ASCO Policy Statement on Clinical Pathways in Oncology Represents Great Progress for Clinical Pathways
The ASCO Policy Statement on Oncology Clinical Pathways shows how far clinical pathways have come in gaining acceptance among providers and supports their potential for improving the value of cancer care.
The American Society of Clinical Oncology (ASCO) recently published their policy statement on clinical pathways in oncology.1 This policy statement was developed in response to concerns raised by ASCO members and stakeholders due to the increasing adoption of clinical pathways by payers and practices. To address these concerns, an ASCO task force created a series of recommendations addressing the development of oncology pathways and processes, while allowing the demonstration of pathway concordance in a manner that promotes evidence-based, high-value care respecting input from patients, payers, and providers. Nine recommendations were made in all.
In my opinion, review of the recommendations shows that oncology practices have come a long way in accepting the pathways concept. It was not that long ago that pathway program sponsors and oncologists were at odds with each other. Perhaps it is the realization that, in this era of health care reform, coupled with major cost trend increases, we all need to work collaboratively in order to “make a difference”. We are now more sensitive to the high costs of the newer targeted therapies being developed. While many of these new, targeted medications are perceived to provide significant clinical benefit, many others do not. Hence, we must all work together to define the value-base equation, and subsequent “value-based care.” Clinical pathways play an integral role towards this effort.
The recommendations articulated by the Clinical Pathways Task Force are very rationale and objective. Although early pathway programs were focused only on medication options and sequencing, in order to have an impact on the quality of care and cost, the pathway must become more comprehensive, addressing multiple aspects of patient care. There should be no disagreement that the pathway must be based upon the clinical evidence. The collaborative nature of the development process, as recommended, is not intended to dilute the importance of the evidence but rather to fortify the integrity of the evidence through the consideration of different interpretations of the evidence, integrated with real-world experience. With that stated, transparency of the process is a must so that the rationale of the pathway is fully vetted and easily communicated down to the provider level. As such, fluidity of the pathway maintenance process is required to keep pathways updated as new information is presented.
In few other specialties are the clinical presentation of the patient and the patient’s tolerability to medications so variable. Unlike with the treatment of other chronic illnesses, the predictability of a patient’s response to oncology treatments is not strong. Hence, treatment variability is a given. The goal of clinical pathways is to treat the majority of the presenting population while allowing for flexibility to treat the outliers. This is not unique to oncology in that other published guidelines state similar goals; it is just more apparent in oncology. The question that remains to be answered, however, is what is the appropriate target threshold for clinical pathways compliance; a 100% compliance target is not a reasonable threshold.
Clinical trials also play a major role in oncology pathways. In some respect, payers should support the use of clinical trials, first as a means to maintaining the research and development process but also to avoid driving the patient down the path of being treated with a regimen that may provide minimal value. Hence, clinical trials are a way to avoid less effective regimens while promoting research. Furthermore, in some respects, clinical trials are a more cost-effective treatment option than subjecting patients to 4–5 lines of therapy. Therefore, the recommendation by ASCO that patients being treated with oncology clinical pathways be enrolled in clinical trials is an important one.
One area that pathway programs have failed to fulfill their promise is demonstrating the impact upon clinical outcomes. The impact upon outcomes is a necessary element in establishing the value proposition. The value of any treatment process is determined by the balance between clinical outcomes and cost: either one in isolation cannot establish a value proposition. Although it is most difficult to show a difference in clinical outcomes in oncology, I would submit that what is needed is to develop surrogate metrics that can be used in place of clinical outcomes metrics. We may already have the metrics in place as primary and secondary endpoint in clinical trials. Once we establish the surrogates, and incorporate them into a value equation, we can start to evaluate regimens on a “value” basis. Some of the initial proposals to establish a value proposition for various treatment regimens have already begun and are being piloted. One such program is the DrugAbacus (www.drugabacus.org), created at Memorial Sloan Kettering Cancer Center. The analytical engine behind the product represents the first attempt to balance clinical outcomes, via a surrogate metric, to cost, thus creating the platform for the basis of the cost proposition.
In summary, the recommendations made by the ASCO Task Force are not only reasonable but also actionable. As with any program early in development, it will take time for all of the stakeholders to come together. In general, pathway programs to date have been narrow in focus, but in order for us to impact quality, patient satisfaction, and control cost, development and implementation quickly will become much more collaborative. We may not win the war on cancer, but we can fight it much more efficiently.
1. Zon RT, Frame JN, Neuss MN, et al. American Society of Clinical Oncology Policy Statement on Clinical Pathways in Oncology [published online ahead of print January 12, 2016]. J Oncol
Pract. 2016. pii: JOPR009134.