How Cone Health Uses Clinical Pathways to Deliver Optimal Patient Care

In this interview, Andre Harvin, PharmD, chief pharmacy officer and vice president of Pharmacy Services at Cone Health, breaks down how their cancer center develops and utilizes clinical pathways and discusses how their team stays up to date on implementing treatment guidelines in practice.

Transcript:

My name is Andre Harvin, I’m the Chief Pharmacy Officer and Vice President of Pharmacy Services at Cone Health, located in Greensboro, North Carolina.

How are clinical pathways developed and used at your cancer center?

Dr Harvin: We actually have a strategic collaboration with Elsevier's product Clinical Path. We've actually been on clinical pathways for almost 8 years at this point time. So we were one of the early adopters. That we saw the benefits of really guideline directed therapy. I know we talk about it as clinical pathways. Now that the name is kind of Clinical Path. I always want to make sure I come back and  say that this is really guideline-directed therapy that leverages best practices and the totality of evidence that's available from clinical control trials.

So here at Cone Health we very much leverage those as much as possible. So we have it integrated within our electronic medical record (EMR). We ensure that all of our oncologists are up to speed with how to ensure that they are leveraging the interface between the Elsevier ClinPath product and our EMR, which is Epic. So when our oncologists are actually working with an Epic, they can see parts of ClinPath as they're staging that patient, so they are able to stage them directly in Epic that flows into ClinPath. That information then starts displayed to them, hey, here are the different lines of therapy that are recommended for the patient, based on some of that very clear, discrete evidence that's available. Obviously, our oncologists have the opportunity to go outside of that directed therapy. But if they do, we have certain things set up to ensure that there are questions around that. So we have things like tumor board. Their adherence to pathways as part of how they're reimbursed from a quality perspective as well, and we encourage our oncologists and our pharmacists as well to provide feedback.

So if there are new pathways that are developed and there is some discrepancy in the data or disagreement with where things should lay, we're actually able to provide that feedback directly to Elsevier and their group to take into account. It doesn't necessarily mean that things change, but at least we understand that our voices being heard. And again, our expectation isn't that every single therapy is right on the clinical pathways. There certainly sometimes where a patient, for whatever reason, specifically, it doesn't make sense for them to go on guideline-directed therapy. Or there's potentially new information that hasn't been updated from an NCCN perspective that it makes sense for us to maybe try new things in therapy for that patient. So we have opportunities for flexibility. But by and large we see ourselves as we wanna follow the NCCN guideline recommendations, and our clinical path partnership allows us to ensure that that's available to providers right as they're working within the electronic medical record every single day.

What are the advantages to implementing pathways at an oncology practice?

Dr Harvin: I think there's a lot of advantages. One of the first things is I remember attending a meeting a few years ago, and I believe it was an ASCO meeting, and they said, if you look at all the information that's coming out within cancer research, you're looking at a doubling of information everywhere from every 70 to 90 days. So things are developing so rapidly with how we approach cancer care practice here in the US.

When you you're asking an oncologist to remember all of that, all the new clinical trials, all the new studies, all the new drugs, the different mutations. What tests did you put the patient on? What labs? When should you give them? When do you need to do imaging it? It’s a lot, right. It's so much to ask for one individual, no matter how accomplished or intelligent they are to remember all these different buckets of information and keep pace with the continuous development that's occurring in all these disparate spaces in order to treat that patient in front of them. Like, what is the best therapy for this patient in front of me how they're presenting to me today. And in my mind that's really where clinical pathways occurs. It's a pathway. Doesn't mean you have to walk exactly, you know, right on that pathway. You can walk on the grass a little bit, but you're making sure you're at least going in the right direction for that patient. So for me, it really kinda simplifies and helps distill all that information down to again, I've got this patient in front of me that is presenting with this specific disease state, what is the best next step for that patient?

At least, let's put the patient on the right direction, and if we have to make modifications, if we have to make some changes based on feedback from the patient based on new data, we have that ability. But at least we're again going in the right direction we’re on the right pathway. And it really helps us, I think, keep one another accountable as well. So because we can monitor things like compliance. How often are we treating patients off a pathway completely different? Is it because that pathway doesn't exist? Well, then, we're not gonna say that that's an issue, or for some reason that oncologists isn't doing the right thing. But if there are pathways and for whatever reason, you know, an oncologist is treating outside those pathways, we get to ask some of those questions. And sometimes it's well, hey are you keeping up with the newest data, or are you still doing, hey this is what I've been doing for years, and it's worked well. There may be new medications. There may be new testing that needs to be done for that patient that maybe you get the same outcome, but the pathway to that outcome is more advantageous for the patient. So there's a lot of things that I think clinical pathways allow us to do with like, I said, bringing all that information together, helping one another states, you know. Stay accountable, you know, allowing us, I say, from pharmacy, to know where we can intervene, or we can help, or we can provide additional education. When we're all in the same pathways, it really helps us focus on that and for a lot of patients this care looks very similar. And then we can really focus our, you know, collective might or collective intelligence on those patients that for whatever reason they fall outside of that pathway. You know, those are the ones that we wanna put more thought a little bit more time and attention to, because we wanna get them to that same clinical outcome that maybe the other majority of patients are able to enjoy.

Within the pathway for patients with CLL, for example, is there one pathway for CLL, or do you further stratify patients from there?

Dr Harvin: Well, you know, CLL has had a lot of developments as of recent. So we've seen a lot of updates, I think there's still a lot of questions. So this, this is one of those areas where we expect that we're still gonna see some of our oncologists maybe not necessarily take what would be considered like a first-line therapy. But maybe jump to something like a second-line therapy. So there's still a lot of questions out there. Probably one of the biggest is like, so what's the optimal approach for a patient? Did we put them on monotherapy? Should we immediately start patients on a combination therapy? If we're gonna do that, is it two drugs or three drugs. And you've got things like the BTK Inhibitors, you've, got the BCL-2-antagonists, the anti-CD20. There's a lot of different options out there for patients, which is great because rewind the clock some years ago and CLL patients didn't have a lot of options. But now that they have them, and when you look at the evidence available, the challenges is we're not really going head-to-head with some of these new therapies. We're going head-to-head with what previously was. Maybe baseline or standard therapy or gold, you know, gold standard. Now we've got these new medications out or applying some of these new medications to CLL therapy, and that's where the question starts to come in.

And I think it's a great problem to have. Because again, now, you're seeing more effective therapy for these patients that didn't necessarily have it. The question is, what is that combination or single therapy that's best for them.

So for us, we expect that we're gonna see a lot of patients or a lot of oncologists choose different options. And we're not going to, you know, necessarily chastise them for that, because, again, right now the evidence isn't necessarily comparing those different combinations of therapy. So we don't really have a lot that we can look at. What we have to question is, how does the patient fit into that? What is the best for that patient? Are there certain side effects that the patient really wants to avoid that they have certain toxicities that we saw with earlier treatment options. What occurred to get that patient there now, as we're assessing what's the right pathway for them? And then what are their goals? What's important to that patient may also help us determine what's the right approach for them. Based on how much time they want to allot to it,  what their actual goals are for therapy. So again, I think it's an area where more research is required. But the fantastic thing is that we've got a lot of research coming out. I expect that we'll get more clarity over the next couple of years. I think you'll see some additional studies that come out in abstracts that try to tackle exactly what we talked about before. Is it monotherapy or is it combination therapy? What are some of those parameters we have to think about for patients that are going through this disease state. And how do you stratify between those options to say, hey, this is the best for my patient.

Would you like to see more research in head-to-head comparisons of new therapies?

Dr Harvin: Absolutely. I would say, regardless of what aspect or what specific disease we’re talking about in oncology that's been one of the biggest challenges out there is that a lot of times when the drugs are being FDA approved, they're going to essentially compare themselves to what has been a standard of practice.

And as a lot of these drugs are being co-developed on the same timeline, then we don't really have that opportunity for them to do head-to-head comparisons, as we think about the these new, you know, novel approaches to therapy. And so, to a degree sometimes that becomes a detriment. But overall, it's a positive, because you are getting again new class of drugs that can be utilized and disease states that we didn't necessarily know were gonna be effective or not. So it's fantastic for patients because now they have more clinical options. It's difficult for providers and those care teams to say, what is the best approach? When given the opportunity, what is the best cocktail for this patient to get them to the most desired outcome?

So I think we'll see that over time. And we can see it sometimes. There's sometimes meta analysis that will say, well, hey, if you just compare the patients that were used to bring one drug A to the market vs drug B, then can you compare that data. That's that kind of real-world evidence that I think is sometimes difficult to integrate into practice. A lot of times we wanna see a true randomized clinical trial that puts these drugs head-to-head. And the reality is that we're likely not gonna see that for a number of years, if ever, for some of these disease states. And so we've gotta make some of those leaps of faith to say, hey, what is the best option?

What we'll likely see in the next couple of years is just more for long term data for these different drugs and how they're affecting patients 3 years, 5 years, 8 years down the line. That's essentially what we're looking for. That’s a challenge I think we all have and it's a great thing. That's how we all come together as well. That's why it's a care team. Obviously, we follow the lead of our oncologists, but we have that ability to really come to the table as pharmacists, as different APPs, as nurses, to really bring our collective wisdom together and help make the right decisions for patients.

Can you talk a little bit about recent updates in the CLL treatment landscape?

Dr Harvin: So when I think about new approaches to CLL, or I would say maybe more updated approaches to CLL, there's a lot of things that as a clinician you would want to consider. So first, what's the stage of the disease? That's one of the big things we have to think about. How is that patient presenting? What have they tried before? And then what's the overall kind of fitness of that patient. Can they take multiple aspects of therapy? Does monotherapy make more sense to them? And then we really haven't talked about it, but you have to get into like, what are some of the genetic risks for that leukemia? So have we done all of our appropriate testing? What is that testing telling us in terms of what’s the right therapy for that patient? When you bring all that together, then I think the picture starts to become a little bit more clear. But again, this is where I'd say, it's a phenomenal time for us all to come together to leverage pharmacists, to leverage other practitioners within the care team to say, let's really talk about this. Let's get bring our genetics team to the table. What is the right direction for treatment for this patient? To me it's exciting. It's an exciting time for numerous disease states, but especially CLL, that's seen some really great updates. And again, we expect that as more evidence as more trials come to pass, that we're gonna be able to further hone in on some of those decision-making aspects.

What process do you use for integrating guideline updates or changes in standard of care into an existing pathway?

Dr Harvin: So we have a governance team that we work on here. It was somewhat newly founded. As we we really assessed that we had this long-term partnership with Elsevier, and we had this great product. But as it related to just making sure we were timely with updates, there's still a lot of work that has to go on to do that. So we're not able just to say very quickly, hey, NCCN updated, Elsevier’s got this update, it's automatically available within our EHR. I think those that have clinical pathways, regardless of what vendors you use, will attest that there's still a lot of work that has to be done in the back end. There's maybe build considerations that need to be done. There's sometimes clinical decision considerations that have to be managed as well, because sometimes we make decisions years ago, and it's how we approach practice. And now the evidence is either to the contrary of it, or just no longer supports some decisions we made. So there's a lot of education that has to go on.

But what we have here is a governance group that when they are assessing new updates that are coming out, and they're pretty much coming out monthly at this point in time, they're essentially reading through that. And they're asking the question of, how does this change our approach to practice here at Cone Health? And what changes are gonna need to occur within our electronic medical record to help ensure that we now align with that new guideline-directed therapy and that can take time. The hope is that we're able to keep up. And every single month when updates are available we're able to accept those updates, but what we found is that we had to go back and do a lot of rebuild. We had to really think about approach to practice. What maybe treatment plans or therapy plans our providers were using. If there were pockets of providers that maybe didn't necessarily agree with some of the updates, how would we approach that? How would we bring them in line? Was there an opportunity for education? Was there an opportunity for learnings all around? And I think we've come across all of those and have walked away with other opportunities to get better as an organization and as a practice, and we’re really proud of the growth that we have seen. But by and large, that that governance group is really the nexus of our ability to ensure that we stay up to date. It has representatives from our medical oncologist, our clinical pharmacy team, our nursing team, and our advanced practice providers, in addition to our informatics team; they come together, they review it. They essentially make recommendations for rebuilds or additions. They make sure that it's ready for prime time, and then we go ahead and push that out to our EHR, which we are then able to let our oncology team and pharmacy team and APP team know it’s available for utilization.

How do you balance optimizing care for individual patients and standardizing treatment decisions across the patient population?

Dr Harvin: I think that's always gonna be the difficult part of it. So again, we really lean heavily on our pathways. But it is not something that we won't allow oncologists to think outside of that. We want our oncologist to really say what is the best direction for the patient in front of me.

You know, patients are more than numbers. They're more than just clinical data. Sometimes it's in that conversation that we pick up on, or we identify things that the patient lets us know is important to them and may actually change the course of therapy. And of course, that's a conversation that we expect our oncologists and our APPs to have directly with that patient and we have to talk to them about the risk and reward of those differences and decisions, and we have to respect that as well. So our goal is to really provide as much information, to provide is that you know the best recommendations we absolutely can, but at the same time, provide that flexibility for the humanistic element of treating cancer care. And sometimes that's difficult because people don't necessarily connect to that very easily. Why would I not do something that's perfect? Well, maybe what's important to you is not important to the next person. And so we have to respect those things as well. But really our goal is that having the guidelines available really allows our oncologists again to focus on the person. And so, they're gonna have all that information in front of them that's saying, hey, this is the best way to go.

If they have a reason to go outside of that, then really, all we ask is that they do something like present that as part of our team or boards, or provide some documentation if we were to need to go back and review clinical decisions as they may come up. It really just helps protect everybody. That's part of the process. But again, our hope is that oncologists are making the best decision based on the shared goals that they discuss with that patient.

What are some other challenges that you face in optimizing decision-making in your practice?

Dr Harvin: The biggest challenges that we're always going to come back on is really providers really being able to keep pace with everything, and to also show that autonomy and their practice. You know, our providers are fantastic. They're incredibly intelligent. They're very dedicated individuals. I've touched on before that just the amount of data and information that are coming out from some of these disease states are so difficult to keep up with. And so, you know, one of our biggest challenges is to make sure that we find ways to help them get that time to stay prepared. That we, as a pharmacy as a clinical pharmacy team, are always able to come together and collaborate with our oncologists to make sure, that they've got the most up to date information, that they're aware of any new pharmaceuticals oral oncology products that are coming to the market with some of the benefits and risk are for it, and really help them in that decision-making.

Again, I think that pathways are fantastic because it really helps, I would say, even the playing field for practices that aren't able to specialize as much. Where our oncologists have to serve as more of a generalist. So they may see a CLL patient and then a breast cancer patient right after that, and we expect that they're going to provide a consistent level of clinical practice to those patients. So clinical pathways really helps direct that information directly to them, and allows them to pull any of the new clinical trials, to read up on new guidelines. That way that they stay informed that they're confident in their decision-making. And again, we as the clinical pharmacy team, are a part of that. So we're part of that clinical service arm. We're right there with our oncologists and our patients to make sure that everyone's informed and that we're making the very best decisions. I'd say what we're really proud of is that we're showing it with our evidence that yes, we leverage clinical trials, and we're seeing it in our outcomes. I mean that's a really strong thing that we're exceptionally proud of. So we know we're doing the right thing for our patients when they come in dealing with cancer. It's a really tough disease to deal with, but we're right there with them in the fight.