No other recent medical advancement has the potential to change the way medical care is delivered as much as personalized medicine. The convergence of growth in genomic data, coupled with the power of big data means big changes for physicians and health systems.
Vanderbilt Health System in Nashville, Tenn., is on the bleeding-edge when it comes to helping physicians use genomic information in treatment decisions. While several leading health systems have developed institutes of personalized medicine to perform genomic testing and use the information to advise treatment plans, Vanderbilt has gone one step further and deployed evidence-based clinical decision support and alerts into its electronic medical record, integrating findings around genomic markers and drug efficacy into physicians' daily work flow.
C. Wright Pinson, MD, CEO of Vanderbilt Health System, speaking about Vanderbilt's Pharmacogenomic Resources for Enhanced Decisions in Care and Treatment (PREDICT) initiative at the Hospital of Tomorrow leadership forum in Washington, D.C., last week, said the health system estimates it will eliminate 400 adverse drug reactions over the next five years because of the program.
"The need for pharmacogenetic testing is great," said Dr. Pinson. Approximately 5 percent of hospital admissions are due to adverse drug events, so the potential for improved outcomes and cost savings is big. Currently, more than 200 drugs have "black box" labels that warn against prescribing the drug to patients with certain genetic markers, and the FDA has mandated pharmacogenomic information on labels for 14 different drugs, according to Dr. Pinson.
What is PREDICT?
Vanderbilt currently focuses its PREDICT initiative to reduce adverse drug reactions for five drugs that have been linked to adverse reactions for patients with certain genetic markers. PREDICT combs data from patients' EMRs to identify patients whose risk factors suggest they will be prescribed one of five medications within the next three years. When a patient is identified, his or her record is flagged, and the physician is prompted during the patient’s next visit to offer the patient genetic testing, which helps ensure genetic information is available to the physician when later prescribing the medications. Vanderbilt has even secured commercial insurance coverage of genetic testing for patients who are meet its testing criteria. While the test is costly (generally a few thousand dollars), it reduces overall costs of treatment by ensuring patients are prescribed the most effective drugs for them, without relying on trial and error.
Vanderbilt is also home to BioVU, the health system’s DNA databank, which has collected roughly 175,000 samples since 2007. The "translational engine," according to Dr. Pinson, includes de-identified genetic data that is link to de-identified electronic medical records, which allows the system to develop genotype-guided treatment recommendations. These recommendations are shared with healthcare providers as well as with the drug makers.
From preventing adverse drug reactions, to treating cancer and beyond
Yet when most people think about personalized medicine, they generally don’t think about preventing adverse drug reactions. Instead, they think of big, scary and deadly diseases like cancer, and how personalized medicine is helping to treat them. Drug makers are actively developing cancer treatments targeting certain genes and many are already on the market, and it’s these drugs that have received the most media attention.
The life-saving potential of targeted drugs is great, but these drugs also prove costly. A recent article in MIT Technology Review examined how these new drugs are priced. A treatment for cystic fibrosis, Kalydeco, runs $294,000 per year. Yet, payers have approved covering the drug because it is highly effective for treating the symptoms of CF for the patients who have a certain genetic marker the drug targets. Only 4 percent of CF patients, about 3,000, are positive for the genetic mutation, so the pool of patients the drug can treat is incredibly small. Thus, one of the many reasons the drug is so costly is because there is only a small group of paying patients to recoup R&D costs.
Genetic information: From Labs to Physicians' Fingertips
While the use of genetic information to determine the course of treatment for a majority of illnesses seems far off, "it's coming a lot faster than you think it is," said Howard. J. Jacob, PhD, director of the Human and Molecular Genetics Center at the Medical College of Wisconsin. But, he believes in most cases physicians aren't aware of how they might use genetics to aid diagnosis and treatment. "We are not giving our physician partners enough information…that’s relevant to that individual patient," he said.
During the panel presentation, Dr. Jacob demonstrated an iPad app he downloaded for just 99 cents that allows him to view his DNA profile. While the current number of patients who have access to their full DNA profile is relatively low, this will change. One day a patient will show up to see a physician with the app and ask for guidance. How will that patient view the physician and his or her institution if the physician has no idea what to do with it?
Dr. Jacob is bullish about personalized medicine and believes health systems need to explore offering these services before they lose out to competitors.
"The driver in this is not going to be us. The driver in this is going to be the consumer," he said. Patients will eventually demand this information, and if you don't offer it, they'll go to someone who will. Even without reimbursement approval from payers, patients are proving they will spend their own money for this information, and this will only increase as the cost of genetic testing comes down.
"If you think that this is a long way away, I'm going to tell you it's an iPad away," he said.
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