Today’s healthcare system offers significant challenges, as well as opportunities that are shaping the practice of cancer care. On the one hand, oncology providers and patients are fortunate to witness the benefits from advancing science and precision medicine, including new drugs and biologic therapies. Additionally, our clinics are filled with increasing numbers of cancer survivors—more than 14 million in 2014.

 On the other hand, the demand for cancer services is increasing as the American population ages and expands. These realities have resulted in tremendous tension on our healthcare system, as evidenced by soaring cancer care costs, attributable to increases in utilization and rising drug prices which result in particular financial toxicity to patients.

In response to mounting pressures to improve the value of cancer care, payers and other stakeholders, including the American Society of Clinical Oncology (ASCO), are pursuing new payment and care delivery models that enhance quality while lowering spending.

 Moreover, in exchange for the US Congress Sustainable Growth Rate formula repeal in April 2015, the Medicare Access and CHIP Reauthorization Act of 2015, also known as, MACRA, was codified to encourage physicians to participate in new payment models in exchange for increased accountability in delivering high-quality care. This has resulted in a paradigm shift away from remunerating quantity of care toward rewarding quality and value. Clinical pathways are one of the tools being adopted to meet the aims of better managing utilization by reducing unnecessary and costly treatment variation, while meeting the stated goals of enhancing quality and value.

As the leading professional organization representing physicians who care for people with cancer, ASCO has been a leader in assisting oncology providers in providing the highest quality care to all patients with cancer. ASCO’s clinical practice guidelines provide critical guidance to practicing oncologists and represent ASCO’s efforts to ensure that evidence-based medicine is the gold standard in oncology.

ASCO’s Quality Oncology Practice Initiative (QOPI) offers a way to provide assessment, achieve program recognition, assess and improve safety, and engage clinical staff in an ongoing culture of quality improvement. Additionally, ASCO’s QOPI Certification program provides a mechanism to formally certify those practices that achieve the highest standards of oncology care delivery to their patients. Our community’s embrace of quality is reflected in the high rate of participation and certification in QOPI.

Clinical pathways represent another important tool for promoting high-quality, high-value cancer care. Currently used by healthcare providers, commercial organizations, and other health systems, pathways are also increasingly being adopted by insurance plans in the United States, with an estimated 60 individual health insurance plans in the United States currently implementing oncology pathways programs.

 More than 170 million individuals covered by those insurance plans are potentially being treated under a health plan-sponsored pathways program—many under active treatment for cancer.

 Furthermore, approximately 15% of oncology “lives” were treated according to clinical pathways in 2010; a percentage expected to rise significantly over the coming years.

Under ideal circumstances, clinical pathways are detailed, evidence-based treatment protocols for delivering quality cancer care for patients with specific disease types and stages. So, why is ASCO providing comment and guidance 

? ASCO members have articulated concerns regarding the current proliferation of pathways in oncology, including lack of transparency, administrative burden, and other factors that could affect patient access and care quality. In response, ASCO established an ad hoc Task Force on Clinical Pathways last year to examine this issue. In January 2016, the Task Force issued a policy statement on clinical pathways in oncology to guide the future development and implementation of these treatment management tools.

From the outset, it’s important to note that clinical pathways in oncology are viewed by many in the field as a way to improve, not hinder, care. Indeed, cancer specialists, themselves, are often leading the development of pathways as a means for promoting evidence-based care and shared decision making with patients. That said, the responsible use of pathways means that not all patients should be treated “on pathway” due to the presence of comorbidities or other patient-specific factors. 

Additionally, the Task Force recognizes that there is a wide variation in the quality and utility of existing pathways, with some pathways placing priority on cost control, inserting hurdles for treating patients “off-pathways,” and being opaque about how a pathways program was designed, is updated, and even how decisions are made about what treatments are put on or off a pathways program. ASCO’s policy statement serves to convey a cautionary note, that we must be thoughtful and deliberate in the development and implementation of pathways to ensure that our patients receive the best and most appropriate evidence-based cancer care possible, as well as have access to well-designed clinical trials.

ASCO Policy Statement on Clinical Pathways in Oncology

		To increase awareness about the growing use of clinical pathways in oncology, and concerns that exist about the manner in which they are being deployed

		To ensure quality, transparency, and consistency in the design and implementation of these treatment management tools

		To ensure that pathways are used in the way they are intended to ensure quality care and reduce costs.

The ASCO Task Force’s review of clinical pathways in oncology identified a range of concerns, including tremendous variation with regard to pathways that do not consistently offer an appeals process when denying off-pathways treatment; pathways that often have a cumbersome approval and appeals process and provide no reimbursement when off-pathways treatment is denied; pathways that do not cover rare cancers and those patients treated in the inpatient setting (eg, acute leukemias); pathways that do not disclose methodology used in development nor report all potential conflicts of interest by the pathway developers; and pathways that focus on cost savings, with efficacy and safety as secondary considerations.

ASCO’s examination also found that the number of regimens offered for specific cancers varies widely from pathway to pathway, and treatment options within the same pathway can be different in different demographic regions.

Additionally, we discovered that the proliferation of oncology pathways has created major administrative burdens on oncology practices, some of which report having to adhere to multiple different pathways by differing payers for the same type and stage of cancer.

 Practices are increasingly forced to sift through the requirements of each payer’s pathway program on a patient-by-patient basis, diverting time away from direct patient contact and potentially eroding the doctor-patient relationship.

At this juncture, the focus should be on learning, revising, and improving the process of pathway utilization through prospective research on current implemented pathways. Although some studies have shown that pathways can reduce costs while improving, or at least maintaining quality of cancer care, data are not complete.

 ASCO’s clinical pathways policy statement calls for additional research to understand the impact of pathways on care and outcomes.

ASCO envisions a collaborative effort for strengthening clinical pathways by involving all stakeholders, including physicians, patients, payers, clinical researchers, pathways developers, healthcare administrators, and policy makers—a specific recommendation articulated in its policy statement. Transparency, consistency, and the full promise of clinical pathways will not be fully realized until all concerns and perspectives are considered and thoughtfully addressed.

We believe that the ASCO policy statement will serve to engage all stakeholders in clinical pathways in oncology and facilitate a constructive dialogue for moving forward. The ASCO policy statement sets forth the following 9 recommendations that can provide the structure for this much-needed dialogue:

		Pursue a collaborative, national approach to reduce the unsustainable administrative burdens associated with the unmanaged proliferation of oncology pathways. This would include eliminating preauthorization requirements if the patient meets the criteria for a selected pathway, and allowing physicians to select one, deemed pathway accepted by all payers.

		Adopt a process for development of oncology pathways that is consistent and transparent to all stakeholders with public disclosure of methodologies for the pathway development and conflict of interest disclosures.

		Ensure that pathways address the full spectrum of cancer care, from diagnostic evaluation through medical, surgical and radiation treatments, and include imaging, laboratory testing, survivorship and end-of-life care in order to maximize opportunities for value-based medical outcomes.

		Update pathways continuously to reflect new scientific knowledge, as well as insights gained from clinical experience and patient outcomes, to promote the best possible evidence-based care. The emergence of big data and rapid learning systems further accentuate the need for rapid pathway refinements and more granular pathways to best serve the needs of distinct populations.

		Recognize patient variability and autonomy, and allow for physicians to easily diverge from pathways when evidence and patient needs dictate. Appropriate variation considering varied patient comorbidities and therapeutic goals should be supported without significant administrative burdens.

		Implement oncology pathways in ways that promote administrative efficiencies for both oncology providers and payers. In addition to removal of preauthorization when providers provide health services consistent with clinical pathways, the additional costs in complying with pathway adherence, which are not currently included in the codes for evaluation and management or care management, should be factored into payment for oncology services.

		Promote education, research, and access to clinical trials in oncology clinical pathways. Furthermore, robust oncology pathways may help with collection of data outside of small trials and help advance understanding of therapy toxicities, patient comorbidities, and survival.

		Develop robust criteria to support certification of oncology pathway programs; pathway programs should be required to qualify based on these criteria, and payers should accept all oncology pathway programs that achieve certification through such a process.

		Support research to understand the impact of pathways on care and outcomes focusing on pathway development, dissemination and implementation, cancer care delivery, patient experiences, and impact on clinical outcomes and value.

The Future Vision for Pathways in Payment Reform

Oncology clinical pathways are likely here to stay, at least for the near future. Value-based pathways are considered by many an essential component of a comprehensive oncology payment reform initiative. This includes the ASCO model, which suggests payment adjustments based on quality, pathway adherence, and resource utilization, as well as alternative payment models such as the Oncology Medical Home. The future could also include the potential integration of rapid learning system data in optimizing the pathway evidence base, and therefore, improving the quality of patient care. Additionally, as pathways are used to measure outcomes, value-based pricing may also be realized, further promoting cost containment. The ASCO Value Framework, which assesses the relative value of cancer treatments by examining effectiveness, toxicity, and cost of regimens in a comparative manner, may also assist pathway development.

The business model for incorporating pathways needs to be more fully examined and understood to assure sustainability of the care model for payers, providers, and patients. This includes mitigating administrative burden through oncology certification and acceptance of a deemed pathway by all payers.

		ASCO believes there need to be uniform standards for the development and implementation of clinical pathways that are transparent to oncology stakeholders including physicians, patients, and payers.

		Pathways should address the full spectrum of cancer care, and be updated in a timely manner to reflect new scientific knowledge, as well as insights gained from clinical experience and patient outcomes.

		Clinical trial access should be considered an on-pathway option.

		Pathways should recognize patient variability and autonomy, and off-pathway options when this is in the best interests of the patient.

		Finally, pathways must be implemented in ways that promote administrative efficiencies rather than burdens for oncology patients, providers, and payers with strong consideration for certification and deeming of pathways.

Recognizing the critical importance of this issue for physicians, patients, and payers throughout the United States, ASCO’s Task Force on Clinical Pathways will continue its efforts to ensure that pathways are developed in such a way that ensures quality, consistency, transparency, and administrative efficiency to all stakeholders. Our recommendations will form the basis of this work, which will involve consulting with payers, vendors, providers, and others to develop a collaborative approach to ensure that clinical pathways promote—and don’t hinder&mdash;high-quality patient care. 

, FASCO, is chair of ASCO’s Task Force on Clinical Pathways and a practicing oncologist at Michiana Hematology-Oncology in South Bend, Indiana.

  James N. Frame, MD, Charleston Area Medical Center, Charleston, West Virginia; Ray Page, DO, PhD, The Center for Cancer and Blood Disorders, Fort Worth, Texas; and members of the ASCO Task Force on Clinical Pathways, contributed to this commentary.

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Articles

Evidence-Based Oncology

Members of the American Society of Clinical Oncology (ASCO) have articulated concerns regarding the current proliferation of clinical pathways in oncology that could affect patient access and care quality. In response, ASCO established an ad hoc Task Force, which issued a policy statement to guide the future development and implementation of these treatment management tools.

ASCO Policy Statement on Clinical Pathways in Oncology: Why Now?

With the skyrocketing costs of oncology care, it is imperative that the cancer care community develop a strategy to control costs, while providing high-quality, comprehensive care to patients diagnosed with cancer. Clinical pathways have been emphasized as a means to deliver efficient, quality care and to ensure better outcomes at lower costs. The Oncology Medical Home (OMH) takes this to the next, more comprehensive, step of quantifying and improving quality and value in cancer care while lowering overall costs. Patients, providers, policy makers, payers, and employers all agree that we must work together to curb the rising costs of cancer care while maintaining and promoting higher quality. This focus should encompass all aspects of the cancer care journey for patients and their family.     

The OMH accreditation model being implemented by the American College of Surgeons’ Commission on Cancer (CoC) was designed to help cancer care teams transition their focus, energy, and processes to ensure the delivery of quality and value in cancer care. The model is centered around 5 core areas including:

Achieving OMH certification includes specific guidelines for these areas that cover well defined policies and efficient procedures, and emphasizes compliance with or results from applying the guidelines. Evidence is to be provided through reporting and trending of compliance with the required policies and procedures, and proof of improved quality and value, as demonstrated in the 18 OMH measures.

 These measures are the result of a collaboration among an 18-member team of insurance payers, cancer care providers, practice administrators, and patients or patient advocacy organizations.

The CoC has been associated with recognizing and promoting quality cancer care. Founded in 1922, the CoC has been instrumental in improving cancer care in hospital-based cancer programs. In addition, the CoC has developed and maintained the National Cancer Data Base, which stores information on approximately 70% of newly diagnosed cancer patients in the United States. The CoC improves care by setting mandatory standards for cancer programs and using the data submitted by cancer programs to compare their compliance with mandatory quality measures. 

Likewise, the OMH model has been developed as a mechanism to hold oncology practices accountable for meeting the standards that ensure quality, comprehensive care, and decreased variation. This is achieved through constant monitoring and measuring of compliance with the accepted standards and quality metrics—measuring compliance, and comparing it against peers, helps raise the bar in quality and will set the foundation for payment or delivery system reform. Examples of compliance measures include:

		Policies and procedures to minimize unnecessary emergency department (ED) visits and inpatient hospitalizations

		Proof of effectiveness of these policies and procedures to avoid ED visits and hospitalizations

		Improving patient satisfaction: each practice must administer a patient satisfaction survey and monitor results. The goal is to ensure that care is truly patient-centered and meets the needs of patients and their families or caregivers.

It Takes a Team: Distinct Perspectives on Quality and Value 

OMH accreditation standardizes measurement and assesses performance against a set of uniform standards and requirements that may improve quality, outcomes, efficacy, and efficiency. Of course, oncologic outcomes cannot simply be defined by survival rates—they include demonstrated compliance and improvement of evidenceâ€based standards, improvement in quality measures, patient and family engagement, and a variety of patientâ€centered services.

There are 3 central perspectives to be considered when measuring the quality and value of the OMH model: patients, providers, and payers.

All cancer patients expect a positive outcome following their treatment, along with an individualized survivorship care plan for the best quality of life. Patients also merit education on diagnosis, treatment, and financial implications, so that they may make informed care decisions, and have confidence that their input and preferences are taken seriously by their trusted clinicians.

Oncology clinicians are being asked to provide evidence and rationale for their clinical decisions with proof in the form of measurable quality and value. Under the OMH model, this includes adherence to proven treatment plans, appropriate and timely communication with patients and their families, minimizing unnecessary visits to hospital EDs, and survivorship care. In return, clinicians are seeking better reimbursement rates along with higher patient satisfaction of the care delivered.

For the payer, cost-efficient care is a priority. Insurance companies are urging hospitals and private clinics to help reduce the rising costs of cancer care by promoting and providing evidence-based care that minimizes unnecessary expenditures. Clinical pathways and performance measures are 2 strategies that can help achieve this. If all these interests are to be met successfully, it is vital that clinicians, patients, and payers continue to work together to define the measures of what high-quality, high-value oncology care is.

Accreditation of the Oncology Medical Home

An ideal cancer care team is focused on providing the 

 place. At the core of the OMH are measures of quality, including patient satisfaction and value. These measures cover the full range of the cancer care journey, from diagnosis to the initial visit, through treatment and to survivorship or advanced care planning. They are intended to help improve clinical outcomes and increase cost efficiency of cancer care.

The OMH program covers all aspects of care delivery in a cancer clinic seeking accreditation. It is an oncology-specific version of the general patient-centered medical home model that takes into account the unique services and issues managed by cancer practices. Cancer clinics achieving accreditation are publicly recognized as, “Oncology Medical Homes.” According to standardized criteria, payers may find this accreditation helpful when evaluating whether payment reform initiatives are being implemented.

This transition to evidence-based cancer care, in all aspects of the team model, begins with commitment. Each care team needs at least one champion who will educate, coach, and encourage the practice to take on this new accountability of their service. Historically, having a practice champion has proven to be the hardest step for any healthcare transformation.

For at least the last 50 years, healthcare has been structured to incentivize volume over value, with the system rewarding consumption or utilization. The concept of having healthcare services be evidence-based, validated, and recognized, in a quantifiable way, is relatively new. But it is an important step; so, having a champion rally the team may need to be repeated several times before a plan can truly be successfully implemented.

Those involved in developing an OMH often hear of how overwhelming and expensive the journey could be. The goal of the CoC-OMH team and allied supporters, who have helped lay the foundation for today, is to minimize the administrative and financial tasks that may be encountered. This sets the OMH program apart from other programs.

The OMH model does not prescribe how to accomplish a certain goal; instead, it simply emphasizes the goal that needs to be met. The cancer care team has the flexibility to determine the most efficient path towards achieving the goal and the target, and measurable outcomes will be proof that they are a leader among their peers.   

For those considering the OMH, implementation of the patient survey is probably the easiest step to grease the wheels of change. Deployment is extremely easy and the feedback paints the picture of how specific areas might be benchmarked, discussed, and addressed. The bonus, for adopting the model, are patient surveys that reflect the patient’s view of how well a practice is performing with achieving high standards. 

Healthcare has come a long way in the last 5 years, and it seems cancer care has been on the forefront of that change. What was a specialty emphasizing clinical pathways 

 is now pursing evidence in all aspects of the field—from comprehensive and timely communications with patients and their families, to efficient and effective care, to appropriate survivor and end-of-life care. Most importantly, evidence is central to the entire care delivery model. 

The CoC accreditation program for OMH provides an organized and comprehensive plan to guide any cancer care team that is ready to distinguish itself as leader in this era of healthcare reform and accountability. 

Daniel P. McKellar, MD, FACS, is chair, American College of Surgeons, Commission on Cancer and 

medical director of Oncology, Wayne Healthcare. 

Charles Bane, MD, is chairman, OMH Steering Committee and medical oncologist, Dayton Physicians Network. 

M. Asa Carter, MBA, CTR, is senior manager, Commission on Cancer.

Allison Knutson, CCRP, is manager of Accreditation and Standards, Commission on Cancer.

Vicki Chiappetta, RHIA, CTR, is accreditation technical specialist, Commission on Cancer.

Bo Gamble, is director of Strategic Practice Initiatives, Community Oncology Alliance.

Director, Strategy Practice Iniatitatives

		18 oncology medical home measures. Oncology Medical Home website. 

http://www.medicalhomeoncology.org/UserFiles/OMHMeasures111015v2.pdf

. Updated November 10, 2015. Accessed March 2, 2016.

Clinical pathways have been emphasized as a means to deliver efficient, quality care and to ensure better outcomes at lower costs. The Oncology Medical Home takes this to the next, more comprehensive, step of quantifying and improving quality and value in cancer care while lowering overall costs.

The Oncology Medical Home - Beyond Clinical Pathways 

Clinical care pathways have been used for more than 30 years in hospitals and physician practices as tools to link care decisions with evidence-based practice in ways that reduce variation, improve patient outcomes, and maximize clinical efficiency.

 Healthcare professionals have been the leaders in pathway development for decades, just as they have been in the creation of the clinical guidelines on which they are typically based.

However, some health insurance companies are now developing their own pathways in ways that may limit physician decision making and restrict patients’ access to new state-of-the-art treatments for cancer and other chronic diseases. Of special concern to providers and patient advocates are programs that pay physicians a monthly fee to prescribe preselected therapies that are “on-pathway.” Coverage is likely to be denied or delayed when the physician opts for an “off-pathway” treatment based on clinical judgment of the patient’s unique circumstances, even one that is considered standard-of-care, according to well-established guidelines. Penalizing “off-pathway” prescribing, either directly or indirectly, when supported by evidence, may cause harm to patients and impose unnecessary costs on the health system. Compounding the problem, the process, by which some clinical pathways are developed, is not transparent—providers and patients may not know why certain treatments are covered, what evidence was considered when creating pathway protocols, and whether their physician has a financial incentive to prescribe specific drugs.

We offer recommendations, in the following areas, in an effort to establish a set of normative criteria for the development and design of pathways that creates trust and transparency: the fundamental elements of a clinical pathway, the necessary transparency standards for their development, and the steps needed to ensure patients receive the best care in a shared-decision making context that reflects their physician’s clinical judgment.  

What Are the Common Characteristics of a Pathway?

Ideally, clinical pathways should consist of a structured, multidisciplinary plan that details essential steps to improve continuity and coordination in the care of specific patients, and should span areas like diagnostics, surgery, nutrition, medications, and discharge planning.

 However, pathway programs in medical oncology often place a greater emphasis or focus on drug selection.

In 2010, a team of Cochrane Review authors identified at least 5 characteristics (

) that define a clinical pathway from the literature that has subsequently been recognized as “a standardized, internationally accepted definition of a clinical pathway.”

 Clinical pathways are often developed and defined at the local or institutional level by the providers who are expected to implement them.4 This approach takes into account variations in the ways providers practice medicine within their local ecosystem to ensure that the needs of their patients are met.

 Some clinical pathways, however, are intended to standardize treatment protocols at a national, state, or regional scale to further reduce variations in the delivery of evidence-based care across sites, particularly in the absence of scientific merit for local variability in treatment regimens.

The healthcare community’s reaction to pathways has been mixed, particularly on the part of medical oncologists.4 Some resist it as a “cookie-cutter” approach that can interfere with personalizing a care plan to the individual.

 Others support it as an important tool for reducing errors and costs while increasing efficiency based on the best available evidence.

A pathway program that is meant to drive coverage decisions for an individual patient treatment will operate differently from one that seeks to create quality at an aggregate level while maintaining flexibility and clinical judgment at the individual treatment level. The methods, by which the pathway is developed, and the preferred concepts on which it is based, are likely to differ when the program is driven by a group of providers as opposed to a payer.

Payers have a financial interest to place greater emphasis on cost control and pathway compliance in lieu of clinical judgment, than typically found in provider-sponsored pathways and guidelines. There exists a concerted and growing effort on the part of some health plans to either standardize pathways or create their own.

Pathways can be designed as a comprehensive decision support tool that enables treating physicians to navigate their patients through various healthcare decisions—including clinical trials&mdash;based on different safety and effectiveness profiles, as well as cost considerations.

 On the other hand, a clinical pathway may serve to limit the need for clinical judgment and customization through rigid standardization based on the “average” patient. Some pathways, for example, consist solely of a pre-determined “checklist” of drug regimens from which the prescribing physician is financially incentivized to select for nearly all patients.

 Such a limited approach to a pathway more closely resembles common utilization management techniques like step therapy or “fail first” requirements that payers apply to regulate patient access to medications in an effort to control cost. Cost containment should not be the central organizing principle for clinical pathways.  

Some healthcare providers have expressed concern with the potential dilemma that might arise when the pressure to follow a payer’s limited set of predetermined pathway options conflicts with the provider’s clinical judgment about the best treatment option based on the individual’s unique circumstances.

 When providers elect to administer therapies that diverge from a payer’s clinical pathway, the latter is likely to deny coverage or require prior authorization and take time to review the provider’s chosen course of treatment regimen. Not only can such delays in physician-recommended treatment threaten patient health and impose unnecessary costs on the system, they also waste providers’ time, effort, and resources. 

Patients place a sense of trust and mutual respect with their physician. This relationship must be protected from attempts to influence the physician’s treatment recommendations in the form of kickback arrangements to the practice by those who stand to benefit financially from the decision. Thus, there exists a growing concern among some physicians and patient advocacy groups regarding the use of payer-designed clinical pathways designed that include payments to physicians to induce the use of a narrow list of “on-pathway” therapies preselected by the payer

 Such pay-to-prescribe incentives might short circuit the shared decision-making process and limit patient access to viable treatment options that are “off-pathway.” 

We recommend that, at the very least, patients should have the right to know when their physician is participating in such a program. Patients need to be aware, not just of how options on pathways were chosen, but also of what other alternatives are viable, according to guidelines, that may not be listed in the pathway. Patients can then have an honest consultation with their physician about the various risks, benefits, and costs associated with each viable option. If reasonable clinical evidence exists to support one drug treatment regimen over others, based on what is going to provide the best approach for the patient, then healthcare professionals should be trusted to follow the evidence without an extra financial inducement to do so.

Pathway development should be owned and led by physician scientists and other members of the care team and/or the professional societies that represent them with specific expertise in the clinical area covered by the pathway. Clear mechanisms should exist for involving patient advocates throughout the pathway development process.

Pathways should be evaluated against their ability to meet transparency standards such as those contained in the 

, that are consistent with those used by groups like the National Comprehensive Cancer Network, when developing clinical guidelines.

The providers who must live by the pathways are in the best position to determine how to translate guidelines into their institutional structures.

 Local design and control also helps prevent pressure to have multiple pathways from different sources deployed in the same provider ecosystem. Competing pathways within the same practice could lead to variability and inconsistency in the patient care experience, which are exactly the types of issues pathways are intended to reduce. For example, if multiple payers were to create different clinical pathways, then different patients with the same disease in the same hospital system might receive different care experiences based on their payer’s pathway.

Pathway protocols should support shared decision making and patient preferences that lead to a personalized treatment plan that accounts for differences in the clinical and biological characteristics of individual disease processes. Discussion and consideration of clinical trial options should be a required pathway element. Efficacy and safety should be the main considerations in pathway design, while incorporating relevant personalized/precision determinants. The pathway process can navigate patients and providers through a cost discussion when selecting from among viable treatment options, and pathway programs should be measured against their ability to improve patient health outcomes and quality. Ultimately, clinical pathways should be a tool for optimizing treatment protocols by personalizing them for each patient in accordance with their physician’s clinical judgment. Isn’t that, after all, what medicine is all about? 

Alan J. Balch, PhD, chief executive officer, National Patient Advocate Foundation, Newport News, VA.

Charles M. Balch, MD, chair, Scientific Advisory Committee, National Patient Advocate Foundation; adjunct professor of Surgical Oncology, University of Texas MD Anderson Cancer Center, Houston, TX.

Al Benson III, MD, associate director for Clinical Investigations, Robert H. Lurie Comprehensive Cancer Center and Professor of Medicine, Northwestern University, Feinberg School of Medicine, Chicago, IL.

Deborah Morosini, MD, vice president, Clinical Development, Foundation Medicine, Boston MA.

Robert M. Rifkin, MD, associate chair for Hematology Research, US Oncology, Denver, CO.

Loretta A. Williams, PhD, assistant professor of Symptom Research, University of Texas MD Anderson Cancer Center, Houston, TX.

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We offer recommendations for the development and design of clinical pathways in an effort to establish a set of normative criteria that creates trust and transparency.

Recommendations for the Role of Clinical Pathways in an Era of Personalized Medicine

The oncology landscape is rapidly changing, in great part due to unprecedented innovations in diagnostic and treatment technologies.

Ironically, the same advances in cancer therapeutics that now benefit many patients also dramatically increase the complexity and costs of oncologic care.

The latter have forced stakeholders to develop new strategies to provide high-quality, state-of-the-art cancer care while simultaneously bending the cost curve.

Among the several new models of cancer care delivery and reimbursement that are currently under evaluation, cancer care pathways (CCPs) are emerging as a strategy to provide evidence-based oncology care at lower costs through reductions in unnecessary treatment variations.

The rationale for adopting CCPs departs from the following assumptions:

		Cancer care and costs vary substantially across clinics and providers, a concern that many studies have confirmed to be true.

		Low-value treatments account for at least a fraction of the variation, including the use of costly, but marginally effective, drug regimens.

		Adoption of CCPs can change physician behavior to prioritize the use of high-value evidence-based treatments, thereby improving patient outcomes and reducing the use of costly therapies that are either marginally effective or more toxic.

To the extent that these assumptions hold true, CCPs have great potential to succeed as a model for the delivery of high-value cancer care. But do they hold true?

As an increasing number of cancer care clinics are adopting CCPs, either voluntarily or as required by payers, an early look at pathways’ performance becomes necessary to inform stakeholders whether the investments in CCPs have resulted in the expected returns and what efforts need to take place to optimize pathway development, if any.

Our goal here is to discuss the impact of adoption of CCPs on treatment variation, patient outcomes, and cancer care costs, based on published literature. This review focuses on commercially available CCPs (ie, computer-based treatment decision programs offered by vendors as part of oncology management programs) because most of the available literature pertains to this particular type of pathway. Several academic cancer centers have developed their own CCPs for internal use, including the University of Washington, Dana-Farber Cancer Institute, and University of Tennessee, to name a few.

A review of these programs is beyond the scope of this article, as very little published literature is available to inform their performance. Although this review is by no means comprehensive or exhaustive, it provides some insights about the promises and concerns regarding adoption of CCPs.

The Process of Developing Cancer Care Pathways

To ensure an informed discussion of how CCPs impact outcomes, a brief explanation is in order to define CCPs and clarify the process by which pathways are developed. Pathways consist of complex electronic treatment decision support tools that provide evidence-based treatment recommendations to physicians at the point-of-care for individual patients. These tools are often integrated with electronic health records (EHRs) in a manner that allows managers to evaluate whether the treatments actually delivered were concordant or discordant with pathway recommendations. This information is relevant for monitoring pathway adherence. Pathways, in general, cover several cancers at all stages. With a primary focus on drug regimens, some CCP programs have also developed content for supportive care and radiation therapy.

CCP programs typically apply a hierarchical order of criteria to select the treatments to be included in the pathways. The first criterion is treatment efficacy, wherein regimens of superior efficacy receive top priority for pathway inclusion. As a side note, the available literature does not clearly specify the disease endpoints used to measure efficacy (eg, overall vs progression-free survival, response rates, etc.). Toxicity is the next selection criterion applied to regimens of similar efficacy; those with lower toxicity and similar efficacy receive priority. Drug cost is the third and last selection criterion; pathways prioritize regimens of lower cost when efficacy and toxicity are similar.

Most CCPs emanate from collaborative efforts involving physician network groups, healthcare payers, and oncology management—program consulting firms. Physicians elect disease-specific committees that appraise the current evidence and select the treatments for pathway inclusion. Leaders of several CCP programs have publically declared that the committees offer an opportunity to all physicians using the pathways to comment on the contents and participate in the process of pathway treatment selection.

The committees are also in charge of continuously updating pathway contents—as evidence becomes available&mdash;to support the use of novel therapies.

Once physician committees decide on the contents of a pathway, the oncology management programs integrate the treatments into the electronic supporting tools and offer technical assistance to network physicians using the pathways in daily practice. Oncology management programs also assist clinics in reporting pathway adherence to healthcare payers, and help monitor patient outcomes and costs. Payers offer financial incentives to maximize pathway adherence, usually in the form of higher fees for on-pathway drugs and by increasing the reimbursement for evaluation and management charges for adherent physicians.

Cancer Care Pathways and Treatment Variation

The central hypothesis for CCP use is that adherence to pathways reduces costs and maintains quality of care by curtailing the use of unnecessary and costly oncologic treatments. Surprisingly, there is very scant published evidence to support or reject this hypothesis. After a short PubMed literature search, I could only retrieve 1 article reporting on the impact of the Cardinal Health Specialty Solutions (formerly, P4 Healthcare) pathway on treatment variations. The study compared the number of chemotherapy regimens used for breast, lung, and colorectal cancers in the year preceding and the year following pathway implementation, in several practices located in Michigan.

Physicians used 168 and 136 distinct regimens in the years pre- and post-pathways implementation, respectively, which represents an 8% absolute reduction in treatment variation (

). Interestingly, 10% of the study population accounted for 81% of the reduction in the number of drug regimens used, suggesting that a minority of patients drive most of the treatment variation, perhaps because of higher disease complexity. Although this single report does not provide any firm conclusions about the effects of pathways on treatment variation, the reduction in the number of chemotherapy regimens used was quite modest. An important point to note is that the report does not provide any information on the cost of the chemotherapy regimens avoided to establish a causal relationship between reductions in treatment variation and costs.

Cancer Care Pathways and Patient Outcomes

At least 1 report indicates that adherence to CCPs reduces the number of emergency department (ED) visits and hospital admissions for treatment-related complications (

). Kreys et al evaluated the effect of adherence to the Cardinal Health Specialty Solutions supportive care pathways on ED visits and hospitalizations for neutropenia, anemia, and chemotherapy-induced nausea and vomiting in patients with breast, lung, and colorectal cancers. Compared with patients who received off-pathway supportive care, pathway adherence was associated with a 15% absolute reduction in ED visits and hospitalizations for neutropenia (adjusted odds-ratio, 0.42; 95% CI, 0.30-0.58).

The study demonstrated no clinically or statistically significant differences in admissions for anemia or chemotherapy-induced nausea and vomiting. Pathway adherence was associated with lower expenditures for hospitalizations to manage neutropenia and anemia, and with lower expenditures related to the use of granulocyte colony—stimulating factors and antiemetics.

Current evidence suggests that adherence to CCPs results in either a neutral or favorable effect on survival outcomes, depending on the disease and treatment setting (adjuvant vs metastatic) (

). Using EHR and pathway reporting data, Neubauer et al conducted a cost-effectiveness analysis of adherence to Level I Pathways among 1409 patients with non-small cell lung cancer (NSCLC) treated at several US Oncology network clinics. After adjusting for patient characteristics and line of therapy, the study showed no statistically significant difference in 1-year overall survival (OS) (HR, 0.95; 95% CI, 0.77-1.16) between patients treated on- versus off-pathway.

Hoverman et al also utilized EHR and claims data to compare disease-free survival (DFS) and OS in patients treated on versus off Level I Pathways with adjuvant and palliative chemotherapy for stage III and IV colorectal cancer, respectively.

Pathway adherence was associated with a substantial increase in DFS (HR, 4.98; 95% CI, 2.11-11.74 for non-adherence) in the adjuvant setting and prolongation of OS (HR, 1.57; 95% CI, 1.04-2.39 for non-adherence) in the metastatic setting, respectively.

Cancer Care Pathways and Direct Medical Costs 

Cost is perhaps the outcome measure for which the evidence is most robust to support the use of CCPs. At least 3 economic evaluations suggest that adherence to CCPs reduces direct medical costs (

). The cost-effectiveness analysis of adherence to Level I Pathways for NSCLC found that total mean direct medical costs were 35% lower in patients treated on- versus off-pathway ($18,042 vs $27,737 per patient), suggesting that pathway adherence saves costs in this disease setting.

The study by Hoverman et al showed mean reductions in total direct medical costs of $52,641 and $60,163 associated with adherence to Level I Pathways for adjuvant and metastatic treatment of colorectal cancer, respectively.

Chemotherapy costs accounted for most of the cost reductions in this study.

Cancer pathways can potentially improve patient outcomes and reduce costs. Recent concerns about pathway adoption deserve attention, including excessive administrative burden to clinics. 


April 2016

ASCO Policy Statement on Clinical Pathways in Oncology: Why Now?

The Oncology Medical Home - Beyond Clinical Pathways

Recommendations for the Role of Clinical Pathways in an Era of Personalized Medicine

Cancer Care Pathways: Hopes, Facts, and Concerns

Developing an Oncology Clinical Pathways Program - the UPMC Case Study

Clinical Pathways: A Systems Approach Toward More Patient-Centric Cancer Care Delivery

Are Oncology Clinical Pathways a Value Framework in the Making?

The Healthcare System's Struggle With Oncology Care Pathways

Conference Coverage: ACCC