By Gordon Kuntz
Since their inception, oncology clinical pathways have adapted to new technologies and changes in care paradigms – from immunotherapy to biosimilars and highly targeted therapies. The COVID-19 pandemic is driving another set of necessary changes in the structure and use of oncology pathways.
The following represent thoughts on how pathways should adapt to the rapidly changing care landscape that includes COVID-19 patients, survivors, and those not yet affected. There are several drivers necessitating these changes:
- The COVID-19 pandemic is not a short-term phenomenon – Though many regions are nearing or past their peak number of COVID-19 cases as of this writing, there remains a lasting need to protect cancer patients from COVID-19 to the extent possible. Until such time as there is an effective, long-lasting vaccine, many of the distancing requirements are likely to remain. Director of the National Institute of Allergy and Infectious Diseases, Anthony S Fauci, MD, has said: “We will have coronavirus in the fall. I am convinced of that.” If we look to history, the Spanish Flu pandemic had three waves that occurred over a little less than 12 months.
- Patient fears – Health care professionals have noticed that patients are not presenting in emergency rooms due to fears of infection from COVID-19, resulting in higher severity of disease later when they eventually are seen by a medical professional. This phenomenon is likely to persist for some time, as many individuals—especially the elderly—remain wary of being in public except as absolutely necessary. Keeping patients as safe as possible (and making them feel safe) from potential disease exposure remains of paramount importance.
- Emergence of COVID-19-specific guidelines – Guidelines for treating patients with COVID-19 are emerging, necessitating changes in standard care regimens. Sufficient numbers of patients are and will be impacted by COVID-19; this cannot be viewed as a “one off” situation, but should be a significant consideration in determining a treatment regimen.
Pathways should adapt to a world impacted by COVID-19 by incorporating several features:
- Guidelines for treating patients with or suspected of COVID-19 disease – Research continues to emerge regarding the ways in which the virus attacks the body and the long-term physical repercussions. It is not restricted to respiratory distress, but has demonstrated increased incidence in stroke, kidney failure, and other significant health issues. Dealing with these at the same time as managing cancer add levels of complexity that pathways can help oncologists manage. Obviously, more and longer-term research will be needed to identify the long-term health impacts from having contracted the disease and how asymptomatic presentation vs severe symptoms play out in the long run.
- Strategies for minimizing contact time – Until there is an effective vaccine, one of the primary goals of care will be to minimize the infection risk to COVID-19-negative patients or those with insufficient immunity to the disease. Treatment choices made under the traditional approach of pathways determination—efficacy, toxicity, and cost—should be amended to consider a fourth criteria: contact time. This may come in the form of the route of administration (oral vs infused), but may also be important when considering a chemotherapy with a long infusion time or more frequent dosing schedule compared with one that has shorter or less frequent dosing or infusion times. Granted, many of these issues are best handled through adjustments to practice workflow, but there are situations where total contact time should be considered—by both the physician and patient—in treatment selection. While efficacy remains the primary consideration, the issue of infection safety, expressed through contact time, may need to be considered alongside side effects when considering safety and toxicity.
The desire to minimize contact time will make the route of administration a more significant decision. Pathways have traditionally been agnostic to route of administration with the choice between an oral or infused formulation, where these options exist for the same therapy, left to the practice’s discretion. In a world impacted by COVID-19, the route of administration can be quite meaningful. Oral drugs may offer less contact time but do require monitoring to ensure that the dosing schedule is being followed, as well as that any side effects are identified and managed effectively. The latter issue has not historically been the purview of clinical pathways, but may become a sidebar recommendation to ensure optimal outcomes.
Managing contact time is not only a benefit for patients, it is a benefit for the clinical staff as well, insomuch as it minimizes their interaction with potentially contagious patients. Numerous operational, physical layout, and workflow changes are being made to further this goal as well, but designing the treatment choice to incorporate contact time as an element of consideration will help address these important issues that are inevitably part of our new reality.
- More frequent updates to pathways – The science around how the novel coronavirus impacts our biology is emerging daily and will continue for months and years to come. Papers expanding the knowledge base about various populations of patients with the virus as well as about the virus itself are being published in scientific journals at unprecedentedly high rates. Incorporating this rapidly expanding and evolving knowledge set will challenge the current update process of pathways.
Oncology clinical pathways have served the oncology community well for the past 15 years, but they are, by nature, always evolving. As we enter this new era of simultaneously managing cancer and COVID-19, the challenges are compounded. Pathways must continue to adapt to more effectively support cancer patients and oncologists in determining the most effective, least toxic (considered multidimensionally), and most cost-effective treatments to provide in this new world.
Gordon Kuntz is a health care consultant and strategic advisor with over 30 years’ experience in a multitude of health care settings, working with payers and providers, and in technology and strategy. He began his involvement with oncology care pathways in 2004 as a consultant with US Oncology as they were deploying Level 1 pathways. He subsequently led payer strategy with ION Solutions, a division of AmerisourceBergen, where he gained familiarity with many other pathways vendors, especially in the context of the oncology medical home model. As senior director of strategy for Via Oncology, he deepened his knowledge of the pathway development process, physician adoption, and how both impact cancer center strategies. Mr Kuntz now provides support in strategy and product design as well as assistance in navigating the cancer care ecosystem to established and emerging companies.
Mr Kuntz also serves as the Column Editor for the regular JCP print series “Tools for Transformation.”