Addressing Disparities in NSCLC With Timely Biomarker Testing and Navigation Tools

Dr. Estelamari Rodriguez, clinical research lead for thoracic oncology at the University of Miami Sylvester Cancer Center, explores how early biomarker testing, equitable access, artificial intelligence (AI)-driven data integration, and payer-provider collaboration can transform lung cancer care—bridging disparities and accelerating precision medicine in non-small cell lung cancer.

Estelamari Rodriguez, MD, MPH: I'm Dr Estelamari Rodriguez. I'm the clinical research lead of thoracic oncology at the University of Miami Sylvester Cancer Center.

I see patients with lung cancer in an academic institution. I'm also in charge of our clinical trials. I'm very interested in getting patients treatment as fast as they can and helping them on the treatment journey, which includes biomarker testing.

How can payers better support the implementation of comprehensive genomic profiling to ensure patients are matched with the most effective therapies?

Dr Rodriguez: Payers have a lot of power in terms of making sure that patients get treated appropriately and get testing results early. Because we know that—especially for lung cancer—we have 10 biomarker-driven treatments that work better than chemotherapy and immunotherapy, it's very critical that patients get matched to the proper treatment. Having standardized policies where drugs are approved for patients that have the proper information in a timely basis is something that payers can help develop so that patients can get uniform care.

I also think that payers can encourage early testing at the point of diagnosis. Currently, the system is very broken in the sense that patients have symptoms, it may take a long time for them to get a diagnosis of lung cancer, and there is a big gap between those symptoms, the diagnosis, and the results of biomarker testing in many institutions. Those biomarker results are only triggered after they meet an oncologist, and already a month or a month and a half has passed.

When the oncologist orders this test, the tissue has to be obtained and sent out to testing companies, and that can add another 3 to 4 weeks to get the proper information. So, you have almost a 2-month delay in getting information that could have been triggered at the point of diagnosis. There have been efforts in institutions that are trying to get pulmonologists to order the test and get this information as part of the workup for lung cancer.

Are there particular reimbursement models or value-based approaches you believe could accelerate adoption of precision medicine in NSCLC?

Dr Rodriguez: There are different parts to that question. There is a big educational gap in the community. We study who's not getting tested on time. There are some messages that come to mind. Patients who are underserved—either by insurance because they're underinsured or especially Medicaid patients who are in rural communities that have poor access to subspecialty care, not only oncologists, but also pulmonologists and interventional pulmonologists. There is a big gap in terms of access to care.

There is also a big gap in terms of education about how critical this information is. One of the things that payers can do is partner with big hospitals for patients who are being missed to make sure that we're meeting all those educational gaps—[possibly] by molecular tumor boards where you could provide assistance to smaller practices so that they can get information, deliver fast, understand what that information means, and make the connection between getting tested and getting the proper drugs. Education and supporting molecular tumor boards may be helpful in communities that are underserved.

Besides having standardized policies for coverage that require testing, there are also things that payers can do [such as] having reimbursement contracts that are determined by the right treatment for the patient so that if patients are getting the wrong treatment, they're not getting paid as much. The institutions that are doing the right thing for patients—getting them tested early and getting those results—are getting some kind of reimbursement that speaks to that proper testing in a timely basis.

So, I think risk-sharing agreements and bundle payments have been considered in different settings to get providers to do what they need to do, especially for those communities that are being missed. Besides education, there needs to be a lot of data sharing about where those who are missed are, and how we can reach that gap.

What are the most pressing equity issues currently impacting NSCLC diagnosis and treatment?

Dr Rodriguez: I alluded to some of this. There are big structural barriers for patients that delay their care. These barriers not only delay their care to have an earlier and potentially curable diagnosis, but also delay their care even when they have advanced disease—thatthey could potentially have a treatment that would extend their lives for years. They're not getting started on those treatments early enough.

The structural barriers are many, and insurance is an easy one. There are also transportation gaps and health literacy gaps. There are even patients and providers who are not aware of what needs to happen before starting treatment for some patients. We see that in communities with patient advocates who are very connected, we have patients who come to tertiary cancer centers, like our centers, who already have a lot of knowledge about biomarker testing. But if you have the same conversation in another community where there is not as much access to advocacy and information, there's a big gap. Patients are not coming into that conversation with physicians asking the right questions. Education and structural barriers are a big issue.

The other thing that delays biomarker testing in underserved populations is not having access to the testing companies and the biopsy. Who's going to do the biopsy? Who's going to do it fast?

We now have liquid biopsies, which has revolutionized the way that we get this information. We used to have to refer patients to get tested and get a CT-guided biopsy. Many patients who are really ill are not able to get the CT-guided biopsy. We had patients who were dying of lung cancer without ever getting this information because it was not feasible. Now, we have these liquid biopsies. They’re called liquid biopsies, but they are basically a test that is done in the blood by plasma, studying circulating DNA and studying the DNA.

We are able to identify many of the mutations of biomarkers that we're looking at through this blood test. Technology has allowed us to overcome some of the barriers of biopsies, but we still need to have providers order the right test for patients, get patients the information, and have access to all of these testing options.

What data or interventions have you found effective in reducing disparities in lung cancer outcomes?

Dr Rodriguez: One of the things that has been done in many aspects of cancer care that has also been done in the biomarker testing space is having a navigation program, the same way that we have patient navigators that guide patients from a diagnosis of cancer to a surgeon. That has been very successful in [lessening] these gaps in treatment, getting results, and getting patients to where they need to be seen fast. You can have a molecular-type navigator who works in expediting all of the steps, from procuring the tissue, to ordering the test, to following up on results.

Sometimes we have to do another biopsy, so the navigator can be there to advocate for patients to move this as quickly as possible. Sometimes when there's something in that process that gets dropped, the navigator can help get the process back online. Patient navigation and molecular navigation will be something that, if it can be adopted in communities that are being missed, would help reach a lot of the barriers.

Also, real-time data tracking tools that exist that have dashboards where patients who have a new diagnosis of cancer—either through electronic medical records or some kind of data sharing—could then have time points where you could tell providers, "Actually, you have a diagnosis and we are already at 14 days and you don't have biomarker testing." The algorithms can help providers do their own navigation that needs to happen to make sure that these results are followed and requested.

One of the things that we have seen that has also added delays is that every institution works with different companies that do the testing. Every testing company has a different way of sending the information back. Sometimes the delay is that the test results get lost, they're faxed to an office and they're nowhere to be found. Integrating test results when they return [is important]. It's one thing is to get the biopsy in order to write tests and follow the result, but make sure those results get to the chart.

Being able to integrate data, give alerts to physicians about patients that are being missed, and also develop these tools to follow what's happening to patients in real time will be very useful.

What do you see as the most productive areas of collaboration between payers and oncologists in the NSCLC space?

Dr Rodriguez: The shared decision-making platforms, where we can have transparency about the decision. One of the most frustrating things for providers, in many aspects of interacting with payers, is that sometimes there are delays in approvals. This has been something that has been recognized by big advocacy groups like the American Society for Clinical Oncology and the American Cancer Society.

Everybody is trying to recognize that patients get left behind when the system is very cumbersome. Prior authorization for test results and lifesaving drugs is a big problem. One of the things that providers are looking for is transparency about the process—about when we have the test results, when they make it to providers, and when we need prior authorization: What information is missing? How can we do this together and work together for patients?

At the end of the day, the patient always needs the treatment and delaying all of this, first of all, is not good for patients, but it also increases a lot of anxiety and burnout from the health care perspective because we have a whole office devoted to trying to track these results and get authorizations for patients. There are a lot of wasted resources in trying to get the system to work. Incorporating genomic results into the system so that payers have it in real time gets rid of some of those delays. Having some transparency about the process, the cost, and using evidence-based recommendations [is important].

We have many National Comprehensive Cancer Network (NCCN) Guidelines pathways. The American Society of Clinical Oncology also have pathways. There are white papers describing the process. There is already a standard for the appropriate use of tissue testing and delivery of results. Being able to incorporate all of that so that everybody knows where we are in terms of what providers need to get drugs approved, what providers need to get testing done, and what companies are the best companies based on this evidence [is important]. We need to have shared decisions and better understandings of what the providers need and the payers require, [leading to] more transparency and more use of these clinical pathways platforms.

There are many ways to follow data in real time. I would mention Flatiron, Guardant, and Informed, which are companies that have a lot of data of the tests that are being done and how the data are utilized. Why that matters is that we already know that for patients who don't get tested, not only does it impact their survival, it also impacts their opportunities to join clinical trials.

In our cancer center, we have a whole program of precision medicine that is geared to matching patients with rare mutations or resistant mutations to the proper drug. Being able to have this information for patients and sharing this opens opportunities for patients to join clinical trials. The patients that never get tested don't have this opportunity. We all should work together to fix that so that we can open more options for patients.

Are there real-world data or shared decision-making tools you believe could help bridge clinical and payer perspectives?

Dr Rodriguez: We're moving to an artificial intelligence (AI) world. We can use the power of big data and real-time data to make all of this easier for all of us. The easiest thing is for providers to open their chart in the electronic medical record and have the information just pop out and be incorporated into the decision tools in all parts of the country.

We can do this in rural and underserved communities if our records are integrated. There are ways to do that. Some of the testing companies are working with big vendors, like Epic, to integrate their results for the data to come back in real time.

There are also pathways—for example, clinical pathway platforms like NCCN—that can be integrated into electronic medical record so that providers know that this biomarker gets this test and this biomarker gets this drug option. That way, they have all of that to match what the payers have on their end in terms of evidence base and what is cost-effective for them.

Being able to integrate pathways that not only have the data but also the most cost-effective value-based medicine—that will be something that will improve care for everyone.