Clinical OMICS

MAY-JUN 2018

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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14 Clinical OMICs May/June 2018 www.clinicalomics.com attempt to make a rational choice to put these all together in ways that make sense." In addition, as much as MedSeq is looking to develop patient data, it also provides a glimpse of the realities of providing genomic information that doctors can use in the clinical setting. "One of the things that was interesting is our physicians were also study participants as they needed to complete in-person education sessions and online educational mod- ules in preparation to disclose information to their patients," said Christensen. "It was a natural experiment to what would happen if we incorporated genomics into everyday patient care rather than instances where you were trying to achieve a specific molecular diagnosis." The influence of MedSeq is far reaching. Not only have lessons learned from it been incorporated in the other pilots Green's group is running like MilSeq and BabySeq, but it has likely influenced other implementations over the past five years. "I believe this led the way in helping both academics and industry imagine how this could be done in a streamlined fashion," Green said. "Then by doing it—even in a small sample size—and showing that it can be done safely and with reasonable results, we've opened the door to so many things and other projects." The Value Proposition The cost of sequencing the patients in the MedSeq study came in at just north of $5,000 per patient. Proponents of incorporating WGS as a fundamental component of patients' primary care note that, while steep, it is a cost that theoretically will pay dividends over time, as the sequenc- ing data can be re-queried throughout patients' lives as their health changes. For this reason, public and private healthcare payers are keeping a keen eye on studies such as MedSeq, as they are increasingly faced with making decisions on whether or not to cover new genomic analytic tools. According to Joe Ferrara, president of healthcare consult- ing firm Boston Healthcare Associates, the data generated by MedSeq and other studies isn't simply about costs, but about the overall value sequencing might bring to the clin- ical setting. Green shares this view. "Cost isn't the problem. Value is the problem," he said. "Is the genomic information valu- able to an average individual over the length of their life? My hypothesis is it is. And as costs come down, it will be even more valuable." While there is little hard evidence of the kind insurers nor- mally look for when making coverage decisions, Ferrara's view is insurers now are more open to paying for it. "I think in the U.S. payers are taking a longer term view on that evi- dence," Ferrara said. "Historically you could argue that pay- ers would say we are going to look at a very narrow time window for some sort of ROI on new technologies. But with payer utilization and with key chronic conditions, it may take longer to realize the benefits of intervention, and sus- tained intervention, so they will need a longer time horizon." In the case of cardiac patients, like those in the MedSeq study, however, there may be an opportunity to develop some of the evidence payers have traditionally sought. "With cardiac patients, being able to identify their risk appropriately, if it leads to near-term more appropriate intervention or more intensive intervention, we should see that play out," Ferrara added. "It is not to say that payers aren't interested in paying more for better outcomes—they are. But they will still be looking, at some level, for what is the budget impact on the patient population for investment in these tests." For many other conditions however, developing the appropriate evidence could take decades and may even requires a leap of faith. "The problem is the value of genomics is amortized over an entire lifetime," said Green. "Pharmacogenomic variance only becomes valuable 10, 15, or 20 years from now when a patient needs that drug. If you are a newborn baby, carrier traits only become valuable when the baby is [old enough] to reproduce. Cancer predisposition variants can take five, 10, 15, or 30 years to come through, during which time you may be able to avert, or lower the risk of cancer through increased surveillance. "But it is very hard to demonstrate. You can demand clinical utility evidence until you are blue in the face, but the research that is available to us is research that tends not to look at benefits and costs over decades. That is our goal—to find creative experimental ways to demonstrate that value," Green concluded. (continued from previous page) "[Payers] will still be looking, at some level, for what is the budget impact on the patient population for investment in these tests." —Joe Ferrara, Boston Healthcare

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