Changes in biopharmaceutical R&D strategies and Technological innovations in clinical research are challenging payers on evaluating novel therapeutics and their involvement in the R&D process. While at the 2015 New York BIO annual convention, I had the opportunity to interview Nathan Tinker, Executive Director at the New York Biotechnology Association about how these changes are impacting payers.
Changes in biopharmaceutical R&D strategies and Technological innovations in clinical research are challenging payers on evaluating novel therapeutics and their involvement in the R&D process. While at the 2015 New York BIO annual convention, I had the opportunity to interview Nathan Tinker, Executive Director at the New York Biotechnology Association about how these changes are impacting payers.
How are payers coping with advances in R&D therapeutic strategies (i.e., from blockbuster models to targeted therapies)?
Payers are getting engaged and involved much earlier in the R&D process for a variety of reasons. One, it eases their road in terms of understanding what therapies are available, how those therapies are going to affect longer term care, and what impact those therapies are going to have on targeted patient populations. Second, as we get more and more personalized medicines coming into the market place, payers are now faced with understanding how to cover and respond to a patient by patient situation; therapies that follow a targeted approach rather than a blockbuster model. I think that’s a scary proposition, and it goes at some of the basic tenets of how the payer consortium works; for example, payers are very conservative about understanding earlier and more deeply what therapies are available, how they are going to hit the market place, and who the buyers (patients, consumers) are going to be.
With the introduction of Obamacare, there is talk about the payer model changing, where a single payer system may become the norm in the US. How are private payers poised to deal with this change?
The challenge of course is that there is a continual push towards a single payer system. It is likely at some point, sooner than later, there will be a single payer system because the traditional model is untenable; personalized medicines, changing demographics of patient populations, having to slice and dice those consumers to narrower and narrower segments and trying to treat them more individually is a big challenge for private payers. Combine that challenge with an increased interest in patient knowledge about their own health, and the rise of healthcare apps that help to organize and coordinate that information will force payers to respond in innovative ways; payers are going to have to be as innovative as R&D companies.
How are mobile health (mHealth) devices and technology applications changing the way we conduct clinical research?
Medidata is already trying to transcend that line between an app, a therapeutic, and a mHealth tracking module, and they’re the first company to have an FDA supported clinical trial of a health app/device from a clinical standpoint. Measuring how many steps a patient takes or vitals a patient takes with their FitBits doesn’t accomplish much in research; what Medidata is trying to do is to take mHealth into a clinical space, where we actually have clinical information induced that is relevant, focused and individualized for a particular patient. How that is going to translate into a therapeutic or opportunities for therapeutics, I’m not quite sure yet, but, that’s where the industry is headed.
The next big leap with healthcare technology is going to be electronic health records that your own body is creating, and obviously, going to back to the earlier conversation about payers, do you want the payer to have that information, is that going to change the way that they respond to your particular medical product?
How will technological applications in clinical research influence payer coverage decisions?
Payers are going to have to be more innovative about the way they approach the business, and that is certainly a primary point, where they end around the system. The metaphor might be that third world countries are able to advance their communications and energy distribution systems faster than the US because they don’t have legacy systems to undo in the process; you go directly to a nationalized cell phone system as opposed to slowly transitioning over from landlines; it’s the same sort of challenge when it comes to payers using technology to circumvent the more traditional systems. I think we see a rise of new smaller consortia and payer groups. We’re still going to have the large private payers for a while, however, there are lots of smaller organizations, such as individual hospital groups, that are becoming more engaged and active in the area.