Clinical OMICS

JAN-FEB 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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28 Clinical OMICs January/February 2018 www.clinicalomics.com types of therapy." Building the Case At St. Jude, the commitment to applying pharmacogenomics for drug prescribing is embedded in how care is delivered. According to Mary Relling, PharmD, chair of the pharma- ceutical department, the hospital embarked on its first phar- macogenetics study in 1986, which led in the early 1990s to the hospital routinely testing patients for the proper dosing of an anticancer drug. Over the ensuing 30 years, St. Jude has identified another nine genes that help inform the selec- tion and dosing of as many as 30 different drugs. "If a patient has a high-risk genetic test result, we utilize that with interruptive clinical decision support to modify our prescribing for the patient based on that test result," Relling said. "We use it the same way somebody might use a drug interaction alert or a renal function alert." While St. Jude is well ahead of the curve in applying phar- macogenomics to patient care, the fact that its three decades of research have yielded relatively few evidence-based gene-drug pairs for more accurate medication prescribing shows the field is still in its relative infancy. Surveys show that "a very small percentage of hospitals, and an even smaller percentage of all clinicians use pharmacogenetics tests routinely—in the single digits for sure," Relling said. In an effort to simultaneously discover more gene-drug combinations to add to its treatment regimen, and to help provide evidence for other healthcare systems on the effi- cacy of a comprehensive pharmacogenomics program, St. Jude is conducting an internal clinical study dubbed PG4KDS. As of November, the program had enrolled more than 4,000 St. Jude patients, with the broad goal of identi- fying which genes are important enough to be added to its list for testing. Integration of Preemptive Testing Like the PG4KDS program, the Mayo Clinic Center for Indi- vidualized Medicine's RIGHT Protocol (which stands for Right Drug, Right Dose, Right Time: Using Genomic Data to Individualize Treatment), is studying how pre-emptively embedding a patient's genetic information in the electronic medical record (EMR) affects doctors' prescribing practices ,and whether it improves long-term health outcomes. Implementing a pharmacogenomics program carries upfront costs related to the genetic testing and the work needed to integrate the data within the EMR or medication prescribing systems. Mayo's RIGHT Protocol seeks to find out if those investments eventually pay off. "This is a new enough area that no one really knows if you implement pharmacogenomics widely across the United States, will it be cost-effective?" Jennifer St. Sauver, Ph.D., an epidemiologist at Mayo involved with the study noted in a blog post. "Is it worth genotyping all of these patients?" Others, including Relling, are more bullish on the value of preemptive genotyping of patients, with the caveat that the information easily moves with the patient from care setting to care setting, and is embedded in the EMR. Bryan Dechairo, chief medical and scientific officer for Assurex Health, a precision medicine company leveraging pharmacogenomics via its GeneSight test, notes that allow- ing doctors to have the pharmacogenomics information at their fingertips can head off the diagnostic and treatment odyssey many patients experience. "What is happening with many patients is it takes two months for the physicians to figure out that a medication is not working," Dechairo said. "When the patient comes in, they want a change right then, and if you can't give the phy- sician tools to make that change right away, neither the patient nor the physician are going to be happy." And while the costs associated with preemptive genotyp- ing of patients may seem unnecessary to some, proponents note that it is an investment that only needs to be made once, but can pay dividends over the lifetime of a patient. "Pharmacogenetics testing results remain valuable and retain their value over the lifetime of the patient," noted Broeckel. "The turnaround time for the first comprehensive genotype and putting the data in the medical record is a few days or a week. If you think about the second use, the turnaround time is effectively zero, since the information is already there. "As healthcare organizations take the first step into pre- cision medicine, they recognize that pharmacogenetics is a place where they can have immediate impact on patient care and outcomes," Broeckel continued. "As the reimbursement goes more to outcomes-based reimbursement, I think phar- macogenetics can play an important role there as well." (continued from previous page) Mary Relling, St. Jude Children's Hospital

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