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Biomarker Testing Can Direct Care, but Only If Clinicians Perform the Right Tests
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Biomarker Testing Can Direct Care, but Only If Clinicians Perform the Right Tests

Interview by Allison Inserro
Opportunities for precision medicine can be lost if clinicians do not perform biomarker testing, and payers may be part of the reason, according to Stuart Goldberg, MD, a hematologist/oncologist and chief of the Division of Outcomes and Value Research at the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey.
The promise of precision medicine calls for directing the right therapy to the right patient based on genomic profiling to identify mutations that will predict responses and guide the course of care. But these opportunities are lost if clinicians do not perform biomarker testing or if the testing is insufficient. 

How often does this happen? More often than cancer specialists may realize, and payers may be part of the reason, according to Stuart Goldberg, MD, a hematologist/oncologist and chief of the Division of Outcomes and Value Research at the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey.

Previously, Goldberg was involved with COTA Healthcare, a company conceived and built by cancer physicians who wanted to tap electronic health records for insights that would guide better care. As reported last year by Evidence-Based Oncology™ (EBO), COTA has assembled a database of records from both academic centers and community practices, representing the breadth of care offered in the United States.1

Goldberg and several coauthors used the COTA database for a study whose results showed that patients receiving cancer treatment are not being tested for all the relevant mutations in evidence-based guidelines. He recently spoke with EBO about the findings, which appeared in JCO Precision Oncology,published by the American Society of Clinical Oncology (ASCO).

The following has been edited slightly for clarity.

EBO: In your study, you note the promise of genomic profiling for mutations that can predict outcomes or response to treatment. But you found that biomarker testing rates are suboptimal. Can you briefly describe the results?

Goldberg: We’ve known for many years that biomarker testing for genomic mutations is an important part of treating colon cancer. This is an important part of the ASCO guidelines; they’ve been part of the [National Comprehensive Cancer Center] guidelines and the [College of American Pathologists] guidelines for many, many years. And we know that, for example, [patients with an EGFR mutation] may not respond to certain monoclonal antibodies. So for the main part, the testing makes the patient not eligible for certain therapies; we don’t, therefore, give them expensive treatments that aren’t going to work. 

We wanted to find out [whether] these biomarker tests [are being done] in the real-world community. So we went to the COTA database, which is a large database taken from the electronic health records of patients throughout the country.1 We looked at multiple states, in both academic centers as well as community [oncology] centers. We pulled the electronic health records for patients with newly diagnosed colon cancer, metastatic colon cancer, and we looked to see [whether] patients had the genomic testing that was done for the year in which [they received their diagnosis] because over the past decade, we’ve added new markers and new genomic [markers]. So we wanted to make sure that the patient in that year—whatever year they [received their diagnosis]—got all the [biomarker tests] recommended under the guidelines. One hypothesis was that…as doctors got more familiar with genomics, the rates would go up. What we found, however, when we looked at over a thousand patients, was that the rates did not go up, and a little bit went down. Yes, doctors were more familiar with genomics and were ordering the tests more often, but because more markers [and] more genomic mutations were now required, they weren’t keeping up and getting all the right testing. So only about 40% of patients were actually tested for all the genomics recommended for that particular year in this retrospective chart review.

EBO: What are some of the barriers to testing, and what are some of the possible solutions? In other words, what can be done to help educate these doctors about the newer tests now available?

Goldberg: In our study—we were doing a retrospective study—we were looking at the charts, so we really couldn’t say exactly why the tests weren’t being done. But we have some hypotheses from other work we’ve done in the past. Part of it is education. Physicians do know that genomics are part of this, and they were ordering tests, but new tests keep coming to them. For markers such as BRAF and HER2, which are some of the newer ones being added to the guidelines, physicians aren’t catching up. They’re ordering the older tests but maybe not catching the newer tests. So [continuing medical education], paying attention to what’s changing, and watching the guidelines are important for [physicians] to stay up-to-date on what needs to be done. 

The second piece is educating the insurance industry. The insurance industry wants to pay for as little as possible. And as you know, if you have to order individual tests and the insurance industry says, “Well, we only want to pay for tests A and B, but we’re not going to pay for these large panels,” well, they’re going to end up missing things. So we have to really explain to the insurance industry that payment for these tests in the long run is good for the patient and may be cost-effective. What we saw in our study is that if every single patient had undergone the testing, it probably would have been cost-effective. It actually would been cheaper because many of the patients who weren’t tested ended up getting the monoclonal antibodies that don’t work. So you’re paying for an expensive treatment that doesn’t work and giving the patient no benefit. In the long run, that money could have been used to get the right tests for everybody in the whole group. And it wasn’t that [expensive] because the tests are relatively inexpensive compared with the cost of the therapy.

We also need to work on coordinating care among the different physicians. Often the [gastroenterologist] does the biopsy. That biopsy goes to the pathologist; the hematologist-oncologist doesn’t have access to it. It’s done in a different hospital that can’t get the tests. Now we’re stuck with, “Oh, do we get a liquid biopsy, [or] do we try to track down the tissue?” So there’s a lot of coordination that needs to be worked out in not only colon cancer, we found, [but also] in lung cancer. Coordination of care is still fragmented in our society, especially when patients cross different specialties and different hospitals.

EBO: Does the process become even more complicated if a patient has more than 1 type of cancer that needs to be profiled?

Goldberg: Fortunately, many patients don’t have more than 1 cancer. But the more complex the disease is, the more complex everything becomes. It’s really not so much a question of different diagnoses, but crossing medical systems. [If patients are] treated in one hospital system and then go to another hospital system, getting that biopsy [and] getting the coordination of care often become very difficult. Because, as you know, our electronic health records don’t talk to each other, and our insurance [carriers] and our doctors don’t talk to one another. So coordination of care becomes a big issue in trying to do simple things like getting genomic profiling.

EBO: What are the implications for patient care if insufficient genotyping occurs? 

Goldberg: If we want to move to the world of precision medicine, which is where we want to be, [we need to give] the right therapy to the right patient, and I also argue in my other hat that we should be giving it at the right value. But if we want to give the right therapy to the right patient, we need to be able to know what that [patient’s] genomics are. So we really need to be thinking about getting all the genomics and explaining to the patients the importance of this, and trying to make sure we get all the right tests. And that’s another area where we are lacking, in explaining the importance of these tests to the patients.

EBO: You just mentioned your other hat that you wear in your work. Would you say that precision medicine is perhaps another form of value-based care? And can you describe the work that you’re doing now, as you’ve been in a new position for about a year?

Goldberg: At our hospital, I run our new Division of Outcomes and Value Research. We realized that as medicine moves to a value-based world, we really need to have somebody at our center who focuses on the outcomes, the value. [Over are] the days of doing old-fashioned chart reducing and once a year writing my [American Society of Hematology (ASH)] paper or writing my ASCO abstract and sending my residents or fellows or students [to the meetings]. That’s gone. We have electronic records, so we can mine the data in real time for all our patients and learn what we’re doing. And we hope that by doing that, we will actually see the better outcomes—see what things are working, what things aren’t working—and then start moving toward better outcomes, better value. 

This is important, not just for academics but also for our pocketbook. Our practices participate in the Oncology Care Model [OCM],3 and we’re going to get paid based on whether we are practicing value-based medicine. Are we being the most effective and most efficient in what we’re doing? So we felt at our center that we needed a physician who’s going to be looking at the outcomes, who’s going to be able to talk to the other physicians in our practice and say, “Hey, you’re doing this, but you know, this biosimilar might be cheaper and give you the same outcomes,” or, “Spend a little more money on a genomic test because in the long run, yes, it’s going to be cheaper for the patient.” 

We actually proved that at our center several years ago when we did a study on Oncotype DX.4 [It costs] several thousand dollars [to do each] Oncotype DX test. We would say, well, we’re going to add several thousand dollars to every single case of breast cancer. Well, it turns out that Oncotype DX often will move patients from getting expensive chemotherapy to getting less expensive and equally as effective hormonal therapy. So [by performing] the test on every single patient, we ended up moving a lot of patients from chemotherapy to hormones. The patients benefited, and in the long run, it was cheaper. Therefore, we were much more value based, and it helped our practice. 

Now, you could argue that in a patient who is 9 years old, you’re not going to [give] chemotherapy, so there’s no reason to do an Oncotype DX. Don’t spend on the genomics. Likewise, if you have a stage I early tumor, very small, you probably don’t need to do the Oncotype [DX test] because you’re not going to give that patient chemotherapy. But in stage II disease, which is what we found in our analysis, where the patient was in the middle, where the doctors—we actually looked at what our doctors were doing— were giving a lot of those patients chemotherapy, and the Oncotype DX test moved enough of them over that they saved money that it paid for the genomic testing.

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