In this new series, Journal of Clinical Pathways features insights from the editorial advisory board members pertaining to a specific question on pathways or value-based care.
For the first edition of Ask the Board, we gathered board members' perspectives on the largest area(s) of growth in clinical pathways at the current moment.
Lili Brillstein, MPH, chief executive officer, BCollaborative (Pine Brook, NJ)
As the move from fee-for-service to value-based care continues to evolve, the role of evidence-based clinical pathways becomes ever more critical. The focus of value-based care is achieving and paying for consistent, best care. Clinical pathways are the tools that physicians and other clinicians use to address and reduce the variations in care that result in suboptimal and inconsistent outcomes and unnecessary use of resources.
Creating partnerships between payers and providers, while leveraging the expertise of both, is the goal. Payers share the longitudinal data that reflects the variations in care, and the clinicians develop and/or adopt pathways to address those variations. Pathways are not value-based care models. But they are at the heart of their success.
Bruce A Feinberg, DO, vice president of clinical affairs and chief medical officer, Cardinal Health Specialty Solutions (Dublin OH)
Over the past decade, mounting clinical evidence has shown that social determinants of health (SDOH)—defined by the World Health Organization as “the conditions in which people are born, grow, live, work and age”—are equally, if not more, important to driving health outcomes than a patient’s genes. These factors, which can include financial security, food security, social isolation, housing security, addiction, access to transportation and patient health literacy, impact all aspects of chronic, disabling, and life threatening disease management – from prevention to diagnosis and treatment to survivor care.
Nationwide, there is growing recognition of the importance of social determinants. Policymakers have incorporated the SDOH into public policy—for example, through the authorization for Medicare Advantage plans to cover non-medical benefits—indicating a shift toward a more comprehensive approach to health care. Even large commercial payers are making investments to help patients with food, transportation and housing, which reflect an acknowledgement that addressing social disparities can not only improve health outcomes, but also lower the total cost of care.
The significance of SDOH has become even more evident during the recent COVID-19 crisis. Those who lack financial security, education, employment, or housing are at greater risk of being infected with the virus and not being able to socially distance or access appropriate medical care. These disparities have led to higher mortality rates. This growing awareness and recognition of the profound impact of SDOH makes it inherent in health care providers to document and incorporate SDOH into real-time, point-of-care decision making. Only by incorporating SDOH into clinical pathways can such a complex process be successful.
Andrew Hertler, MD, FACP, chief medical officer, New Century Health (Brea, CA)
At face value, clinical treatment pathway design in oncology is a straightforward process. Therapeutic regimens for any given clinical scenario are compared first in terms of efficacy, followed by toxicity and then, all else being equivalent, costs. However, what happens when the evidence used in these comparisons is incomplete? Lack of good clinical evidence occurs for several reasons. Increasingly, drugs are approved via accelerated FDA programs such as breakthrough designation. Often, surrogate endpoints other than progression-free survival (PFS) are utilized in the studies leading to drug approvals. In pathway design, determining efficacy of competing therapeutic options with PFS is of paramount importance. Though post approval studies are required, they are completed just over half of the time. Secondly, all too frequently the studies leading to approval have either no control arm or an archaic control arm which has long not been the standard of care. Finally, the patient population in clinical trials are not representative of those who will be treated in the real world – tending to be younger, fitter, and more often Caucasian.
Given that clinical trials are designed to lead to drug approval and not to provide evidence needed for clinical treatment pathway design, the above situation is unlikely to change. This highlights the importance of real-world evidence (RWE) to supplement clinical trial data. In addition to providing duration of clinical benefit end points, RWE has the potential to monitor post-approval toxicities – essential information for pathway construction. Ultimately, one can envision clinical treatment pathways that utilize personalized patient data (including social determinants and genomics), published evidence-based literature, and RWE at the point of care to develop an individual pathway for each patient – which optimizes their opportunity for a good outcome.
Gordon Kuntz, partner, Kuntz Consulting (St Paul, MN)
Worth noting as the largest growth areas in clinical pathways are a continued focus on ease of use of pathways programs, expanding the use of genomic and molecular testing in pathways (both in workup and in treatment selection), and the expansion of pathways beyond oncology.
Ease of use, or the lack thereof, has been a longstanding barrier to more widespread adoption of pathways. In many cases, pathways are used despite the time and effort required of clinicians. Flatiron and other health care technology companies are trying to address these issues in different ways, both through integration as well as more intelligent systems that anticipate a clinician’s decision and reasoning.
There is growing conversation around how and when genomics should be used in pathways, from the initial workup through treatment selection, as a way to better target therapies and make treatment decisions more accurately for an individual patient.
A third trend is the expansion of pathways outside of oncology. There are several initiatives in various stages of development to bring the structure and rigor of pathways to non-oncology specialties. The characteristics of what have made pathways successful in oncology, as currently constituted, do not always exist in other specialties. For example, pathway development for some diseases may be challenged due to a lack of a clear evidence base, lack of independent bodies to determine standards of care (such as ASCO), and a limited pre-existing consensus about standards of care.
Gary Owens, MD, president, Gary Owens Associates (Glen Mills, PA)
Patient-reported outcomes (PROs) can help optimize care and bridge the gap between patient experience and clinician understanding of the disease. Currently, most pathways are very good at optimizing clinical effectiveness of various therapeutic regimens while maintaining a balance with cost elements. Included now are not only cost of therapies, but also potential cost impact to the patient as part of the pathway. In recent years, regulatory agencies such as the FDA and EMA have increasingly promoted the use of PRO data in the development and approval of cancer products. While the standard primary endpoint for oncology trials is focused on survival and overall response, regulatory agencies are lately placing weight on the importance of PRO-based secondary endpoints that are indicative of clinical benefit in terms of patient symptoms and overall quality of life. This emphasis now needs to move from the trial area to clinical practice. Future pathways need to consider that third axis of PROs in addition to clinical effectiveness and economics in their development.
Patient self-reported outcomes may more accurately reflect an individual’s physical functioning and well-being because they are not subject to physician interpretation and bias, which can occur in a time-limited visit. Research has demonstrated that incorporating PROs improves physician-patient communication, symptom awareness and management, and patient quality of life. Additional research has shown that PRO measures when routinely collected at the clinic result in physicians being more likely to discuss patient outcomes during consultation visits. These discussions facilitated an increased number of supportive care referrals, improvements in patient satisfaction, and improved healthcare usage at the end of life.
In essence, PROs can help support the oncology care provider’s assessment of patient status to guide treatment decision making, supportive care interventions, and estimations of prognosis. Hence, adding PRO considerations to pathways should become a critical and growing element of pathway development.
Ray Page, DO, PhD, FACOI, FASCO, president and director of research, The Center for Cancer and Blood Disorders (Fort Worth, TX)
As we continue to see evolving payment policies from both private payers and Medicare's Quality Payment Program, providers have increasing incentives for financial reward by showing value-based care (VBC) for their patients. VBC creates a host of challenges for physician practices as the rewards come from better global management and comprehensive care of their patient populations. Clinicians are now seeking and utilizing a variety of business and clinical tools to assist in improving a VBC delivery of health care. Clinical pathways are now expanding their scope as a way to improve VBC.
Navigating clinical care for patients has become extremely complex. Clinical knowledge in healthcare is doubling every 71 days. It is virtually impossible for clinicians to keep up with daily treatment improvements that come our way. Genomic profiling is becoming increasingly important in the diagnosis and appropriate treatment opportunities for our patients. Yet, genomic profiling requires expansive understanding and we all need guidance in the prudent use of these tests. Evidence-based pathways are rapidly growing in the management of genomics, which can facilitate that decision making process.
Furthermore, another area of accelerated pathways growth involves the use of biosimilar drugs. Complex biological drugs, typically given intravenously or by injection, are now being manufactured and sold by numerous biotech and pharmaceutical companies at a breakneck pace. We are seeing as many as five or six biosimilars of an index drug in the market. Many payers are developing preferred formulary relationships on the biosimilars in order to improve VBC administration of typically expensive drugs. This creates huge burdens on infusion centers and cancer centers, matching the expanding formularies to the payer and the patients. Treatment pathways are growing to match the biosimilar formulary with the patient, therefore easing administrative burdens, reducing financial risk, and assuring patient safety.
Frederick M Schnell, MD, FACP, chief medical officer, Community Oncology Alliance (Macon, GA)
This year will prove to be a year unlike any other for reasons obvious to everyone, and not only so in the US, but across the world. As pathways relate to care provision, the providers in the oncology space have proven to be both resilient, but equally creative in the almost overwhelming stresses on all sectors of the cancer care continuum since March 2020. COVID-19 has affected pathways of care in ways that will not soon disappear. From telemedicine, increasing applications of artificial intelligence, as well as the relocation of caregivers from the clinic to the home for many portions of care delivery, many things new to all will linger for months and possibly years as pathways to care are re-engineered. Nothing will rival the pandemic in the realm of care impact.
Other aspects of care pathways are moving into the dynamic space of cancer care delivery. The most compelling influences, in my opinion, relate to the evolution of precision medicine driven by the impact of genomic testing in treatment selection and care delivery, and the need to create broader awareness and understanding of the increasing and more intelligent use of genomic data in the crafting of pathways. Finally, the winds are shifting in how care is orchestrated and to and for whom, as the self-insured US employers and their employees assume larger roles in cancer care delivery with an overriding focus on both quality and cost. These sectors will soon become a dominant force in how, where, and when cancer care is delivered in 2020 and beyond.
Amy Schroeder, RPh, senior consultant, Avalere Health (Charlotte, NC)
It is clear that there has been more advancement in the technology that is integrating pathways, especially in pulling data from and returning data to electronic health records (EHRs) as well as comparing care across sites. Some larger provider health systems are connecting different modalities of care (eg, medical oncology, radiology, surgery, genetic and molecular testing), through b- or cloud-based platforms. Not all programs are currently capable of making these connections, but the added value is guiding more informed decisions. Provider and payer programs that are linked to or integrated within EHRs pull data from but may also return data to these EHRs. Where these technology advancements are not available, the integrated informed decisions are more of a challenge, and entering information is then a manual process.
Regardless of technology capability, genetic and molecular testing are being added to clinical pathway algorithms, if not already included. In some cases, clinical pathways may not document testing and results for the purpose of pathways performance, but rather collect data to determine what testing informs decisions and should be included in pathways and what testing is not medically necessary. One question that comes up a lot is whether pathways drive use of certain tests. Test preferences generally do not require being conducted by a certain method, per pathways. Methods (eg, PCR, IHC, NGS, companion diagnostic kit) come into play at the broader provider process or payer coverage level. Clinical pathways guide use of what test should be done and what decision it informs. Broad genomic testing is still in limbo regarding acceptance as a "must have." Payers have commented that the value of broad genomic testing above individual tests that inform decisions needs to be made clearer.
Richard G Stefanacci, DO, MGH, MBA, AGSF, CMD, chief medical director, EVERSANA (Philadelphia, PA)
The largest growth of pathways at the moment is the rapid Incorporation of the “real world.” Historically, clinical pathways have been extremely rigid treatment directives, but today they have moved to embrace the real world. In the real world, clinical pathways are needed and thus used by a range of stakeholders beyond physicians and payers. Today’s stakeholders include nurse practitioners, patients, caregivers, care managers, health systems, and more. In addition, rather than simply focusing on a limited patient diagnosis or stage appropriate for a specific pharmaceutical treatment, clinical pathways are now incorporating patient characteristics including social determinants of health and care recommendations. The site of care has also shifted from hospital and office settings to non-traditional care sites such as the home. Some of these “real world” shifts have been forced by the COVID pandemic, which is as “real world” a situation as possible.
This incorporation of the “real world” also includes where clinical pathways exist. Pathways have shifted from paper to incorporation into electronic medical records. Clinical pathways are and will continue to be extremely usable and impactful in improving both clinical and financial outcomes – factors that are very much in tune with the needs of our new “real world.”
Edward Stepanski, PhD, senior vice president and chief operating officer, real-world data products, Concerto HealthAI (Boston, MA)
A variety of factors are advancing the importance of pathways programs in oncology care centers. Molecular testing is growing in significance as approved targeted agents steadily grow and show superior outcomes compared with the prior standard of care. As a result, matching patients to the optimal therapy is increasingly complex. Additionally, as the technology for liquid biopsies improves, these will replace tissue-based testing. Molecular testing to assess resistance further increases the complexity to obtain diagnostic data at various time points during treatment as needed to optimize treatment decisions and improve patient outcomes. In this model, pathways provide more sophisticated decision support, but also pose challenges to assess compliance. Molecular data in electronic form is not typically in the same database with the clinical data, making data mining difficult. Innovative information technology solutions are needed to facilitate delivery of pathways recommendations as well as compliance reporting.
Another emerging consideration in fueling pathways programs is the introduction of a growing number of biosimilars for monoclonal antibodies and other drug classes. Optimal integration of biosimilars into guideline-driven care is needed and introduces another important driver for pathways to contribute to value-based care.
Finally, clinical pathways are an increasingly important component of an oncology practice business model. For an oncology practice to be financially viable, they must get optimal drug pricing and payer reimbursement. Participation in a pathways program is a requirement to meet these aims and decrease financial risk in the context of declining reimbursement.
Tom Valuck, MD, JD, MHSA, partner, Discern Health (Washington, DC)
Clinical pathways are becoming increasingly important with the accelerated adoption of value-based care delivery and payment. By decreasing variability in care, pathways can help control costs while maintaining or increasing quality. Pathway adherence can provide a welcome alternative to reporting burdensome process measures for accountability under value-based payment programs. However, pathways may hinder access to personalized care for patients, implementation can be complex, and methods of development may be obscure.
To evolve and be successful, standardized pathways must be flexible so as to recognize personal preferences expressed through shared decision-making between patients and clinicians. Pathways must include genetic and genomic testing, where appropriate, to assess relevant individual physical characteristics and speed up time to targeted therapy. As pathways become more important, scrutiny will increase, so pathways must be based on sound principles, such as being transparent, evidence-based, and patient-centered. To be meaningful to a broad range of perspectives, pathway development must include the voices of patients, purchasers and employers, payers, and professionals. To remain relevant and accurate, pathways must be continuously evaluated for unintended undesirable effects and meticulously updated as the evidence base advances.
Winston Wong, PharmD, president, W-Squared Group (Longboat Key, FL)
From my perspective, there are two significant growth areas in clinical pathways at this time. First, COVID-19 has undoubtedly impacted the delivery of health care services. Face-to-face office visits have declined, only to give way to the rise of telehealth. From the standpoint of clinical pathways, there appears to be a renewed interest in the development and implementation of novel pathways outside of the oncology space, likely due to the increase in telehealth medicine and the need to more closely coordinate virtual health visits. The interest in clinical pathways may be in part due to the growing evidence showing the benefits of a clinical pathway program. For example, The Children’s Hospital of Philadelphia developed and implemented a Clinical Pathway for Emergency Department Screening and Evaluation for COVID-19 Disease as part of their clinical pathway program. Originally posted in January 2020 based upon the medical evidence, best practice, and local expert consensus, the fluidity of the pathway maintenance process is seen through the numerous updates made (most recent of which in early June) as new information, guidelines, and recommendations were available.
The second area of significant growth is the incorporation of genomic profiling into pathways. As more targeted pathways are being discovered and leading to more targeted therapies, companion tests are being parallelly innovated. Companion profiling tests have been in pathways for some time, confirming the need for targeted treatments. However, broader profiling tests have not had as rapid of an uptake. However, Lee Schwartzberg, MD, FACP, recently stated that, “comprehensive genomic profiling has come of age to the point where it truly belongs in pathways.” He states that metastatic disease, especially in metastatic non-small cell lung cancer, is a logical first place profiling should be considered. The next area may be the incorporation of broad genomic profile testing for tumors of unknown origins.
