The Inaugural Clinical Pathways Congress
September 16-18, 2016; Boston, MA
As US expenditures on cancer-related treatments continue to grow, new solutions for managing these costs have increasingly become necessary to ensure that patients receive the highest quality care without bankrupting the US health care system or causing irreparable financial damage to patients and their families. In recent years, clinical pathways—standardized methods of care that reduce costs and variability while driving value and optimal care—have emerged as one of the primary tools for addressing this issue. However they have also raised inherent questions about patient access, physician autonomy, care quality, and transparency.
For three days in September, some of the leading experts in pathways development, precision medicine, oncology management, and patient advocacy will gather to discuss these and other important issues related to oncology clinical pathways at the first ever Clinical Pathways Congress in Boston, MA. Brought to you by the Journal of Clinical Pathways and steered by leading pathway experts such as Bruce Feinberg, DO, Cardinal Health Specialty Solutions, and Robin T Zon, MD, chair of the American Society of Clinical Oncology (ASCO) pathways taskforce, this brand new meeting will help to aggregate lessons and ideas about how to best ensure that pathways are designed to meet the needs of patients, providers, and payers.
Some of the landmark sessions include a keynote presentation on integrating precision medicine into pathway development by ASCO vice president and chief medical officer, Richard Schilsky, MD; a session on how medication cost should be factored into value-based cancer care by Alex Bastian, MBA, vice president of GfK Bridgehead, and numerous other sessions relating to clinical pathways utilization. To highlight these and some of the other big sessions happening at the inaugural Clinical Pathways Congress, Journal of Clinical Pathways spoke briefly with a few of the presenters to get some quick opinions about what they will be discussing and the issues and opportunities related to clinical pathways.
Precision Medicine: An Essential Component of Oncology Clinical Pathways
Richard Schilsky, MD
JCP: What would you say is the underlying tension between clinical pathways and precision medicine?
Dr Schilsky: A primary goal of oncology pathways is to help ensure rapid deployment of evidence-based clinical advances that lead to high-quality care and improved outcomes for people with cancer. While it may appear that the use of clinical pathways, which aim to treat similar patients with a common approach, is at odds with the concept of precision medicine, which aims to individualize care based on the unique characteristics of each person and their tumor, this is not necessarily the case. Well-designed pathways not only help reduce undesirable treatment variability and promote adherence to evidence-based care, but they also allow for individualization of treatment options, taking into account individual patient differences to achieve the best clinical outcome for individual patients.
JCP: How are pathways improved through the integration of precision medicine principles?
Dr Schilsky: As our knowledge of precision medicine increases, this knowledge can be used to improve clinical pathways by making them even more personalized to specific subgroups of cancer patients. For example, one could imagine a time in the not-too-distant future when there will be many different pathways for a single cancer diagnosis, based on the molecular makeup of a person’s tumor cells. Additionally, the ability for patients and physicians to participate in clinical trials helps us learn more about precision medicine and, ultimately, prove the efficacy of new and innovative treatments. Well-designed pathways should always promote participation in clinical trials. When pathways allow variation in care to incorporate precision medicine approaches based on strong scientific evidence and well-validated biomarker tests, the patient’s care, as well as cancer care in general, is improved.
Clinical Pathways: A Point-Counterpoint from the Provider and Payer Perspective
Ray Page, DO; Winston Wong, PharmD
JCP: What are the advantages to ensuring that physicians have control over clinical pathways development?
Dr Page: In all of history, dating to the Hippocratic Oath, the physician has always been the trusted advocate of patient care through diagnosis and treatment. The physician–patient interaction is still the fundamental model of shared decision-making for treatment choices in the United States. This is despite the intentional actions of many agents in undermining physician credibility and honor in this country.
JCP: What advantages are there to allowing payers control over clinical pathways development?
Dr Wong: Although I am not an advocate of payers having sole control of clinical pathway development, the advantage of payers controlling the development process is that it allows the clinical pathway to take on a sense of accountability. If left up to clinicians to initiate the development process, development would be at a slower pace. With the payer setting the ground rules and the incentives surrounding the pathways, the development process should then take on a life of its own. Payer driven initiatives then have significance, and developers are motivated to see the process to the end product. Allowing the payers to control the development process works because the payers, for the most part, holds the financial risk. In the case of CMS creating the Oncology Care Model, CMS is not so much controlling the clinical pathway development process, but rather driving it through their financial incentive program.
In short, payers give the development process significance and accountability.
JCP: As part of a payer organization, what are your primary goals when developing a pathway?
Dr Wong: The primary goal of developing a pathway program is to incorporate best practices, as demonstrated by the medical literature, into a standardized approach to treat the majority of the target population. In Oncology, the goal is that the clinical pathway are usually able to be used for 80% of the population. This would allow 20% for outliers. The hope that by standardizing care for 80% of the population, the quality of care will improve, overall cost will be reduced for at least controlled, and patient satisfaction will improve.
JCP: Dr Page, how have the pathways you’ve developed at The Center for Cancer and Blood Disorders differed from those you’ve seen developed by payer organizations?
Dr Page: We have used the Via Oncology pathways for the last 8-9 years. It has been an outstanding addition to our practice providing evidence based standards of care and enhanced patient safety by minimizing chemo regimen variation. The Via system is far more robust and transparent than any payer model I have seen.
JCP: Do you believe that payers should be forced to cover physician-developed pathways, provided they are based off the most current evidence available?
Dr Page: I realized payers developing their own pathways to adhere to their formularies and methodologies can be a value proposition for their clients. However, payers should be required to accept a physician-developed pathway that is “certified” by meeting criteria established by an “honest broker.” A practice should be able to choose one certified pathway in their practice that all payers agree to. Theoretically, payer A could develop a transparent physician developed pathway that is “certified,” and a practice could accept that single pathway for their practice. And payer B would need to accept that pathway also. (But I know that is a stretch.)
JCP: Are there areas where payers and physicians can work together to improve clinical pathways development?
Dr Wong: In a simple statement, the one way that payers and physicians can work together to improve the development process is that they simply need to collaborate and work together towards the same goals. Payers need to provide the administrative and financial perspective, whereas physicians need to provide the objective clinical expertise. Both parties also need to support the process by being open to new concepts and making sure that the pathways are comprehensive, including patient navigation support, follow-up and triaging for adverse effect, etc.
Can Physician Behavior Change? The Case for Provider-Driven Pathways
Sushil Beriwal, MD
JCP: Why are some physicians hesitant to buy-in and adhere to clinical pathways?
Dr Beriwal: They feel it takes away their autonomy and decision-making authority. They also feel this would not allow them to individualize care and would enforce preset care for the patient.
JCP: What was done at your institution to encourage both buy-in and adherence to pathways from your hospital staff?
Dr Beriwal: The process of pathway development was inclusive with participation in a conference call from all stakeholders. The discussion and decisions were based on evidence and consensus. To encourage adherence, we developed an online mechanism for peer review where all off-pathway choices are discussed with site-specific directors, which adds accountability for the decisions. Also, compliance with the pathway is recorded both by the online mechanism through the Via portal and a random audit of charts every month. The department strives for more than 95% compliance with the process.
JCP: How have payer organizations reacted to provider-driven pathways developed at UPMC CancerCenter?
Dr Beriwal: We have not had direct interaction with payers for these pathways, but our participating physicians do use the pathway tool and evidence when discussing cases in the peer review process with the insurance carrier in order to get the plan of care approved, in many cases with good success.
How Should Medication Cost be Factored into Value-Based-Cancer Care?
Bruce Feinberg, DO
JCP: What influence does drug price have during the development process of a clinical pathway?
Dr Feinberg: My observations over the past 6 years of moderating payer-sponsored pathways steering committees are that participants use the three pillars of value assessment: efficacy, toxicity, and cost. But Cost is complex, as it may reflect cost to patient, cost to payer, cost to society, and cost to practice. Price alone is not considered a vacuum.
JCP: What will the shift to value-based care models mean to current drug pricing?
Dr Feinberg: It is unclear how the shift to a value-based care model will impact price—in some ways they are disconnected. One of the unique aspects of cancer medicine is its complexity: these life-and-death-nature diseases are treated with 3 or more modalities, including surgery, radiation, and chemotherapy—the latter itself often consisting of a multi-drug regimen or cocktail. Value-based care in an episodic, predictable, non–life-threatening medical condition such as vaginal delivery/C-section or joint replacement is fairly straightforward; assessing the value of care for a patient with advanced cancer is not.
JCP: Is there ever a perception among stakeholders that a drug will perform better because it is priced higher?
Dr Feinberg: One of the central issues in the value-based care debate should be recognition of the cultural underpinnings of US health care. We are a society that values more over less, now over later, and new over old. Such a value system leads to overprescribing of antibiotics and an inability to conduct clinical trials with a watch-and-wait control arm. This cultural belief system is in direct contrast with the premise of value-based care. It is very different from Asian cultures, which highly value traditional medicine, and European cultures, which are more cynical of interventionist health care.
Health Information Technology: Software Solutions for Clinical Pathways
Marcus Neubauer, MD
JCP: What use do health information technologies (HITs) offer to medical oncologists and practicing physicians?
Dr Neubauer: Technology is needed to incorporate new science (such as target mutations and companion diagnostics); quality metrics; and patient-centered work flows into the electronic medical record.
JCP: Many clinicians have complained about the lack of interoperability among different electronic health records systems. How can this issue be mitigated so as to not interfere with best practice while on clinical pathways, which often involve multidisciplinary care?
Dr Neubauer: Mitigation will be achieved when technology platforms can interact. Unfortunately, there are many barriers including patients who are seen at competing health systems. So, the answer is simple but making it happen is very complicated.
The Oncology Clinical Pathway: A Gateway to Comprehensive Cancer Care
Jim Koeller, MS
JCP: How successful have clinical cancer pathways been when implemented at health care institutions?
Dr Koeller: From a handful of published results on oncology clinical pathway use, from a payers perspective, all have shown to have decreased the total cost of cancer care. In addition, a few studies have also demonstrated that clinical efficacy was maintained even with lower cost.
JCP: What factors or tendencies separate the successful pathway from those that are less successful?
Dr Koeller: Having providers involved in the development of the pathway and the selection of the actual interventions appears to benefit the uptake. In addition, if the pathway can show a benefit to the patient, uptake is enhanced. Also, if a “return” to the provider for his/her involvement is given, that also helps with the uptake. In contrast, forcing pathways on providers with little notice or feedback tends to hamper uptake.
Patient Impact on the Implementation & Effectiveness of Clinical Pathways
Edward J Stepanski, PhD; Alan Balch, PhD
JCP: Are personalized medicine and clinical pathways intrinsically adversarial concepts, or can one be integrated as part of the other to provide patients with the best possible care?
Dr Stepanski: Elements of personalized medicine can and are built into clinical pathways. But there is an essential tension between the two in that the trajectory of personalized medicine is aimed at defining the best treatment for a unique individual (n of 1), versus a clinical pathway that provides value by standardizing treatment for cohorts of similar patients.
JCP: Why are patient-reported outcomes (PROs) becoming such an important topic in cancer care, and how can they be integrated as a part of clinical pathways?
Dr Balch: The health care environment is trying to shift from volume to value, and payments will be increasingly based on measure set performance, some of which will be driven by PROs. Thus, PROs are likely to play an increasingly important role in measuring key aspects of the performance of the system that reflect value to patients. Also, in an era of precision medicine, there exists increasing value to the creation of rapid-learning environments that can help identify the unique attributes of a particular subpopulation most likely to respond to certain treatments in terms of benefits, side effects, and adverse events. PROs can play an important and unique role in that process.
JCP: How important is it to include patient input during the development of clinical pathways?
Dr Stepanski: At a minimum, the evidence base used to gauge efficacy and safety trade-offs between treatments should routinely include PROs. Patients have unique information about their experience not captured by traditional research endpoints.
JCP: What are some things that clinicians and patients need to be discussing at the point of care?
Dr Balch: The most important starting point is a conversation about the patient’s goals, values, and preferences related to treatment. When a clinical pathway is being applied, it should be explained clearly what the variables are that determine the most appropriate option for the patient and what are the common reasons for “off-pathway” prescribing most relevant to the patient. A properly designed pathway should actually facilitate such a conversation and help provide guideposts for discussion that should lead to a single or a set of evidence-based options in the pathway that are appropriately customized to the individual patient.