Abstract: The National Comprehensive Cancer Network (NCCN) Guidelines are seen as the most comprehensive and most frequently updated cancer clinical practice guidelines available. Clinical pathways have a narrower focus and include evidence-based treatment protocols based on organ site, stage, molecular subtype of disease, and may include patient-specific factors. They take into consideration efficacy, toxicity, and, unlike guidelines, routinely consider cost. Clinical pathways for oncology at The US Oncology Network (The Network) were initially created in 2005. The Network later partnered with NCCN Guideline panel members to develop clinical pathways that further narrow guideline options to a subset that meet criteria of comparative effectiveness and cost-effectiveness. This article details the journey undertaken by The Network to evolve their clinical pathways and integrated platforms.
Key Words: clinical pathways, value-based care, NCCN Guidelines
Cancer care has seen incredible progress over the past few decades, both in treatment options and in the development of innovative tools and resources that help oncologists select optimal treatments. Among the significant advancements in this area has been the emergence of treatment guidelines and clinical pathways1 that have led to improved patient outcomes and quality of life as well as reduced costs.2-8 Initiated in the 1990s, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines®) function as a drug compendium and include all treatment options with supporting data.9 NCCN Guidelines serve as the foundation for the development for nearly all oncology clinical pathways. Clinical pathways for oncology at The US Oncology Network (The Network) were initially created in 2005. The Network later partnered with NCCN Guideline panel members to develop clinical pathways that further narrow guideline options to a subset that meet criteria of comparative effectiveness and cost-effectiveness.
This article details the journey undertaken by The Network to continue to evolve the clinical pathways program, including rationale for changes and an update on current technologies used to optimize pathways use and effectiveness.
Guidelines vs Clinical Pathways
NCCN was formed in 1995 as an alliance of 13 institutions who came together to develop standards of care for the treatment of cancer.9 The Guidelines were created by leaders in academic institutions, and that is still the approach taken by the organization today. Now an alliance of 27 cancer centers, NCCN continues to gather scientific information to help providers evaluate treatment options.9 Any cancer treatment with supporting data and/or Food and Drug Administration (FDA) approval can be included in a guideline, and the strength of the data, along with panel consensus, is rated to help users assess the significance of the recommendation. Notably, NCCN Guidelines do not consider cost of therapy as one of the primary drivers of decision-making. They are broad in scope and make recommendations that span the spectrum of care, including diagnostic workup, radiation, surgery, supportive care, anticancer therapy, follow-up care, and survivorship.
Clinical pathways are based on NCCN Guidelines but have a narrower focus and include evidence-based treatment protocols based on organ site, stage, and molecular subtype of disease. Pathways may also include patient-specific factors. Pathways developers review NCCN Guidelines and other treatment/outcomes data and pare down pathways guidance according to efficacy, toxicity, and if equivalent, cost.10,11 Resulting treatment recommendations aim to offer options with lower costs and consistent outcomes, providing the most value to the stakeholders—patients, payers, and health systems. Oncologists then select from these vetted options, identifying the best fit for their patient.
Many oncology practices rely on clinical pathways today to help them deliver high-value care.12-15 An American Society of Clinical Oncology (ASCO) report from 2017 found a 42% increase in practices reporting compliance with a pathways program from 2014 to 2016.14 Oncology care was–and still is–highly variable, complicated by patient preferences, varying expert opinion, and supply of resources.16 Given the tremendous influx of data and the rapid rise in oncology drug approvals, it is difficult for providers to keep up with this critical information without assistance. Pathways guide treating providers to the most up-to-date and effective anticancer regimens in an effort to standardize high-quality care delivery.
Origins of the Network’s Clinical Pathways
Clinical pathways developed by The Network began as Level I Pathways™ in 2005 and were adopted across The Network (approximately 1400 physicians spanning 25 US states) over the next year. The original goal of pathways was to create a practice profile as to how chemotherapy could be used with the goal of delivering higher value. Level I Pathways were designed to identify choices that were not only clinically effective but also represented greater value compared with other options. Seven pathways were originally developed: breast cancer, colon cancer, non-small cell lung carcinoma, small cell lung carcinoma, prostate cancer, multiple myeloma, and ovarian cancer. The goal was to drive value in cancer care in the outpatient setting by ensuring delivery of consistent evidence-based care while eliminating unnecessary variation in treatment.
An important partnership with the NCCN began in 2012 when Level I Pathways were converted to Value Pathways powered by NCCN™. alue Pathways are physician-designed treatment pathways that highlight evidence-based treatment options based on efficacy, toxicity, and an evaluation of financial impact to patient and payer based on allowable reimbursement by Medicare. Derived from NCCN Guidelines through close interfacing with NCCN panel members, Value Pathways consist of a narrower list of treatment choices, 100% concordant with NCCN Guidelines that support delivery of high-quality, cost-effective patient care.
Value Pathways Design, Maintenance, and Technology
Pathways development is governed by over 75 physicians and four oncology-trained pharmacists from The Network and NCCN member institutions who make up the Pathways Task Force (PTF). The process begins with a literature review that focuses on randomized phase 3 trial data or best available data. Value Pathways primarily focus on medical oncology but also incorporate recommendations for radiation therapy, as appropriate. Oncology-trained pharmacists work with disease chairs from the PTF to recommend pathway modifications for the PTF to review, deliberate, and determine whether to adopt. The PTF meets monthly to review data and discuss the value of the proposed pathway changes. After the proposed changes are voted upon by members of the PTF and NCCN panel, the recommendations flow through a period of open comment for providers within The Network. Ultimately, all recommendations must be formally approved by the Pharmacy & Therapeutics Committee.
Each pathway is reviewed twice yearly on average. A complete disease review occurs annually and includes utilization trends, as well as a review of new FDA approvals or expanded indications for existing therapies. Additional reviews occur as-needed based on emergence of new data. Historically, pathway changes were released quarterly, but, due to the pace of changes in oncology over the last 5 years, implementation time has shortened significantly. Relevant clinical updates are now implemented at the point-of-care within 2 weeks of discussion and approval by The Network.
Prioritization of Value Pathways development is based on cancer types most commonly seen in community practice. Expansion has occurred based on this same principle. Today, 30 Value Pathways cover more than 90% of diseases seen in outpatient oncology settings across The Network. The broad scope of pathways coverage is particularly useful in the community, where many oncologists function as generalists. Having pathways that are concordant with NCCN helps guide providers to care that is up-to-date with the latest practice-changing therapies.
Value Pathways are embedded in Clear Value PlusSM (CVP), a decision-support tool that prompts users for information about a patient’s disease, staging, biomarkers, and previous treatments to determine the most appropriate treatment options. CVP is embedded within McKesson’s oncology-specific electronic health record (EHR), iKnowMed™.17 Having the pathways embedded in the EHR at the point-of-care decreases both user and administrative burden and empowers oncologists to provide consistent, value-based care that is based on the latest clinical evidence. Moreover, they promote the use of clinical trials–always considered an on-pathway option–and include antiemetic, neutropenic, and adjunct supportive care medications within order sets generated by CVP.
Importance of Supporting Technology, Transparency, and NCCN Expert Input
As noted previously, there has been a proliferation of clinical pathways, driven by the recognition that pathways can promote high-value, quality cancer care. However, as various members of ASCO have noted, some pathways are plagued by “a lack of transparency, administrative burden, and other factors that could affect patient access and care.”12 Value Pathways meet the criteria defined by the ASCO Task Force for high-quality clinical pathways, which cover pathways development, implementation, and use as well as availability of data analytics.15,18
Due to the integration within CVP, measurement of pathway adherence is conducted and reported simultaneously. The platform enables prospective review of off-guideline and off-pathway regimen orders. Compliance reports are used for continuous quality improvement activities. Clinical data tables are also available at the point of care to assist with decision-making. Following Value Pathways is not a requirement for any member practice, but a target of 80% on-pathway is recommended for practices who participate in the program. Off-pathway choices require the user to enter an “exception” for use, and practices manage their own exception process. Value Pathways uptake varies by practice but is high for those engaged in value-based contracting and Oncology Care Model (OCM) participants. CVP is required to utilize pathways; it can and has been interfaced with EMRs beyond iKnowMed or can also be used on its own. The reporting from CVP/iKnowMed is available in real time and satisfies requirements for OCM/MIPs as well as value-based contracts—it displays the critical decision-making elements and both patient and disease characteristics gathered through the decision-support process and treatment selected. All data are exportable.
Gaining physician buy-in and creating trust in decision-support tools can be a barrier to a successful pathways program.19 As noted above, the Value Pathways development and updating process builds in opportunities for providers across The Network to give feedback on proposed pathways changes via the open comment periods. All 30 Value Pathways are designed and maintained in this transparent manner by practicing oncologists who understand the day-to-day complexities of community-based oncology care. The unique collaboration of the PTF experts with NCCN physicians of an academic mindset allows for specialized input on each pathway, resulting in high-quality, high-value treatment recommendations. For example, some pathway review meetings have resulted in discussions with NCCN members about why therapies were included on pathway and why they should also be included within the guidelines; pathways have removed several therapies that were not supported by the guidelines.
Lower Costs With Consistent Outcomes
The Network has conducted several studies2-4 that prove following pathways results in lower costs with consistent outcomes.
One study performed at eight practices in The Network evaluated the cost-effectiveness of Level I Pathways in patients with non-small cell lung carcinoma found that outpatient costs were 35% lower for on-pathway vs off-pathway patients (average 12-month cost, $18,042 vs $27,737, respectively), with no difference in overall survival or by line of therapy.2
Another study of Level I Pathways outcomes and costs in colon cancer found overall costs from the national claims database—including total cost per case and chemotherapy costs—were lower for patients treated according to Level I Pathways compared to patients who were not. Pathways use was also associated with a shorter duration of therapy and lower rate of chemotherapy-related hospital admissions. Survival for patients on-pathway in the EHR database was comparable with those in the published literature.3
In addition, a study of an OCM population with non-small cell lung carcinoma found a 19% lower mean total cost of care ($47,287 vs $58,564; P <.0001) and 40% lower chemotherapy costs ($24,967 vs $41,806; P <.0001) for patients treated according to Value Pathways compared to those who were not. Median overall survival was not significantly different between the two cohorts, indicating clinical outcomes were maintained following Value Pathways.4
As clinical pathways programs mature in their technology and data collection, more studies with longer term data will become available.
On the Horizon
With the health care landscape moving away from fee-for-service, clinical pathways are and will continue to be important to drive success in value-based programs. With Value Pathways’ real-time reporting capability, practices can demonstrate quality, including key performance metrics such as adherence, regimen utilization history, and program participation for an individual provider, a single site, or across a practice. Pathways and reporting have facilitated payer conversations and agreements involving prior authorization relief and alternative payment models. Additionally, Value Pathways serve as a fundamental metric and indicator to substantiate delivery of high-value care in numerous local and national value-based care programs.20,21
Value Pathways will continue to advance with precision medicine. The current process includes review and incorporation of all biomarkers relevant to treatment decision-making, thus individualizing care for each patient. With the expanding number of biomarkers in non-small cell lung cancer and other diseases, CVP prompts for various tumor-differentiating characteristics to recommend the most appropriate targeted therapy. As biomarkers are identified and their use expands, pathways will continue to evolve to incorporate these new discoveries.
Value Pathways bring the expertise of both practicing and academic-minded oncologists together. The technology supporting these pathways has similarly evolved, allowing for faster, more detailed data insights and a streamlined user experience.
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