Recommendations for Enhancing the Value of Clinical Pathways: Findings From the 2020 Care Pathways Working Group

Clinical pathways are treatment optimization algorithms aimed to improve quality of care by standardizing and streamlining treatment decisions.^1-4 During the pathway design process, developers must ensure that the pathway is evidence-based and leads to better outcomes. Therefore, all stakeholders (eg, payers, providers, and patients) must contribute to their development and implementation. Pathway tools have increased precise treatment strategies, which lowers health care costs.^5-8 In addition, pathways assist in value-based care reimbursement, unification of historically siloed stakeholders, and alignment of drug utilization and pricing. They also bring value to patients by promoting patient-centered and guideline-concordant care with the right treatment at the right time and to the right patient, regardless of the site service.^9-12 Lastly, clinical pathways help providers stay up to date with the evolving treatment advancements and inform them on where the advancements fit into the overall treatment strategy.

Evolution of Pathways

Since the introduction of formal pathways in 2005 by the US Oncology Network, the scope and utilization of oncology clinical pathways have increased in the United States.¹³ 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, controls costs and reduces unwanted variations in care. As the complexity and cost of cancer treatments increased, payers and providers managed oncology care costs beyond their traditional medical policy and precertification programs. Thus, two developments occurred: (1) the entry of payers into the clinical pathway arena, which occurred in 2008 and (2) the value-based care movement where payers partnered with practices to promote cost-effective care.^14,15

Over the next several years, large practices and academic institutions implemented clinical pathway programs. The programs were supported by organizations like US Oncology Inc (who created Level 1 Pathways, now McKesson Value Pathways powered by National Comprehensive Cancer Network [NCCN]),¹³ ViaOncology (now Elsevier’s ClinicalPath), and academic cancer centers, such as Moffitt Cancer Center, who developed highly detailed, multidisciplinary pathways,¹⁶ and Dana Farber Cancer Institute.¹⁷ Payers also entered into the clinical pathway movement and were supported by organizations like Eviti, eviCore, New Century Health, or via internally developed programs such as the Oncology Care Program developed by Anthem.^15,18

With the statutory implementation of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA)¹⁹ and the transition of US health care away from a volume-incentivized, provider-centric model to a value-based, patient-centered model,²⁰ well-designed pathways have grown in importance. They serve as a foundation for comprehensive patient care while promoting high-quality, value-focused care.^12,21 

The American Society for Clinical Oncology (ASCO) created a Task Force to address concerns regarding the variability and transparency of pathway development and the implementation process as it pertains to impacting the delivery of care, especially from a workflow perspective and patient outcomes. In January 2016, they released a Policy Statement on Clinical Pathways.²¹ The purpose of the statement was to address mechanisms to ensure the integrity, efficient implementation, and outcome assessment of clinical pathway programs. Concordant to the Policy Statement, ASCO released the Criteria for High-Quality Clinical Pathways in Oncology.¹² The ASCO Criteria focus on three key areas: development, implementation, and analytics—each containing specific criteria for assessment. The criteria are consensus-based, and recommendations for the criteria were sought from the patient advocates, payers, pathway vendors and providers. Each criterion is presented as a series of concrete, practical questions that provided a framework for assessing individual pathways programs. The ASCO Criteria assists practices, oncologists, and other stakeholders to evaluate clinical pathway programs and ensure their effectiveness.

In March 2018, the ASCO Task Force evaluated 4 pathway providers to advance the evaluation effort. Anthem/AIM, New Century Health, McKesson Value Pathways, and Via Oncology were evaluated against the ASCO Criteria to help stakeholders better navigate the current pathway environment.¹⁸ No expectations were made on the part of the Task Force that any provider would meet all the criteria and no judgments were made regarding the ability of each provider to meet the criteria and their suitability for any clinical pathway program applicability.

The ASCO Task Force’s clinical pathway Policy Statement and Criteria will continue to evolve as providers gain experience with implementing the pathways into practice. They will also continue to improve as the science evolves, value-based care grows, the regulatory process improves, technology advances, and overall focus becomes the patient.

The Journal of Clinical Pathways hosted the Care Pathways Working Group (the Group) in the spring of 2020 to further the evolution toward value-based care and build upon the work of the ASCO Clinical Pathways Taskforce. The Group’s aim was to identify the highest priority concerns related to available care pathways and their implementation. Additionally, they aimed to promote the development and use of high-quality pathways. The recommendations presented in this report will guide stakeholders to further enhance their pathways tools and programs as well as highlight areas where stakeholder collaboration is imperative. 

Participants

The Journal of Clinical Pathways commissioned an expert panel led by three co-chairs with over 50 years of pathways experience from the payer, provider, and vendor perspectives to determine the main research question and to lead the discussion and research of the Group. 

The co-chairs determined that the Group would use oncology clinical pathways standards and programs as the starting point for discussion and investigation because many advances in the development and utilization of pathways are focused in this space. While the findings were briefly examined by the Group in the context of broader use of pathways beyond oncology, this article focuses on the oncology-related recommendations.  

Fourteen subject matter experts were invited to participate and assess current oncology pathway standards. The participants included oncology clinical pathway leaders from academic, hospital, and community settings; oncology pathways champions experienced with vendors and payer strategy teams; pathways operations experts; payer strategy professionals; employer group representatives; health economics and outcomes research/comparative effectiveness researchers; health policy researchers; and individuals with experience in the broader use of pathways and alternative care models beyond the oncology setting. Many participants had overlapping experience in these domains. 

Design

Co-chairs began by reviewing recent and authoritative publications capturing clinical pathways evolution and current discourse (Table 1).

Two Group meetings were conducted via virtual calls to examine the topics chosen by the co-chairs. Both Group calls were recorded, transcribed, and made available to the participants for reference. Research was conducted between meetings and a third short meeting summarized preliminary findings.

During the first Group meeting, co-chairs reviewed the existing literature with the participants and explored the topic areas of pathways development and maintenance, pathways management and measurement, and market impact and pathways future directions.

Participants were encouraged to connect individually and in small groups with the co-chairs via email and phone outside of these organized meetings to contribute additional ideas or expand upon mentioned topics.

Once all members finalized their contributions and shared them with co-chairs, all member input, transcribed discussions, and notes were reviewed by co-chairs and discussed at the third short meeting. The information gathered was presented at the 2020 Oncology Clinical Pathways Congress. 

Pathways Development and Maintenance

Traditional Pathways Definitions and Determining Value 

A clinical pathway is traditionally defined as a set of clinical decision support rules, following a branching logic based upon efficacy, toxicity, and then cost considerations.⁴ However, pathway components should include value and integrate pathway presentation within a software tool. Thus, a more comprehensive definition of a clinical pathway would be “an evidence‑based decision support tool that takes into account efficacy, toxicity, and cost, to promote value‑based care decision‑making.”

The definition of value in value-based care is determined differently by different stakeholders (eg, patients, clinicians, and payers) (Box 1). Patients consider value from the perspective of improved quality of life and functionality, survival, and affordability. Affordability is an area of concern since the cost of cancer care has increased exponentially in recent years.^22-25 Despite having insurance, patients experience “financial toxicity” and are unable to afford treatments and medications due to high financial liability.²⁶ Clinicians define value in terms of improved outcomes, improved tolerability, and ease of administration with some correlation to cost. Cost is related to reimbursement levels as opposed to the true list cost of the treatment option. Finally, payers relate value to the overall cost of care related to the reimbursement cost of the treatment option, the ability of the treatment option to minimize waste and unnecessary care, and the ability of the treatment option to minimize ancillary services (eg, radiation, laboratory, surgery, emergency room visits, and inpatient admissions). 

In short, value is defined differently according to the stakeholder and cannot be classified by outcomes or quality divided by cost. However, the consensus between all stakeholders is that creating more value is important and should be highlighted in care tools and models. Clinical pathways, as defined by the Group, are high-quality and comprehensive pathways, as per ASCO criteria.¹² 

Pathway Committees and Evidence Synthesis 

During the Group discussion, co-chairs focused on the composition of the clinical pathway committee and the type of evidence that will be considered when developing and maintaining the clinical pathway.

The Group agreed that oncologists should be included as part of the ideal oncology clinical pathway committee. Other members of the committee should be selected depending upon the overall intended scope of the pathway, which must be defined. Most oncology clinical pathways are focused on medical oncology and the sequencing of various treatment regimen options. The Group concurred that they should include other aspects of cancer care as called for by ASCO (eg, integration of surgical oncology, radiation oncology), ancillary services (eg, supportive care, predictive and prognostic genomic profiling, nurse navigators from the social aspect), and patient advocacy.¹² A broader focus allows the clinical pathway to become a structured tool that reflects a multidisciplinary plan of care.

The clinical pathway program should be broad in scope and focus on the entire spectrum of care, which includes surgical and radiation oncologists and interdisciplinary interactions. Pharmacists can play a key role in the treatment decision‑making and pathways development. Supportive care and other ancillary services are also important (eg, physical and occupational therapy, nutritional support). Supportive care resources can assist to identify appropriate times for interventions like advanced care planning and establish goals‑of‑care. Representation from the genomics arena and genetics counselors are needed for decisions requiring personalized medicine. Including nursing staff and patients create the necessary series of physical steps that are critical to achieve the desired clinical outcome. Finally, inclusion of a medical ethicist would ensure that issues of autonomy, beneficence, nonmaleficence, and justice are examined; their role is to objectively represent the patient perspective. The default statement commonly noted is that, as long as there is no harmful impact to the patient, a service may be provided. However, this is problematic in the situation of payer or independent pathway developers. A negative impact to the patient is not always clear, especially given the absence of evidence in some of these early‑phase drugs that are approved through accelerated pathways.

The scope of the oversight committee should be determined. Once the clinical pathway is developed, the pathway must be implemented throughout the delivery system (ie, made available at the point-of-care and monitored for clinical and financial impact and performance). The development process should begin with the acceptance that the committee will be charged with the management and delivery of the clinical pathway program, along with clinical evidence oversight. As such, the committee needs to include expertise such as care delivery, ancillary health services, finance with these deliverables in mind. Monitoring and performance metrics will need to be developed and managed to attain the clinical and financial goals. In short, the committee must be composed and charged to provide value-based care. 

After the pathway committee composition and scope are established, the type and level of evidence used, how much evidence should be used, and how real-world evidence (RWE) is integrated should be determined. The best starting point for evaluating evidence is using accepted levels of evidence in clinical studies.²⁷ However, Evidence Levels 1, 2, and 3 only pertain to clinical trials. Evidence is limited if the quality of the pathways for the full continuum of care is being evaluated. In the later stages of the disease, the critical decisions and supporting evidence for formulating recommendations is often based upon experience and real-world data rather than explicit trials. Therefore, Level 1, 2, or 3 evidence supports treatment decisions for adjuvant therapy in newly diagnosed and early-stage patients. In later stages, pathway development will require the value of adding practical, expert‑driven consensus recommendations as well as real-world data. 

The Food and Drug Administration (FDA) Accelerated Approval Program fast-tracked several treatment options due to unmet needs for effective and tolerable treatments.²⁸ The increased number of accelerated approvals created considerable difficulty for the pathway evaluation, development, and maintenance process. Pathway developers—whether in the form of an individual practice, or a pathways vendor—are operating in an environment where the body of evidence is being generated so quickly that it is either incomplete or simply does not exist. The challenges this creates includes incomplete evidence of true efficacy, efficacy and toxicity may not be representative of the real-world experience, and difficulty in analyzing the overall costs.²² 

The Role of Patients in Pathway Development and Use

The patient’s role as it relates to clinical pathway development and utilization should be considered. The patient barriers to care and clinical value from a variety of patient populations must be considered in future pathways. Care inequity is of concern among different populations, providers, practices, and health systems and can result from geography, socioeconomic status, provider preferences, payer preferences, and financial motivations. Single practices encounter patients from multiple payers, and treatment options are selected according to payer requirements. Limited access to services to address financial toxicity leads to concerns about equity and variations in treatment options available. Both value and care inequity are of concern for the large employers and their respective coalitions. Employees must have access to treatment options that maximize value and outcomes, while maintaining quality of life for both the patient and caregiver. Thus, the co-chairs investigated whether clinical pathways could be used as a tool to address care inequity and help reduce the inequity concerns across the population. In addition, they addressed whether pathways could be used to improve care beyond the immediate boundaries of a single practice or health care system.

Patient representation can be achieved by including patients, or those who represent patients, as part of the development process and including relevant patient preferences as a filter within pathways. Patient preferences can be gathered from RWE as clinical trials include more socioeconomic data points. Patient preferences include work disruption, caregiver burden, transportation, and financial toxicity. In providing patient-centric care, patient variability must be taken into consideration to ensure the best pathway treatment decision. The goal of development is to have the pathway represent a sense of patient-centricity, but because of patient-specific factors, the care administered or received may be different from the pathway recommendation.

Patient representation in the pathway development process can occur through patient-reported outcomes (PROs) monitoring. Some practices incorporate PRO monitoring as part of the pathway in the same manner that imaging and laboratory utilization is monitored. Incorporating PROs into the pathway development and evaluation process adds value with an independent measure of efficacy, outcomes, and quality. PROs indicating a patient’s satisfaction with their treatment, or their acceptance of the level of tolerability is an indicator of the patient experience. The patient experience will impact the patient’s perception of the value of their care. Ultimately, the use of PRO monitoring will contribute to the RWE movement, as well as lead to more patient-centric care. This real-world data is currently being collected by data platforms such as ASCO’s CancerLinQ.²⁹ Integrating this observational data, including unpublished clinical trials, into the current treatment paradigm and pathway programs in a scalable way remains a challenge.

The Group concluded that basic principles and rules are required to define the evidence to use and to integrate observational data into a pathway. An aggregated framework of evidence was proposed with a mandatory check and balance measurement of the patient outcomes within the pathway. Furthermore, by inclusion of RWE into the pathway algorithm, pathways can better serve as a decision support tool as they will more accurately reflect the variety of populations being treated.

Whether the approach toward the recommended treatment option is from the perspective of the provider, payer, employer, or patient, the most important driver is the perceived value. Perhaps, a clinical pathway should be viewed as a treatment starting point and that there will be different points along the decision tree depending on a specific patient parameter or need. The pathway should be based upon efficacy, tolerability, and cost to recommend the preferred treatment options. The art of medicine and personalized care will ensure the final treatment option is the right regimen for that patient and their circumstances, which would occur outside of the clinical pathway decision process. Minimizing variability in the initial treatment recommendation may be the goal, however, variability will still exist due to patient and provider preferences and value-based decisions (Box 2).

Pathways Management and Measurement

The Group examined ongoing management and outcome measurement, including costs and return on investment. Technology became a key focus in this section, as software and data collection platforms underpin all operational concerns and data reporting needs as well as basic practical utility. 

As previously noted, clinical pathways programs are currently focused on the optimal selection of a therapy, mainly antineoplastic agents such as chemotherapy and, more recently, targeted immunotherapies. Some pathways also include recommendations regarding radiation and/or surgery, but these are used in a significantly smaller sample size. The method for selecting the most appropriate chemotherapy agent—reviewing a list of literature-derived choices for efficacy, toxicity, and cost—has resulted in an underrepresentation of total cost of care, patient preferences, and other issues in developing pathways recommendations.

The Group considered different approaches to representing the cost to various stakeholders in the pathway development or use models. Issues of data availability, reliability, and relevance and how they might be used most effectively in the pathways setting were reviewed. The Group also discussed how pathways hold a unique place in the care continuum. Electronic medical record (EMR) systems are backward-facing in that they record events that have already transpired, while order entry systems are future-facing, initiating a workflow to deliver a regimen to a patient once a decision is made. Pathways, however, exist at the point of treatment selection. Occupying this particular nexus means that they not only reflect but also influence the selection of treatment, heightening the importance of the information that is presented and collected during the process of accessing the patient, and integrating this information into the pathway as part of the treatment selection process.  

A third issue is EMR integration. Pathways programs have become easier to access from within EMRs and the clinician workflow has been streamlined over the past few years.^13,16 This increased integration notwithstanding, the difficulty of accessing pathways as part of the treatment selection workflow remains one of the primary barriers to the smooth adoption of pathways.

The final topic the Group discussed was the issue of pharmacogenetic testing. With more regimens relying on genomic data, incorporating recommendations for pharmacogenetic testing into the pathways would help ensure that testing is used efficiently and appropriately to optimize clinical outcomes.    

Availability of Cost Data Beyond Drugs

Cost influences a small percentage of pathways vendors decisions regarding the regimen to recommend. When considering cost, only limited published pricing data are used. For infused drugs, Average Sales Price is used, while Wholesale Acquisition Cost is commonly used for oral agents. While these are useful benchmarks, the overall cost of care is still largely undetermined and not considered.

The Group discussed ways to address the scarcity of data to complete the cost picture. The discussions identified numerous challenges, such as the availability and unpredictability of data. Not all of the desired data around cost is readily available. The necessary data may be spread among many different sources, creating challenges to acquire and analyze the information. Additionally, payers are reticent to share detailed cost data for services. Cost to manage and treat side effects can be highly variable, for example. Costs for lab and imaging work also varies significantly by site. Many of the value-based arrangements being used in oncology care include some accounting of payer-borne costs outside of those incurred through the practice. Medicare’s Oncology Care Model, for example, provides total cost of care data as that is the measure on which program success is conditioned.³⁰ 

Pathways as a Data Collection and Distribution Tool

Pathways accessed at the point of treatment decision-making provides an important opportunity to present and collect data. Because of the volume of data presented to clinicians as they are deciding on treatments, any additional information must be relevant, significant, and properly contextualized. Similarly, while there may be opportunities to collect more information about the patient and treatment decisions, great care must be taken to avoid any additional data entry on the part of the clinician.

The Group recognized that partnerships with payers can provide additional data and analytics to help contextualize costs, both at a clinic level but also for pathways vendors. As described above, creating and promoting awareness of the cost of various therapies, including much more than simply the cost of the primary therapeutic agent, helps clinicians to understand the ramifications of their decisions for patients, payers, and their respective practices. 

One of the challenges for pathways vendors is in finding reliable data sources for cost and clinical data to integrate with pathways data. The data source needs to represent a sufficiently diverse population to be meaningful but may also benefit from a sufficiently large sample size to allow cohort matching to the patient population seen in various clinics. For example, Medicare data is more or less available but does not fully represent the absolute costs—or even the relative costs—for a commercial patient population. 

Data regarding actual costs at the real-time point of decision-making is necessary if the pathways are to represent cost-effectiveness and be useful for value-based care. Patients request information on how treatments worked and what toxicities were experienced in similar patient populations, which can be addressed by synthesizing RWE data into pathways programs. From an institutional standpoint, pathway performance can be analyzed to assess cost, calculate bundle payments, and generate data by using commercial data based around cost and analyzing subpopulations. Data on pathway compliance has been utilized by practices and payers to achieve a shared cost-savings model.³¹ Value-based care will be dependent on transferring timely data, not only to the providers for clinical decision support, but also with the payers who can aggregate it and inform what the costs are. Ideally, value-based care should reflect the total cost of care. Value-based care models can be as narrow as being applied to a specific cancer type, or as broad as the total cancer population within a practice. Comprehensive pathways embodying the care continuum from diagnosis through treatment, including outcome analysis, and integrated with claims data, would allow for performance measurement, benchmarking, and myriad data to advise value-based, patient-centric care. 

Integration With EMRs

Despite significant advances in the integration of pathways and EMRs, the Group identified much work that remains to be done. Significant resources have been invested by pathways and EMR vendors to improve the data exchange, interface, and integration between pathways and EMRs. iKnowMed has worked with integrated pathways for many years.³² More recently, Flatiron built a pathways program as a fully integrated entity within the oncology-specific EMR.³³ Elsevier’s ClinicalPath adopted the latest technology to enhance integration with EPIC and Cerner EMRs.³⁴ Even with these advances, clinicians demand yet more seamless integration and fewer keystrokes and clicks to navigate a patient on a pathway.

Changing EMRs is a costly, time-consuming, and distracting proposition for any practice. Clinics with older EMRs have a difficult time with pathways integration. Newer integration technologies are not always supported by the pathways vendor, or the EMR, or both. The pathways vendor must support integration or interfaces with an EMR vendor that can support the most functionality with the least amount of resources. Pathways vendors also look at the size of the installed base, both with their existing clients and with prospects, thus rewarding the most popular EMRs.

The persistent lack of deep, effective, and easy-to-use integration limits the adoption of pathways. The Group encourages pathways vendors to continue to develop more highly integrated offerings, including with less common EMRs and those with older technologies to the degree that this is technically and economically feasible. 

Pharmacogenetic Testing

Because existing pathways do not consistently support decisions around pharmacogenetic testing, the Group concluded that this is an area where pathways expansion is expected to make a significant impact. Because of the proliferation of testing, payers and employers need help understanding what type of pharmacogenetic testing should be done with various diseases. Lacking the clinical expertise to decide, these organizations and many clinicians are unable to make sufficiently informed decisions about the appropriateness and timing of certain testing. Pharmacy benefit managers and other sources are not currently supporting these efforts, leaving an opportunity for pathways programs to step into this field.

The Group encourages pathways vendors to include pharmacogenetic testing as a component of the pathway to assist and educate clinicians, payers, employers, and others around these important diagnostic tools.

Full recommendations related to pathways management and measurement are listed in Box 3.

Market Impact and Future Directions 

Unique business models exist within the landscape of clinical pathways, wherein the pathways are provider- or payer-facing and developed to address the needs and concerns of the customers. In the past, as mentioned above, early pathways only addressed drug utilization. The advances in cancer care are associated with pathways becoming more inclusive of genetics (germline) and genomic (somatic) traits, thus evolving to a more personalized care management plan. Additionally, as total cost of care is a sine qua non for true value-based care, pathways programs are becoming more inclusive of the multidisciplinary approach (eg, radiation oncology, surgical oncology) and the continuum of the cancer care journey from diagnosis, treatment, supportive care, survivorship, and through end-of-life care. As the transition to value-based care continues, pathways can serve as the cornerstone for payment methodologies and quality-of-care improvements and can better position practices and institutions to assume financial risk for patient populations while ensuring the best care.^10,30,35 

The Group concluded that future pathways should align stakeholder’s 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. 

Pathways as Central to the Business Model of Care

The Group agreed that standards by professional societies, specifically the ASCO Criteria for Pathway Development,¹² should be met by all pathway programs regardless of the author(s). Transparency is necessary to obtain trust with the provider and patient and critical to the adoption, acceptance, and utilization of pathways. Additionally, benchmarks and performance goals for the pathway programs and the participating clinicians are crucial to achieving high-quality, reasonably cost-effective or value-based care. However, when the Group discussed “gold-starring” or certification of pathway programs, this was not endorsed. Rather, the Group favored pathway evolution, growth, and innovation while meeting the criteria set forth by ASCO.

The Patient. MACRA mandates that all future reimbursement models must support a patient-centered model of care. A necessary consideration for a pathways program to be considered standards compliant and be considered “best care” for the patient is the inclusion of patient constraints and resources. Health decisions are determined by complex interactions between social and economic factors, as well as physical environment and individual behaviors. These factors are not currently captured in pathway programs. An example of this is a patient selecting a mastectomy over a lumpectomy due to geographic or support resource issues. Similarly, a patient may select an oral agent over an intravenous pump due to transportation issues. In both these instances, the selection should prioritize patient choice and be considered legitimate and compliant care management plans be incorporated under the pathway umbrella.

From a health equity perspective, pathways could ensure the patient is receiving the same high-level, evidence-based advice regardless of race, gender, ethnicity, geographical location, urban or rural community, tertiary care vs private sector provider. Pathway programs that are designed to address specific disease states and treatment options are agnostic to these determinants. Institutional implementation of pathway programs can ensure that the same patient education and care options are offered across the system and reduce unwarranted variations in care.

In recent literature, pathways supporting reimbursement for the time needed for the cancer care team to listen and respond to patient preferences is addressed.^36,37 Reimbursement for time spent upfront relates to how that information can be utilized to deliver the right care to the right person at the right time. The Centers for Medicare & Medicaid Services (CMS) changes in reimbursement for office visits, effective January 2021,³⁸ may assist with this communication gap. These changes allow for more reimbursements with office visits and promote shared decision-making between the provider and patient. This much needed change would encourage opportunities for patients and caregivers to support person-centered pathway care. 

The Provider. An ever-expanding knowledge of cancer processes, scientific advances, and FDA approvals for cancer care interventions leads to improved cancer survival and the transformation of cancer to a chronic disease. However, this creates a challenge for all providers since this vast knowledge can no longer be easily managed and recalled within our daily point of clinical decision making. Pathways based on the highest level of evidence available, which are up to date and include clinical trial options, can serve to support clinician education and can encourage practice at the top of their license. Additionally, as provider teams continue to expand and are inclusive of nurse practitioners, physician assistants, clinical research staff, pharmacists, social workers, and patient navigators. Thus, pathway programs can assist in reducing unwarranted variations in care and in the delivery of consistent patient-centric care.

The Employer. Employers are a fragmented group, least talked about in the media, and underrepresented in health care policy dialogue despite being the largest source of private health insurance in the United States. Large health care business groups identify cancer costs as the second most significant condition driving up costs, coupled with the fact that funds are not expanding. This results in employers adopting strategies that are utilization-management focused. Participants representing the employer perspective in the Group stated they do not only want cheap care, but will pay for care if there is value and quality. Many employers defer to health plan administrators, but business coalitions and large employers want a network solution, which may include pathways. Many employers look to centers of excellence for second opinions, but realize and appreciate the importance of local care. As a result, employers are increasingly participating with local community providers and clinically integrated networks to optimize value of service delivery, which may incorporate pathways for oncologic care. Employers are aligned with providers and patients and want the right therapy, for the right person, at the right cost, at the right time and place.

The Payer (Private). Health plans issued by private payers or administrators are purchased by employers or individuals and vary in benefits offered and costs associated. Traditional fee-for-service often sets the payer against the provider. This structural problem has been transformed with the focus on value-based care, rewarding quality over quantity. The challenge in this transformation has been in the replacement of misaligned oncology incentives with financial opportunity aligned with quality oncology care, while eliminating unnecessary administrative burden. In the past, some payers focused solely on drug selection within the pathway. As the US health care system transforms to a quality basis with a focus on patient-centricity, several payers over the past decade have been collaborating with providers in demonstration projects to achieve shared savings by separating reimbursement from drug cost and rewarding clinicians for improved quality and reduction in total cost of cancer care.³⁹ In some instances, pathway programs incorporate into the clinical model and include clinician participation in the development of value-based pathways. These clinical models have been successful in delivering systemic cost savings, while providing share savings and value-based pathway adoption bonuses, and quality care.⁴⁰

The Payer (Government). The MACRA statute, implemented as the Quality Payment Program (QPP), has never mandated the use of oncology clinical pathways in either the Merit-based Incentive Payment System or in the Advanced Alternative Payment Model.Pathway utilization rates among oncologists in the QPP is unknown. The Oncology Care Model (OCM) is focused on increasing the coordination of oncology care through financial and performance accountability for chemotherapy episodes of care. The program encourages practice transformations by requiring participating practices to implement “practice redesign activities” to improve the quality of care being delivered. These redesign activities include provider enhanced services, use of data to drive continuous quality improvement, and the use of certified electronic health record technology.³⁰ Within the OCM, drug spending has been proven to be reduced with the utilization of clinical pathways.⁴⁰ This proof of principle becomes relevant as approximately 50% of the cost-drivers in the OCM was attributed to drugs (Part B+D). Understanding successful factors in the OCM may provide opportunity for real-world data to influence and promote provider innovation and possible pathway utilization. 

A summary of the Group’s full recommendations on market impact and issues for the future are listed in Box 4. 

Care pathways should be based upon efficacy, tolerability, and cost to recommend preferred treatment options. They should also allow the art of medicine and personalized care to lead to a final treatment option that is right for that patient and their circumstances. The goal of the clinical pathway should not be to guide treatment decisions toward the lowest cost outcome simply for the sake of treatment, but rather toward the outcome that is the greatest value for the patient. While cost has a place in the list of considerations in any discussion of appropriate treatments, it is the value as determined by each stakeholder that is important. The industry should work toward a data source that is both independent and objective with data inputs from multiple sources to advance the understanding of total cost of care for any given patient population. In addition, integration of the care pathway is needed to ensure smooth implementation into the stressed practice workflow. In future of alternative payment models, all stakeholders must be included in pathway discussions to focus on how care pathways be positioned to achieve high-quality, cost-effective care.

Building on 2020 learnings, future pursuits of the Care Pathways Working Group will continue to connect the major stakeholders (patients, providers/practices, payers) to inform on and lead the integration of various perspectives into pathways decisions. We intend to focus on identifying and reconciling the different pathway drivers that are important to each stakeholder in the present and 5 years into the future. Our goal is to continue to develop a pathway framework based upon a set of core priorities and value points for all stakeholders, which will be used to encourage collaboration in the pathway ecosystem. This would facilitate conflict resolution to assist in defining the goals, value, and potential limitations of a patient-centric care pathway program.

Research Question: What are the highest priority concerns related to care pathways and their implementation that need to be addressed in order to promote high-quality pathways that offer utility in payer negotiation, reduced costs, and reduced unnecessary variation in care while improving patient care?

Mission: To convene a group of experts to clearly identify challenges and actionable solutions for stakeholders as they face the evolving design and implementation of care pathways.

Authors and Affiliations: Winston Wong, PharmD, W-Squared Group, Longboat Key, FL;Gordon Kuntz, Kuntz Consulting, LLC; Robin T Zon, MD, FACP, FASCO; Michiana Hematology-Oncology, PC, Mishawaka, IN; Vasily Belozeroff, PhD, Center for Observational Research, Amgen Inc.; 2020 Care Pathways Working Group

Author Contributions: All authors contributed equally to the conception, interpretation of data, drafting, and revising of the work. 

Disclosures: Dr Belozeroff is an employee and a shareholder of Amgen Inc. All other authors report no relevant financial relationships. 

Working Group Participants: Lee Schwartzberg, MD, FACP, West Cancer Center & Research Institute; 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 

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

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

Disclaimer: This article has been peer-reviewed by 4 experts with experience in clinical pathways, value-based care, and payer strategies