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Transcription

Zach: Hello, and welcome to another episode in our Start Your Day with Avalere podcast series focused on value in oncology. My name is Zach Levine, and I’m a Senior Associate in the Market Access practice here at Avalere. I’m joined today by my colleague Amy Schroeder, who is an oncology pharmacist and Senior Consultant, also in the Market Access practice.

In part one of this segment, we discussed an overview of clinical pathways and their importance and influence in oncology care. In today’s episode, we will dive a bit deeper into pathways, exploring how they are developed and what cancers and treatment modalities are included. We will also address how organizations across the healthcare industry can get a handle on pathways.

To begin, Amy, can you tell our listeners about the pathways development process? Who develops pathways and what criteria are used to create pathways content?

Amy: What we hear from many of the stakeholders is that it really starts with the question of, what diseases need clinical pathways? According to vendors, that is often decided by their customers. For instance, payer customers may decide that they want clinical pathways for cancers that are their highest spend, whereas providers may decide they would like to provide consistent care across all cancers they treat, so they want to include all cancers.

Stakeholders that develop their own pathways internally tend to sit down together and decide what’s important for the institution or the practice itself. Is it important to have all those cancers in there, or do they want to start small and then build from there? So there really are some different answers to that question, but that covers what we’ve been hearing.

When it comes to development process criteria, where do you even start? If you decide as a payer that you would like a clinical pathways program for certain cancer types, or as a provider deciding you want something, first you have to decide if you are going to buy or you are going to build. Then you must think about what criteria you want to use for determining what clinical pathways are to your organization.

Many times, especially in oncology, we hear that the National Comprehensive Cancer Network (NCCN) plays a big role across all clinical pathways programs. That doesn’t mean that every pathways program is using it in the same way, but it is usually one of the top resources.

Literature also plays a big role. Many clinical pathways programs still choose to read up on the literature, and that may be up to certain support staff or pharmacists.

Those are two of the main sources that we hear of as providing the criteria for clinical pathways content. Sometimes we also hear about clinical drug compendia and their reviews helping providers and payers and vendors build programs.

To your question about who develops the clinical pathways programs, sometimes they’re programs developed internally by practices themselves, and they may be using those resources that we mentioned: literature, NCCN, and other compendia. They’re pulling all that information together and deciding as a group what the content should be.

There can also be situations where a provider does not have the staff to do that, so they choose to purchase a program from a vendor, so it’s the vendor who’s creating the content and providing it to that provider practice. We also have payers that buy from a vendor.

Sometimes payers and providers are willing to work together. We’ve actually researched some of this in the Midwest, where there are some payers and providers sitting down together and saying, “Hey, why don’t we just work together and come up with what this content should be?” So, there are multiple parties involved.

I think, overall, this really leads to what we keep saying in clinical pathways that there’s really no set rule for what’s included, how things operate, or who develops what. That’s why we’re trying to stay on top of all this because there are so many different answers to these questions.

Zach: Absolutely. One of the main things we have drilled down with clients in the clinical pathways space is this idea of variants. With so many different pathways vendors on both the payer and provider sides, including both sides working together, and so many differently managed programs out there, how does a typical provider navigate all these programs?

Amy: If you think about all those different types of programs that we’ve just mentioned, and then think about a provider who’s walking into their practice to see maybe 15-20 patients that day, what are they actually encountering? Many times we hear that providers have their own clinical pathways, or they may not have clinical pathways, but they have some sort of order templates or preferences loaded into their electronic health record, so they have guidance about what they would like to do.

But then think about all the payers that have clinical pathways programs. So any time a provider is seeing a patient, and that patient has a certain insurance plan that has its own clinical pathways, is the provider also logging into that tool and navigating through it to make a decision as well? And do those preferences in that clinical pathways program match what the provider would have picked on his or her own?

We’ve heard from providers that throughout the course of the day, they can actually engage several different clinical pathways programs and not all of them align. A patient may be given a diagnosis and go through a provider’s clinical pathways program, and then maybe three or four different payer pathways, what if they all come up with a different recommendation? The provider, who is trying to give consistent care, is dealing with these overlapping issues with different clinical pathways programs. Which one of those takes priority?

Many of the providers we speak to try to follow their own clinical pathways program around 80% of the time because that is their employer’s recommendation. So, what happens when they also encounter these payer programs? Does one override another? It’s important to understand on the payer side how many of those programs are mandatory and how many are voluntary. There are many payer clinical pathways programs that may be driving a provider to a different decision, but are still voluntary. The payment for the actual care and the drug regimen is separate from the clinical pathways. So as long as you’re following that patient’s health plan’s prior authorization criteria, the provider would still get coverage for the product, even if that product is not on that payer’s pathways program. As long as they’re willing to let go of that extra incentive, they can still follow their initial own guidance.

So that’s another thing that’s important, as well—not only all the different types of programs that providers encounter, but also which ones override others.

Zach: Absolutely, Amy. Switching gears into the types of providers who encounter these pathways, I know that pathways are very prolific in oncology. Why is that the case, and in what other therapeutic areas are pathways prevalent?

Amy: As you mentioned, pathways have entered oncology first. Oncologists need to make many different decisions. That’s not necessarily any different from other health care providers, but there is so much experimental care in oncology.  Also, so many of the products are getting increasingly more expensive, and we’re getting really crowded in some of these spaces. If we think back to our goals in clinical pathways programs, we’re supposed to be streamlining care, making consistent care across the continuum of the US for different patients with the diagnosis. How do we do that? I think it makes sense for it to start in oncology first, but some other areas that we also see pathways entering are other chronic diseases such as cardiology, rheumatology, primary care, emergency medicine, and obstetrics. But for the most part, those are still pretty elementary. We’re still seeing the most advances and the most evolution in clinical pathways in oncology.

Zach: And so, diving even deeper into oncology, understanding that it is by far the most sophisticated therapeutic area that clinical pathways currently impact, what types of cancers and modalities are often included in oncology pathways?

Amy: Great question. Let’s think about providers first. If you think about why a provider wants to do clinical pathways, it’s about, “Am I making decisions consistent with my peers in a different location within our organization?” It’s about providing that consistent care. It’s about documenting evidence-based care. What better way to do that than to include everything that you do? So, what we’re hearing more from providers is that they are integrating other modalities with the drugs.

We usually see the drugs as the starting point of clinical pathways, but larger healthcare institutions like integrated delivery networks are also integrating, for example, the radiology department with laboratory. They’re bringing all of that together. You can see if a patient got an MRI or a PET scan or CT scan somewhere else because it’s all integrated. Even though the institution itself has been able to pull all of that together, is that being pulled together in clinical pathways? We’re now seeing more of those different modalities being pulled in.

Many times, we’re dealing with targeted therapies, so it’s really important to say, “Do we have genetic and molecular testing in there?” especially when it’s got some sort of diagnostic, prognostic, or predictive value. That’s another way to bring in other modalities because they help inform decisions.

Now on the payer side, we often hear that even if a vendor is offering many different cancer types in clinical pathways, they’ll start out with those cancers that are their biggest spend. Breast, lung, colon, prostate, myeloma, lymphomas, and melanoma tend to be the cancers that we hear picked first. Payers will then add other cancers later, such as leukemias, kidney cancer, etc. Payers tend to start small and build up as needed.

An important question to ask is, “What subsets are also including clinical pathways?” So, it’s not only about whether a cancer is included in clinical pathways, but what scenarios? Providers are interested in comprehensive, consistent care across the board, so they’re more likely to have all the different lines of therapy because they want to track everything. On the payer side, we don’t necessarily see all lines of therapy. For instance, if a certain line of therapy has one novel agent for treatment, and there’s little competition, we might not actually see that in payer clinical pathways programs. The choice is obvious and there’s not a lot of variation, so does a payer really need to track that?

So, it’s important to look at what cancers, what scenarios, and which lines of therapy. The short answer is that no cancers are exempt from clinical pathways, but we make sure that we’re always doing research with all the stakeholders because it’s constantly changing.

Zach: Absolutely, Amy, thank you. One of the reasons why I love doing this work with you and working in this pathways space is that there are a lot of moving parts. It is a very large space and still a bit of a wild west in terms of the variety of vendors and programs out there. Understanding that this might be overwhelming to stakeholders who are trying to align themselves and their company’s clinical pathways strategy, let’s end with this final question: How can organizations better situate themselves to keep up with all things clinical pathways?

Amy: Wow, that is a big question. The way that we approach our conversation with our life sciences clients as well as providers and payers is staying up on what this is. And by that, I mean, it’s aligning at an organizational level on what clinical pathways are. We mentioned in the previous episode that we don’t have a standard definition for clinical pathways. That’s important because what we find is that, especially with our life sciences clients, there’s different groups working on different things. Some that have payer accounts are doing one thing, medical affairs is doing another, and they may actually be conflicting with each other. We try to help our clients level set across the organization. What are you focusing on when you’re doing a clinical pathways strategy? What is the definition to you? Are you all on board together so that you understand everyone’s roles and responsibilities?

We also ask that they think about these probing questions to understand if there is a concern about access. Is it just about confirming where your product is, or are life sciences clients hearing from the field that providers are having trouble accessing products for patients? This is important because that may change what a strategy is, whether it becomes more active and less passive. That’s something that we always try to understand when working with different clients: what is the concern with clinical pathways?

If deciding that you want to take an active approach, there are several different ways to get involved in the clinical pathways market. There are vendors that have publicly available processes for submitting information. There are certain meetings to attend and be actively involved.

We find it most helpful to be thinking about the patient at the end, to really think about patient access when we’re thinking about clinical pathways and what they mean. It is the most successful way for all of us to come together. That’s where we start with clients. After that, it’s important for us to sit down, determine what they need, and tailor a solution to that.

Zach: Great. Amy, thank you so much for your wisdom and for joining us today. It’s been a pleasure to chat with you in this follow-up conversation to our first episode on clinical pathways. Thank you all for tuning into Avalere Health Essential Voice. If you would like to learn more, please visit us at Avalere.com.