Abstract: Clinical pathways are a critical structural element in the effort to reduce variation in health care delivery, allowing for cost reduction as well as more predictable, measurable, and accountable outcomes. At the 2nd Annual Clinical Pathways Congress (September 8-10, 2017; Washington, DC), a mock clinical pathway was conducted using a modified Delphi methodology. The goal was to make the process of developing consensus-driven, evidence-based clinical pathways in oncology transparent and educational. Nine medical oncologists and 1 surgical oncologist of diverse geography and practice type served on a steering committee to simulate the development of a clinical pathway for the treatment of metastatic breast cancer. The simulation provided an opportunity for meeting attendees to observe the process by which oncologists determine initial diagnostic tests critical to treatment selection, the most appropriate treatment for each line of therapy, and criteria for subsequent treatment selection.
Consensus-driven, evidence-based clinical pathways represent the natural evolution of treatment guidelines such as those developed by the National Comprehensive Cancer Network® (NCCN), which categorize the universe of evidence-based care options that might be included within pathways. Value-based care requires comparisons of various care options to establish consensus standards. It might be concluded that clinical pathways are the end products of those consensus standards and thereby critical to the transition to value-based health care delivery.
A host of oncology clinical pathways programs have been developed and have demonstrated an ability to modify physician prescribing behavior thereby improving clinical and financial outcomes.1-7 Like the NCCN guidelines, these pilot pathways programs were created by physician representatives of sponsoring institutions, eg, practices, payer networks, academic institutions. These representatives performed in-depth evidence reviews and achieved consensus in an iterative process to reduce the number of treatment options recommended for common clinical scenarios based on efficacy, toxicity, and cost. The resulting pathways were then disseminated to the broader physician group where adherence was encouraged, monitored, and usually rewarded financially.
The first pathways program of its kind was reported in 1998, when a group of private practice medical oncologists designed and implemented a novel cancer care delivery model that included the use of clinical pathways and treatment protocols.1 In the 3 years following the implementation of that model, resource use, specifically hospitalization, was reduced by 50%.1 Nearly 2 decades later, results from other clinical pathway programs have affirmed that cancer care cost savings and resource utilization, specifically reductions in cancer-related emergency room visits and inpatient admissions, can be achieved with provider participation in payer-supported or practice-initiated oncology pathway programs.2-7 These analyses also affirmed that as much as a 15% savings can be achieved in the first year of a pathways program on aggregated breast cancer, colon cancer, and lung cancer spending, with as much as a 7% reduction in hospital admissions.3,4 One analysis suggested an annual savings in excess of $30,000,000 for a mid-Atlantic commercial insurer with 3 million covered lives if the pathway program was expanded beyond the pilot to the entire provider network.4
It seems increasingly more apparent that consensus-driven, evidence-based clinical pathways in oncology will become a foundational platform in the transformation to value-based cancer care. Whether that care is
delivered through an accountable care organization or an oncology medical home, reimbursed via episode of care or bundled payment, or configured as an Oncology Care Model (OCM), clinical pathways are a critical architectural element that reduces variance while also making costs and outcomes more predictable, measurable, and accountable.2 Previous assertions that pathway success requires appropriately aligned incentives and must be instituted as a collaboration between a payer, the majority of community providers, and other network providers may no longer apply in an era in which providers hold accountability for treatment cost, as is now the case for OCM-participating practices.
Increased attention to the utility of clinical pathways in value-based care has also heightened interest in the development process of clinical pathways. In 2016, the American Society of Clinical Oncology (ASCO) published a policy statement on oncology clinical pathways recommending that, in order for collaboration and consensus to occur, transparency is an absolute requirement.8 Cardinal Health Specialty Solutions (CHSS), an innovator in the pathway movement,2,3 has developed a mock clinical pathway program to simulate a process undertaken by payers and provider groups, allowing health care stakeholders to witness first-hand the process by which physicians determine rules, review evidence, and reach consensus in the creation of disease-specific oncology pathways. To remove any bias from the mock pathway steering committee’s decision-making, the programs have historically been double-blinded; that is, the steering committee members are blinded to the interested stakeholder, and the stakeholder is blinded to the participants (ie, physician name, practice name, city, state).
At the second annual Clinical Pathways Congress (CPC) in September 2017, a live mock clinical pathway was conducted, simulating the process of developing a clinical pathway for managing metastatic breast cancer (MBC) patients. The goal of the mock pathway simulation was to examine the willingness of community providers to participate in pathway development and to provide an opportunity for interested stakeholders—payers, providers, pharmaceutical companies, and patients—to observe the processes by which oncologists determine initial and subsequent diagnostic tests critical to treatment selection, timing and extent of such testing, the most appropriate treatment for each line of therapy, definition of treatment failure, and criteria for subsequent treatment selection.
The Journal of Clinical Pathways was established in July 2015 to provide a peer-reviewed journal for the presentation of pathway-related research. CPC, the official meeting of Journal of Clinical Pathways, first convened August 2016 in order to provide an opportunity for stakeholders to further discuss clinical pathways and their impact on value-based care. Based on journal editorial interest and feedback from the first conference, the CPC program committee engaged CHSS to provide a mock demonstration of how a clinical pathway is developed to be presented live at the second annual CPC meeting, September 8-10, 2017, in Washington, DC. Subsequent discussion resulted in the decision to simulate the development of a clinical pathway in MBC.
CHSS developed a feasibility screener to identify 12 oncology specialists agnostic to group provider organization affiliation or institution from diverse geographic locations and practice type to serve as a steering committee. Clinicians were randomly selected from a proprietary master recruitment list. Clinicians were screened to identify oncology specialists (surgical, radiation, and mostly medical) who had at least 10 patients currently with breast cancer under active treatment per week and who have previously been involved in the development of practice- or payer-sponsored cancer treatment pathways.
A total of 12 oncologists met the screening criteria, of which 10 (9 medical, 1 surgical) accepted the invitation to serve on the steering committee for this initiative. A summary of the backgrounds of the 10 committee members is presented in Table 1. Physicians were compensated for their time at established fair market value rates, and their room, board, and travel were reimbursed.
The NCCN Clinical Practice Guidelines in Oncology for Breast Cancer with Evidence Blocks (version 2.2017)9 were distributed via email to the steering committee members with request to review them before the live event in preparation for mock development. The steering committee was only brought together live the day of the mock pathway program without prior interaction.
The Delphi method, a structured communication technique, developed as a systematic, interactive forecasting method which relies on a panel of experts, was described as the process by which pathway consensus would be achieved. The Delphi exercise consists of several iterative phases, beginning with broad concepts that become increasingly specific, gaining eventual consensus to all items in the pathway.10 Consensus was determined when at least 80% (8/10) of the experts agreed on a given item. Items not reaching consensus were summarized by the moderator and re-presented to the panel for further discussion with the aim to achieve consensus. New items for discussion needed to be voiced by at least 2 panelists in order to be considered for further refinement and achievement of consensus. The Delphi method for this exercise was slightly modified as a pre-meeting survey was not obtained.