For a woman diagnosed with HER2-negative, estrogen-receptor negative breast cancer that has spread to the lymph nodes, guidelines from the National Comprehensive Cancer Network (NCCN) recommend chemotherapy following surgery.
Within this recommendation, however, is a lot of room for variation. In fact, there are 16 possible chemotherapy regimens, explained Dr. Bruce Feinberg, chief medical officer of Cardinal Health Specialty Solutions, based in Dublin, OH. Many of these regimens are similar, “but most of them will never be tested head to head” to determine which are the most effective, least toxic, and least costly, he said.
Clinical pathways can help physicians choose the best treatments for individual patients from several possible regimens.
As a result, even within the same oncology practice, two similar patients may get very different treatments, often because their oncologists prefer or are more comfortable with one particular regimen than another.
Enter “clinical pathways”—programs that are being designed and implemented by large networks and smaller practices to limit such variation. The programs do this by helping doctors select what the available evidence indicates are the best regimens for a particular patient. That evidence is derived from sources that can include clinical trial data and professional guidelines.
In the breast cancer example above, the clinical pathway used by many Michigan oncologists narrows the first-line treatment options from 16 to 4 regimens, explained Dr. Feinberg, who ran a large Atlanta-based oncology practice for 23 years.
Pathways programs that Cardinal Health has helped to establish in Michigan, Maryland, Pennsylvania, and several other states have “reduced variation, and allowed those oncologists to gain more refinement and better knowledge of the treatments,” Dr. Feinberg said. And that, proponents of clinical pathways believe, can improve the quality of care.
Pathways may also save money, by reducing treatment complications and the unnecessary use of some drugs, for example. And with annual direct costs of cancer treatment in the United States estimated to reach $173 billion by 2020, any way of cutting costs—without sacrificing quality—is under serious consideration.
Building a Pathway
The pathways concept appears to be picking up steam. In a small survey conducted at NCCN’s 2012 annual conference, for example, nearly 60 percent of respondents said they had implemented or were considering implementing clinical pathways.
Clinical pathways are just one route the oncology community is pursuing to improve the quality and efficiency of care, explained Dr. Steven Clauser, chief of the Outcomes Research Branch in NCI’s Division of Cancer Control and Population Sciences (DCCPS).
“In the last few years, we’ve begun to see a real emphasis on trying to improve and measure quality,” Dr. Clauser said. That includes efforts to track adherence to clinical guidelines, “and using [the resulting] data to better understand an organization’s clinical environment and how they’re treating their patients,” he continued.
Clinical pathways are similar to clinical guidelines, but they take the concept one step further.
The US Oncology Network, a nationwide network with approximately 1,000 oncologists, develops its clinical pathways following a specific formula, explained Dr. Roy Beveridge, chief medical officer for McKesson Specialty Health. (McKesson acquired US Oncology in 2010.)
“First, we look at randomized controlled trials…which we believe are the most important data,” Dr. Beveridge said. “We want to see the manuscript, and we look for definitive trials.”
When a randomized trial shows that one treatment is significantly better than “anything else out there,” he continued, “then that is the top choice in the pathway. Period.” In cases where two treatments are equally effective but differ in toxicity, the less-toxic regimen is favored. And in cases where efficacy and toxicity are similar, then cost—in the form of what insurers pay—is taken into account.
The idea that adherence to a guideline or a pathway is a measure of quality is complicated. That’s the part we have to be careful about.
—Dr. Stephen Taplin
Cardinal Health and Via Oncology, a spinoff of a clinical pathways program developed at the University of Pittsburgh Medical Center (UPMC) Cancer Center, follow similar criteria. All three companies rely on physician-led committees to review clinical trial results, published studies, and, with the exception of Via Oncology, professional clinical guidelines to develop each pathway.
In the physician networks that implement pathways, oncologists can review and comment on draft pathways before they’re finalized. These committees convene regularly to review the latest data and determine whether a pathway needs to be updated.
The pathways are not iron clad, nor should they be, explained Dr. Peter Ellis, Via Oncology’s medical director. In all of the major pathway programs, the rule of thumb for adhering to a pathway is 80 percent, a threshold that appears to be based primarily on clinical experience, not firm data.
If an individual oncologist has an adherence rate above 80 percent, “we’re worried about it,” said Dr. Ellis. Adherence above 80 percent “could mean that they’re not thinking through the needs of individual patients. There are going to be circumstances when a patient really should be on something other than the pathway choice.”
UPMC, Dr. Ellis said, has a compliance rate of 77 percent with its available pathways, which now cover approximately 90 percent of cancer treatment decisions, as well as tests, post-treatment surveillance, radiation therapy, and supportive care.
The pathways concept isn’t always welcomed with open arms, though. Practicing oncologists must “deal with reality, where variances [to pathways] go by different names, such as vomiting, fever, drug shortages, pulmonary emboli, frustration, grief,” Dr. Craig Hildreth, an oncologist in St. Louis, wrote last year on his Cheerful Oncologistblog. (Free registration is required to access the blog.)
In some cases, medical practices within a health care network that has implemented a pathways program have refused to use them.
At practices in the US Oncology Network, Dr. Beveridge said, the response has been good. “Our Level I Pathways is an evidence-based medicine initiative,” he said. “The buy-in has been high because these treatment guidelines are physician-led and developed based on proven evidence.”
A practice’s setting will also likely influence the decision to implement clinical pathways, said Dr. George Weiner, director of the University of Iowa Holden Comprehensive Cancer Center. Academic medical centers with tumor boards and “strong in-house multidisciplinary programs,” where there is a significant amount of collaboration and discussion among the different clinicians involved in patient care, may be less likely to go the pathways route, he believes.
Do Pathways Improve Care, Save Money?
The Systems around the Pathways
The US Oncology Network’s clinical pathways are built into the organization’s electronic health record (EHR) system, iKnowMed. The EHR lists the “on-pathway” treatments for a given diagnosis and the documentation to support their inclusion in the pathway.
The documentation of the evidence to support a pathway is particularly helpful for oncologists caring for patients with less common cancers, said Dr. Debra Patt, medical director of the US Oncology Network Pathways Task Force and a breast cancer specialist at Texas Oncology, a network affiliate.
The documentation can also help patients, she continued. “It’s a wonderful experience to show patients…the hyperlinks to the studies, then hyperlinks to the Pathways Task Force committee report,” Dr. Patt said. “It’s a great educational tool, and I can say to them, ‘This is the evidence to support the recommended treatment,’ and it helps them to participate in informed decision making.”
Building a robust IT infrastructure around clinical pathways has been a top priority and a big financial investment for Via Oncology, Dr. Ellis explained. The most recent version of the company’s web-based pathways portal can connect directly into a practice management system, so pathway choices are incorporated into the doctor’s schedule for each patient visit.
The concept of clinical pathways is a strong one, said Dr. Stephen Taplin, chief of the Process of Care Research Branch in DCCPS. But, he cautioned, it’s unclear whether clinical pathways improve quality.
“The idea that adherence to a guideline or a pathway is a measure of quality is complicated,” Dr. Taplin said. “That’s the part we have to be careful about.”
Oncologists must consider factors like patient preference and suitability for treatment when making decisions about care, he stressed.
The best way to develop and use pathways will need to be closely studied, noted Dr. Weiner. “How rigorous should they be? How much flexibility should they include?”
Dr. Ellis acknowledges that it’s difficult to prove that clinical pathways improve care quality. Even so, he argued, “If a pathways system can document that evidence-based care is given, then it naturally follows that the quality of care will improve.”
But at this point, Dr. Feinberg noted, the idea that pathways improve care quality is “largely an act of faith…. You have to look for behavior changes that you believe represent better care.”
Some documented behavior changes include less use of combination chemotherapy as third- and fourth-line treatments. Patients treated on a pathway also have fewer emergency room and hospital admissions because of chemotherapy side effects, the US Oncology Network and Cardinal Health have reported.
The US Oncology Network is, thus far, the only group to publish data on potential cost savings. Using electronic medical record data from eight of its affiliated practices, they found that, over 1 year, outpatient treatment costs were 35 percent lower ($18,000 versus $28,000) for patients with non-small cell lung cancer treated on-pathway than off-pathway.
Some insurers have been skeptical about whether pathways can improve care or reduce costs, Dr. Beveridge acknowledged. “That’s why we conducted the study,” he said. “Because of our study results, I believe most payers are now interested in learning more about a pathways approach.”
Insurers are central to the model used by Cardinal Health, which facilitates collaborations with insurers and oncology groups on pathway development. As part of that collaboration, the insurers provide financial incentives to practices that participate in the program and meet compliance benchmarks.
Even with the uncertainty, clinical pathways are proliferating. The US Oncology Network has licensed its pathways to several hospital systems and practices, Dr. Beveridge said. Hospitals and oncology practices in 11 states are using Via Oncology’s pathways. The most recent addition came just last month with Indiana University Health System, which will implement the pathways at the central site and its affiliated oncology practices.
With the advent of accountable care organizations and other efforts to measure quality of care and reduce costs, clinical pathways—or something like them—may very well be part of the future for all hospitals and medical practices, Dr. Ellis believes.
“There’s got to be more accountability and proof of quality of care,” he said. “You’re not going to be able to say to patients and payers, ‘Trust me, I’m a good doctor.’”