Clinical Pathways: The Path Forward
Orlando, FL—Clinical pathways have become a central component of medical oncology practice and a cornerstone of future reimbursement methodologies and quality-of-life efforts, according to Robin Zon, MD, FACP, Medical Oncologist, Michiana Hematology Oncology, IN, and Chair, ASCO Task Force on Clinical Pathways.
Although guidelines often offer multiple recommendations, clinical pathways aim to delineate a single best treatment and to facilitate quality care in all aspects of patient interaction, Dr Zon said at ASCO’s first Oncology Practice Conference in March 2017.
ASCO’s Clinical Pathways Task Force was established in January 2015 in response to concerns regarding the abundance of pathways programs and the associated administrative burden.
“Our charge was to consider the proliferation of commercial pathways programs and their impact on access and quality of care, as well as to develop a set of recommendations to address the concerns raised,” said Dr Zon.
Concerns were raised over the cumbersome appeals process involved in many pathways programs, the lack of automatic preauthorization related to pathway compliance, and because in some areas of the United States, providers were expected to adhere to >5 pathway programs at once. According to Dr Zon, the sentiment of “caring for the pathway and not the patient” began to be widely shared among providers.
Additional concerns included the lack of transparency in disclosing conflicts of interest among those developing the pathways, dispute over the methodology and rationale used in the development of pathways, and trepidation about adherence rates and patient autonomy. The need for comprehensive cancer care highlighted the lack of pathways for rare cancers and inpatient treatment, and because many of the pathways were “drug motivated.” Finally, the importance of clinical trials was missing from some programs, and publicized analytics of performance were absent as well.
With the introduction of the Medicare Access and CHIP Reauthorization Act, however, the Oncology Care Model, and other federal and state regulatory forces, pathways have become an increasingly central component of cancer care. Driving this increase in the implementation of clinical pathways are numerous factors, including the ability to manage drug utilization in a world moving toward bundled payments, avoid time-consuming prior authorization and appeals with payers, and capture stage and molecular data for a more refined risk adjustment.
Pathways put pressure on drug prices by explicitly accounting for cost when drug-related efficacy and toxicity are similar, they allow providers to demonstrate their care quality to key stakeholders, and allow cancer centers to ensure consistency of evidence-based patient care among their physicians.
Payers are now incentivizing oncologists to use clinical pathways, by offering increased reimbursement, care management fees, and shared savings, Dr Zon said.
Changes in Prescribing Behavior
In recent years, payers and providers have increased their use of pathways, with relatively national market penetration. ASCO’s 2016 report, The State of Cancer Care in America, documented a 46% increase between the years 2014 and 2015 in the percentage of oncology practices reporting compliance with a clinical pathway program.1
Similarly, The 2016 Genentech Oncology Trend Report noted that 60% of oncologists anticipated using oncology clinical pathways by the year 2015.2
Studies suggest that the use of pathways can lead to standardization and changes in physician prescribing behavior, she said. The ASPECCT trial, a head-to-head comparison of panitumumab and cetuximab, showed no difference in outcome in terms of overall survival or toxicity,3 and a 2015 analysis suggested potential savings for switching from cetuximab to panitumumab as part of a first-line regimen for metastatic colorectal cancer.4
At the University of Pittsburgh and Indiana University, a substitution of panitumumab for cetuximab was made across all metastatic lines of therapy as part of a clinical pathway initiated in August 2014, demonstrating the power of clinical pathways to rapidly change prescribing habits across 2 large cancer networks. The use of pathways in the triage setting has also been effective, streamlining prescribing practices, empowering nurses with standard protocols and standing orders to treat patients’ symptoms in real time, and reducing emergency department visits and hospitalizations, Dr Zon emphasized.
Pathways Protecting Patients
One retrospective cohort study of approximately 982,000 women with breast cancer showed that appropriate receipt of adjuvant endocrine therapy varied significantly by age, race, geographic location, and receptor status, according to Dr Zon. She noted that pathways can potentially protect patients from this kind of overtreatment, undertreatment, and mistreatment, and can also protect against patients’ concerns about undertreatment in the alternative payment model.
“I believe we need an escalation in analytics regarding patient and system outcomes as a result of pathway utilization, so we can use this to evolve pathways not only scientifically but also from an economic standpoint,” she said.
ASCO’s recommendations to improve the development and use of clinical pathways in oncology are based on 2 key principles:
- Protecting patient and physician autonomy in making treatment decisions based on the most recent evidence
- Decreasing the administrative burden imposed by various requirements and reporting standards.
“The bottom line is to elevate awareness and convey a cautionary note that no current mechanism exists to ensure integrity, efficient implementation, and outcome assessment for these care management tools,” said Dr Zon.
Criteria are currently available to assist oncology practices in selecting appropriate pathway therapies. Dr Zon encourages educating patients about pathways, and starting a dialogue with payers about their utilization with regard to contracting and claims processing.
- American Society of Clinical Oncology. The State of Cancer Care in America, 2016: a report by the American Society of Clinical Oncology. J Oncol Pract. 2016;12:339-383.
- Genentech. The 2016 Genentech Oncology Trend Report: Perspectives from Managed Care, Specialty Pharmacies, Oncologists, Practice Managers, and Employers. 8th ed. South San Francisco, CA: Genentech; February 2016. www.genentech-forum.com/content/dam/gene/managedcare/forum/pdfs/2016_Genentech_Oncology_Trend_Report.pdf. Accessed March 20, 2017.
- Price TJ, Peeters M, Kim TW, et al. Panitumumab versus cetuximab in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer (ASPECCT): a randomised, multicentre, open-label, non-inferiority phase 3 study. Lancet Oncol. 2014;15:569-579.
- Graham CN, Hechmati G, Fakih MG, et al. Cost-minimization analysis of panitumumab compared with cetuximab for first-line treatment of patients with wild-type RAS metastatic colorectal cancer. J Med Econ. 2015;18:619-628.