This is an excerpt from a 2,700-word article in the January 30 issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: One essential element of precision medicine — the wave of the future in healthcare —will be the regular use of pharmacogenomic testing to provide additional guidance to physicians when selecting the most appropriate therapeutics and optimal dose for each individual patient. Even as THE DARK REPORT reports on another laboratory hit with a massive recoupment demand for such tests, one health system is finding a way to make it work to the advantage of physicians, hospitals and patients, while gathering data that could help persuade payers of PGX’s value.
PHARMACOGENOMIC TESTING is one of laboratory medicine’s new frontiers. Physicians and pathologists know that patients metabolize medications at different rates. Pharmacogenomic testing is also expected to play an integral part in personalized and precision medicine.
Yet today, few health systems gather this information on every patient, due partly to the cost of genotyping and partly because research into the clinical value of this information is ongoing.
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As most clinical laboratory scientists know, currently few health insurers pay for such testing. In 2015, the federal Centers for Medicare and Medicaid Services stopped paying, saying such assays were screening tests. Despite these concerns, Avera Health, a health system in Sioux Falls, S.D., has put itself at the forefront of personalized medicine.
The health system’s largest hospital, 545-bed Avera McKennan Hospital and University Health Center in Sioux Falls, performs pharmacogenomic testing on all surgery inpatients. The tests determine how well these patients metabolize pain medications.
In addition to inpatient surgical-pain patient testing, AIHG also performs pharmacogenomic testing for psychotropic, anti-platelet, statins, and other medications. AIHG staff work with Avera McKennan providers and the pharmacy department to gather information that proves to be useful for about half of the patients tested, especially when evaluating the drug-drug-gene interactions.
“Avera Health seeks to determine the economic value of pharmacogenomic testing to a health system,” stated Krista Bohlen, PharmD, the Director of Personalized Pharmaceutical Medicine at the Avera Institute for Human Genetics. A research pharmacist on the genetics research team, Bohlen said Avera is collecting data on the cost effectiveness of the program and is planning to publish those results in a peer-reviewed journal this year.
Avera’s interest in pharmacogenomics testing began in 2006. “Since then, we have regularly pursued genetics research opportunities by genotyping human subjects involved in registries and other projects,” explained Bohlen. “Then, in 2009 and 2010, we added a study for pharmacogenomic testing for psychotropic medications for behavioral health patients.
“We started a research protocol for testing CYP2C19 for the antiplatelet agent clopidogrel in 2011,” she said. “Next, in 2013, the AHIG lab earned its CLIA certification and we started performing clinical pharmacogenomic testing for pain patients.
“Our administration recognized the potential of pharmacogenomic testing to improve patient care and to reduce costs through quicker treatment success and fewer adverse effects,” Bohlen added.
Early work on pharmacogenomic testing was funded by Avera Health, through a desire to promote research and recognition that someday, such testing would be reimbursed. “We pursued research to show the value to treating physicians, along with patients and researchers,” Bohlen said.
Selecting right Medication
“Pharmacogenomics is a tool that helps clinicians to narrow their choices for medications from as many as 20 or more down to maybe eight to 12 medications,” Bohlen said. “Such testing allows physicians to target the right medication for each patient while doing their best to avoid adverse effects.
“Once our laboratory reports the test results, then physicians follow the dosing guidelines published by the Clinical Pharmacogenetics Implementation Consortium (CPIC) and Pharmacogenetics Working Group of the Royal Dutch Association for the Advancement of Pharmacy,” she said. “In addition to these guidelines, we also evaluate primary literature.”
A key hurdle is logistics. “Any pharmacogenomic testing program like this needs a rapid turnaround of results from the lab,” Lauterbach explained. “For example, if the specimen is collected by 8 a.m., our lab would want to deliver the results by that afternoon or—in some cases—within 24 hours so the results are available to the physician at the point of care.
“To do this, our lab does the genotyping and then enters the result into the EMR so that the physician knows the recommendation for which medications may be best metabolized,” she explained. “Having this information in the EMR means physicians can take this action without having to go outside of their normal workflow.”
Bohlen continued, “This allows the doctor to get the patient on the right medication that same day. We want the patient to be stabilized and make sure the medication is effective for pain before the patient is discharged, especially in our efforts to prevent readmission,” she said.
“In addition, we had an EMR system that wasn’t initially designed to handle pharmacogenomic results,” noted Bohlen.
a reimbursement Challenge
Fair reimbursement is another hurdle to overcome. “The theory behind this program is that there are benefits to doing preemptive pharmacogenomic testing, but a big barrier to such testing is getting health insurance companies to pay for these tests,” observed Bohlen. “For that to happen, we need more data on patient outcomes and further data to confirm that testing helps prevent adverse drug events.
“Second, we need to demonstrate to payers that clinicians used these tests to put patients on the recommended medications,” she added. “With such data, health plans may be more willing to pay for these tests.”