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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 am a senior associate in Avalere’s Market Access practice. I am joined today by my colleague Amy Schroeder, who is an oncology pharmacist and senior consultant in our Market Access practice.

In today’s episode, we will discuss primary pathways topics, including the definition of clinical pathways, how pathways are used, their importance to manufacturers, and why Avalere conducts primary research into pathways. Let’s start with the basics. Amy, what are clinical pathways?

Amy: As we know from years of research, there is no standard definition of clinical pathways. We hear from different stakeholders that clinical pathways are clinical decision support tools that align with clinical guidelines and other standards based on efficacy, safety, and cost. There are also some other modalities, and how they use each of these criteria can vary. There are some organizations, such as the American Society of Clinical Oncology (ASCO), that are trying to bring everybody together, but ASCO has come to the game a little late. Stakeholders have already applied so much time, effort, and money into clinical pathways that it’s very difficult to bring everyone together now. Without a standard definition, all the stakeholders will be applying things in a different way.

Because we have no standard definition of clinical pathways, when we do the research, we try to normalize that variation in the beginning so that we can try to bring all the information together. So, unfortunately, there is no easy answer to that question, but we can get into that further.

Zach: Thank you, Amy. That is really insightful, and a good basis for this conversation. Even though there is not a standard definition for clinical pathways, could you tell our listeners some common goals of clinical pathways programs?

Amy: Sure. When we speak with clinical pathways vendors, as well as payers and healthcare providers that use clinical pathways programs, we hear three basic goals, though there may be variation in the wording:

1. Promoting quality care for patients
2. Reducing variability in care, where it is not necessary
3. Controlling cost where possible

As I mentioned before, because these goals can be measured differently, it is important to understand who the customer is and what is important to them. It is not necessarily what a vendor develops, but how the program is used. For instance, we know payers may look to reduce costs, but providers can no longer ignore cost. So, we must understand that how safety, efficacy, and cost come together and how each of those is measured may vary, making it imperative to talk to all stakeholders.

To me, variation in the goals and how the criteria is used is not necessarily a bad thing. In cancer care, every patient expects that their care will be personalized. When speaking to stakeholders, we try to understand how personalized care comes into the equation and how it is measured. Some clinical pathways programs allow for it up front and say, “We’re going to have broad criteria, which allows for personalized decisions. We’re not going to look at that too closely in the beginning.” Then, there are others that apply strict criteria up front but allow exceptions for personalized care. There are different ways to look at it, but ultimately the goals are similar among programs. The difference is in how each goal is measured.

Zach: Something that just struck me in your answer is that the goals of a clinical pathways program can vary depending on what the customer of the program – whether that is a payer or provider – is looking to achieve. Can you dive into how pathways programs are typically used?
Amy: Sure. We understand that payers and providers are going to use pathways differently.

Payers may be leveraging pathways as utilization management tools. They can tie reimbursement to pathways adherence. We might see a payer pathways program that offers incentives such as pay-for-performance or an increase in reimbursement for selection of a preferred regiment or option. There might also be shared savings involved, where, at the end, the vendor, user, and pathways customer may see some savings from the preferred option.

We might also see lower reimbursement for certain decisions, perceived by a pathways user—a network physician using a payer program—as a penalty. For example, vendors offer programs where certain treatment options have an enhanced reimbursement, while others have a basic reimbursement. To a small practice, the basic reimbursement could put them under water, so they perceive it as a penalty despite that not being the intent.

Providers leverage pathways to promote consistent high-quality care. It is a documented form of something they were already doing. Participating in the Oncology Care Model (OCM) is one example. A provider may already have a clinical pathways program or is following evidence-based guidance, but the pathways program enables them to do all the required reporting in the OCM.

Sometimes providers are successful in leveraging their own clinical pathways program with a local payer. By showing the payer results of adherence, the payer gets on board and allows them to continue with that program.

We know that clinical pathways are applied at the population level. This can make it very difficult in research. We are often asked by our clients to help them understand what is preferred in a particular situation, but we need primary research to understand that. There are so many different factors that are considered in clinical pathways, especially when they are being used as prospective tools. You must consider many details about the patient, like performance status, comorbidities, time to failure of their last treatment, and other healthcare concerns. In many cancers, the preferred pathway is based on whether the patient is a transplant candidate and if transplantation is a goal.

So, those things show the importance of speaking with various stakeholders. We cannot ask one person a question and expect the answer applies across the market. It is different with each pathways user.

Zach: I think it is helpful to see the differences in how payers, providers, and other stakeholders use pathways. To further this point, why are clinical pathways so important for us to understand?

Amy: We’ve learned that clinical pathways are really growing. It’s challenging to stay on top of them. Pathways are changing and evolving, but even more so, they’re increasing. We have confirmed over 300 active cancer management programs, but since only 80% call what they’re doing clinical pathways, it’s probably even higher than that. From our stakeholder conversations, we know that pathways are expanding in cancer types, therapy types, drug types, and other modalities. The number of payers and providers who are new to clinical pathways or buying or developing their own is also growing.

Because this information is not anywhere in the public domain, it is important that we do this research, particularly since it is impacting decisions.

Zach: Thank you, Amy. It seems to me that the growth in clinical pathway programs is impacting treatment selection, and moreover, impacting patient access to therapies. So, why is Avalere conducting primary research in clinical pathways?

Amy: Again, one of the main reasons we do this research is because this information is not publicly available. AIM Specialty Health posts their medical oncology pathways online, but most vendors do not, so we must talk with key stakeholders to understand who is involved and how clinical pathways are evolving.

This information affects patient access to treatment options. We will expand on this in part 2 of this series, but I want to mention that, because this information is not publicly available, it is important to understand how it affects decisions. Many times, we hear clinical pathways described as a barrier to a provider’s care decision. We have learned that we need to emphasize the importance of clinical pathways education and transparency. Patients want to understand how and why they affect a treatment decision. Do the clinical pathways lead to a different answer than what the physician would have selected? That is really the big question.

So, with this type of research, we’re able to help different stakeholders in the market. Life sciences companies have opportunities to educate and contribute to clinical pathways. Many vendors have processes where information can be submitted. Key opinion leaders and users of clinical pathways can participate in different processes offered by vendors. Providers developing their own programs can be involved in the process. Many times, medical teams from our life sciences clients can participate and submit information. So, there is a path and role for life sciences clients in this process, whether it’s engaging directly with vendors or clinical pathways users, or at a higher level, promoting patient access and working with patient advocacy groups. It’s also making sure information about a clinical pathways program or product is being published. Many clinical pathways programs rely on clinical guidelines in compendia, so where a product is positioned in those resources that can be a great way to get involved in clinical pathways strategy.

I think all those things together can help our life sciences clients understand their role and how they can participate. We’re hoping this research can educate everyone in the market.

Zach: Thank you, Amy, for your expertise and for joining us today. Your insights are extremely valuable to our listeners. Clinical pathways are continuing to evolve and take shape in oncology and other therapeutic areas. While these areas are in flux, Avalere will continue to conduct this research to monitor what is happening and how it affects our clients and patient access in general.

Thank you all for joining Avalere Health Essential Voice. Please tune into our next episode, in which Amy and I will provide a deeper dive into pathways content and stakeholders. If you would like to learn more, please visit us at www.avalere.com.