Abstract: The American Society of Clinical Oncology (ASCO) has set forth foundational policy statements regarding the utility of clinical pathways in oncology and outlined basic requirements and aims from clinical pathway development and use. ASCO has established that pathways programs should be evidence-based and transparent for delivering quality cancer care for patients with specific disease types and stages. As clinical pathways program use grows in popularity and complexity, real-world practice and application of these programs may vary from initial concepts. DK Pierce & Associates (DKP) sought to determine how health care decision-makers define and perceive their own clinical pathways programs and clinical pathways in general. DKP conducted proprietary surveys and interviews to compile feedback directly from oncology providers, payers, and other stakeholders to identify how they currently view and use pathways.
Acknowledgments: DKP would like to thank the vendors, health care providers, and payers that participate in our research.
For more than 7 years, DK Pierce (DKP), a consulting firm committed to improving patient access to treatments for cancer and rare diseases, has reported market research findings on clinical pathways and other cancer management models. Research and findings have included multiple stakeholders, spanning perspectives of vendors who develop pathways to the health care providers and payers that use them.
Based on our proprietary research, collected quarterly over the past 7 years, clinical pathways are growing in popularity, especially with many key stakeholders participating in models that assess value of cancer care.1,2 The qualitative research DKP conducts includes the collection of basic information on the structure and function of clinical pathways and cancer management programs (eg, who drafts content, references used, frequency of updates, incentives, etc), from 7 major vendors who had clinical pathway and cancer management programs active in Q1 2018:
- Via Oncology, LLC (ie, Via Pathways);
- McKesson Specialty Health/US Oncology/National Comprehensive Cancer Network (NCCN) (ie, Value Pathways powered by NCCN);
- AIM Specialty Health;
- eviCore;
- NantHealth (ie, eviti);
- Oncology Analytics; and
- New Century Health.
Feedback from the health care providers and payers that use these programs or develop programs of their own without a vendor is also compiled during data collection. Each quarter DKP updates profiles of select vendors and interviews or surveys new providers and payers, with the understanding that we are adding new programs to the database each quarter.
With the American Society of Clinical Oncology (ASCO) Policy Statement on Clinical Pathways in Oncology3 in 2016 and follow-up statement by ASCO’s Task Force on Clinical Pathways,4 it has been established that pathways programs should be evidence-based and transparent for delivering quality cancer care for patients with specific disease types and stages. But definitions of some terms, like “transparency” for example, may differ across different contexts, stakeholders, and programs. So how do stakeholders define appropriate transparency? How do they quantify “consistency”? We started asking these questions in our data collection.
Without getting into the specific issues in comparing quality and utility of existing clinical pathway programs, our research uncovered a finding that made us step back and take a broader look at the questions we were asking and speculate: “What exactly is a clinical pathways program?” What we found across vendors, providers, and payers is that their definitions vary.
Methods
We surveyed and interviewed care providers and payers of 337 cancer care management activities from 2011 through Q1 2018, including but not limited to, stand-alone clinical pathways, the Oncology Care Model, oncology medical homes, broad oncology management programs, etc.
In Q1 2018 proprietary interviews, we had also asked 10 payers (pharmacy and medical directors) and providers (clinical pharmacists and oncologists) what their definition of clinical pathways is and how they would categorize their program based on that definition.
Results
Provider and Payer Feedback on Current Cancer Management Activities
Of the 337 activities, 326 had confirmed cancer care management programs in oncology. Of the 326 confirmed programs, 257 (78.8%; 76.3% of the 337 total) included a clinical pathways component, and 69 (21.2%; 20.5% of the total) did not have a clinical pathways component. In addition, 11 (3.2% of the total) providers and payers did not have official cancer care management programs but are following nationally-recognized guidelines—an observation that will be discussed later. Of the 257 programs that included clinical pathways, either complemented by provider or health plan, 167 (65%) were vendor programs, and 90 (35%) were internally-developed programs (Table 1).
After reviewing this data, we wondered, “Are programs that include clinical pathways doing something very different from those that do not?”
Provider and Payer Perspectives on Clinical Pathways Program Definition
We received a variety of comments on the different approaches to the concept of clinical pathways, including those outlined in Boxes 1-4. These selections of quotations were chosen as the best representations of the feedback as a whole from each group.
Vendors agreed that clinical pathways programs meet a higher standard and have been vetted with their health care provider and payer customers (Box 1).
According to health plan professionals, including regional and national pharmacy and medical directors across the United States, documentation and reporting structure of clinical pathways programs equate to additional value and cost savings; however, there are different thoughts on how that happens (Box 2).
According to community- and hospital-based health care providers across the United States, clinical pathways more commonly can be interpreted as taking a broad list of treatment options and reducing that to a narrower selection that is considered clinically reasonable and appropriate. From that selection, they would then provide compliance metrics on preferred selections from that narrower list. But providers also can apply NCCN guidance broadly by stating that selections are appropriate if rated at or above a certain NCCN Category of Evidence and Consensus (eg, Category 2A or 2B) and consider that appropriate as well. Currently, however, there is no true consensus across all the provider programs we have captured throughout our research on whether clinical pathways should be narrower than a list of all appropriate options, such as seen in NCCN Compendium and/or NCCN Guidelines (Box 3). Even among those using clinical pathways, we do not have a standard definition of the purpose of clinical pathways and clinical criteria.
Comments in Box 4 are a selection from the 11 payers and providers identified in our research that are not using clinical pathways or an official cancer management program but are following nationally-recognized guidelines. These comments imply a perspective that clinical pathways may not be necessary for providers to use to document evidence-based care.
For 2 practices that are selecting treatments for patients, one is using a clinical pathways vendor program based on NCCN Category 2A evidence and consensus, while the other reported not having a clinical pathways program but following the same NCCN guidance. Thus, absence of clinical pathways should not imply that evidence-based care is not happening.
Discussion
In summation, what we have gathered thus far, among clinical pathway users and non-users, is that there are varying definitions of clinical pathways, including varying criteria, varying means to measure compliance, and how to make appropriate clinical treatment decisions.
Similarities Among Criteria in the Different Activities
As mentioned above, our collective interviews and surveys also took into account payers and providers that use nationally-recognized clinical guidelines as the basis of decision support (eg, NCCN Category 2A or 2B) or for treatment and reimbursement decisions with no confirmed cancer care management program. We compared these data to entities that will use NCCN to assess treatment options and prepare a select set of preferred pathways. An important takeaway in relation to this is that NCCN content may be considered to be the basis for selecting preferred regimens in a clinical pathways program, a decision tool for individual patient treatment decisions in cancer care management programs that do not include formal clinical pathways, and as general guidance for evidence-based care when a confirmed cancer care management program does not exist. In each case, the payer or provider asserts that they are approaching transparent, consistent evidence-based decision making (Table 2).
Although the numbers in Table 2 are not high, there is still some consistency in findings, whether in the presence or absence of official cancer care management programs or clinical pathways. As represented in Table 2, without a standard definition of clinical pathways, providers and payers may apply similar criteria (eg, following NCCN), but they refer to clinical pathways as something different. Thus, interpretation and definition of clinical pathways can include something prescriptive (eg, limited, preferred regimens with metrics), guiding (eg, NCCN category 2A), or a little of both.
Implications of Data
Based on the interviews and surveys conducted and subsequent findings, it seems that before we can judge what providers and payers are doing specific to evidence-based clinical decision making, we need to:
- define what constitutes a clinical pathway program;
- consider a program, no matter what the source;
- understand that providers may not identify treatment plans as pathways (even though clinical criteria are similar to clinical pathways programs); and
- establish the value of being considered a clinical pathways program.
In the end, this will assist in bringing all interested parties together—vendors, payers, providers, industry—to concur if there is a need for clinical pathways (regardless of whether the decision to use them is according to the asserted standards of clinical pathways or through alternative activities) before more time and money are spent on developing them.
Conclusion
While ASCO has introduced helpful policy statements to assist in the evolution of value-based care delivery and the dissemination of clinical pathways, variations in use, perceptions, and execution of clinical pathways programs and similar (perhaps alternatively named) programs will persist in real-world practice. It is important to understand these variations in perception, criteria, and practice in order to move forward in enhancing clinical pathways programs with the aim of delivering high-quality, value-based oncology care.
References
1. Schroeder A. Cancer management systems–are we heading down the right road? Oncology Issues. 2012;27(5):30-37.
2. Schroeder A. Clinical pathways: a current snapshot, and the journey ahead. J Clin Pathways. 2017;3(2):33-40.
3. Zon R, Frame JN, Neuss MN, et al. American Society of Clinical Oncology policy statement on clinical pathways in oncology. J Oncol Pract. 2016;12(3):261-267.
4. Zon RT. ASCO policy statement on clinical pathways in oncology: why now? Am J Manage Care. 2016;22(5 special issue):SP162-SP164.
5. DK Pierce & Associates, Inc. DKP Critical Insights®—Clinical Pathways and Other Cancer Management Models–Vendor, Provider, and Payer Perspectives, 2011-2018 [proprietary research].
