Transcript: Clinical Pathways in the Era of Precision Medicine at Tennessee Oncology

Winston Wong, PharmD: Welcome to the Journal of Clinical Pathways. My name is Winston Wong, editor-in-chief of the journal, and I will be moderating today's discussion. I am joined today by Dr Stephen Schleicher, Director of Value-Based Care at Tennessee Oncology and OneOncology, located in Nashville, Tennessee.

Welcome, Dr Schleicher. Can you please tell us a bit about yourself and your role as the director of value-based care at Tennessee Oncology?

Stephen Schleicher, MD, MBA: Hi, Winston and Journal of Clinical Pathways. Thank you so much for having me today. I really appreciate the opportunity to discuss this work. I'm Dr Stephen Schleicher, medical oncologist from Nashville, and honored to be back here, practicing actually in a clinic about 30 minutes outside of Nashville in rural Tennessee.

Currently spend time, half my time, in clinical practice, where I do see a lot of lung cancer, and then half of my time working on quality initiatives in value-based care implementation for both Tennessee Oncology and then the larger OneOncology.

Through my background, I attended business school, spent some time in consulting, and doing some policy work. Value-based care and how to handle the rising costs of drugs, and the complicated care that is cancer, and tie that to value, has been a passion of mine, so great to be here and discuss this.

Dr Wong: Great. Welcome, Dr Schleicher, and thank you for joining us today. Can you give us a brief background on Tennessee Oncology?

Dr Schleicher: Yeah. Tennessee Oncology is a physician-owned community oncology practice based out of Nashville, but we currently have 34 sites of care across Tennessee, and proud to say that most of those sites are in rural Tennessee.

The goal is really to bring accessible, comprehensive, cutting-edge care to the community where patients live, since not every patient can drive to the urban area. We have a partnership both with OneOncology at a national level, which gives us access to a lot of resources to help us deliver care.

Also, locally with Sarah Cannon for our research arm, so we can offer a plethora of clinical trials to the community as well. Really pride ourselves on being able to do that. OneOncology, which we are a part of as well, is a larger group of about 600 oncology providers practicing across about 200 clinics, also with the same mission of comprehensive, cutting-edge care close to home.

That's the larger scope of how deliver care in the community.

Dr Wong: Given today's topic, I'm assuming you do have a clinical program in place?

Dr Schleicher: We do. We have a clinical pathways program in place that varies across the practices for OneOncology, but at Tennessee Oncology, we've used the same program now for several years. As we move into value-based care, and many of the OneOncology groups are in oncology care model.

Tennessee is, and we'll soon have about 60% of our patients in some form of value-based care arrangement, so clinical pathways is a part of lots of those programs, and we're happy to get to use pathways here.

Dr Wong: What led the practice to implement a clinical pathway program?

Dr Schleicher: I think a few things. One, if you just think big, cancer care is getting complex. If you're focused on lung cancer, it's one thing to keep up with everything. If you're in a rural clinic, where there's one or two of you, you have to see everything that walks in your door.

Pathways is a lever to make sure that providers are able… it's a tool to provide the right cancer treatment to the right patient at the right time. From a quality standpoint, that's most important.

In addition, as payers are looking for ways to understand why certain drugs are given, since drugs have high price tags, even if they're very effective, pathways are a way to show that, for this specific patient and cancer phenotype, we are giving the right drugs.

It's a tool to help providers do that and to show quantitatively to payers that that is what's being done. I think, too, we saw both of those things happening and decided we need a pathway program to be prepared for the future and help accomplish those goals in the meantime.

Dr Wong: Do you utilize a vendor to help maintain your pathways, or is it internally maintained?

Dr Schleicher: Great question. We use a third-party vendor right now. OneOncology larger is working on a partnership to internalize a lot of that, largely with the goal, one, so that we can make sure that everybody's aligned and our internal disease thought experts are aligned with what the treatments are.

Two, also, to hopefully incorporate pathways into the point of care through the EHR, so as you're ordering a regimen, incorporating the staging information, the pathway helps guide you to the right treatment. Right now, with the third-party vendors, a lot of that's done externally.

While it's still useful, less than ideal, even if I think the quality of the pathways is great. Less than ideal when it's external, just because it's not truly at the point of care.

Dr Wong: Great. You recently published an article, "Time to Rethink the Role of Clinical Pathways in an Era of Precision Medicine: A Lung Cancer Case Study,” in ASCO's JCO Oncology Practice.

In the article, it seemed to me that, although you were suggesting that the original intent of clinical pathways to promote consistent evidence-based care has not changed, you're suggesting perhaps that we need to shift our focus of a successful program away from cost savings, as noted in earlier programs, to something broader in this era of precision medicine.

Can you explain your thought process?

Dr Schleicher: Yeah, so to go back to a little bit of historical perspective—well, not that historical—but a few studies over the last, call it, 10 to 15 years really when the treatment, and I use lung cancer as an example, because lung cancer has changed so much with immunotherapy went from second-line to first-line. Now, actually, in the consolidative setting for stage three cancer, even now. Some data at ASCO, showed immunotherapy has benefit even in the neoadjuvant-adjuvant setting.

As immunotherapy's moved up, as we've developed or found molecular targets, EGFR, ALK, ROS1, BRAF, KRAS just presented with survival benefit at ASCO this week, the treatment paradigm has just changed so much in lung cancer, so it's a good example.

Lung cancer, we also highlight, because there's several studies from a decade ago, before all these targeted therapies, immunotherapies were happening, showing that pathways could save a significant amount of money on the treatment of lung cancer.

I don't mean treatment just in terms of hospitalizations, ED visits, imaging, but really with the therapeutics. I think no one's really questioned, is the time we're in now the same as it was when those pathways showed huge savings?

The point of this was really to show that, back then, a lot of the treatment options for first-line, stage four lung cancer, especially adenocarcinoma, were platinum doublets. A lot of the doublets varied by price significantly depending on what doublet you use.

If a pathway could guide you to a preferred doublet when there's no survival difference, one's way less expensive, pathways are going to save a lot of money, which it did show then, and that was great. I think, back then, that was a real...

One, it both showed pathways could do that, but it also, I think, made payers and policymakers think that there was all this optionality for a specific patient and cancer type, and providers could just choose the cheap drug, if they wanted, or the less expensive drug, if they wanted, with no effect on quality.

We're just in a different world now. We wanted to take a look at what's a realistic expectation of pathways and provider choice on anticancer agents or therapeutics right now, versus back then, to rethink what is the real role of pathways?

Also, as important, as we're creating value-based arrangements, what the real expectations we can have on providers to be able to choose inexpensive but high-quality drugs, when those just might not be options now, as we've had immunotherapy and targeted therapy move up?

I think that was the impetus behind doing this study, and non-small cell lung cancer was chosen, because it's complicated, and pathways are really beneficial to get you to the right treatment. Also, that right treatment's often expensive, because it's usually new agents, such as immunotherapy or targeted therapies.

Dr Wong: Yeah, I completely understand your thought process in many respects. I am glad that I am not back in my payer days today, because at least I can get some sleep at night now.

In essence, we are in an era where biomarkers are driving the treatment decisions, which results in targeted therapies being used, and these targeted therapies are definitely at a higher cost. We are stuck, if we're only looking for cost savings, I totally agree with you.

Dr Schleicher: To add to this, and again, it goes back to this accountability versus control. I think payers think a large piece of the drug costs or the immunotherapy costs are really in the providers' control. I think this case study shows that's not the case.

We can control the utilization, but if the utilization is appropriate, and the drugs are just high cost, we can't control that. I have NCCN pulled up on my other screen here, Winston, and for a very common cancer type, which this paper used as an example, non-small cell lung cancer that is PD-L1 less than 50%, no targetable mutations, the preferred agent is carbo/Alimta/pemetrexed.

Which we use as an example here, and that is the right regimen to use at that point in time. That's a very common one, but it has a high price tag. The only days of being able to use carbo/taxol alone just is not high-quality care anymore, even if it's inexpensive.

Dr Wong: Maybe you're suggesting as well that the utility for clinical pathways these days goes a little beyond truly trying to find a low-cost option. It's really to find the higher-quality, high-outcome option.

Dr Schleicher: Exactly, and when high-quality, high-outcome options, when there's multiple for a specific patient in front of you and cancer phenotype, based off molecular studies, histology, etc, if there are multiple options, and one's less expensive than the other, then 100% support that less-expensive option.

There are a few cases when that can happen. I just think the assumption is that there's many cases where that happens, and in the lung cancer example and many other examples, that's just not the case. You get the one really high-quality, high-outcome option, but there's not another option that's less expensive.

Pathway is important to get you to that option, but payers need to understand that option's probably expensive, so they can't expect a pathway program or a VBC program—sorry, value-based care program—to reign in those costs, because it's the right thing to do at that time.

Dr Wong: Obviously, with your specialty being really lung cancer, I'll have you step out of your box now and say, and ask you, are there other cancer types where this can also be applicable to?

Dr Schleicher: Yeah, I think 100%, and breast cancer's a common example. People will say, "Breast cancer, there's so many treatments, there's got to be a low-cost alternative." Sometimes, there are, but if you look at HER2-positive metastatic breast cancer, which is...

We are fortunate that there are so many new treatments. In San Antonio a year back, we had Enhertu and tucatinib come out. There's so many great treatments, and pathways are important to get people to the right treatment, but it's still algorithmic.

There's a good first line, usually with HP. There's a good second line, with T-DM1. Sometimes, you can use the tucatinib treatment, especially if there's brain mets. Then there's third line with Enhertu or the tucatinib-based treatment, and all of those are high-cost.

They're really good. They're high-quality. They are high-value drugs, because they are high-quality, but their cost is expensive. Pathways can make sure they're using the right drug at the right time, but there's not an inexpensive drug along that pathway.

I think the same thing applies to breast. You see a ton of treatments, but it doesn't mean there's a ton of inexpensive treatments that you can use. Same with if you look at the triple-negative breast cancer data, and you have metastatic triple-negative breast cancer.

If you're PD-L1-positive, you're going to use immunotherapy. That's inexpensive. The atezolizumab was the only beneficial with Abraxane. That's expensive. A pathway can drive you there, which is the right thing to do, but it's going to be an expensive treatment.

Similarly, pathways are important for high quality. Can't be expected to lower costs, with certain exceptions, of course, but not to the level that I think prior data suggested when we didn't have Keytruda part of so many of these pathways, and other targeted therapies, etc.

Dr Wong: The examples you mentioned are solid tumors. I'm assuming it's also applicable to hematologic tumors as well?

Dr Schleicher: Yeah, 100%. Caveat, or disclaimer, I'm far from a malignant hematology expert, but you look at multiple myeloma, and there are so many amazing treatments now, but most of these have come out in the last few years.

They're also going to have a high price tag. It's important. Pathways are more important than ever, because it's really hard for someone to keep up with that. To make sure the patient is getting the appropriate treatment for them along their course of disease is the most important thing, and pathways have a great role in doing that.

Again, most of those treatments are going to be expensive, so it's not a fair expectation or a realistic expectation that those costs are going to be lowered, but it's an appropriate, very important expectation that high-quality care is delivered, which is the goal of all this.

Dr Wong: Great. I'm assuming that, since you're the Director of Value-Based Care at Tennessee Oncology, Tennessee Oncology participates in value-based arrangements with payers. Have you had these types of discussions with the payers when you're trying to go and develop the performance metrics with them?

Dr Schleicher: Yeah, we have, but I think it's challenging. That's why this piece is important. Providers for a long time now have said the cost is due to the price and the utilization, and we can't be on the hook for the price. We would love to be on the hook for utilization, because it's aligned with our mission.

We've been preaching this for a while, but I think we need data to show that. This, even though it's a theoretical case study, this type of data's important to show payers, who often don't have a practicing oncologist on board, why this is complicated.

I will say, it's tough, and I understand from the payer side, you can't ignore the cost of drugs. That is a big piece of oncology care. For value-based care to work, we've got to reign in those costs of drugs. My hope is to show them that let's take the drugs that are on-pathway.

If we can agree that the pathway is the right care for that patient at that time, and the high-quality care, if a patient is on-pathway, or a treatment is on-pathway, my goal would be to get those costs out of the equation, because there's no way to change that.

Utilization, we've done correctly. Let's get the costs out and then focus on other drug costs, where we can actually influence utilization. Lots of supportive meds, biosimilars, which we published, we had an oral at ASCO Quality last year that we had converted almost all of our patients to biosimilars.

We want to put our money where our mouth is, do that, and be on the hook for that, or other supportive agents. There are drugs where there is utilization opportunity that we think models should encourage, because it's the right thing to do.

Then there are treatments where there's no utilization opportunity from a cost standpoint. There is from a quality standpoint, and we want pathways to help, one, guide us to that high-quality treatment, but also show payers we are doing that.

If that's been done, we'd love to take that out of the cost equation that the carbo/Alimta/Keytruda treatment doesn't dilute the success of keeping a patient out of the emergency room. We're trying to do that.

It's an ongoing discussion to understand the challenges that payers have, but trying to educate them as well on what it's like to actually be a provider, what's in my control, and what's not.

Dr Wong: Great, and I love that response from you as well.

What parting thoughts would you like to leave with our listeners as they're thinking about clinical pathways, how to talk to payers about performance metrics? As you said, payers are so focused on cost savings. How would you recommend or coach our listeners to embark on that discussion to get payers away from, or not as focused, on cost savings?

Dr Schleicher: I'd say a few things. One, if you're not using pathways yet, really consider doing it, because I think the way of the future. I think there's ways for pathways to be beneficial for the provider as well, as cancer care gets complex.

I also think payers are going to demand some evidence that utilization is accurate. Now is the time to invest in pathways, if you haven't done so yet. That's number one. Number two, as much as that we can, as a group, show payers that we are using the right drugs, and not just choosing drugs because they're expensive...

Which I know is not the case, but because of some of this old data, I think there is an inherent thought from a lot of the non-oncology community that's happening. As we can really double down and take on risks for utilization, and show that, "Hey, we are using the right drugs. We have to use them, because it's the right thing to do, but they're expensive."

Pathways are a way to show that. As much as we can, as a group, really show that that's what's happening, and let payers, or reassure payers that we are practicing with evidence-based care, and we are driving towards appropriate utilization all of the time, I think that's important.

Hopefully, we can teach payers that, if that's happening, then the cost of those drugs should not be within our control, so we can focus on the other things that we all want to do, like double down on keeping patients out of the emergency room, improving end-of-life care, etc.

We need to use pathways, one, to improve the quality of care we deliver, but two, to show payers that we are using the right drugs. Until all of us do that, collect that information, and educate payers, I think we're going to be in the same challenge we're in now.

I am hopeful, because I know it is the right thing and correct, that we can teach payers over time how to really think about cancer care and therapeutics correctly.

Dr Wong: Thank you, Dr Schleicher, for a very interesting discussion. In one respect, we are seeing improved clinical outcomes with better tolerability in this era of personalized medicine growth. However, while we're seeing improved clinical outcomes, we are also seeing increases in cost of oncology care. We all know that.

While the intent of the clinical pathway remains to promote consistent evidence-based care, we must also shift our metrics of success to not be so focused on cost savings, as I'm sure you agree. As always, thanks to the Journal of Clinical Pathways for the opportunity to have this discussion.

Finally, thanks to the audience for taking the time to listen in on this discussion. For the latest updates on issues related to the development, implementation, and evaluation of clinical pathways, please check out our website at www.journalofclinicalpathways.com. Good day.

Dr Schleicher: And thank you all very much.