What Do We Mean When We Talk About “Clinical Pathways”?

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. Gordon now provides support in strategy and product design as well as assistance in navigating the cancer care ecosystem to established and emerging companies.

For those new to the world of clinical pathways, the jargon, development process, and ramifications of pathways can seem mysterious and obscure. To put clinical pathways into context, many disease or medical treatment categories use order sets or treatment protocols to define the testing and procedures that constitute the best practice or state of the art for a particular situation. Such order sets collate care standards to increase efficiency of care. Clinical pathways are much more complex and sophisticated than order sets or triage protocols but the goals are similar. This column will provide an overview of clinical pathways as they exist today and attempt to demystify the language, process, and expectations surrounding their development and use. 

The Impetus for Clinical Pathways in Cancer Care

The development of clinical pathways has been especially effective in treatment planning for cancer care. The treatment for many other diseases, such as diabetes, is largely drug-based but has evolved less dramatically over the last several years, or, like orthopedic care, is highly dependent on the skill of the surgeon and uses relatively few drugs. The treatment of cancer lends itself to the use of more complex protocols, ie, pathways, for several reasons:

Cancer itself is complex. With more than 50 major categories and multiple disease presentations based on disease stage, lab values, genetic variations, etc, there are hundreds of unique disease presentations in cancer.

The treatment for many types of cancer is largely drug-based, and the drug therapies are complex and can be highly toxic. Oncologists must ensure that the drug selected is the most effective against the patient’s specific disease presentation while still being tolerable to the patient.

Available therapies are expensive. With many cancer drugs costing tens or hundreds of thousands of dollars per course of treatment, it is imperative to select the most appropriate treatments in the context of the investment.

Drug therapies continue to evolve rapidly. In 1990, there were 37 drug-related chemotherapy treatment options with 60 indications.¹ Today, there are well over 500 approved antineoplastic drugs.²

The literature evolves rapidly, ie, multiple new studies are published daily, with implications for best practices on an increasing number of ever-more-targeted patient subpopulations.

Without an effective tool, like clinical pathways, to help identify the most appropriate standard of care therapy for a specific disease presentation, oncologists would be left to their own research or would rely on what had worked in other similar cases. These approaches are inefficient and much less likely to result in the delivery of high-quality and high-value care with the enormous complexities of and surrounding cancer treatment. 

Many oncologists practicing in a community or hospital setting see a wide range of cancers daily. The use of a tool to assist with clinical decision support, such as pathways, helps ensure that they are providing optimal treatment to every patient—even patients with less common disease presentations. Having these tools to recommend appropriate treatment options helps ensure that these doctors can effectively treat a higher percentage of their patients, allowing them to be treated in their own community rather than having to travel a longer distance to receive care at an academic center.

So, What Are Pathways? 

First, what shall we call them? Various terms have been used to refer to the same concept, in general. “Clinical pathways,” “treatment pathways,” “treatment selection pathways,” and “oncology care pathways” are all different names for the same type of tool but what we will refer to here simply as “pathways.” 

Pathways are a set of treatment recommendations that aim to integrate evidence regarding the clinical efficacy, toxicity, and affordability of treatments (weighed in
that order of importance) to create optimal standard-of-care recommendations for patients, while simultaneously reducing the unnecessary variation in care across similarly situated patients. Pathways may also include prompts or entry areas for patient preferences, integrating specific patient characteristics or care goals into treatment recommendations.

Another term commonly associated with pathways is “clinical decision support” (CDS). CDS systems, as used in relation to pathways, operate by querying the user for information or gathering it from underlying interfaces through integration with data sources, usually the electronic medical record. Information would include patient demographic, major tumor type, stage, genetic and lab test results, prior therapies, etc. The response to each question leads to the next related question, refining the description of the disease presentation. Once sufficient data has been captured or brought in, the recommendation is offered. The pathways tools that exist in the market today are generally designed to provide this type of decision support. An automated or visual tool will rely on a conceptual decision tree, with each decision leading to a branch with either additional considerations or one or more recommendations. 

The operational definition of what an ideal pathway looks like includes adherence to the following 4 criteria: (1) a structured multidisciplinary plan of care; (2) the translation of guidelines or evidence into an algorithm; (3) detailed steps within the pathway along a timeframe in a course of treatment/care plan; and (4) standardized care for a specific population.³

An important distinction to note, pathways differ from guidelines in that pathways offer one or more specific treatment recommendations based on a hierarchy of selection criteria. Guidelines, on the other hand, offer a set of reasonable treatment options but without prioritizing specific recommendations. Think of it as the difference between “could” and “should”: guidelines tell an oncologist what they could do; pathways tell them what they should do. Neither tell the oncologist what they must do, however, which will be discussed later when off-pathway decisions are addressed.

Pathway Types

There are 2 major types of pathways: payer-initiated and provider-initiated, referring to the type of organization sponsoring the pathway and controlling its design. While both types of pathways use similar criteria, they may offer differing recommendations. 

Payer pathways may be perceived as having a “cost-first” approach, but this is not the case. While it is true that payers, in general, want to reduce costs, they, or the vendors working on their behalf, use the same basic process as provider-initiated pathways. There are 3 primary goals for payers who sponsor pathways programs: (1) reduce unnecessary treatment variability, (2) improve quality as defined by consistent use of evidence-based care, and (3) cost management, primarily by identifying the treatment most likely to be successful at each line of therapy or, when clinically appropriate, the lower-cost treatment.

Developing and maintaining pathways is a very time-consuming and expensive proposition, especially if integrated software is involved. The pace of change and number of situations to consider make the use of a vendor much more palatable. Provider-initiated pathways may be developed by providers themselves, especially in larger cancer centers, but most providers use pathways developed by a pathways vendor.

Many payers also rely on third-party pathway vendors to develop and maintain their pathways for similar reasons, but payers have the added consideration of wanting to avoid the perception that they are practicing corporate medicine and are directing physician decision-making in cancer treatments. In addition, several of the payer pathway vendors help practices ensure they will receive prior authorization for the proposed treatments.

How Pathways Are Developed

The process used in developing a set of pathways starts with identification of the need for a new pathway, often due to the publication of some new piece of research describing a potential new standard of care for a specific disease presentation or based on a scheduled review of an existing pathway. Generally, there is a disease-specific committee or an expert in the treatment of a specific disease that will head the development and review process. Colleagues with an interest and expertise in a specific disease often collaborate in developing pathways, especially in provider-driven pathways organizations.

The latest literature regarding treatment of the specific disease is gathered and may be categorized by the quality of the research and the studies supporting it. Quality is assessed based on sample size, methodology, and independence of the findings. As mentioned above, treatments studied in the literature are compared alongside the existing standard of care in terms of 3 criteria: efficacy, toxicity, and cost. The following evaluation process is used by most of the vendor and institution pathways developers in the United States (those operating in different health systems such as the United Kingdom may follow a different approach):

The committee first reviews the literature to identify the treatment(s) that are most effective in treating the disease. This evaluation is not formulaic, but balances often conflicting or inconsistent studies. For example, one study may evaluate overall survival, another may evaluate progression-free survival. The result of this process is the identification of one or more therapies with outcomes documented to be superior to others. If there is one therapy that has significantly better outcomes compared to the others, this is chosen as the standard of care. If there are 2 or more of roughly equal and superior efficacy, the evaluation continues.

Considering only the 2 or more deemed to be of roughly equal and superior efficacy, the committee then evaluates toxicity or safety of the therapy. Again, the approach does not use a specific formula but looks at the probability, frequency, and grade of toxicities occurring with the studies for each therapy. If one of the therapies considered is substantially safer, that becomes the standard of care. If multiple therapeutic options have roughly equal and superior safety as well as roughly equal and superior efficacy, the evaluation continues.

Should there be multiple therapies with similarly superior efficacy and toxicity profiles, then and only then is cost considered. Despite the proliferation of available therapies, it is unusual for there to be multiple options where the efficacy and toxicity profiles are substantially similar; in fact this happens in about 5% of analyses.⁴ The cost that is often considered is cost to the payer, not acquisition cost for the practice or cost to the patient. Historically, this has also reflected only the direct drug cost, not costs for administration, supportive care, hospitalization, or total cost of care. The therapy with the lowest drug cost would then become the standard of care. 

Flexibility to Go “Off-Pathway”

All pathway programs acknowledge that they are imperfect and that the recommended treatments will not be appropriate for all patients with the specific disease presentation. In general, pathways are designed to accommodate about 80% of patients with an on-pathway recommendation.

If a physician determines that the recommended treatment is not appropriate for a specific patient, they may select an “off-pathway” regimen. Off-pathway does not necessarily mean that the patient is less likely to survive, it is just that the physician, in their professional judgement, does not believe that the recommended treatment is appropriate for that patient. Most pathways tools will ask the physician to indicate the regimen they expect to use and the reason for noncompliance. Common reasons include a patient comorbidity or drug sensitivity, or patient or physician preference.

Pathways Evolution: Metrics and Multistakeholder Uses

These 2 principles—the use of the 3-stage evaluation and designing pathways appropriate for 80% of patients—were employed by the practices that developed cancer care pathways in the mid-2000s and remain the gold standard in pathways development today.^5,6 Pathways have expanded from that time to include, in some cases, radiation and surgery in addition to drug therapies, as well as nurse triage and other related patient support functions.

Pathways tools evolved starting around 2008/2009 as a way to track metrics around pathways use and demonstrate compliance.⁷ Specifically, pathways software tools measure 2 key statistics: 

Capture Rate—the proportion of pathways-eligible patients that were navigated through a pathway. Patients who were seen for a consult or second opinion, as well as non-malignant hematology patients are typically excluded. Depending on the pathway system, patients with rare diseases for which no pathway exists may be excluded as well. The target for this is 100%.

On-Pathway Rate—the proportion of patients navigated through a pathway for whom the recommended treatment was chosen. Clinical trials and palliative care are often considered “on-pathway” choices. If a physician elects an off-pathway treatment, they are usually required to provide a reason and indicate the regimen they have chosen. The target for this across all diseases is 80%, although some diseases such as localized breast cancer may have much higher on-pathway rates due to a high consensus on appropriate standard-of-care treatments, whereas other cancers with less well-developed standard of care options may have lower on-pathway rates.⁸ Interestingly, an 80% aggregate on-pathway rate has remained consistent across multiple vendors and through 15 years of pathway development. 

Pathway tools that are integrated into an electronic medical record capture many other metrics regarding pathway use, recommended treatments, patient characteristics, etc. The metrics captured along a pathway have many potential uses for multiple stakeholders. The cancer center implementing pathways is the most significant stakeholder of all, from leadership to all members of the care team. While the cancer center implementing a pathway system may be the primary user of the system, there are numerous stakeholders watching along the way.

Pharmaceutical Manufacturers 

Many pharmaceutical manufacturers see pathways as a barrier to product adoption. However, if the drug they offer has demonstrably superior efficacy, toxicity, and cost, it will be the recommended standard of care. While it is true that just because a drug is new, there is no guarantee that it will be included as a pathway recommendation, any drug with well-constructed trials and studies, and better results, will be. And manufacturers do not always consider that any physician can choose an off-pathway treatment for any patient where they believe that to be appropriate. 

Payers

Payers also have an interest in the pathway solutions chosen by network providers. Payers value not only lower costs and better quality but predictability. Be reducing treatment variation, payers have a more predictable cost landscape. It is important to remember that an on-pathway selection is not always lower cost than the off-pathway alternative. But it is the best clinical choice for most patients with the specific disease presentation. As noted above, some payers have their own pathways; others sponsor or approve certain pathways tools to help practices make decisions compatible with that payer. More payers are evaluating how to limit prior authorization burdens for practices that are using provider-initiated pathways, however, this is not yet possible for most. But it is generally advantageous for a practice’s relationship with their payers if they use pathways.

Physicians

Obviously the oncologists involved with the practice have a direct interest in securing high-quality, reliable pathways content delivered by an efficient tool. Referring physicians also have an interest in a cancer center’s adoption of pathways. As they consider where to refer their patients, the use of pathways helps provide confidence that they will be taken care of to the highest possible standards. 

Patients

Many oncologists are hesitant to share details of the pathway process with patients out of concern that the patient will feel that they are getting a cookie-cutter treatment plan for their cancer. Given the complexity of cancer care and pathways programs, anyone using pathways knows that to be far from the case. Patients will benefit from understanding that they are being offered the most appropriate care for their specific situation based on the latest scientific evidence. It is important to emphasize that pathways do not dictate the treatment—they help their physician to select the most effective and least toxic treatment. 

Conclusion

Again, the cancer center implementing pathways is the most significant stakeholder of all, from leadership to all members of the care team. Pathways support the cancer center’s key business strategies. Taking into account cancer centers of all varieties, there are 12 common strategies a cancer center may pursue that are supported by a pathways program, with each cancer center usually focusing on 3 to 4 at any one time. Identifying the strategies supported by pathways and connecting those to the physician engagement efforts helps ensure a successful pathways deployment and maximizes value for the cancer center. 

The next installment in this column series will discuss these cancer center strategies in more detail.  

References

1. Martell RE, Sermer D, Getz K, Kaitin KI. Oncology drug development and approval of systemic anticancer therapy by the US Food and Drug Administration. Oncologist. 2013;18(1):104-111. doi:10.1634/theoncologist.2012-0235

2. National Cancer Institute (NCI). A to Z List of Cancer Drugs. Cancer.gov website. https://www.cancer.gov/about-cancer/treatment/drugs?redirect=true. pdated December 12, 2018. Accessed February 5, 2019.

3. Lawal AK, Rotter T, Kinsman L, et al. What is a clinical pathways? Refinement of an operational definition to identify clinical pathway studies for a Cochrane systematic review. BMC Med. 2016;14:35. doi:10.1186/s12916-016-0580-z

4. McCutcheon S, Ellis PG, Hess R, Krebs M, Lokay K. Frequency of efficacy, toxicity and cost as the deciding factor when determining clinical pathways. J Clin Oncol. 2017;34(suppl 15):e18169. doi:10.1200/JCO.2016.34.15_suppl.e18169

5. Ellis PG. Development and implementation of oncology care pathways in an integrated care network: the Via Oncology pathways experience. J Oncol Pract. 2013;9(3):171-173. doi:10.1200/JOP.2013.001020

6. Butcher L. Clinical pathways in practice: a report from the front lines. Oncol Times. 2007;29(5):18-19. doi:10.1097/01.COT.0000267751.25033.3b

7. Bowman D. US Oncology launches oncology-specific EHR to the open market. June 11, 2009. https://www.fiercehealthcare.com/healthcare/us-oncology-launches-oncology-specific-ehr-to-open-market. Accessed February 5, 2019. 

8. Via Oncology. Who develops Via Pathways? https://www.viaoncology.com/wp-content/media/content_development_slides.pdf. Accessed February 5, 2019.