Next-Generation Clinical Pathways

From a payer perspective, clinical pathways have been a management concept/tool since the early 2000’s. This idea was formulated even earlier by providers. In the early 2000’s, clinical pathways focused on the most cost-effective sequencing of treatment regimens that could be used in approximately 80% of the population. Clinical pathways started with the most prevalence cancer types, and quickly expanded to a much broader scope, which in some cases, included all cancer types. Looking back at this period, you may recall that this was before the wide spread utilization of targeted therapies, genomic testing, and patient navigation. These early programs showed cost saving opportunities through decreasing the variability of chosen treatment strategies and regimens, as well as in decreases in emergency room visits and inpatient days.  With now 10-plus years of experience, as well as the advancement of technology and patient support, the question to be asked is “What will the next-generation of clinical pathways look like?”

As noted, we have had significant advances in targeted therapies, genomic testing, and patient navigation in recent years. In its broadest sense, all of these advances fall under the umbrella of “Personalize Medicine.” Many have contended that personalized medicine signifies the end of clinical pathways. I would contend that personalized medicine does not end the use of clinical pathways, but rather, expands their use. There will be a need for general chemotherapy for those patients where targeted therapy is not appropriate. To be even more specific, genomic testing can be broken down into two major categories of profiling: predictive and prognostic.  Predictive testing generally is used to estimate if a specific treatment will be effective or not, or what is more commonly referred to as companion tests. Prognostic testing is an indicator of future risk, such as the test for a 10-year recurrence of breast cancer. While the focus of each category of testing is very different, there is no rationale that precludes the inclusion of genomic testing within a clinical pathway. This is especially true for predicting testing, but I would contend that prognostic testing should also be included from a quality of care and patient satisfaction standpoint, as the results of the test can and will have significant future impact. In short, genomic testing has a place in clinical pathways.

Advances in treatment have contributed significantly to the concept of personalized medicine, where treatments are being decided upon the presence of a specific gene deficiency or mutation. These products usually have a very specific indication. Hence, the inclusion of targeted medications can be included, along with the necessary genomic testing, in clinical pathways. As with any other regimen sequencing, the actual sequencing is based upon efficacy, tolerability, and cost. Targeted agents tend to be costlier; however, in the appropriate patient identified via genomic tests or some other biomarkers, the decision to use a targeted agent is rational and can certainly be incorporated into clinical pathways. In many respects, the decision to use a targeted agent is an easier decision when compared to deciding which chemotherapy regimen to utilize.

The initial clinical pathways were rooted as a chemotherapy decision process. Over the years, we have observed the integration with radiation and surgical interventions as well. While patient navigation programs are being implemented in practices and decision support systems, they have yet to be widely addressed by clinical pathways. Patient navigations program have shown their value by reducing emergency room visits and inpatient stays. It is personalized medicine from a different point of view, but nevertheless, it is personalizing care based upon the patient needs. Clinical pathways can easily integrate a “patient needs trigger” based upon the regimen being administered. As I pointed out in the March issue of this journal, clinical pathways today are missing the patient experience. This point was confirmed by Alan Balch, PhD, in the May issue, in which he offers his insights on this important issue and how the patient experience can be incorporated into a clinical pathway.

What should the “next-generation clinical pathways” look like? Certainly, they need to maintain their foundation of treatment sequencing. Clinical pathways need to incorporate targeted therapies and genomic testing, as well as integrate other treatment options (ie, radiation and surgical interventions). The patient experience is also a vital component.

Furthermore, the premise of the clinical pathway has always been built on efficacy, tolerability, and cost. I propose that the definition of tolerability needs to go beyond that of adverse effects and the ability of the patient to continue therapy to include some measure of the quality of life to further integrate in the patient experience. While there is no consensus of a standard quality-of-life measurement tool, I would also submit that oncology is one of the few specialties where quality of life will have a significant impact on the overall outcome of the patient.

Lastly, we need to use real world evidence to incorporate clinical outcomes into the development process, as well as use outcomes as a measure of the impact of clinical pathways. We all struggle to define value. However, with a clinical pathway built upon efficacy, tolerability, cost, patient experience, and real-world outcomes, we may be a step closer to a consensus.