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Avera Health Introduces PGx Testing for Pain Meds through Pilot Effort Eyeing Broader Implementation


Avera Health, a network of hospitals, clinics, and nursing homes serving South Dakota and surrounding regions, has launched a pilot project to use pharmacogenetic testing to personalize pain medications in orthopedic patients.

After researching the genetic underpinnings of drug response for several years, the Avera Institute for Human Genetics decided in mid-December to begin offering PGx testing for pain medications given the variable responses patients have to such drugs.

"Pain pharmacogenomics is a very big question across health systems, [and] pain scores are very important to patient satisfaction," Gareth Davies, scientific director of the Avera Institute for Human Genetics, told PGx Reporter recently. "So, we made our decision based on our research background and our patient needs to roll out pain pharmacogenetics in the orthopedic surgery setting."

In the US, where more than 30 million children and adults undergo surgery, as many as 50 percent report experiencing serious side effects and ongoing pain after taking opioids. Some of these pain medication-related side effects have a negative impact on the healthcare system, by extending patient hospital stays and adding treatment costs.

Avera chose to initiate the pilot PGx project for pain medications in orthopedic patients first because the standard care continuum in this setting provides opportunities for integrating genetic testing and education. Orthopedic patients see their doctors before a scheduled surgery, during which physicians can collect a blood sample for genetic testing, for example.

In the project, Avera researchers are using Affymetrix's Drug Metabolism and Transporter (DMET) Plus platform, which gauges 2,000 markers in more than 200 genes, to predict which pain drugs orthopedic patients are likely to respond well to. The pilot study began enrolling patients in December and will include a variety of orthopedic patients, from elderly patients needing hip replacements to high school students with sports injuries.

Davies and his colleagues at the genetics institute have garnered much experience working with the DMET Plus platform through various research efforts. Although Avera is planning to primarily use the DMET Plus in its PGx efforts, the genetics institute has also developed some tests in its own lab, Davies noted.

One of the advantages of deploying a PGx program in a healthcare system with its own genetics institute is that all the testing can be performed in-house. "That's where we really think we have a niche," Davies said. "None of these tests are sent out to a third party. They're done in house. That allows us to give that extra layer of personalized care."

In implementing PGx testing, Avera will also employ the help of its pharmacists. When a physician within the Avera system orders a PGx test, pharmacists will provide education to doctors and nurses and explain test results. Several years ago, pharmacy benefit manager Medco implemented a pharmacist-driven program in which researchers provided PGx testing to patients in the context of clinical trials and their test results were stored in the Medco system. Then, when a doctors prescribed a drug that might be impacted by a patient's genotype, the system alerted Medco pharmacists, who contacted the physician to encourage them to implement a PGx-guided treatment strategy.

Not all doctors factored PGx information into their treatment strategy even though this information was available, but Medco's studies often suggested that genetic testing was having a positive impact on patients' outcomes. For example, in the case of warfarin, Medco was able to show that with genetic testing information doctors followed patients more closely, which reduced hospitalizations by 30 percent. After being acquired by Express Scripts, however, Medco's PGx efforts have been scaled back, as Express Scripts has chosen to focus on using other strategies to reduce unnecessary drug utilization and improve outcomes.

According to Krista Bohlen, research pharmacist with the Avera Institute for Human Genetics, Avera's approach to PGx implementation is different than the PBM model. Avera's physicians will order the PGx tests that they want, and only then do the pharmacists get involved.

"We're providing physician and nursing education, but physicians are asking for the PGx information by writing the order. It's not done on the other end," Bohlen said. "It's coming from the physician and then the pharmacist is providing support. With their order, physicians will be recording why they feel the patient needs testing and documenting the changes once the testing comes back." Doctors will garner consent from patients and follow them long term to find out if PGx testing improved their outcomes.

Davies declined to provide a price for testing on the DMET Plus, but said Avera would offer it as an "affordable" price point to encourage reimbursement. Since launching the PGx program for pain medications, several private insurers and Medicare have paid for testing, he said.

Bohlen explained that Avera will bill once for testing a patient on the DMET Plus panel, but then provide interpretive services to physicians as they request information about specific markers. "We're exploring right now the best way to put this information into the [electronic] medical record," she added.

Avera is one of the largest healthcare systems in the Midwest, employing 14,000 providers and staff and clocking 2.5 million inpatient and outpatient visits annually across five states. Although Davies hopes that one day all the doctors in the Avera system will perform pharmacogenetic testing for their patients, he wants to drive adoption gradually.

Outside of the PGx program around pain drugs, Avera has a similar pilot for personalizing treatment with the anti-platelet drug clopidogrel in cardiac patients. Behavioral health is another area ripe for future PGx testing implementation, according to Davies.

Several years ago, officials from the South Dakota Developmental Center (SDDC) enlisted the help of Avera's genetics institute to investigate if PGx testing would improve the efficacy of treatments given to its patients with developmental and psychiatric disorders. Noting that several of SDDC's patients were utilizing more than $1,000 worth of medications each month, Avera researchers invited 46 of the patients using the most drugs to participate in a study where they were genotyped for various drug metabolizing polymorphisms and given treatment recommendations based on the test results.

Six months into the study, for patients who were on two or more antipsychotics, doctors accepted 90 percent of the PGx-guided recommendations. Davies recently gave a talk on pharmacogenomics to a group of psychiatrists working in the Avera system, and he felt that they showed "an overwhelming enthusiasm toward using pharmacogenomics information" in their practices. "Prior to this, some doctors have been a little skeptical [about PGx testing] for [clopidogrel] and warfarin, for example," he said. "But what we're seeing from our behavioral physicians is an overwhelming desire to get more information."

Avera has also launched a number of tumor-specific registries and biobanks to advance its research on personalizing cancer treatments and diagnoses.

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