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JCP Special Report

Recommendations for Creating an Oncology Clinical Pathways Framework Tool Based on Payer, Provider, and Patient Priorities: Findings From the 2021 Care Pathways Working Group

May 2022

J Clin Pathways. 2022;8(4):28-46. doi:10.25270/jcp.2022.05.3

Executive summary: Rising oncology costs have led to shifts from volume-based to value-based care. Alternative payment models and innovative provider contracting are two ways of creating new value frameworks. Another way to potentially reduce treatment cost while standardizing care is by using clinical pathways. Oncology clinical pathways can reduce unintended variations of care and improve organizational efficiency of care delivery. In an era where research is abundant and standards are quickly changing, pathways make it easier for providers to deliver high quality care plans, and for payers to approve them. Pathways still need honing, though, and payers, providers, and patients approach them from different angles and concerns. The Journal of Clinical Pathways convened the 2021 Care Pathways Working Group to identify and reconcile the different pathway drivers for each stakeholder now and five years into the future. The goal was to create a framework tool based on oncology care stakeholders’ core priorities and value points, to inform and encourage greater collaboration among stakeholders.

The inefficiency and variation in oncology care in the United States is well documented, with avoidable hospitalizations and emergency department (ED) visits occurring frequently, high service utilization at the end of life, and use of high-cost drugs and biologicals when lower-cost, clinical equivalent options exist.1 The quality of patient care often varies based on numerous factors, such as health care setting, geographic location, access to medications, insurance coverage, and treatment protocols.2 Attempts to mitigate rising oncology costs have led to a shift from volume-based to value-based care. The result is the introduction of alternative payment models as well as innovative provider contracting, and new value frameworks.3 This focus on value has driven an increased interest in payment models, including clinical pathways and other decision support as a way to maximize evidence-based care, while minimizing ineffective or costly treatments. These tools hold promise in supporting patient-centered care and improving care quality for patients with cancer. They also hold potential in reducing inappropriate and wasteful spending and constraining rising prices by demanding a stronger link between treatment cost and value.4 The scope and utilization of oncology clinical pathways have increased in the United States since they were first introduced in 2005.5 Reducing unintended variations of care, improving organizational efficiency of care delivery, and increasing value are the primary focuses of oncology clinical pathways. Improvements in these areas, especially decreasing treatment variability, helps control costs and reduces unwanted variations in care. As the U.S. health care system moves away from a volume-incentivized, provider-centric model to a value-based, patient-centered model, well-designed pathways have grown in importance. They serve as a foundation for comprehensive patient care while promoting high-quality, value-focused care.6-8 Building on the work done by the American Society of Clinical Oncology (ASCO)9,10, Clinical Pathways Taskforce, the Journal of Clinical Pathways convened the Care Pathways Working Group (the Group) in 2020 to further the evolution toward value-based care. The Group detailed recommendations in three key areas of pathways: pathways development and maintenance, pathways management and measurement, and market impact and pathways future directions.11 In light of its findings, the Group concluded that future pathways should align stakeholders’ concerns and integrate them into the model of care. Furthermore, they agreed that achieving patient-centric, value-based care is not the responsibility of any single stakeholder. Instead, value-based care must be driven by collaborative dialogue among the various stakeholders that works toward a shared goal and complementary action.11 This article details the work of the 2021 Care Pathways Working Group as it sought to identify and reconcile the different pathway drivers that are important to each stakeholder now, and five years into the future. The aim was to create a framework tool based on oncology care stakeholders’ core priorities and value points, which can be used to inform and encourage greater collaboration among stakeholders.

Methods
 

Participants and Design
The Group was led by three health care experts with more than 50 years of combined pathways experience from the payer, provider, and vendor perspectives. Table 1These experts also led the 2020 Working Group. Five subject matter experts were also invited to participate in the Group. The Group outlined the key pathways stakeholders: payers (including self-funded employers), providers/practices, and patients. Representatives from each of these three groups were identified to participate in 1-hour interviews to collect data on each stakeholder’s priorities and perceived barriers in the context of current environment, with the goal of encouraging collaboration among stakeholders over the next five years. Interviewees included two payers; five practicing oncologists with documented experience in value-based care, pathways, and quality improvement; and two patient advocates. Box 1Co-chairs then compiled a list of questions to use in qualitative interviews to identify areas of agreement, overlap, conflict, and areas of complete disconnect among stakeholders (Box 1). Following the interviews, findings were compiled and reviewed by Group members. The Group compiled a table of key priorities and concerns for each stakeholder group.

 

Results
 

Payer Perspectives
 

Putting the Payer Perspective of Clinical Pathways in Context
In 2020, prescription expenditures in the United States totaled $535 billion, a 4.9% increase compared to 2019. The ambulatory prescription drug market, including both retail and mail order, accounts for $373 billion, or about 70% of the total pharmaceutical market. In-office and clinic medication accounts for a little over $98 billion, or just over under 18% of the total market. Overall cost drivers were: changes in utilization, new product releases, and higher costs of existing products.12

In terms of medication costs, the leading therapeutic areas are immunology, diabetes, and oncology, with the total oncology medication cost reaching $72 billion in 2020. The oncology cost drivers are the release of new molecular entities, balanced by brands losing exclusivity, and the availability of biosimilars and generic alternatives. Five of the top 10 tumor types (breast, non-small cell lung cancer (NSCLC), multiple myeloma (MM), prostate, and non-Hodgkin’s lymphoma), had double-digit spending growth, accounting for 52% of the total cost of cancer medications.143

Respondents to the 2021 Journal of Clinical Pathways benchmark survey indicated that traditional fee-for-service reimbursement is down from 2020, balanced by increases in payfor performance and full financial risk models. Partial financial risk reimbursement also increased. All these indicators point towards a continued movement towards performance-based or value-based financial arrangements.14 Payers are still viewed as a driver of pathway utilization, whether tied to their utilization management program or tied to payers moving more to performance-based reimbursement models. Alternative financial reimbursement models were a significant driver increase from 2020 to 2021, as were pathway programs pushed by parent organizations, mostly like a result of increased consolidation in the oncology provider arena.15

The Current Payer Perspective of Clinical Pathways
Payers see the utility of clinical pathways from three perspectives. The first is that payers feel clinical pathways are a cost containment and utilization management tool. They have the fiduciary role of managing cost and ensuring appropriate care administration. That is because a good portion of oncology costs are driven by variations in care. By using pathways to reduce these variations, new standardized optimal care could improve risk-based contracting.

Payers also see that clinical pathways can assist in coordinating care as new treatments are approved and precision medicine advances. Treatment advancements are overwhelming for providers and almost impossible to keep up with. This is especially true from a payer perspective since payers are not directly providing the care.

Payers see pathways becoming the foundation of alternative payment models in a risk-based or performance-based environment. This is not to imply that all alternative payment models, be it risk-based, performance-based, or a combination, will mandate the use of care pathways. However, oncology practices may independently implement a pathway program as one tool to allow the practice to be successful under one of these reimbursement models.

The Payer’s Priorities
Our research indicates that there are two priorities for payers with respect to clinical pathways: reducing cost of care and reducing treatment variations. The primary payer priority is cost of care. The cost is currently mostly focused on the treatments, which is primarily driven by the rising cost of treatments, and treatment variations, a perspective commonly shared by other stakeholders.

Research shows that using pathways to reduce variations in treatment regimens reduces cost. High-cost medications are generally newer, targeted therapies, and pathways will help ensure they are being used appropriately.

Pathways can also assist in defining and standardizing optimal care, which can then be used as the foundation for performance-based contracting and other alternative financial models.

It is likely that the early pathways adopters and innovators will be the practices and organizations most expected to transition to future alternative financial models. These will probably be a risk-based model. The question is who will take the risks and how much of the risk they will be willing to accept.

Barriers: The Payer Perspective
Payers face several barriers in getting clinical pathways adopted. One is that the current healthcare system is fragmented, with minimal interface between providers, and minimal data sharing. This makes it nearly impossible to gain a total cost picture, especially when medical and pharmacy benefits are under different carriers. Determining the total cost of oncology care is vital to the success in developing alternative financial reimbursement arrangements.

There is also a growing realization by payers that any payer-based initiative forced on practices will disrupt practices’ workflow. It will reduce the level of acceptance by practices that cannot afford to stretch their resources to accommodate varying plans. This is especially true of utilization management programs, as the payer-imposed administrative burdens on practice workflows can be difficult to accommodate.

Payers are realizing that the size and type of practice may also be a barrier. This perception is shared by providers, but it differs based on the practice type. Academic institutions are generally not focused on pathways as they are more concerned with clinical trials and innovations. Non-academic and integrated delivery networks are the groups that are most accepting of pathways, as they are trying to differentiate themselves from the academic centers, and are more patient-focused. Community-based practices often do not implement pathways, as they do not have the resources nor means for implementation, especially from a return-on-investment (ROI) perspective. 

5-Year Vision:
The Payer Perspective What does the 5-year vision hold from a payer perspective? For the most part, the future payer priorities remain the same. That includes the top priority of controlling the cost of care. The health care system needs to develop the ability to identify the true total cost of care, including direct and indirect, so there is a sound method to evaluate a pathway’s impact. Payers must transition the focus from the cost of individual treatments to the total cost of care. While payers currently have the most comprehensive cost data sets available, these data sets fall short of providing a full cost view. The key success factor will be the ability to integrate cost data sets and allow the data to be shared between the stakeholders providing care. However, this will only address direct medical expenses.

The indirect costs of providing care such as caregiver time, productivity, and social determinants of health are still unknown. Also unknown are the true impacts of patient preferences and social determinants of health, but sensitivity to these factors is important for the future.

Another key priority in the next five years is to create a more sound and sophisticated analytical process or system, to help in developing a financial framework. This will allow payers to partner with practices to create win-win arrangements. An analytical process will help give the payer confidence that high quality and cost-efficient care is being provided. This would allow payers to help support practice workflows by reducing the administrative burden through gold card-type programs. Payers may simply delegate the total provision of care to the practices through an alternative reimbursement model and support the model and practice by providing data. 

5-Year Vision: Payer Barriers
The barriers to care pathways in the future will generally remain the same. We will still have a fragmented health care system. The impact of minimal system and data integration is minimal care coordination. This leads to the potential for duplicative services and testing, and lack of services coordination. Overcoming this barrier will go a long way toward improving care coordination.

The administrative burden to the practices will continue to exist in all oncology practices, especially those that work with multiple payers. Most practices do not have a predominant payer. With an increase in clinical pathway adoption from the payer side, practices will experience greater administrative burdens to accommodate the various programs. 

5-Year Vision: Payer Goals
In the next five years and beyond, we hope that the health care system can tackle the problems of fragmentation and lack of data integration, simply because there is a vital need to decrease the administrative burden for the practices. Practices need data to support their care provision efforts and gold card programs to help reduce the administrative burden.

Payers need to be more aware of patient preferences because it will lead to greater patient value, even if it also leads to more off-pathway services. Services like molecular testing, supportive care, and end-of-life (EOL) care need to be utilized and covered to allow oncology care to become more patient-centric.

Future payer priorities should also include learning more about social determinants of health and allowing them to be addressed earlier in the treatment decision-making process. The topic should not be addressed by forcing payers to be more flexible with their utilization management program. Instead, the impetus for learning more about social determinants of health is to understand how and why specific treatment decisions are made and to address patient issues based on what is learned.

How payers view value in the future will likely be the same as today, but payers need to evolve in their perspective of off-pathway utilization. Perhaps payers should not be using pathways concordance as the ultimate performance metric because as we bring social determinants of health into the algorithm, there is the potential for appropriate off-pathway care.

In five years, it is possible that payers will not be driving pathways programs. The payer role could unfold in one of two ways. The first is that payers will delegate total patient management to practices and simply support the practice by providing data, thus creating some type of full risk arrangement for the practice. The second is that payers will move into two-sided risk sharing partnership with practices.

Many argue that payers will likely delegate care and create risk arrangements. In this light, payers can help establish or support a care pathway to define or represent optimal care; but the payer then must get out of the practice’s way to allow them to factor in social determinants of health and patient preferences to arrive at the final treatment decision, which may or may not be on pathway. Payers should not penalize the practice for lack of consistency.Table 2

There will likely be unintended consequences of shifting dynamics as we work to develop new solutions. We don’t know what the future barriers will be because we don’t yet know the future solutions. However, we can be sure that as change occurs, new barriers will evolve, for which we will need to continue to develop new solutions.

Provider Perspectives
 

Essential Priorities for Pathways from the Provider PerspectiveFrom a practicing provider perspective, the Group identified several essential priorities for pathways to embody. This includes today’s primary care focus: to provide the best quality care at the lowest cost and with the highest patient satisfaction. Providers are bombarded with rapidly expanding scientific knowledge and increasing cancer care options and paradigms. In this environment, clinical pathways become even more important in helping educate the patient and provider about new treatment options, and offering the best options for patients while considering social determinants of health, cost, effectiveness, and patient preference. 

Providers also want to utilize the data collected from pathways to learn whether and how clinical outcomes are affected by pathway choices, and the associated costs. The US health care system is moving away from a volume-incentivized, provider-centric model to a value-based, patient-centered model. The total cost of care along the cancer care continuum is part of the comprehensive assessment of high-quality patient care. 

Therefore, as practices are increasingly assessed by quality and cost metrics, clinical pathways must be able to improve practice success in value-based models. This will assist practices participating in two-sided risk payment models, with shared savings realized by the payer and provider.

Barriers: The Provider Perspective 
The Group identified several barriers to achieving these priorities, including inconsistent integration into electronic health records (EHR) and practice workflow across all pathway users. Differing pathway programs, whether payer- or provider-facing, seem to have varying success in this domain. Another barrier is the cost of pathway purchase, implementation, and maintenance. Pathways may be cost-prohibitive to practices of all sizes, and practices note that the ROI in using the pathway program must cover these costs. 

Additionally, practice flow integration is needed to improve provider satisfaction and the working environment. Provider burnout and the continued early retirement exodus of experienced oncology providers remains a concern, especially with the increased stress of practicing during the pandemic. The Group acknowledged that current pathway programs increase administrative burden and do not support this important aim. Pathway programs have not consistently reduced administrative burden, and have not omitted the need for preauthorization for proof of compliance. 

Similar to what the ASCO Pathways Task Force identified, a practice or health care system’s business model may be a barrier to clinical pathway uptake. Instead of the word barrier, a health care system might instead say that clinical pathways are not relevant to the organization’s needs. For example, clinical pathway programs focus on evidence-based medicine, in addition to clinical trial options for decision-making. However tertiary care centers, which offer expert opinions and novel intervention options, by definition, may not find pathways helpful for their patient population.

Finally, in reference to the initial ASCO Development Criteria for High Quality Pathway Programs, comprehensive pathways across the cancer care continuum were identified. The Group agreed that in order to fully assess and deliver effective, high-value patient-centered care across the continuum, a number of things must be included: diagnosis, treatment, supportive care, survivorship, and EOL management. The cost analysis for pathway programs needs to include more than just drug treatment options. 

Only using those costs excludes associated costs for variations in diagnostic testing, acute care presentations, and quality of life analysis as a reported patient outcome. True value-based patient-centered care must include the patient’s total care experience and the total cost of care associated with the patient’s cancer experience. 

5-Year Vision: Essential Priorities for Providers
This 5-year vision is based on the identified priorities and barriers. If clinical pathways are going to support value for entire cancer care continuum, they must be comprehensive, with timely and clinically-relevant updates, and support the value-based models of care by providing real-time data analysis. The data analysis should include metrics to assist the practice with daily business management, such as drug purchasing, payer and employer contract management, and clinical care improvements.

The vision also includes pathway support of institutional business models, acknowledging that not all business models will benefit from clinical pathways as pathways do not uniformly address all demographics seeking care at a particular institution. The interviews showed that in tertiary care centers, patients seeking expert management will not fit into the usual pathway algorithm. One suggestion is to accept that clinical pathway adoption does not represent an all-or-nothing proposition. Adoption should be tiered, based on common needs. For example, treatment side effect triage, survivorship care, and EOL care pathways could be adopted by all sites of service, as these algorithms will likely be similar. However, advanced diagnostic and drug therapy pathways could be adopted by the institutions following evidence-based and National Comprehensive Care Network (NCCN) guidelines, and may not be appropriate for centers offering novel and innovative care. To this last point, the Group agreed that innovation should not be stymied by mandatory pathway adoption by institutions serving unmet patient needs in NCCN-guided clinical pathways. 

The providers also support the concept that pathway programs must be easily and seamlessly integrated into the daily workflow and provide real-time patient care management recommendations. The current lack of integration adds administrative time to the provider and business operational flow, and often delays care decisions. Providers articulated that they feel they are working for the pathway, when the pathway program should work for the patient and provider in an efficient manner, while also recommending high-quality care.

5-Year Vision: Barriers for Practice Adoption
Pathways do not serve the needs of advanced cancer scenarios where innovative interventions would be most appropriate. This is a barrier for pathways usage from a treatment and diagnostic perspective. It does not necessarily exclude the possibility of utilizing some pathway algorithms based on cost and ROI opportunity in survivorship care, for example. 

Another barrier to pathway adoption is if multiple payers require their own pathway programs, with differing reimbursement models for drugs. It is also a major barrier for payers to require use of a pathway program without payment to support pathway operations.

Finally, some providers do not trust artificial intelligence (AI) as the sole, final authority in care delivery decisions. AI-driven pathways may guide discussions, and in many cases offer reasonable, standard of care options. However, the provider and patient must be allowed to make final decisions, while considering social determinants of health, the patient’s unique needs, and the resources available to support the most appropriate care management options. Pathways and artificial intelligence may be a tool in the tool box, but they do not capture the art of medicine and the nuances of the patient/ provider shared decision-making process. 

Final Thoughts: The Provider Perspective
Pathway programs are considered one care management strategy in promoting high-quality care in a value-based healthcare system. Barriers for not adopting pathway programs are unresolved. Based on the ASCO Development Criteria for High Quality Pathway Programs, there are opportunities to act, especially in the areas of integration and analysis. Another need is for data analysis that proves that high quality care is being delivered in a cost-effective way while incorporating patient and provider wishes.

For providers, value-based care should reflect the total cost of care and proof that quality care is based on clinical outcomes and patient-reported outcomes. Clinical care should continue to incorporate innovation and new discoveries from clinical trials, and care directed by subspecialty experts. It should not be one-size-fits-all, only relying on evidence-based NCCN pathway options. Pathway usage should consider an institution’s care delivery business model. Pathway programs need to be better integrated into daily clinical practice and work for the provider and patient. That means offsetting the utilization costs and staff resources, or uptake will not continue and expand. This is especially true when different payers use different pathways programs and reimbursement varies.

The Provider Satisfaction Perspective
 

Essential Priorities for Pathways from the Provider Satisfaction PerspectiveHow pathways are deployed and used within a practice ultimately determines their effectiveness. Pathways that are only used to record decisions, sometimes days or weeks after the fact, will not improve quality of the care, and these pathways will be subverted or abandoned. The main takeaway from talking with practices with years of pathway usage is that culture is one of the most important factors in determining provider satisfaction. Pathway integration, ease of use, and a pathway program’s administrative burden also influences adoption rates.

Pathways and Cultural Fit
The practices that we consulted for this project all had several years of pathways experience, including one practice with 14 years’ experience. This practice fully committed to pathways as an essential tool in its oncology work. For them, pathways usage is a cultural norm and a condition of employment. This approach results in almost 100% pathways utilization, with few complaints. 

Our interviews also showed that community oncologists found greater pathways benefits than academic physicians. The community oncologists had higher utilization rates and satisfaction levels than their academic peers. Overall, practices that use pathways as a cultural norm see high levels of compliance and satisfaction.Table 3

Barriers: Provider Satisfaction
Because pathways are usually not fully integrated into the EHR and workflow, many oncologists find them frustrating to use because they are required to reenter data in another system. Pathways are also not seen as providing sufficient value quickly enough, especially for oncologists in academic centers. Clinicians recognize value in access and prioritization of available clinical trials, as well as treatment selection and decision support, primarily for community oncologists. They see value in data about practice patterns that allow the organization to learn and adapt. In academic practices, they want to determine which physicians and subspecialists would be most appropriate to treat each patient. This is especially true for practices with geographically dispersed sites of care. 

The biggest challenge for practices, especially for provider satisfaction, is the administrative burden imposed by pathway usage. Physicians perceive that pathway navigation will be more time-consuming from an administrative perspective. Physicians also perceive a long time period before they will see benefits from using pathways, and that it will be time-consuming for them to help choose pathways and update them.

Physicians and practices detailed other barriers like the ease of use. They are concerned that patients have a limited understanding of what pathways are and how they are used in developing care plans, with about 10-20% of patients understanding them. Lastly, providers also see a limited payer understanding about pathways.

5-Year Vision: Essential Priorities for Provider Satisfaction
The practices we spoke with had a long wish list for future pathways development. It included having the pathways tool and information seamlessly integrated in the EHR, reducing double entry needs. They want to move from “process” pathways to full pathways of care. They want to incorporate a risk-based approach to screening, and incorporate social determinants of health and patient constraints to adherence into the pathways design.

Providers want to include the value-based savings and financial terms in internal compensation calculations, allowing physicians to be adequately compensated for pathways usage. They also seek better patient and payer education so that patients and payers can better understand how pathways are used.

5-Year Vision: Barriers to Provider Satisfaction
Despite many pathways advances in recent years, integration and ease of use are expected to remain a significant barrier to achieving the goals set out by the Group.

Additionally, social determinants of health present ongoing barriers to provider satisfaction in adopting pathways. The Group recognized the need to address these issues but cautioned against creating a solution that might inadvertently lead to substandard care. In other words, it would not be acceptable for an oncologist to design a plan of care in response to a patient’s social situation, whether based on access, affordability, or support services, that would be less effective than an alternate treatment plan.

Provider Satisfaction Perspective: Final Thoughts
From a provider support and satisfaction perspective, care pathways need to be up to date, provide the current treatment options, and provide access to clinical trials while minimizing administrative burdens. Practices that found ways to provide immediate value to physicians, through access to clinical trials, the ability to retain patients, or just through cultural norms, have been the most satisfied and successful with pathways implementation and adoption. 

The Working Group identified two remaining questions for future consideration:

  • How can we share best practices of high utilization/satisfaction with those experiencing low utilization/satisfaction? 
  • How do we influence pathway design to demonstrate more immediate value to providers? This can include incorporating data already in anther system, involving patient perspectives, and providing more advanced predictive analytics.Table 4

The Patient Perspective
 

Helping Patients Understand Pathways and Incorporating Their Needs
Cancer patients are the ultimate pathway users even if they never enter data in a portal or understand whether pathways were used in determining their course of treatment. Many patients do not understand that pathways are being used in determining their care. Some oncology practices do mention on their websites that pathways or, more generally that evidence-based treatment decisions are followed. However, most patients don’t seem to understand what pathways are, what they do, and what being on or off pathways really means. The stakeholders said that as few as 10% of patients understood how pathways had shaped their care.

Additionally, pathways programs have typically focused on the tumor, meaning that the inputs to the pathway’s algorithms are almost exclusively focused on describing the tumor characteristics, not focusing on the patient. The resulting recommendations focus on chemotherapy, radiation, or surgical interventions, with an implicit assumption that patients will be fully compliant with the recommendations once decided. 

However, in the real world, patients are not always able to adhere to a treatment regimen. A patient’s unique circumstances and social situations shape their ability to adhere to a pathway regimen. Patients may miss appointments, they may be confused with complex dosing regimens with multiple drugs, or they may be physically, emotionally, or otherwise unable to adhere to the defined regimen.

There were two overarching issues we found from a patient perspective. The first is that patients are generally unaware that pathways are being used on their behalf, or are unsure what pathways actually are. The second is that today’s pathways do not meet the needs of patients. They do not address the social constraints affecting patients, and they are too focused on medical oncology and treatment regimen selection, instead of being a more holistic care pathway.

Essential Priorities From The Patient Perspective 
The Working Group identified several key priorities in the current pathways landscape for patients. While there is much detail to be fleshed out, the most important finding was a broad criticism of the historic exclusion of patients in pathways design and development. 

Terminology remains an issue, as well. Patients, and indeed some clinicians, may not understand the distinction between pathways, guidelines, and care pathways. This may seem trivial, but the differentiation is important when considering how each type of guidance is used and the level of specificity and direction that is inherent to it.

Patients are not aware of what pathways are or how they are used in determining a treatment plan. A small portion of patients–maybe as little as 10%–understand that pathways are even being used on their behalf. This benign neglect means that patients are excluded from the decision-making process at critical junctures. 

The patient representatives were also concerned about pathways that deliver a single recommendation. Their preference is to narrow the treatment options down to three or four choices, then bring the patient into a shared decision-making conversation, incorporating their perspectives and acknowledging any constraints the patient is under. The concern is that single endpoint pathways don’t adequately allow for patient input. But they also create a false sense of certainty by relying on consensus for all patients instead of science-based recommendations for individuals. 

Lastly, the Working Group identified that pathways do not meet patients’ specific needs, including addressing barriers to treatment adherence and social determinants of health.

Barriers: The Patient Perspective
There are a number of structural and logistical barriers preventing patients from participating fully in pathways development and from fully benefiting from pathways. One of the key barriers is that pathways were never envisioned as a tool for patients but were instead a tool for clinicians to construct a treatment plan that reflected the best available treatments for a specific disease presentation. The decision process is based on a consensus review of published literature and never dealt with patient-focused issues. Oncologists and other clinicians would discuss the treatment plan with patients, modifying it as needed, but the plan itself was developed in a “pure” environment.

Even with a desire to incorporate more patient feedback and factors, there remain several barriers to allowing pathways to better serve patients today. There is inadequate consensus on how to share with patients that pathways are used by their doctor to help inform treatment decisions. Pathways remain challenging for patients to understand and interpret, even if they are aware of them.

Patients are not treated like the stakeholders they are during the process of developing and using pathways. Too often, patients are excluded from treatment decisions, despite the movement towards shared decision-making. In too many situations, pathways deliver a recommendation and oncologists present it for confirmation by the patient. If they do include patients in a shared decision-making scenario, the implication may be that patients are not experts in the disease or treatment. And while that is and perhaps should remain true, patients are experts in their own lives, and the constraints that may impact their ability to adhere to a regimen.

One of the most important barriers is the terminology that the medical community uses to refer to the issues that impact patients and their ability to adhere to therapy. We have historically referred to these issues as “patient preferences,” when the logistical realities and constraints faced by patients are barriers to adherence that may make or break their treatment.

In general, pathways have been too narrowly focused on the chemotherapy treatment selection. While some pathways do include other treatment modalities, nurse triage, and side effect management pathways, pathways are primarily medical oncology-focused. While this serves one aspect of the patient’s needs, it is far from comprehensive.

5-Year Vision: Essential Priorities for Patients Challenging as the current situation is, the Working Group identified opportunities for improvement that are more inclusive of patient needs. The patients do not need to become oncology experts, but they should be allowed to be experts in their own lives. Oncologists should ask, collect, and act on the four factors that most influence a patient’s ability to adhere to a treatment plan. That includes transportation and parking (including cost and availability); employment and impact of treatment on employment (since most health care coverage is tied to employment); childcare (whether for their own child or others they care for, such as grandchildren); and the availability of a reliable caregiver. 

In addition, the patient representatives would like to see other advancements in pathways over the next five years. One advancement would be the inclusion of real-world evidence in addition to clinical trials. Another is for pathways to help guide the use of diagnostics. Lastly, pathways should incorporate care management and coordination, broader care planning, and survivorship issues.

Another priority is to make pathways more accessible and easier for patients to understand. Physicians using pathways should respect a patient’s decision-making autonomy by narrowing relevant treatment choices to several options, and then involve the patient in a shared decision-making conversation so that the treatment plan reflects patient needs as well as the best available science.

5-Year Vision: Barriers to Incorporating Patient Perspectives
Truly making pathways more responsive to patient needs will require a mind-shift by pathways developers and the clinicians who use them. Even with the interest in making these shifts, there are several practical logistical issues to making meaningful change in the scope and reach of pathways to include patient needs and priorities.

First, there are not enough published real-world studies to reflect how different patient populations respond to different treatments and approaches. It is difficult for pathways vendors to create the nuanced pathway type that oncologists and the patients need to deliver treatment plans that balance clinical utility and a patient’s ability to fully complete the treatment. There also are not well-documented and agreed-upon protocols for broad care pathways that include supportive care and social factors to help optimize patient adherence.

Final Thoughts: The Patient Perspective
We learned that the constraints patients experience with accessing oncology care are real barriers to their success in treatment. Pathways that incorporate these constraints in the treatment decision process will help support a patient’s ability to successfully complete their therapy. Our conversations highlighted that many patients do not fully understand their treatment options or the pathway choices that went into developing the treatment plan. Creating awareness about pathway usage and involving patient-specific factors and constraints much earlier in the treatment decision process will provide more relevant results.

The Working Group found two unanswered questions on this topic: 

  • Patient constraints are not represented in pathways today. How can they be and to what end? 
  • Patients prefer to participate in decisions impacting their care: how do we ensure that pathways incorporate patient input/shared decision-making earlier in the process?Table 5

Oncology Care Stakeholder Framework

Discussion
Each stakeholder group has its own priorities and needs for how they view pathways as a successful tool in clinical oncology care. They also had unique barriers to adoption or to incorporating pathways into the treatment paradigm. To improve pathways usage and have them serve all stakeholders, the pathways must overcome these barriers.

Patients are traditionally excluded from pathways development, and often don’t know that pathways are a part of their providers’ treatment decision-making process. Even if told that the practice relies on “evidence-based care,” that does not necessarily translate to pathway usage in the patient’s mind. The provider may tell the patient their treatment preference, to get agreement or consent. But even if the treatment plan is derived from a pathway, the patient does not know that or understand how the pathway works. 

Pathways are designed to offer evidence-based care, and to reduce care variation. This has two results. The first is that pathways rely on medical studies showing how patients as a group responded to treatment. The pathways are created using a consensus approach based on the results of clinical trials, but they may not account for patient constraints such as social determinants of health or the patient’s ability to adhere to treatment. Pathways, as currently developed, are not patient-centric. They do not look at patients as individuals. When using pathways, patients may not be offered multiple treatment options, but just the one shown as the proper option based on the pathway. Patients may not be comfortable asking about other treatment options, whether they don’t know to, they are fearful of disappointing the provider, or they are uncomfortable sharing social or personal issues that would impact treatment adherence. Pathways, without any patient involvement, do not align with patient-centric care.

Payers have the responsibility to not only pay for oncology care, but to ensure it meets certain standards. By controlling variations in care, costs can more easily be controlled. Relying on evidence-based care means that the treatments are vetted and likely to work for that population as a whole. This means a patient could be offered fewer treatment options, but the options are more likely to be successful. Adding in patient factors like social determinants of health can affect the treatment offered and lead to off pathways care. This treatment can be more expensive and less standardized, and payers do not necessarily understand its impact on treatment decisions or outcomes.

Payers and providers are increasingly sharing risk, based on the shift from volume-based to value-based care. These alternative payment models, combined with innovative provider contracting, allow providers to take some responsibility for the financial risk aspects of care. To do this, though, the payers and providers need comprehensive data. This is difficult to come by, as the health care system is fragmented, and it is challenging to capture the all medical costs in addition to the social costs of care. Payers wanting to share the risk need to give providers better data so they understand the risks and can mitigate them. Funding is also needed to compensate providers for the administrative burden for adhering to pathway mandates.

Oncology providers have a different perspective, and are not just one group. Providers can be broken up into academic settings, non-academic and integrated delivery networks, and community-based practices. Even these subgroups are not one-size-fits-all. Traditionally, academic practices are the least accepting of pathways, as patients see these doctors for highly specialized care, second opinions, clinical trials, and novel treatments. The non-academic integrated network physicians, on the other hand, are the ones most open to using pathways.

They are patient-focused and trying to differentiate themselves from the academic centers. Community-based practices may also value these pathways, to help with evidence-based decision-making and to provide value. All these groups need administrative burdens lessened if required to use pathways, especially if working with multiple payers.

To maximize adoption rates, care pathways should fit into the practice philosophy and business model. The pathways should be comprehensive and remain current. If provider groups are sharing financial risk with payers, or taking on full risk, they need comprehensive and accurate data covering the care spectrum. This will allow the greatest success with these models. The technology available now is not adequate in supporting these data needs, to track treatment cost, clinical outcomes, and the value provided. The pathways must be flexible enough to include access to clinical trials and to go off pathway, based on social determinants of health or other patient preferences.

Providers and practice administrators need pathways to fit into the practice workflow, without creating additional burdens and with compensation to cover any investments. Ideally the pathways would integrate with EHR systems, so it is not burdensome to use from an administrative capacity and provider perspective. The practice must also include pathways as part of the culture, for maximum adoption. It can take time for the value of pathways to be realized.

Conclusion
 

Clinical pathways in oncology hold great promise in reducing unintended variations of care, improving care delivery from an organizational efficiency perspective, and decreasing the overall cost of care. They also have the potential to improve patient outcomes. Before pathways can be fully adopted, though, payer, provider, and patient concerns need to be incorporated in the framework. Each stakeholder comes from a different perspective, all valid and important to consider. 

Oncology care relies on clinical studies, but there is a growing volume of research and the continuing introduction of novel treatments. It is difficult for providers to stay on top of the research and changing standards, and even harder for payers to do so. Add in patient preferences, social determinants of health, and other reasons why it may be difficult for patients to adhere to their treatment, and the situation is even more complex.

Providers are increasingly taking on financial risk through alternative payment models. These are developed as the models shifts from volume-based care to value-based care. The problem, though, is obtaining enough accurate data to understand how treatments impact the patient outcome, and what costs are part of the care continuum. The fragmented health care system makes it difficult to track all care data and share it along the patient journey.

With the information gleaned from the cohorts interviewed from the 2021 Working Group, stakeholders can better understand the various needs and barriers to creating better pathways. 

Working Group Participants
Participants in the 2020 Working Group include the following: Lee Schwartzberg, MD, FACP, West Cancer Center & ResearchInstitute; OneOncology; Ray Page, DO, PhD, FACOI, FASCO, The Center for Cancer and Blood Disorders; Marcus Neubauer, MD, US Oncology Network, McKesson; Karen Fields, MD, Moffitt Cancer Center; Joshua Liao, MD, MSc, Univ. Washington School of Medicine, Value and Systems Science Lab; Alan Balch, PhD, National Patient Advocate Foundation; Gary H. Lyman, MD, MPH, FASCO, FRCP, Fred Hutchinson Cancer Research Center; Univ. Washington School of Medicine; SWOG Cancer Research Network; Bruce Sherman, MD, FCCP, FACOEM, National Alliance of Healthcare Purchaser Coalitions; Adrian Levy, PhD, Department of Community Health and Epidemiology, Dalhousie University; John Fox, MD, MHA, West Michigan ACO, Spectrum Health Systems; Tom Sondergeld, MHA, Former VP Global Benefits & Mobility, Walgreens Boots Alliance, Inc; Charles Barr, MD, MPH, Pivotal Strategic Consulting, LLC; and Ira Klein, MD, MBA, FACP, Johnson & Johnson, Health Care Systems Inc. funding: The 2020 Care Pathways Working Group was sponsored by Amgen, Inc. The findings from Group participants were not influenced by Amgen.

Funding
The 2020 Care Pathways Working Group was sponsored by Amgen, Inc. The findings from Group participants were not influenced by Amgen.

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Author Information

Authors: Winston Wong, PharmD1; Gordon Kuntz2; Robin T. Zon, MD, FACP, FASCO3; 2021 Care Pathways Working Group 

Affiliation: 1W-Squared Group, Longboat Key, FL; 2Kuntz Consulting, LLC; 3Michiana Hematology-Oncology, PC, Mishawaka, IN

Disclosures: All authors report no relevant financial relationships. 

Address correspondence to:
Winston Wong
1975 Gulf of Mexico Drive #211 Longboat Key, FL 34228
Telephone: (941) 487-7823
Email: wwong@wsquaredgroup.com