Brad Tice, PharmD, MBA – CEO of RxGenomix
As we celebrate ten years of RxGenomix, we are even more convinced than when we started that personalized prescribing needs to become a reality for everyone. The more we’ve worked toward improving medication use through pharmacogenomics, the more potential we see for it to fundamentally change healthcare. And the more we work with pharmacists, the more convinced we are that their expertise is absolutely vital. They are the ones who best understand the variations in individual response to medications, and they are the ones who will be essential to making truly personalized medicine a reality.
The saying “The days are long, but the years are short,” certainly rings true. As with many start-up stories, we have gone through many iterations of how to bring this solution to market. We have seen reimbursement start, stop, re-start, and change. We have seen the regulatory environment inhibit new science and solutions from getting adopted in healthcare, just as Clayton Christian references in his Harvard Business Review article “Will Disruptive Change Cure Healthcare?”
We have seen health care providers dismiss the value of new science they have not been trained on, with one even calling it “voodoo science.” Others have experienced these same barriers, and we have seen many others with similar visions come and go. Still, we see others in the market working to break through the same barriers and we know we are making progress, about to break through.
Why the optimism and what needs to happen for this vision to truly become a reality? When you see the real impact on people’s lives from made possible through truly personalized prescribing, it’s easy. Here are three examples:
Our challenge to ourselves lies in making the impact we know needs to happen. For ten years we have worked to make prescribing personal and we see the difference PGx can make first-hand. The personal testimonials and the mounting body of evidence around the costs of inappropriate medication use make us realize it is time we take the bold position that pharmacogenomics needs to be a standard of care. Not only can PGx correct inappropriate medication therapies in progress, but it can be invaluable as a preventative measure for longer-term therapies and more urgent needs.
Everyone should have a PGx test performed and should review the results with a pharmacist so they know how to apply them, either for now when they are taking medications, or to be prepared in the future when needing to consider using medications. The biggest problem to adoption of this science is simply awareness. Once people understand that this science exists and how it can help them, there is a high rate of adoption.
Let’s make the case for this bold position more specifically using just one genetic pathway as an example. CYP2D6 is a part of the cytochrome P-450 (CYP) pathway in the body that metabolizes medications. It is responsible for at least a part of the metabolism of up to 30% of medications. These are very common medications like antidepressants, pain medications, and cancer-treating medications just to name a few. Eight percent (8%) of the population will be in the Ultrarapid or Poor Metabolizer (UM or PM) categories of CYP2D6 and 29% of people will be in the “Intermediate Metabolizer” (IM) category, meaning they will still have some variation.
This means up to 37% of people will have suboptimal responses to 30% of medications on the market on just one pathway. Prescribing by trial and error isn’t necessary anymore. It simply isn’t good enough. Prescribing medications to people without this information risks failures, complications and additional medical costs that far exceed the cost of the test, the results of which can be useful for a lifetime across dozens of pathways and hundreds of medications.
It is no wonder that the estimated cost of suboptimal medication use is $528 billion per year in the United States alone. When you translate those dollars into the avoidable, negative consequences for people’s lives, it is easy to see why PGx testing needs to be the standard of care.
Beyond making PGx testing the standard of care, two other approaches must be institutionalized. One, the data from the test be able to be utilized on future medication considerations. Payers today, including Medicare, treat the results of these tests today like they are any other lab test that changes over time with the physiology of the body. This results in denials, inefficiencies, and waste. Since people’s DNA does not change, the results must be stored and established in systems so that they can follow the person as they age. This leads us to the second approach.
The results of pharmacogenomics tests must live with the person. This is the person’s DNA, not a payer’s, a lab’s, or any other company. Once a person has had their DNA tested, the results should be able to be owned by the person and enabled to be used for their benefit.
Fortunately, from examples like Uber and GrubHub, we can see that remarkable start-ups often spend their early lives in obscurity only to seemingly be thrust into the marketplace and become household names overnight. I can’t be more excited for the years ahead of us. The impact we make on people’s lives every day is truly rewarding. Our mission is to help everyone understand this so that they can experience the benefits of medication use without the burden and unintended consequences of adverse drug reactions and inefficient healthcare.
