NEW YORK (GenomeWeb) – Healthcare software company Epic Systems has agreed to integrate pharmacogenetic testing firm Genelex's clinical decision support tool into its electronic health records (EHRs).
In a deal announced today, healthcare systems and providers using Epic EHRs will be able to license Genelex's YouScript Precision Prescribing software, which analyzes patients' risk of a drug-related adverse event based on their prescriptions and genetic information and alerts their doctor. Epic EHRs contain more than half the medical records in the US. As more integrated healthcare systems launch PGx testing programs, the deal with Epic could provide Seattle-based Genelex a substantial revenue stream in addition to sales of its PGx test panel, list priced at around $900.
"The deal is a step forward for pharmacogenetics when a company like Epic recognizes that this tool is widely needed," Genelex CEO Kristine Ashcraft told GenomeWeb. "We need to know who will benefit from this intervention and we need to know what we will do with the information within the EHR."
Around the country, healthcare systems that have implemented PGx testing, such as St. Jude Children's Research Hospital and Mayo Clinic, have done so in a preemptive fashion, where ideally patients are tested before they need it. The test results are incorporated into the EHR, so when a doctor attempts to prescribe a risky drug that is variable according to a patient's genotype, a decision support system alerts the doctor and usually suggests an intervention, such as changing the dose or giving a different drug.
But developing such tools requires resources and involves some art, according to experts who have built such resources. "It does take a fair bit of work to embed all the knowledge you need to have guided pharmacogenomic clinical decision support," James Hoffman, chief patient safety officer at St. Jude, told GenomeWeb.
In a paper published two years ago in the Journal of the American Medical Informatics Association, Hoffman and his colleagues described how they developed the PGx clinical decision support tool at St. Jude on a Cerner EHR system. Researchers had to consider what to tell doctors before a PGx test was performed, what to tell them after results were available, and how many alerts were too many, resulting in doctors ignoring, instead of heeding, them. The information being provided to doctors has to be backed by the published literature, medical guidelines, and US Food and Drug Administration-approved labels, and communicated using standardized terms.
Without such support, time-strapped doctors would have to sift through the latest scientific knowhow and decide when they should genetically test patients. Even then, if the results aren't integrated into the EHR, PGx information that could have helped a patient avoid a drug-related adverse event, can be overlooked as he or she moves through the healthcare system seeing different doctors for various needs.
Since his group published St. Jude's experience, other healthcare systems at Vanderbilt University, the University of Florida, and elsewhere, have launched similar PGx testing programs utilizing EHRs and decision support tools, Hoffman noted, but not every organization has the willingness or expertise to build the resources from scratch. "For pharmacogenomics to advance as an important component of precision medicine and be broadly implanted, we need these kinds of resources to be developed, so not every organization has to customize everything," Hoffman said. "So, if there are tools being developed to embed [PGx information] into major electronic health records that sounds really exciting."
According to Ashcraft, Genelex currently has five large customers that use Epic EHRs and is in the process of signing on new customers that also use the system. The integration deal will allow providers offering PGx testing — from Genelex, another company, or developed internally — to license the YouScript analytics tool. Ashcraft explained that even when providers are using another lab's PGx tests, they could input the genotype and phenotypes in the back end and Genelex's tool would use that information to disseminate decision support for doctors.
Traditional decision support tools can inform doctors about potential drug/drug interactions or allergy-related reactions but don't factor genetic variation or the cumulative effect of all the drugs patients are taking. When such tools do factor in genetics, they tend to focus only on drug/gene pairs, based on which guidances pop up in the EHR. For example, if a patient happens to be a poor CYP2C19 metabolizer, and the doctor goes to prescribe Plavix (clopidogrel), an alert will suggest the doctor consider giving that patient something else.
Genelex's YouScript Precision Prescribing software goes beyond this, according to Ashcraft, to characterize "cumulative interactions" caused by drugs, herbals, over-the-counter medications, and genes for individual patients, as well as for populations of patients. The YouScript system includes information on 2,700 drugs and metabolites, according to Genelex, and the evidence underlying these analytics are based on 14,800 notes curated from the published literature and product labels. The software allows doctors to test out hypothetical prescribing scenarios and model their patients' potential risks for interactions and adverse events with certain drug combinations.
Published data suggest that more than half of all clinically significant drug reactions are attributable to genes involved in metabolizing certain drugs, as well as to interactions between multiple drugs, or to the involvement of multiple drugs and genes. Moreover, Genelex estimates that three out of four patients have genetic variations impacting their ability to respond to therapies. The FDA has updated the labels of around 100 drugs with information about genetic markers that influence people's ability to respond to them, and groups like the Clinical Pharmacogenetics Implementation Consortium have issued guidelines for using PGx test results to guide patient care.
The growing appreciation of PGx testing is expected to be big business one day. A Research and Markets survey last year forecasted that PGx will be one of the main growth drivers of the global genotyping market, expected to reach $17.0 billion by 2020 from $6.2 billion in 2015. The PGx testing portion of the market could grow at a compound annual growth rate of 23 percent in that period, according to the survey.
However, ongoing reimbursement challenges in the molecular diagnostics space could put the brakes on these optimistic projections. At Genelex, test orders were doubling annually each year since 2008, according to Ashcraft. Then, last year, the company saw its lab testing revenue slashed by as much as 70 percent after Medicare contractor Noridian issued a local coverage determination that covered only a handful of gene-drug indications, but not its entire PGx testing panel.
This didn't help Genelex convince private payors to cover its test, since they often follow Medicare's lead. So, Genelex stopped trying to sway payors and decided to sign agreements directly with large health systems that bear full financial risk for their patient populations.
Healthcare systems implementing PGx testing and incorporating results into EHRs are doing so in the face of payor reluctance. For example, Inova Health System in Virginia recently began offering PGx testing to newborns for free, recognizing it as a public health good that could yield benefits over a person's lifetime.
Studies have shown PGx testing to be particularly useful for the elderly, who take many medications at once and are at higher risk of experiencing adverse events from a drug-drug or a drug-drug-gene interaction. In one study, researchers from Genelex and the University of Utah showed that Medicare-eligible patients who received PGx testing had fewer hospitalizations and emergency room visits than patients in the control arm. This translated into estimated potential savings of $218 per patient for those who received PGx testing.
Ashcraft is hopeful that Epic's decision to integrate its decision support tool will help sway payors about the value of PGx testing. "It's an indicator of market adoption and market demand for pharmacogenetic information," she said.