NEW YORK (GenomeWeb) – The Chicago-area's NorthShore University HealthSystem has already been an enthusiastic proponent of precision, or personalized medicine for a number of years, but is now kicking its efforts into a new gear with the launch of new training programs for primary care physicians, and a more concerted effort to move pharmacogenomic testing and other genetic analyses into routine consideration at annual well visits.
One change that the organization has implemented recently is a direct-access program for pharmacogenomics testing. Instead of having to go to NorthShore's PGx clinic, patients can now use a take-home sample kit, or potentially give a sample in their primary care doctor's office.
NorthShore began an in-house PGx program in mid-2016, implementing decision support tools within its electronic medical records system to help doctors incorporate the results into patient care.
At that point, the organization reported that its PGx clinic had only seen about 218 patients over the prior year, many of whom came to the clinic on their own, having learned about national precision medicine efforts in the popular press.
"As we pushed forward with the Center for Personalized Medicine being created … our institution realized that as we push this type of incorporation out past a niche population of specialists into primary care, we need to have not only more organized implementation but also better ways to educate and get the right information to the clinician at the right time," said Peter Hulick, Director of NorthShore's Center for Personalized Medicine.
To look at how PGx testing might be expanded, the center began an initial pilot program for a new direct-access PGx offering, in which a patient could produce a sample at home with results returned to them and to their doctor through the system's EMR platform. NorthShore calls the model MedClueRx.
Researchers evaluated early experiences with this model in a study published this August in Future Medicine. Amongst the findings from this survey of 15 providers, researchers reported that giving doctors an opportunity to have their own PGx test helped them understand the value of the approach, and how results might be implemented.
The study also reported that while providers believed there were benefits to PGx testing, including avoiding side effects, titrating doses more quickly, and improving shared decision-making, they also recognized areas of concern and future need, such as addressing cost, insurance coverage, and the complexity of test results.
The organization has now incorporated the lessons learned into a larger system-wide rollout in which MedClueRx is offered to all patients at annual primary care visits.
Modifications have been made in response to concerns raised in the survey, including a revision of the report itself, and the provision of different types of support to doctors in counseling patients on their results. Amy Lemke, the study's first author, said that she and her colleagues are also working on a similar study of patients who have gone through the PGx test to identify other areas that could be improved.
NorthShore is also now using the findings from MedClueRx as it moves forward with a new program aimed at giving primary care doctors an easy way of identifying patients who could benefit from other types of genetic testing.
This is something the health system calls a Genetic and Wellness Assessment. It is essentially a voluntary questionnaire, offered as part of the signing-in process at annual well visits, which evaluates family history and other risk factors that might signal a need for, or a value in offering patients some sort of genetic test.
Hulick said that the questionnaire involves five initial yes-or-no questions that pertain to a family history of things like cancer, cardiac diseases, neurological problems, and diabetes.
"Depending on the answer there is then a branching logic, and if there is [utility in a genetic test] a best practice alert may be triggered for the primary care doctor," he added.
If nothing is indicated by the questionnaire, patients are also offered something called the Healthy Gene Panel, Hulick said, which interrogates a list of genes that NorthShore says are related to inherited conditions that, if detected early, "have effective medical interventions and preventive measures" associated with them.
According to Hulick, the idea behind the genetics and wellness assessment is that it is a framework that can be employed across the NorthShore system, consistently, to determine who might benefit from genetic testing.
"It's hard to keep clinicians up to date on what they should recommend … and when this should be considered," he said. "This way clinicians don't have to be content experts, but they are reassured that they can identify patients that might benefit."
So far, over 22,000 patients have completed the assessment since NorthShore initiated it about six months ago, Hulick said. As a result, over 700 clinical consults have been recommended, and over 400 testing orders have been placed.
Researchers from the program intend to share more details about the early implementation of the GWA in a presentation at the annual meeting of the American College of Medical Genetics and Genomics in Charlotte, NC.
Interestingly, NorthShore is also involved in research efforts to advance a SNP-based method for measuring individuals' genetic risk for developing cancer, to see if the test can identify those who would have been missed by traditional family history-based screening.
According to Hulick, that research question is still open, so there is no plan in place now to try to incorporate a genetic risk score into standard annual visits as is being done with the family history-based GWA.
Adoption and growth of NorthShore's two existing programs — MedClueRx, and the GWA, may also not happen in close parallel, Hulick said, because the reimbursement landscape for PGx and for genetic risk testing is so different.
With the GWA, the goal is to identify patients eligible for tests based on their family history or other clinical risk factors. In these cases, the endorsement of professional guidelines is strong, and reimbursement is relatively widespread.
For PGx the picture is different, although Hulick said that dropping costs may increase the number of patients who choose to pursue testing regardless. Currently the out-of-pocket cost at NorthShore is $450. Since NorthShore serves a relatively affluent population, Hulick added that the institution is also hoping that it will able to test enough patients and collect enough data to be able to help tip the balance in terms of clinical utility evidence to persuade payors and broaden access further.