In this journal section, we speak with cancer care practitioners about their clinical pathways and the pathways programs being used in their practice, how they are being applied in a particular disease state, and what challenges persist regarding
treatment decision-making and personalized medicine integration.
In this “Pathways in Practice” installment, we speak with John Burke, MD, medical hematologist and oncologist at Rocky Mountain Cancer Centers (CO), and Aimee Ginsburg, PharmD, BCPS, director, Pathways and Clinical Content, McKesson, about the specific challenges and considerations for the creation of a clinical pathways in chronic lymphocytic leukemia (CLL) that is utilized throughout The US Oncology Network.
Could you give us a general overview of how clinical pathways are defined, developed, and implemented at US Oncology Network?
Dr Ginsburg: Over the course of the last 15 years, we have developed pathways for the most common cancers seen in community practice where providers would benefit from pathways guidance and clinical decision support. We have also determined which diseases do not need a pathway based on incidence, the treatment setting, or a small number of available treatment options. For example, if the disease is primarily treated inpatient, we often choose not to design a pathway.
After we determine the disease, we review the National Comprehensive Cancer Network (NCCN) guidelines for concordance then review data with the Pathways Task Force, a committee composed of expert providers in The Network. This review includes oncology-trained clinical pharmacists who outline a proposed pathway structure with details about how a physician approaches treatment decisions for a patient, including both diagnosis and treatment determination. We also consider any biomarkers that should be collected as well as disease characteristics that could help streamline the pathway.
We then gather literature and evaluate it in a similar fashion. Are there agreed upon best practices everybody should be using or is there a dichotomy? We look at published trials, breaking them down into their endpoints and assess the data through our three pillars: efficacy, toxicity, and cost.
From here, we create a preliminary outline of the pathway. We circulate it through the Pathways Task Force. We also look at current treatment patterns in our network to see if the pathway is in line with the way our providers are treating patients. We ask this larger group if they agree with the preliminary outline.
Our Pathways Task Force is made up of generalist and specialist physicians—either by interest or by actual patient population treated—who help determine if this pathway is logical and if the options apply to 80% of the patient population.
Once we get approval of a preliminary pathway via that process, it is sent to a disease research committee of physicians heavily involved in research or extremely interested in this specific disease for vetting. From here, the pathway is circulated more broadly to our 2000 physicians and providers in The Network for further review and approval, as “Here is what we put together. It’s gone through two layers of approval. Please provide feedback before it is added into the clinical decision support in the electronic health record.”
Can you elaborate on the role that your relationship with NCCN plays in the pathways development/maintenance?
Dr Ginsburg: The collaboration we have with NCCN is one in which our pathways are 100% concordant to the NCCN Guidelines—not 100% identical. That is, our pathways deliver a more narrow subset of treatment options that focus on efficacy, toxicity, and then layer in cost. We are in constant communication with NCCN about pending changes to the guidelines, and their panel members have the opportunity to participate on the Pathways Task Force and weigh in on potential updates to the pathways.
Could you provide more detail about US Oncology’s pathway for CLL? What is the approach to stratifying patients for this treatment pathway?
Dr Burke: In the CLL pathway, like all of our pathways, the stratification approach is what is used by the NCCN Guidelines. It has the same tenants of age, frailty, comorbidities, and genetic mutations that might drive treatment decisions.
We have a first line of options for initial therapy and then options for relapsed disease that physicians might choose from. That is kind of the general design of the pathway.
Are there arms or different paths within the treatment pathway for specific treatment related adverse events or end-of-life care? How specific is the pathway regarding patient reaction to treatment?
Dr Burke: Our pathways do not address those issues. The pathways are generally drug choices that might be chosen in the first line and then second line and beyond. If somebody had side effect number one, then you switch to a different drug. We don’t get that specific on the pathway. That is really left up to the treating physician. In a scenario like, If the patient has atrial fibrillation on ibrutinib, what would you do next? We leave it up to the physician what they choose for a specific side effect. End-of-life care is also not addressed by our pathways. Pathways are used for treatment decisions.