The Pathway to a Successful Launch for a Novel Diagnostic
The good news is that there is a pathway! And that is good, because there hasn’t always been one. Now some people would say that the pathway still has unnecessary detours and is not the most efficient route. Of course that is true, however you can say that about healthcare in general so why should it be different for novel diagnostics?
The reality is that if we want to successfully launch a novel diagnostic test in the United States we have the necessary information to do so. We all are very aware of the challenges that we face when launching a new test. We have been trying to improve upon the coding limitations, with limited success. However, not having a code will not stop you from being successful. There are ongoing efforts in revising the way we value (price) these tests. For the vast majority of the time pricing of precision medicine diagnostic (PMDx) testing has not been the rate-limiting factor to success either. So what has been the limiting factor for adoption?
You can’t say its coverage or adoption by the majority of payers to accept your test because adoption or coverage is a result of something else – data. I know, I hate to admit it, but it always comes down to data. My problem is that data does not speak for itself, it must be interpreted and, depending on who is reviewing the data and their motives and intentions, entirely different conclusions can be made. So does this mean that the pathway has hit a dead end? I don’t think that is the case.
The reality is that the path for success has roundabouts – you know those intersections where you take turns entering and then begin jockeying for position so you can exit at your desired street. Many times it seems like we get stuck (remember the scene from “Vacation” where the family goes to England and is stuck in the round about for hours). Well the same thing is true in the world of novel diagnostic tests; since the data can’t speak for itself you have to speak for it. Passion isn’t the key, sometimes that just scares people off.
Complaining of the location of the roundabout doesn’t work either. I personally think we complain too much as an industry and don’t offer enough in the way of meaningful solutions. The solutions we do provide are often industry self-serving and minimize the concerns of the other stakeholders (there I used a consulting term) involved. So what helps your data get interpreted the way you want it to? First, speak the same language! Here are my analytical validity studies, here are my clinical validity studies and here are my clinical utility studies. This framework is a start to having a meaningful conversation. At least you are speaking the same language.
For my next piece I look forward to sharing my thoughts on clinical utility. But for now, thanks for visiting the website and we look forward to being a part of the solution.
The goal for Perry’s perspective is to give you a dose of reality. At Premier Source we are working side by side with our clients on a daily basis to ensure that when an ordering physician feels a test is medically necessary for the treatment of their patient that we make sure that patient gets the PMDx test. I hope you join me on this exciting and challenging adventure of commercializing precision medicine diagnostics
Post by Perry Dimas
Perry Dimas, Senior Vice President and General Manager of Premier Source, is one of the true trailblazers in the area of reimbursement support for novel, precision-medicine diagnostics (PMDx). He has been working in this field for well over a decade and has lived through countless changes and seen numerous players come and go. With this experience, Perry has developed a well-informed and unique perspective on the world of diagnostics as well as specific issues that have tremendous impact on their commercialization and on patient access. Perry is very keen to share his perspective on the latest industry trends, emerging technologies, coverage, regulatory policies, and universal challenges facing diagnostic providers.