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EVOLUTION OF PATHWAYS

A Decade of Progress: The Evolution of Clinical Pathways and the Role of the Journal of Clinical Pathways in Advancing Value-Based Cancer Care

February 2025

J Clin Pathways. 2025;11(1):8-12.

This year, we proudly celebrate the 10th anniversary of the Journal of Clinical Pathways. During our 10 years, we witnessed the transition from what was once a sequencing of medical oncology (med-onc) treatment regimens to what is now one of many tools needed by health systems and practices to navigate the complexity and challenges of value-based can­cer care successfully.

The Development and Distinction of Clinical Pathways in Oncology Care

The scope of clinical pathways has evolved from med-onc drug treatment regimen sequencing to an encompassing compre­hensive care plan embedded in an electronic medical record (EMR). As first noted back in 2015, health professionals use the term “clinical pathways” a lot. However, the reference to clini­cal pathways will differ across different stakeholders. Clinical pathways—also referred to as “treatment pathways,” “patient pathways,” or simply “pathways”—have been used to repre­sent anything from treatment protocols to mandated treatment plans. Furthermore, many use the label of clinical pathways in­terchangeably with clinical treatment guidelines, such as those developed and maintained by the National Comprehensive Cancer Network (NCCN) or the American Society of Clinical Oncology (ASCO) for cancer treatment.1 Yet, oncology care stakeholders must clearly distinguish between clinical guide­lines and pathways. While both are driven by clinical evidence leading to decision support, clinical guidelines will delineate treatment options in any given clinical situation. In contrast, clinical pathways are conceptually intended to be utilized by a multidisciplinary team focusing on quality and care coordina­tion while introducing the concept of accountability.1

The differences between clinical guidelines and pathways are subtle but definitive. In this article, we will look at the evo­lution of the clinical pathway arena from the perspectives of payer and provider organizations, eg, health systems and prac­tices. We will discuss the successes, lessons learned, and the “work in progress” concerning the vision for clinical pathways since the journal’s inception 10 years ago.

Challenges and Progress in Managing Oncology Costs Through Value-Based Care

According to our research, most small- to mid-size payer organizations have not approached the topic of managing their oncology spending. At a minimum, these health plans rely upon their pharmacy benefit managers (PBMs) to administer a prior authorization (PA) program to control the utilization of oral chemotherapy medications and the distribution chan­nel, ie, driving the distribution to the specialty pharmacy for tighter monitoring and follow-up activity. These PA programs focused on ensuring “appropriate use” as defined by compendia listing or US Food and Drug Administration (FDA) approval.

Early Oncology Management Programs

A few payer organizations had minimally controlled the uti­lization of individual oncology medications through medi­cal “precertification” programs on top of their prescription benefit-based PA programs, which also tended to be focused on appropriate use, as defined by compendia listing or FDA approval.2 Only a few larger national and regional payer orga­nizations implemented pathway programs, promoting select­ed preferred med-onc regimens. Treatment regimens, pro­cessed under the medical benefit, were evaluated internally or through a vendor partnership, eg, New Century Health, evi­Core, or P4 Healthcare, based upon efficacy, safety/tolerabil­ity, and cost to arrive at the preferred treatment option.1 Pro­gram models varied, as these were the first attempts for payers to manage their oncology cost of care. The goal of these early programs was to decrease the variability in treatment regi­mens and sequencing, reduce waste, improve outcomes from both a quality of life and a clinical outcomes perspective, im­prove the patient experience, and control cost, thus fulfilling the goals of the Triple Aim.1 The variability was mainly the prescriber’s level of adherence, eg, voluntary vs mandated, with mandatory participation resembling a strict PA/precer­tification program.

With the initial results of the Center for Medicare and Medicaid Innovation (CMMI) primary care accountable care organization (ACO) program and the implementation of the CMMI Oncology Care Model (OCM), many envisioned that these basic med-onc treatment sequencing pathway programs would transition into a value-based care (VBC) model arrange­ment. The Journal of Clinical Pathways shared this vision with the retirement of the tagline, “The Foundation of Value-Based Care” in favor of a new tagline “Advancing Value-Based Care,” in 2024, reflecting the continuing need to balance cost and clin­ical perspectives in health care without losing sight of the end goal, which is delivering the best patient care and optimizing clinical outcomes.

The question is: what were the successes and lessons learned from the past 10 years? The greatest success payers experi­enced was educating and informing providers of the merits and considerations of new and old treatment options. In some respects, this education process could stem from a traditional prior authorization program. Still, educating and inform­ing providers is valuable when the PA program incorporates treatment sequencing, much akin to the NCCN guidelines or traditional step-therapy standard in the prescription benefit. Providers are made aware of other treatment options and the basis of those treatment options as a preferred alternative. This educational process proved valuable as the rapid approval of new and novel medications proved challenging for providers to stay up to date.

The vision of payers was that there would be a slow transi­tion to VBC models, like the OCM and Enhancing Oncology Model (EOM) programs, where fee-for-service would transi­tion to favorable risk arrangements and then further transition into upside and down-sided arrangements. Unfortunately, this transition is not occurring as anticipated from the payer’s perspective. Potential hurdles to the VBC transition include the rapid emergence of new and novel technologies, streaming from a pipeline fueled by advanced research for more effective and safer treatment options. Unfortunately, these new and novel treatment options come with a price premium.

Interoperability, Patient Preferences, and Scalability Challenges

Another significant hurdle is our inability to achieve interop­erability at a high enough level to comprehensively evaluate a patient’s status at any given time, as well as the inability of a practice to determine their level of providing cost-effective care. Our health system primarily operates in a fragmented world, where there is little communication of resource utili­zation and cost information between payers and providers and minimal communication between provider specialties. As a re­sult, care provided to patients remains disjointed. The move­ment of creating a successful VBC model requires practices to be able to review their resource utilization, with possible alternative treatment options explored and evaluated. From a payer perspective, especially the national payers, interfacing with network practices to communicate utilization informa­tion is not a scalable capability. Thus, the provision of care will remain a one-sided discussion between the payer and pro­vider, as opposed to a two-sided collaboration.

Finally, as the industry becomes more sensitive to social disparities in cancer care, discussions of patient preference are increasing. However, with increasing patient preference discus­sions comes a greater opportunity for inconsistency in cost-effective care. Patients may opt for more aggressive care when more aggressive care is either inappropriate or has minimal po­tential to improve or change the outcome. In contrast, patients may opt out of treatment for financial reasons, thus having the potential to increase overall care costs due to the more rapid progression of the disease. Whichever the situation, such pa­tient decisions may blunt the enthusiasm for practices to accept a two-sided VBC agreement simply because they cannot con­trol the patient’s decision.

These, and many other hurdles, have slowed the success of developing, implementing, and administering VBC mod­els. Most payers are still at a stage where they cannot create an intraoperative environment that can support a two-sided col­laboration. One payer organization noted as having developed a collaborative VBC agreement successfully. However, the pro­gram was recently implemented, and we all are awaiting the results.3 While conceptually viable from a strategic perspective, scalability remains the issue to support the practice by most payers. Payers are left with having to deal with higher treat­ment option prices, as well as an increasing prevalence due to better diagnostic capability, driving the cost trend higher.

In summary, the uptake of VBC agreements is slower than anticipated, and payers indicate that they are moving back to­ward the pathway PA model. While this places an undue bur­den upon the workflow at the practice, it is also noted that the PA process will most likely not go away until the practices start taking some portion of the risk. In some cases, payers are placing pressure upon their vendor partnerships to share the financial risk; however, with the cost trend of oncology treat­ment registering over 10% annually, assuming risk as a vendor is also a precarious proposition. Finally, due to the rapid emer­gence of new and novel medications, more payers are turning to vendor partnerships to manage their oncology care costs. Vendors already have processes to manage high-cost populations and may accept partial risk. To mitigate financial risk, they could expand management to include radiation, diagnostics, and artifi­cial intelligence (AI)-enhanced algorithms. However, payers still face significant challenges in controlling cancer care costs.

Clinical Pathway Progress With Providers

While payers have found limitations in the utility of path­ways, oncology practices of all types have embraced pathways to improve quality, enforce practice consistency across multi­ple sites, and control utilization in the face of increasing VBC contracts.

The Oncology Care Model and Pathway Adoption

The US Department of Health and Human Services (HHS) an­nounced a payment and care delivery model for cancer care, the OCM,4 which launched in 2016. OCM included a key feature that drove rapid adoption of pathways: it required par­ticipating practices to treat patients with “therapies consistent with nationally recognized clinical guidelines.”5 Because of the need to document their adherence to these “nationally recog­nized clinical guidelines,” licensing a pathways product from a commercial developer was the fastest and most certain path to success. For that reason, several practices, including academic medical centers such as Jefferson Health,6 licensed and imple­mented pathways programs in 2015 and 2016 to comply with this requirement.

The key change that this and other program-specific path­ways programs created is that pathways were not deployed for just the patients covered by OCM or other VBC programs; pathways were usually deployed for all patients in the practice. This approach was similar from a workflow standpoint, and oncologists could also more rapidly see the benefits of using pathways regularly.

A few larger cancer centers built their pathways during this period instead of licensing existing ones. Moffitt Cancer Cen­ter created its own pathways as early as 2009 to better reflect its models of care. The Carolinas HealthCare System’s Levine Cancer Institute launched its first oncology clinical pathways as early as 2012.7 Cleveland Clinic collected data on its care path­ways in 2014,8 and they were followed by Emory’s Winship Cancer Institute and Kaiser Permanente.

In some instances, the driver behind the in-house develop­ment of pathways was that a particular institution had a dif­ferent model of care than was supported by existing pathways programs. This was the case with Moffitt Cancer Center, whose care model integrated multiple modalities of care as well as supportive care throughout the treatment process. For others, such as Kaiser Permanente, the key decision point was cost— for a cancer program with the size and scope of Kaiser Perma­nente, the cost to license a pathway developer product was seen as prohibitive.

A new innovation in pathways was launched in 2017 when IBM’s Watson AI engine showed promise in a clinical setting for oncology treatment selection.9 Initiated in 2012, the part­nership between IBM and Memorial Sloan Kettering Cancer Center (MSKCC) trained Watson on selecting treatment pro­tocols for multiple cancer types based on patient-specific clini­cal data presented to it. It was in testing with multiple cancer centers by 2017.9 As it grew and was exposed to more clinicians who found its limitations, this first instance of using AI in a pathways model was scaled back in 2018 when many custom­ers canceled contracts, citing “high costs and underwhelming results” and “recommendations [that were] simplistic, biased toward MSKCC practices, and poorly adapted to local guide­lines.”10 Despite having spent over $4 billion dollars for its de­velopment, IBM sold the Watson Health division to a private equity company in 2021; specific terms were not disclosed, but IBM had been seeking a price of $1 billion for these assets.11

Standards, Innovations, and Adoption Trends

The proliferation of pathways development from multiple sources prompted the ASCO to create a set of criteria defin­ing high-quality oncology clinical pathways12 development. Though there have been issues around the inclusion of patient voices in pathway development, decreased transparency in dis­closing the methodology, and potential conflicts of interest in the years since these criteria were put forward, most pathway developers today still adhere to most of these criteria.

In 2019, Flatiron joined the ranks of pathway developers when it launched its Flatiron Assist platform. Initially designed to allow clinicians to more easily access NCCN guidelines us­ing data already in Flatiron’s OncoEMR health record, the plat­form also allowed practices to build their own content. OneO­ncology and OnCare are pursuing this path of using Flatiron to develop practice-specific pathways.

With Flatiron Assist, Flatiron introduced an innovative way to access treatment recommendations.13 Instead of requiring a clinician to enter all the fields needed by the system, Flatiron presented a list of possible recommended treatment plans that were narrowed with each additional piece of data entered by the clinician. Once the clinician saw their preferred option on the “short list,” they could select that, and Flatiron Assist would ask them to confirm the remaining missing data, infer­ring it from the clinician’s choice. This allowed Flatiron Assist to confirm the plan and ensure the data in the electronic health record (EHR) was complete and accurate.

The high level of integration with OncoEMR, the under­lying EHR, facilitated the goal of saving time and clinician keystrokes. Pathway organizations such as Via Oncology, in­creased the efficiency of their systems through better and deeper integration.14 The advent of EMR-vendor “app stores” that provided ready-made data connections helped with integra­tion. However, it was still less well integrated than those path­way programs that existed as part of the EHR platform.

During 2020 and 2021, the adoption of pathways slowed considerably as oncology practices delayed or cut capital projects due to the pandemic and reduced patient volumes. Despite these cutbacks, OneOncology launched its internally developed pathways in 2022 with 12 disease committees.15 The primary difference between OneOncology and other cancer programs that have developed their internal pathways are the scope and scale of the OneOncology effort. OneOncology has grown from about 230 oncologists formed by West Clinic, Tennessee Oncology, and New York Cancer and Blood Spe­cialists in 2018 to over 550 oncologists today.

A similar effort to develop network-wide pathways was un­dertaken by OnCare Alliance, a group of 32 practices and over 472 oncologists.16 Formed in 2024 by a merger between Quali­ty Cancer Care Alliance (QCCA) and NCCA, two independent practice groups that appeal to independent community prac­tices, OnCare has also landed on the Flatiron Assist platform for its pathways.

Trends in Provider Pathways

Over the past 10 years, several notable trends have emerged in the use and adoption of pathways in oncology practices. On­cology clinical pathways have become more reliant on NCCN as a basis, more clinics have developed their own pathways for various reasons, and more oncologists are using pathways than ever before.

The US Oncology Network launched its Value Pathways Powered by NCCN in 2013. At that time, the US Oncology Network chose to forgo the traditional internal expert-driven disease committee approach in favor of leveraging the guide­lines NCCN offers, then narrowing the selection to a pathway using experts from NCCN institutions as well as some internal disease experts.17

Other pathway developers, including many payer programs, also rely on NCCN to build their narrowed list of acceptable recommendations by disease presentation. Except for Elsevier ClinicalPath, which incorporated NCCN recommendations as primary off-pathway choices, most pathway developers refer­ence NCCN in some way.

Despite the high cost of building and maintaining pathways for various disease presentations, numerous major cancer pro­grams have chosen to develop their own pathways instead of relying on an existing vendor. Moffitt Cancer Center, Winship Cancer Institute at Emory, Kaiser Permanente, Levine Cancer Institute, and many others have internally developed oncology pathways, usually for their own use.

As mentioned above, developing and maintaining a high-quality oncology pathway program can incur substantial costs for a cancer center. For a cancer institute to take that one step further and decide to become a software developer so they can sell their pathways program to other cancer centers increases the financial commitment considerably. Additionally, the gen­erally deliberate, consensus-driven nature of cancer centers, especially those attached to academic institutions, is often in­compatible with the fast pace required to develop software and adapt to customer needs.

The user base of oncologists using pathways has expanded significantly. Between internal development, network-wide adoption of pathways, and the impetus of VBC in driving path­way adoption, more and more oncologists are using pathways to determine treatment plans.

For example, Elsevier’s ClinicalPath has roughly doubled from 28 practices and 1150 oncologists in 201518 (when it was Via Oncology) to over 2100 oncologists and 51 practices in 2024. Only one of the originating practices in OneOncology, Tennessee Oncology, and one additional practice that joined later, The Center for Cancer and Blood Disorders, histori­cally used pathways. Launching its own pathways program and ensuring its adoption network-wide will consistently expose over 400 additional oncologists to the benefits of pathways. As more oncologists and practices join national networks such as OneOncology, OnCare, and the US Oncology Network, they are being brought into the fold of pathway users.

In 2017, Kathy Lokay, who was instrumental in the ini­tial launch of oncology clinical pathways at US Oncology Network in 2005 and led Via Oncology from 2009 through its acquisition by Elsevier in 201819 said, “Our biggest com­petitor is delay,” indicating that resistance to adoption was the biggest sticking point for providers.20 Thankfully that seems to be changing for the better. Gaining adoption among many oncologists entrenched in their ways remains challenging, but the economic realities and the needs of evolving payment mod­els means that there is less latitude of unwarranted individual variation in treatment patterns between oncologists.

Conclusion

Clinical pathways have made significant strides in shaping the landscape of oncology care over the past decade. What began as a tool for sequencing treatment regimens has evolved into a cornerstone of VBC, addressing the complexities of mod­ern health care. Pathways have become essential for improving quality, promoting consistency, and navigating cost contain­ment, even amid challenges like interoperability, scalability, and rapidly advancing treatment options.

Despite the hurdles, the widespread adoption and refine­ment of clinical pathways by payers, providers, and pathway de­velopers demonstrate their critical role in achieving the Triple Aim of health care: improving patient experience, enhancing population health, and reducing costs. Innovations in technol­ogy, such as Flatiron Assist, and institutions’ dedication to cre­ating tailored solutions have further advanced pathways’ utility and accessibility.

As we celebrate the Journal of Clinical Pathways’ 10th an­niversary, we recognize the progress and the challenges that remain. Our shared goal—to deliver the best patient care while optimizing outcomes—continues to drive us forward. With ongoing collaboration, innovation, and a commitment to addressing barriers, the future of clinical pathways holds prom­ise as an integral component of high-quality, value-based oncology care.

References

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