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Evidence-Based Oncology April 2016
ASCO Policy Statement on Clinical Pathways in Oncology: Why Now?
Robin Zon, MD, FACP, FASCO
The Oncology Medical Home - Beyond Clinical Pathways
Daniel P. McKellar, MD, FACS; Charles Bane, MD; M. Asa Carter, MBA, CTR; Allison Knutson, CCRP; Vicki Chiappetta, RHIA, CTR; Bo Gamble
Recommendations for the Role of Clinical Pathways in an Era of Personalized Medicine
Alan J. Balch, PhD; Charles M. Balch, MD; Al Benson III, MD; Deborah Morosini, MD; Robert M. Rifkin, MD; Loretta A. Williams, PhD
Cancer Care Pathways: Hopes, Facts, and Concerns
Bernardo Haddock Lobo Goulart, MD, MS
Developing an Oncology Clinical Pathways Program - the UPMC Case Study
Peter G. Ellis, MD
Clinical Pathways: A Systems Approach Toward More Patient-Centric Cancer Care Delivery
Joseph Alvarnas, MD
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Are Oncology Clinical Pathways a Value Framework in the Making?
Surabhi Dangi-Garimella, PhD
Conference Coverage: ACCC
Surabhi Dangi-Garimella, PhD

Are Oncology Clinical Pathways a Value Framework in the Making?

Surabhi Dangi-Garimella, PhD
Evidence-Based Oncology invited a panel of experts who are experienced in the creation of oncology care pathways, use them in their practice, and have researched the development and implementation of care pathways, to exchange ideas on the topic.
When queried on the increased administrative burden of pathways, Polite said, “Well, there’s no question it can be a very clunky process as you start a pathway.” However, some pathways, like the ones used by practices within the US Oncology network, have been around long enough that they are a part of the clinic’s regular workflow. When used as a stand-alone, pathways can add to the administrative burden, Polite said, but he expects this will improve with time.
“If we’re facing a situation where I have to use a different pathway based on whether my patient is a Blue Cross patient or an Aetna patient or Medicare Advantage patient, and each one of those has a different order set and different priority, that is going to create significant frustration and blowback from the oncology community,” said Polite, adding that the field is moving in the direction of a consensus for which payers, the pharmaceutical industry, and providers all need to lend an equal voice.
Encouraging Off-Pathway Regimens

Doctors are concerned that they would be penalized for wavering from the recommended treatment regimen, based on patient response or if they want to include a new and innovative treatment. Lokay explained that 100% pathway adherence is never the goal. “Really what you’re doing is you’re saying ‘Can we really develop pathways to address about 80% of the patients within a given disease?’ There’s always the ability to go off-pathway.”
According to Lokay, the pathway program developed by Via Oncology offers physicians the option to explain why they chose to go off-pathway and to document the alternative treatment being used. Lokay said that newer therapies are included in the bucket of therapies that can be used if a physician decides to go off-pathway. Depending on the impact of the new treatment, the decision committee could either meet immediately or discusses the inclusion of the new treatment at its quarterly meeting. “Ultimately, everything comes back to that shared decision making between the physician and the patient,” added Lokay. “The pathway should never drive an inappropriate decision.”
Fisch agreed with Lokay on the need for flexibility in pathways, especially in the scenario that a uniform set of pathways could be used across health plans to allow nimbleness to the process as new evidence builds. He said that clinical pathways will never be exhaustive because they are built “to make adjustments in real time.”
Creating a Learning Healthcare System

Can the standardized, evidence-based regimens proposed by care pathways provide assurance of high-value care? According to Polite, the definition of the term “value” is muddled at best. Technically, value is a ratio of efficacy and cost, and he believes pathways prevent oncologists from being penalized for offering the optimal treatment to their patients. Citing biomarker-driven treatment as an example, Polite said that if oncologists use anaplastic lymphoma kinase (ALK) expression or programmed cell death protein 1 (PD-1) expression to decide that their patient should be treated with an ALK inhibitor or a PD-1 inhibitor, respectively, being on- or off-pathway becomes a moot point.
On the other hand, pathways stop physicians from repeatedly administering expensive treatments that are less efficacious, he said. “There may be one or two patients that you decide that’s appropriate for, but if that becomes your pattern of care, that’s not going to be acceptable.”
Dubois agreed, but emphasized that clinical trial data—the evidence most commonly used to develop pathways—are a snapshot in time, which contradicts the longitudinal nature of pathways. Collecting evidence to support the continual impact of following a pathway to treat a patient would require quality measures that out healthcare system currently lacks, according to Dubois.
Lokay argued that clinical pathways are embedded with quality checks—from the tests to be ordered to the drugs to be used based on mutational analysis. She believes that empirical evidence is built into the pathways. When Dubois argued that these are actually process measures and do not provide a window into patient performance and effectiveness of a treatment, Fisch responded that there is opportunity to gather evidence over time. He reasoned that one can collect patient performance data over time from clinical trials and by following clinical guidelines as well as Choosing Wisely recommendations. Additionally, hospitalization data, other outcomes data, cost of care data that assimilate over time can be fed back to modify the pathways, resulting in a learning healthcare system, Fisch said. Polite pointed out that it is often missed that pathways provide granularity to data collection that would otherwise be impossible to assemble with claims data, such as the pathological detail, performance status, or biomarker expression.
Challenges With Adoption

Is it harder to implement pathways in a small community center versus in a bigger place like an academic cancer center? According to Polite, who works in an academic hospital setting, a bigger cancer center might witness more resistance from physicians. “The struggle that you have at an academic medical center is that the people who are treating these cancers are all justifiably experts in their field,” said Polite, and they can have strong clinical opinions, making it difficult to drive consensus. So the approach devised by several cancer centers is to be flexible and to involve the experts at the institute in pathway creation, in tandem with the pathway vendor, he explained. “I think it’s about having a process, like at Via Oncology, where people can be at the table and express their opinions on why they think things should be done differently.”
Fisch would like to see academic centers break their mold and focus on ways to distinguish themselves beyond having the most renowned experts on the roster. He said they need to highlight their unique research environment, which creates a melting pot of diverse medical experts such as in surgery and pathology. These centers would gain from emphasizing the extent of communication and patient-centered care that they provide and the various resources that are coalesced to improve patient outcomes, Fisch said.
Patient Awareness on Clinical Pathways

Dubois highlighted another important and interesting finding from their survey, which was the level of transparency for the patients being treated on pathways.1 The survey found that patients are not necessarily aware that doctors are making treatment recommendations based on pathways. “I think what is probably the least transparent are the financial incentives to pathway compliance and whether the patients are aware of that,” Dubois noted. He believes that patients should be told if their treatment follows a predetermined pathway, and they should also be made aware of financial incentives that may be associated with adherence to pathways.

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