value of an innovative therapy will be determined by its success in treating disease.  That success remains uncertain until the clinical investigation is complete and the first patients -- and their physicians -- can tell us how they're doing.  Bringing the third party -- government and commercial insurers -- into the game before the opening bell is putting the cart before the horse.  Good luck pulling it into the station.