Episode 6: Rapid Scientific Advancements in Value-Based Arrangements: Why Are Pathways Important?

On episode 6 of Oncology Innovations, host Gordon Kuntz sits down with Aimee Ginsburg, PharmD, McKesson Value Pathways, to discuss the value of clinical pathways in a world of rapidly advancing scientific data, and how decision support tools can help ensure providers use the latest and greatest treatments in their practices. 

Catch up with more episodes of Oncology Innovations.

Transcript:

Gordon Kuntz: Welcome to Oncology Innovations, the Journal of Clinical Pathways podcast, focusing on candid discussions with innovators aiming to advance quality and value through the cancer care ecosystem. I'm your host, Gordon Kuntz. I'm a consultant with almost 20 years’ experience on oncology clinical pathways in the business of oncology. I've worked with oncology practices, pharma, payers, GPOs, and pathway developers. Basically every aspect of the oncology ecosystem. I'm very excited about today's podcast because I'm joined by Aimee Ginsburg, who's a PharmD with McKesson Value Pathways. I've had the pleasure of getting to know Aimee over the last couple years. She leads the clinical Content and Value Pathways program for McKesson. So Aimee, let's jump right. In a world where scientific data is constantly advancing, why do we need to follow pathways?

Aimee Ginsburg: That's a really good question, and I think the answer lies in the fact that there's no longer data that is held for major meetings. So data is coming out constantly in our world, which makes it increasingly difficult for generalists to keep up with published data, FDA approvals, expansion of indications, and NCCN guideline updates if there is no pathway to help guide them to the most appropriate therapy for their patient.

Gordon Kuntz: Excellent. So what do pathways have to offer in a discipline where practice-changing data is released constantly? As you said, they're constantly being released. We have ASCO coming up here in a couple of weeks. I'm sure there'll be big releases around that, but that big event that used to happen really isn't controlling all that anymore. So tell me a little bit more about sort of how you see pathways reflecting that on an ongoing basis.

Aimee Ginsburg: I think that the fact that the world is constantly changing, there needs to be something that is consistent, that is expected and it happens the same and every disease is treated the same way. So I think that pathways offer the standardization of being able to assess the same patients, the same way, every single time. With keeping in compliance with evidence-based medicine. So as the medicine changes, pathways offer this standardization to be able to treat all patients appropriately and identically.

Gordon Kuntz: So with that pace of change, one of the challenges I know from a pathways organization standpoint is... From your standpoint, keeping up with that, right? Doctors have to keep up with it, but they're receiving the information from you with those decisions. There's a lengthy process that all pathways organizations go through, thank goodness, to ensure quality and to make sure that the recommendations reflect the best thinking that's available. How do you and your organization keep up with that flow? Especially around things like new genetic testing information, which is constantly evolving at a very rapid pace.

Aimee Ginsburg: Definitely. It takes a village. And so we have a team of PharmDs that work with us to be able to keep a pulse on the data. So we are always following data that comes out of major meetings or published data at any random point in time. FDA approvals, those expansion of indications as I mentioned, and also NCCN guidelines. So we have a very close relationship with NCCN where we're following and keeping up with the changes that they are planning to make or are discussing at the same time.

And so our goal is to have the most appropriate care at the appropriate time. So as new treatments come out, as new genetic testing opportunities arise, we want our pathways and our decision support tool to reflect that so providers can be treating with the latest and greatest treatments at any given moment.

Gordon Kuntz: In looking at those genetic testing... Guidelines that are influenced by genetic testing. Probably a better way to put that. Do you all consider just those tests that are considered standard of care? And the reason I bring this up is, on the testing side itself, the evolution is so fast it really seems to outpace almost their ability to describe it, much less the ability for our practice to integrate that.

Aimee Ginsburg: Sure.

Gordon Kuntz: And I guess the question I have is, the boundaries that we had established 20 years ago for what was considered appropriate to put on pathways were really around standard of care. But with that evolution and the trajectory being sort of near vertical integration, on the integration scale... Or on the innovation scale, excuse me. How do you incorporate these tests that maybe have a very small sample size and a very short track record, but clearly are pointing a direction that clinicians are interested in going?

Aimee Ginsburg: That's a great question and it seems like every new treatment comes with its own new biomarker and its own new test that is associated with that. And so what we do is rely on FDA approvals to see if the study that got the FDA approval did require a test. If the FDA did also require a positive test or a mutation, for example. And how the information was entered into NCCN. And so to us, there are occasionally studies that have some sort of testing that does not make it into the approval or into NCCN. And we default to whatever those governing bodies have opted to include in their tools. So whatever their recommendations were is how we implement them as well.

Gordon Kuntz: Excellent, thank you so much. So let's pivot just a little bit and talk about value-based care, which I used to say was always five years away, but it's definitely here now. And I think most practices are in multiple value-based arrangements, certainly those in the McKesson family. How do pathways help participants in those programs to be successful within a value-based care arrangement?

Aimee Ginsburg: That's an interesting question. I think that at the core pathways are based on value. Hence the name Value Pathways powered by NCCN. But the fact that we are reviewing not only the efficacy and toxicity of these regimens as they are coming to the pathways committee, but the cost is also factored in. I think that we have trained, if we're allowed to say trained, for providers, the providers to think about treatments in terms of overall value.

And so providers that are used to following pathways and answering the questions and using the decision support to help guide that treatment will not be surprised by the options that are at the end of the algorithm. So when they actually have the treatment decisions, those are the best value regimens. Now, if that also overlaps, let's say with a payer pathway or some value-based care arrangement they're in, it's more of a double win. But I think that the fact that the providers have gone through this process and are accustomed to following and answering the various questions about their patients' clinical and disease treatment characteristics leads them to success in value-based care arrangements.

Gordon Kuntz: Thank you. So one of the questions or one of the aspects I should say of value is obviously cost. And you mentioned that. At what point in your evaluation does cost come into play? So at one point ASCO had value blocks where they were trying to create a balanced scorecard, if you will, between efficacy, safety and cost. And essentially create a value score that really wasn't... The uptake on that was not what they'd expected, I don't think. How do you all deal with that? Because certainly cost and whether it's contracted cost or ASP cost or whatever, how do those kind of factor into your decisions, especially in a world where providers have to be conscious of the cost, especially in a value-based arrangement?

Aimee Ginsburg: So cost is an upfront consideration for us, but only after the efficacy and toxicity have been discussed. And so our first conversation is about, here's what the study showed. Here was the efficacy over standard of care, over the other treatment arm. Here's what the toxicities were. And then cost is an upfront discussion for us, at this cost.

And we talk about it in terms of a monthly cost in the metastatic setting. If there is a total cost we can calculate for a treatment course. That is also discussed as well. And cost is also discussed in terms of other treatment options in this space, how does this cost compare? Is it more than, is it similar to, is it equivalent? And we look at cost for our purposes in terms of cost to the patient and cost to the payer. So you mentioned perhaps there's discounts or rebates or certain pricing for different practices or organizations. That's not a factor to us because that does not impact the total cost of care. And so we're always looking at cost as the whole to try and make a determination of the incremental value of adding a certain treatment to pathway.

Gordon Kuntz: Thank you for clarifying on that last point. I know we've had that conversation a couple of times offline and I know there's a lot of people who don't believe you, which is too bad because you've been very consistent in that message, as was your predecessor. So that's good to hear, clarity around that. And hopefully that will put some of that to rest for the industry. Value Pathways by McKesson have been around in various forms for a very long time. That's sort of how I got involved in the pathways world. Back in 2004 was when level one pathways were just being released by US Oncology at the time. How do you see pathways evolving in the future?

Aimee Ginsburg: Just as you mentioned that you would say value-based care was going to be here in five years and, oh, it's already here. I sort of have the feeling about pathways that the evolution has already begun and it's already in the new format. So as you referred to the pathways in 2004 when they were the level one pathways, that was more of a way to guide providers to treatments that were appropriate. And in that case it was mostly use of generic drugs to be able to have the best efficacy at the lowest cost.

I think that that is no longer a thing we can say with all of these precision medicines and really expensive treatments that have come to very niche spaces. I think what pathways have begun to offer and will continue to offer is that really patient tailored treatment option. So the process of going through our decision support tool is answering various questions about disease characteristics, comprehensive genomic testing, previous treatments that were given, et cetera, et cetera, to offer a very narrow list of the most appropriate treatments for that given patient at that point in time.

And so I think that the ability to gather additional details and more stratify the patient as to where they should go next is the evolution itself, from previous iterations of pathways or just gathering treatment data in an electronic health record. So I see the future going more in depth in that area as we have more biomarkers that are coming out, more niche groups to look for or patients that may have had X treatment that now would be better to have Y treatment based on the Z trial that just came out. I think we'll be able to have more patient specific recommendations going forward based on the data that we've collected on patients already.

Gordon Kuntz: Great. That's very interesting. So at the last Oncology Clinical Pathways Congress, 2022, there was a lot of discussion about pathways kind of moving beyond their historic roots as you were just describing, and taking into account a number of other factors. Some of the things that were talked about were things like social determinants of health, health equity, and really that, it's sometimes described as patient preferences. I don't think anyone prefers to not have transportation, by the way.
So I sort of tend to think of it as patient constraints. How do you think that the value pathways will be able to account for that? Or is that something that's really being handled by physicians or the practices independent of the value pathways?

Aimee Ginsburg: I think it's something that both sides, so the pathway side and the provider side, really have the reason to do that. So both groups need to be looking at this. And I think that from an SDOH or a health equity perspective, from the pathway side, I think what we can use is the data that we've collected on patients to be able to look and see are there any disparities.

So obviously everybody thinks we treat everyone equivalent, which is probably the goal obviously at the outset. But to be able to look at the data and say, different patient populations based on the data we've collected, were they treated with the best possible care or the most appropriate care? And I think that we can look in our own data to do that. I think any group honestly that has a pathways program and collects data can do this as well.

So investigate to see what the current state is, to see if there is a problem. And then if there is, obviously you can propose solutions from there. But I think that using your own data to look at real world outcomes in subsets of the population is what will help determine if changes need to be made. If there's subsets that need to be called out or more forward looking processes that need to be implemented to ensure equivalent care.

Gordon Kuntz: Super. So one of the issues that I think challenges the notion of pathways and as one of your competitors put it, the very academic view of efficacy, safety, and then cost, are high cost therapies. And again, this was kind of brought up at the last OCPC, and there was some beginning discussions around that. These very high cost therapies like CAR T and bispecifics, which have outstanding results typically, but also come with sort of eye-popping costs associated with them. $500,000, and especially if you're multiple treatment course of therapy, it can add up to millions quite easily.

Can that traditional evaluation, especially with the rigidity that it's always held of, we want to know about efficacy first, and if we find one that's best, then we're going to just... I don't even want to know about the rest of it. Then we'll talk about safety. Then we talk about cost. How can we responsibly think that that's going to reflect... Maybe it's good for an individual, but it frankly is a problem for society, right? Because then there's not enough money to go around for everyone who needs it. So how do we evolve, maybe it's in certain circumstances, to a more balanced scorecard, a value-based model when considering these very high cost therapies? I mean, how do we handle that? I think those are something that could break the back of the system.

Aimee Ginsburg: Absolutely. This is something that we've had a lot of discussions with over the last year to 18 months with the pathways task force is, what do we do about these treatments? So they're really kind of bracket busters in terms of cost. And it was something that initially we thought we wouldn't have to deal with directly. They would be held outside of pathways. And so if your patient was eligible and if you could get the drug in many cases, you could give it. Or you should give it. Or the patient would be eligible to get it. And I think that as more of the studies came out, so in the CAR T setting, we started to think about, it's really not appropriate for us to just not address and turn a blind eye or kind of keep them in an area that's not defined by our pathways.

And so what we did was really lean into our cost analysis and look at cost effectiveness data, pharmacoeconomic data to be able to assess that overall cost or value of a treatment compared to the standard of care. Obviously there's a huge delta in cost compared to standard of care in many of these instances. And so I think one thing to call out here is it's very important for pharma to know that in these situations where these treatments are extremely high and significantly higher than other available options in that space, cost effectiveness studies go a very long way. So there's no disagreement that it's an expensive therapy, but the difference is looking at literature, whether published or not, about pharmacoeconomic data, and looking at the impact of the clinical improvement of these treatments really helps make decisions. And so our task force has started to look at the totality of costs.

So instead of an individual line of therapy, fourth-line myeloma for example, we would say thinking about CAR T-cell therapy or bispecifics, what is that cost compared to maybe a stem cell transplant in those patients? And another way to look at it is, if they get these really expensive therapies earlier in treatment, so in earlier line of therapy, what does that mean for treatments down the road?

Are they being saved or spared the cost of expensive and toxic treatments down the road, because this highly effective, although highly expensive treatment was given earlier in care? We've started to ask if the outcomes are such that spending more money initially helps save the patient from additional treatments or subsequent treatments down the line. And so it's a totally different way of evaluating and weighing the data, but we're trying to look at the whole course of treatment for a patient in a disease and try to evaluate from that perspective. Not to justify the cost, but to help explain the cost and when it comes into effect.

Gordon Kuntz: And is the same analysis applicable for those drugs that are expensive, but maybe not in that category, that are being applied to earlier and earlier lines of therapy? So again, a lot of times it was the third line and it was $200,000 or $10,000, $15,000 a month or whatever it would be. And it was a small percentage of patients. It was a small number of patients, the impact size wasn't that large, and then they applied for an indication in first line. Oh, my gosh. The bottom of the pyramid is a lot broader. Is that same kind of analysis something that you're looking at in those kind of situations?

Aimee Ginsburg: It is. So we had initially started in that space and said, let's try and model if they get that really expensive treatment in first line instead of third line, what would their options be in second line? What would their options be in third line? And try and calculate the cost over the entire course of treatment to be able to determine is this more cost effective? And are you saving future rather expensive, similar drugs that you would not be given had the patient had this treatment upfront? So yes, we are doing that in diseases where we've seen the really expensive therapies sort of get in later lines and start to move up closer to frontline.

Gordon Kuntz: So is that something that your team is doing or McKesson is doing? I mean, I know you have a lot of data capabilities. Or is that something that you rely on pharma to provide, maybe the data and some structure and you double check their work? Or how do you handle that? I mean, obviously pharma has a lot of data. Usually are very happy to put that together for you, but I think that this is good direction for them in some ways. But the HEOR and the value and evidence teams at pharma, I think if they know what to put together, they can start to work on that.

But I also know there's a general skepticism about, as someone said, "It's not that we don't believe you, it's just that we don't believe you." On the part of pharma, pathways talking to pharma, how do you validate that work and is that something you're trying to do uniquely or is that something you're relying on them to provide?

Aimee Ginsburg: No, it's a really great question. And I would say today because that data does not exist, we are doing it ourselves. And so we are, the PharmD team that I have is modeling that information. And the cost and the data. Now, if that were data that came from pharma, obviously we would validate the numbers, but the idea of pharma modeling and expensive treatment in first line and what the potential course could be in terms of a pharmacoeconomic analysis, I think would go very far.
So I think that would also help them in, I don't want to say justification of cost, but maybe support for the cost that that treatment has. And so having the numerical data, the financial data to back up what it would look like for a given patient and the survival that they're expected to have from a treatment in first line, what that looks like for second line, third line, and down the road. To be able to calculate more of that totality of care for a given patient, I think would be very impactful.

Gordon Kuntz: And the underpinning of that, that survival, I'm assuming you're encouraging them to rely on possibly both clinical trial but also real world evidence in that respect.

Aimee Ginsburg: Absolutely.

Gordon Kuntz: Okay, very good. Maybe a little more specific question to wrap things up here. Value Pathways are a subset of NCCN guidelines. If you could talk for a minute about that process and how it works, how that might evolve in the future. And especially the fact that you have non McKesson, non-US Oncology oncologists helping to make decisions on the recommendations that you all are looking at.

Aimee Ginsburg: So what I would say is the Value Pathways are a formal subset of the NCCN guidelines that are 100% concordant to the guidelines, but not identical. So by design they're a smaller group of it. We have a narrow list of recommended treatment options that are most valuable in the community setting. And that's the major differentiator between the Value Pathways program and what is listed in NCCN. So in terms of the relationship, it's really a symbiotic one where we're able to, as you mentioned, have NCCN panel members join our calls as non McKesson providers or non-US Oncology Network providers, that join our calls and also vote on our pathways.

And so the panel members that join help us with decision making. So we have an academic conversation with them asking for input and differing perspectives. Maybe how their conversation went. What led them to give a certain category of evidence or place an additional restriction maybe beyond the FDA approval or make it wider than FDA approval.

So just sort of the thought process that went into effect. Have a conversation with them and helps inform our decision making and also does help improve the guidelines. So occasionally there's been conversations that say, "Huh, we didn't see it that way." Or, "We didn't interpret it that way." Or, "We didn't review the data in that manner." And the guidelines are subsequently updated and rereleased. And so I think that having those discussions is really beneficial to talk with experts in the field as we're making decisions.

So as we're trying to apply a standard set of value pathways, rules, guidance, interpretation on any given pathway that we have, we'd like to treat them all equally, obviously back to the standardization piece, it's helpful to have experts that point out nuances that would maybe make a difference in how something gets either added to pathway or not. And so a lot of times the panel members that are joining are the principal investigators of the trials that we're discussing.

So we're able to ask additional layers of questions that perhaps didn't come out in the data or that maybe were only mentioned in one of the publications or one of the presentations at a major meeting. And so having NCCN panel members join and vote on our pathways, I think is a really unique aspect of our program. And it's really helped shape the pathways over the past 10 years that we've been collaborating. I would say that their attendance, their participation, and their voting is what really sets the program apart.

Because it is a formal subset of the guidelines that has a value focus for the community oncology setting. And so the way the pathways has evolved in the tenure since we've joined with NCCN, I'd say that our pathways are stronger, that they are more complete, that they are really applicable to 80% of the population that walks into a community oncology practice. Which is our goal. So I would say that the relationship has really helped us achieve our goals in that manner.

Gordon Kuntz: Excellent. Let me ask one final question. You talked about standardization and obviously through the US Oncology Network and the broader McKesson network that might be users of those value pathways, how... I don't know if you have access to this information or not. How completely are they used, I guess the question would be. Especially within the US Oncology Network where there's obviously a number of very large practices distributed geographically across the country. How uniform is their usage so that there's an assurance that in fact the standardization is actually occurring throughout that network?

Aimee Ginsburg: That's a really good question. So the fact that all of our providers are using the same electronic health record means we have that data and are able to evaluate it. And so part of our process of reviewing a pathway is to look at the use over the last year. Now we're able to look at that use and see what are people doing off pathway. So is there data that we've missed? Is there new data that's coming out? Has there been a change in something that we need to pay attention to?
Maybe there's been a price change or there could be various factors of patient population, things like that. So we're always looking to see what providers are doing that is not on pathway. And we're also looking to see where is that coming from. So each practice is an individual, standalone practice. They can make their own decisions. The practices, the overwhelming majority follows pathways, puts their information into the EHR, documents appropriately, answers the questions appropriately.
There's always outliers, folks that don't think they need to answer the questions or do it their own way, whatever the case may be. But each practice is able to set that expectation of whether a provider is following, if they are holding them accountable for entering the information and things like that. So in terms of completeness, I would say that over two thirds, three quarters of the practices are doing exactly what they should do in terms of answering the questions and getting to treatment options. Now, if they select something on pathway that's on or off is a different story, but I would say that the use case is very high for practices using the program as intended with the decision support.

Gordon Kuntz: That's outstanding. Anything you'd like to add for our audience?

Aimee Ginsburg: I would just say that maybe 10, 15 years ago, pathways was something new, something that a lot of people didn't follow or didn't have or weren't interested in doing. But I think that with everything we've discussed today, as fast as data is changing, the number of precision medicine options that are coming out and the changes that are happening so quickly, I would highly recommend that practices or providers have some sort of program to be able to refer to and ensure that they are following evidence-based care. Not that they don't intend to, but to show them exactly what is the best option for their patients, I think is the way of the future. To have additional hands on their back, trying to keep them updated on all of the data that's changing.

Gordon Kuntz: Awesome. We'll let you have the last word there. So that wraps up our episode, this episode of Oncology Innovations. Aimee, I want to thank you for joining us today. As always, thank you to the Journal of Clinical Pathways for producing this episode. Please download, rate, review and subscribe to the podcast. For more episodes, you can visit www.journalofclinicalpathways.com or you can find us on Apple Podcasts, Google Podcasts and Spotify. Also be sure to share Oncology Innovations with a friend or colleague. Let me know your reactions to episodes, questions, or recommended topics for future episodes. You can find me on LinkedIn or you can send an email to gordon@gordonkuntz.com to request specific topics and guests. See you next time. Thank you.