Providers and practices across medical specialties have eagerly adopted clinical pathways in efforts to standardize care and achieve uniform outcomes. However, few disciplines have been as receptive to the concept of pathway utilization as hematology and oncology. As new therapies are rapidly approved for a variety of different cancers, the potential costs of treatment have continued to steadily rise, making high-quality care at manageable costs more necessary than ever. Key opinion leaders in the oncology world have looked to pathways to reduce treatment variation, control costs, and provide the most benefit to patients.
ASCO has been a leading voice regarding clinical pathway development and implementation in oncology, forming a Task Force to develop recommendations for best practices in the area in 2015. In January 2016, ASCO’s Task Force on Clinical Pathways offered an initial policy statement, which was published in Journal of Oncology Practice.1 The statement focused broadly on the need for collaborative insight from all stakeholders in the development process, as well as a reliance on validated scientific literature and outcomes research to create the most effective pathways.
ASCO’s research suggests that up to 25% of “covered lives” receiving oncology treatment were treated under a clinical pathway in 2015, an increase from 15% in 2010.2 To strengthen its commitment to supporting the use of high-quality clinical pathways in oncology, ASCO issued a list of 15 interrelated criteria for clinical pathway development, implementation, and analytics, taking into consideration the needs and interests of all stakeholders.3
To better understand how medical societies can shepherd clinical pathway development and adoption, Journal of Clinical Pathways recently spoke with Robin Zon, MD, FACP, FASCO, who serves as chair of ASCO’s Task Force on Clinical Pathways. Dr Zon—a practicing oncologist at Michiana Hematology Oncology, a multisite practice with offices across the state of Indiana—explained the benefits of clinical pathways for community oncologists and how best to educate and inform patients with cancer about care under the pathway system.
The oncology community seems to have overwhelmingly embraced clinical pathways. Why do you think that is?
Clinical pathways have been around the oncology world for a little over a decade. I think the reason we see them increasing in prominence today is because there are multiple pressures on the health care system in general that come directly from treating cancer. There are three key pressures that I would identify. First, baby boomers are rapidly moving into the age where we start to see increased cancer diagnoses. In addition to the increased number of people we see diagnosed with cancer, we are also seeing an increase in survivorship. And with survivorship, there is an increase in the possibility of second or third cancers diagnosed within one individual. We can understand, then, where the cost burden comes in—more people need treatment, and are healthy enough to receive treatment, than even just 20 years ago.
Over the past decade, we have also experienced a wonderful explosion of scientific discovery, which has led to increasing numbers of improved interventions in diagnostics and drugs. All of this comes at a high cost. The combination of these two factors is starting to break the bank. Well, one of the primary aims of pathways is to reduce variation and control costs. The volume of information that practicing community oncologists have to manage can be simply overwhelming. At the Clinical Pathways Congress this past September, there was a presentation on the number of different pathways available for patients with chronic lymphocytic leukemia (CLL).4 This is a disease that, as recently as 10 years ago, was treated with one or two drugs. Now that we have all these diagnostics to keep track of—which direct the treatments we offer in the first or second line and vary based on mutation status—we are living in a very different world. The pathway helps manage scientific knowledge and, if used correctly, reduces treatment variation, so that a CLL patient with a certain deletion in New York City will get the same treatment as the patient in Montana with the same deletion. This can eliminate unintended inequities based on the geographic reality of where you live or where you’re treated, which is reassuring to the patients.
You mentioned community oncologists, the doctors who treat the majority of cancer patients in the United States. What specifically do pathways have to offer them?
What we have discovered is that not many oncologists in the community have been affected by clinical pathways yet—but they will be. ASCO is working to ensure that doctors are getting access to high-quality, cost-effective pathways. We have a range of experience in the community setting. I talk to oncologists for whom pathways haven’t even entered their market yet, and other practices where multiple pathways are juggled every day. That can lead to an untenable administrative burden. That said, there are a lot of issues that have been brought to our attention, and they mainly come from our community members. This is the setting where the rubber meets the road, where 85% of cancer patients received their treatment.
Some of the concerns I am hearing range from pathway variations, such as not having a consistent appeal process, because pathways generally have an adherence rate. So if a doctor is not “compliant” with a pathway, some of our members were saying that the appeals processes were quite burdensome. Then, there is the matter of not reimbursing for patients who are treated appropriately off of a pathway. This leads to concern about patient access. The pathways have been noted to not always cover rare cancers or cancers treated in the inpatient setting, like acute leukemia. There is also the lack of disclosure of the exact methodologies used to develop a pathway with regards to efficacy, toxicity, and cost, and a lack of transparency in conflicts of interest by developers. There is a concern that some of the pathways could have been designed to deal with cost savings more than efficacy and safety. These concerns were articulated, and they led ASCO’s then-president Peter Paul Yu, MD, to create the [Clinical Pathways] Task Force.
And what has the Task Force done to mitigate these concerns?
ASCO initially hired a consultant to do an environmental scan and help us understand pathway penetration throughout the country, vendor/payer relationships, and vendor/provider relationships. We learned that there is a diversity of stakeholders in the clinical pathways world, ranging from national pathway vendors to payers who use their own pathways, to providers developing individual pathways in their own offices. We have also seen regional pathway development: Fred Hutchinson Cancer Research Center (Seattle, WA), for example, has developed pathways that are specific to their community. But at the end of the day, we noted that what was lacking was that, although everyone was working on pathways, and many of them seemed very good, there was no standard to measure them against each other and know which would have a high value. So we initially developed the guiding principles that evolved into the recommendations published in January 2016.
The guiding principles we developed included having practicing oncologists play a central role in the development and revision of oncology pathways, and that quality should be the central goal of developing and continually updating pathways. Transparency is a key theme in what we are recommending, as well as expediency. As practice-changing scientific data becomes available, it is appropriate to integrate it into the pathways in a timely manner. This mirrors how we have always done things in community oncology. For example, I went to the ASCO Annual Meeting several years ago, and there was an update presented that patients with KRAS mutations shouldn’t receive cetuximab [(Erbitux, Lilly)].5 Once I returned from the meeting, I halted the trial that was not using KRAS testing for cetuximab, in order for the trial sponsors to make appropriate amendments. It changed how we practiced, because we determined that no patient would receive cetuximab without mutation testing first. Community doctors are quick adopters, so we expect that pathway programs should be equally adept at adopting evidence-based, practice-changing information.
What would you tell doctors who are concerned about adherence rates?
I would say that clinical pathways, as they are developed, need to identify key parameters such as the number of patients they are intended to cover, the types of cancers, and the expected adherence rate. But they should know that the adherence rate should never, and probably will never, be 100%, at least not at this time. And there should be measured outcomes associated with adherence, as well as the cost associated with adherence. Because rare cancers can sometimes be difficult to adapt into the clinical pathways world, there will always be patients who may not benefit from clinical pathway use, and that needs to be acknowledged.
What role do you expect the most recent ASCO criteria to play in clinical pathway development and adoption?
The criteria are meant to be used as a resource for providers who are looking into program vendors within practices. I can give a very real example of this, because I am currently leading such an effort within my practice. As I interview vendors, I am inquiring about the product’s compliance with the criteria. And I am seeing the differences already. Without discussing the specifics, because this is an ongoing negotiation, I can say that the difference is notable.
Now that criteria are published, we would hope to help our members be able to facilitate these criteria in a manner that allows them to use it not only to find an appropriate pathway program—whether it’s regional, national, or local—and to adapt and feel confident that pathway programs are in the best interests of their patients. We want this to lead to practicing the best medicine, while being cost-effective and helping to control resource utilization. Developing and delivering a high quality of care has always been our primary goal, but there is now a level of accountability on our shoulders with regards to resource utilization, which has been formalized through the Medicare Access and CHIP Reauthorization Act. We are all being asked to have a stake in the game when it comes to ordering tests, ordering drugs, and making sure that we are doing everything efficiently and effectively. I can envision that as pathways move forward, if they follow the standards we have recommended, they will help reassure providers who elect to purchase or use a particular pathway program that they are not only delivering the best care to their patients, but that they are simultaneously managing their stake in the game when it comes to accountability.
What is the best way to introduce patients to clinical pathways, so that they can fully comprehend how it affects their treatment?
It is very important that we don’t forget the patients throughout this process. When I first started meeting with patient stakeholders, they were very upset about the idea of clinical pathways, largely because they didn’t understand it. That is why I feel that going forward, communication will be extremely important, and providers should make themselves available to help patients understand how pathways help them and their specific course of treatment.
Patients in the community setting talk to each other all of the time. A patient with stage III colon cancer might come to his doctor and ask why they are getting treatment 1 but their friend with the same disease is getting treatment 2. They are not doing this to challenge the doctor’s authority or judgment—they are just trying to understand. So we need to be able to explain why for that specific person, treatment 1 is the best course of action for their situation. If you can imagine how difficult the management of scientific advancement is on the provider’s side, you can only begin to imagine what it looks like from the patient’s perspective. There is a good opportunity for pathways to help facilitate that conversation between patients and providers.
Have you had to deal with much hesitance or misconceptions about clinical pathways?
At the end of the day, the largest purchasers of nongovernment insurance are employers. The employers are asking for accountability as payers to manage their accounts, and they are faced with the challenge of providing insurance for their employees that is both cost-effective and offers, comparatively, the biggest bang for their buck. As a result, payers are even more accountable for all of the reasons I have already enumerated—soaring costs, multiple diagnoses, and increased survivorship. I have personally spoken to employer groups who are looking to pathways as a possible solution to managing the total costs of care.
Regarding whether any misconceptions exist, I guess I would rephrase the question and say that because there is diverse activity within clinical pathways, a lack of standards would definitely lead to misconceptions. Some people might come to think that all pathways are bad. I, of course, don’t believe this; I believe that pathway programs have great potential, and some may already be adhering to some of the established standards. The concern and the uncertainty around pathways is whether, at the end of the day, it will deliver the best care while controlling costs when appropriate. The issue has been a lack of governance on these standards, but you cannot blame the developers or the pathway vendors for that. They have been out there trying to show us what a pathway should look like with little guidance.
My perception as both an oncologist and a businessperson is that sometimes all you need to do to change the field is move the needle. In this case, I think the very important work the Task Force has done is to publicize standards that will raise the threshold in the development, implementation, and analytics of pathway programs. Accountability will be increased, and as a result, these standards will put pressure on the system as well. But it’s a good kind of pressure—a pressure to become compliant with some, if not all, of the standards that we expect will assure the delivery of high-quality care, while managing resource utilization.
References
1. Zon RT, Frame JN, Neuss MN, et al. American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology. J Oncol Pract. 2016;12(3):261-266.
2. American Society for Clinical Oncology criteria for high-quality clinical pathways in oncology. ASCO website. https://www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/documents/2016-ASCO-Criteria-High-Quality-Pathways.pdf. Published November 29, 2016. Accessed January 9, 2017.
3. ASCO releases criteria for high-quality clinical pathways in oncology. ASCO website. https://www.asco.org/advocacy-policy/asco-in-action/asco-releases-criteria-high-quality-clinical-pathways-oncology. Published November 29, 2016. Accessed January 9, 2017.
4. Nabhan C. Challenges and strategies in an evolving treatment paradigm: pathways for chronic lymphocytic leukemia. Presented at: Clinical Pathways Congress; September 16-18, 2016; Boston, MA.
5. Venook AP, Niedziwiecki D, Lenz HJ, et al. CALGB/SWOG 80405: Phase III trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab (CET) for patients (pts) with KRAS wild-type (wt) untreated metastatic adenocarcinoma of the colon or rectum (MCRC). Presented at: ASCO Annual Meeting. May 30-June 3, 2014. Chicago, IL.
