The use of a standard treatment protocol—i.e., pathway— for treating patients with non-small-cell lung cancer can save money with no difference in survival, according to the first published cost-effectiveness study of evidence-based pathways.
The study, published in the Journal of Oncology Practice (2010;6:12-18) and involving 1,409 patients treated in eight U.S. Oncology practices around the country, found that annual outpatient costs were 35% lower for patients treated “on-pathway” versus “off-pathway.” No difference in 12-month overall survival was found between the two groups or for patients in adjuvant, first-line and second-line settings.
The lead author, Marcus Neubauer, MD, an oncologist at Kansas City Cancer Center, said the results help validate two concepts: “First, when you practice evidence-based medicine in cancer care, at least by this example, there is no compromise in patient outcomes. Second, if you follow pathways you can actually reduce the cost of care.”
Those findings are important because they may point the way to value-based cancer care. In all of medicine, a tremendous variability in treatment patterns has led to growing concern that many health care services are wasted, contributing to the nation's unsustainable health care costs. Employers, insurers, and patients are pushing for value-based care—the highest quality care delivered at the least cost.
Many oncology groups around the country are experimenting with ways to prove they deliver value, and several of them use standard protocols, or pathways, to reduce variation and the higher costs associated with it.
Cancer Care Northwest in Spokane, Washington, is one of them. Bruce Cutter, MD, a Cancer Care Northwest oncologist, says he hopes the paper is the first of many to document how oncologists can improve patient care while saving money.
“Where in the health care reform debate is anybody talking about saving 30 or 35 percent of costs and patients doing just as well, if not better?” Dr. Cutter said. “This is an important illustration of how pathways add value in what can be a transformed delivery system.”
Cancer Care Northwest, formerly a member of US Oncology, is analyzing data from its own use of cancer care pathways and expects to publish it later this year.
Meanwhile, Via Oncology, a company affiliated with UPMC Cancer Centers in Pittsburgh, is planning to publish findings of two studies of its clinical pathways program.
The company's President, Kathy Lokay, said she believes the use of clinical pathways can keep oncologists in charge of oncology: “We can either lead and be part of the solution or we can have solutions handed to us. In order for oncology to preserve patients’ access to care and to preserve financial stability, oncologists are going to have to step up and offer solutions to payers.”
When Less is More
The US Oncology study is a retrospective review of patients with NSCLC who started chemotherapy between July 1, 2006, and December 31, 2007. The analysis included all services billed by physicians, except the costs for diagnostic services or surgery. The costs of radiologic services, including radiation therapy, were also omitted because not all US Oncology practices provide those services. If a patient received inpatient treatment, the researchers applied an average total hospitalization cost for lung cancer patients provided by Aetna.
Of the 1,409 patients, 78% were treated on-pathway and 22% were treated off-pathway. The overall 12-month survival probability for on-pathway patients was 45%; for off-pathway patients, 46%.
The average 12-month outpatient costs for a patient on-pathway was $18,042, which was 35% less than the average $27,737 for an off-pathway patient. Chemotherapy costs were 37% lower, and nonchemotherapy medications, including both erythropoietin-stimulating agents and white blood cell growth factors, were 39% lower.
Those savings came both from the use of less expensive drugs and lower total use of drugs. US Oncology's pathway for NSCLC patients includes expensive therapies, including bevacizumab and erlotinib, when evidence justifies their use. However, the pathway does not include any chemotherapy beyond third-line therapy, and relatively few on-pathway patients receive third-line care.
Implications for Reimbursement
Aetna participated in the study, but the official line from the insurer is that the study has no coverage implications and that Aetna will continue to pay physicians and hospitals for cancer care as it has in the past.
However, if the cost-effectiveness of pathways holds up under further study, that position is unlikely to hold for most payers. For one reason, employers and insurers will see they can save money if physicians follow standardized treatment plans that offer equal outcomes for patients.
“Why should anyone pay $1.50 for something that should be paid $1?” said Francois de Brantes, CEO of Bridges to Excellence, an organization that promotes the use of value-based health care practices.
The second is that under the current reimbursement model, physicians have a financial disincentive to use pathways. So unless a new reimbursement strategy is introduced, the potential cost savings associated with pathways will never be realized.
“Let's be real: Under the current model, if I save money [for payers], my income goes down. I get penalized for doing the right thing,” Dr. Cutter said. “That's why health plans have to come in as part of this process, both as partners in developing these kinds of programs, but also as partners in developing new ways to compensate physicians.”
Kansas City Cancer Center started using Level 1 Pathways, as its program is called, six years ago, but no insurers pay the practice specifically based on its compliance with the pathways. However, Dr. Neubauer said payers have shown appreciation for the practice's development and use of pathways.
“We feel our pathways program has helped us get the type of contracts that we think are fair and deserving. Since starting pathways our interactions with payers have been more collaborative.”
U.S. Oncology is working with national payers to explore ways in which payment for cancer care is tied to the value of care delivered.
Dawn Holcombe, MBA, FACMPE, ACHE, owner of DGH Consulting in South Windsor, Connecticut, said she thinks that oncologists who can prove they are consistently using evidence-based clinical pathways can differentiate themselves as value-based providers.
‘I would love to see payers lining up with open arms to say ‘how can we work with you to encourage this?’’ she said.
Mr. De Brantes is also CEO of Prometheus Payment, which is piloting the use of “evidence-informed case rates” to replace fee-for-service payment. While none of those pilots involve cancer care, he said the U.S. Oncology study suggests that the concept of case rates, which require limiting variation in practice, can be applied to cancer treatment.
“This study shows how important it is for the industry to stop looking at units of service and paying by the unit, and rather create accountability around the episode and hold physicians accountable for delivering good results within the constraints of an evidence-informed case rate,” he said.
Implications for Patients
At US Oncology, pathways are designed using three criteria determined in this order:
- Greatest survival benefit.
- Least toxicities.
- Lowest cost.
Dr. Neubauer said that aside from the financial implications of the pathways, he believes patient care is improved when oncologists follow pathways.
“Treating people on pathways should be less toxic because we're deliberately trying to find regimens that are more tolerable to patients if their efficacy is equal,” he said.
The pathway regimen has standard order sets that define dosing strengths and number of cycles, eliminating the tendency for physicians to add cycles for patients who are not responding.
The study found that patients treated on-pathway have 22% fewer chemotherapy infusion visits and 23% fewer administrations of antiemetics and other supportive care agents than off-pathway patients. Dr. Neubauer suspects those two factors go hand in hand.
“Many patients [treated beyond third-line of care] basically suffer toxicity without benefit,” he said. “That's much less likely to happen when they're treated on-pathway.”
What is a Pathway?
Although most oncologists agree that cancer treatment should adhere to guidelines published by the National Comprehensive Cancer Network or another reputable source, the use of evidence-based pathways is much less common.
“I like to say guidelines are a six-lane highway, and a pathway is the selection of one preferred lane with a backup lane,” said Dawn Holcombe, MBA, FACMPE, ACHE, Executive Director of the Connecticut Oncology Association and President of DGH Consulting in South Windsor, CT.
Indeed, the use of clinical pathways requires not only the process for determining the regimen for a particular disease state, but also the processes for enforcing and monitoring compliance and determining when exceptions to the pathway are justified.
“When people say they're ‘doing pathways,’ you have to pay a lot of attention to how broad or narrow the pathway is, as well as to the process by which the pathway is accomplished,” said Bruce Cutter, MD, of Cancer Care Northwest.
Ready access to the pathway regimen and mandatory participation in the pathways program are essential for making the concept work, added Marcus Neubauer, MD, of Kansas City Cancer Center, lead author of the U.S. Oncology study, explaining that clinical pathway information at U.S. Oncology is incorporated into the electronic medical record used by more than 80% of the corporation's physicians.
Physicians who want to deviate from the pathway for a particular patient must go through a peer review process in their local practice before treatment is administered.
“Having a peer-reviewed pathway exception process adds more ‘power’ to the pathways and also eliminates the criticism that pathways are too restrictive,” he said.
An appropriate exception to the pathway would be a patient who has an allergic reaction to a certain drug or a health condition, such as diabetes-related neuropathy, that would be exacerbated by the pathway regimen.
“Inappropriate exceptions are trying to recycle drugs for fourth- or fifth-line therapy and trying drugs that haven't really been shown to be of any benefit,” he said. “That's not evidence-based; that's conjecture.”