On a typical day, oncologist Dr. Linda Bosserman spends hours poring over lists meant to guide clinicians toward the optimal course of treatment. These "clinical pathways" are based on the cancer's stage and location in the body, and patient-specific factors, like comorbidities.
Then, after she and the patient have chosen a plan, Bosserman says she spends hours explaining to payers how and why the choice was made.
Because payers and for-profit companies create and distribute these pathways and because many are tailored to different agendas, the process is laden with inadequacies, conflicts of interest and “unsustainable” administrative burden, said the American Society of Clinical Oncology in a new policy statement, of which Bosserman was the senior author.
“The administrative burden is at a breaking point,” said Bosserman, who works at City of Hope, a not-for-profit cancer research center in Southern California.
While it is difficult to estimate how many clinical oncology pathways exist, they are likely well into the thousands. The pathways work on what might be described as an "if-then" format. For example, if the patient has breast cancer that has metastasized, then X has shown to have the best results; or if the lung cancer patient also has diabetes, then Y would be better.
The pathways were first created more than a decade ago when personalized care began to trend. But some argue they've had the opposite effect.
Cookie-cutter approaches can impede the ability to personalize care, said Dr. Robin Zon, chair of ASCO's Task Force on Clinical Pathways.
In too many cases, clinical pathways undermine physicians' ability to optimally care for patients, ASCO President Dr. Julie Vose said in a news release.
“The authorization and preauthorization work is taking away from our face to face time with patients,” Bosserman said. “Pathways are here to support doctors and patients, but they need to be comprehensive and they need to be practical.”
The National Comprehensive Cancer Network's guidelines to treat more than 40 different types of cancers alone includes hundreds of pathways for each cancer. Each tool breaks down the specific courses to follow based on the tumor size, whether it has metastasized, or if the patient has other chronic conditions, like heart disease or diabetes.
For each patient and for each type of disease, a provider may be faced with multiple pathways created by different interest groups. According to the ASCO task force, these may include payers, who incentivize certain pathways by offering increased reimbursement or shared savings. Benefit management organizations, or intermediaries between providers and payers, also create pathways that favor cancer drugs.
At least six companies actively market oncology pathways, ASCO revealed in its research, without naming them. A report from the Advisory Board lists three; Innovent, P4 and Via Oncology.
The Via Oncology pathway program was developed more than a decade ago and was used at the University of Pittsburgh Medical Center before it expanded commercially in 2009. The pathways are now used at 25 UPMC sites in Western Pennsylvania and by numerous provider groups throughout the country, including five academic medical centers.
The system's chief medical officer, Dr. Peter Ellis, agrees with ASCO that it's time to regulate clinical pathways. Ellis said that if one were to print the full list of pathways created by Via Oncology's oncology committees, "It would be more than 12,000 "
“The unfortunate truth is that people have bastardized what the name pathways means, using it to further other means,” he said. “They should not be about limiting care to patients, but rather making sure the care patients get is the best evidence-based care.”
Ellis voiced other concerns with pathway development in a , called "All clinical pathways are not created equal."
Concerns need to be addressed “as rapidly as possible,” ASCO said in its nine recommendations. It recommends better collaboration among payers and the oncology community to adopt flexible policies; consistent and transparent methodologies for pathway development; changes that allow pathways to be updated more rapidly, in real-time; and more focus on the full spectrum of care, from diagnosis to end of life.
The report falls in line with other projects the oncology group has been pushing to help physicians and patients choose appropriate therapies amid the skyrocketing costs of cancer drugs. In June, ASCO released a tool for oncologists to compare various drug treatments for four common cancers based on survival, side effects and costs.
They have also been finalizing CancerLinQ, a not-for-profit subsidiary that is bringing together more than a dozen oncology groups for a big data initiative. The participating practices share data from millions of electronic health records, with the goal of providing real-time feedback on cancer trends and patient outcomes.