ORLANDO – A decision support tool safely reduces use of colony-stimulating factors (CSFs) in patients undergoing chemotherapy for lung cancer, suggests a retrospective claims-based cohort study of nearly 3,500 patients across the country.
The rate of CSF use fell among patients treated in the nine states that implemented the tool – a library of chemotherapy regimens and their expected FN risk that uses preauthorization and an algorithm to promote risk-appropriate, guideline-adherent use – but it remained unchanged in the 39 states and the District of Columbia, where usual practice continued, investigators reported at a symposium on quality care sponsored by the American Society of Clinical Oncology and simultaneously published (J Oncol Pract. 2017 March 4. doi: 10.1200/JOP.2017.020867). The adjusted difference was nearly 9%.
Dr. Abiy Agiro
“Decision support programs like the one highlighted here could be one way, definitely not the only way, of achieving guideline-adherent CSF use and reducing practice variation across the country,” commented coinvestigator Abiy Agiro, PhD, associate director of payer and provider research at HealthCore, a subsidiary of Anthem, in Wilmington, Delaware.
“Such efforts could also have unintended consequences, so it’s important to study relevant patient outcomes,” he added. “In this case, although it appears that the incidence of febrile neutropenia rising does not seem to relate with the program, the study does not establish the safety of CSF use reduction in lung cancer patients receiving chemotherapy. So, we should take the results with that caveat.”
Parsing the findings
Although the United States makes up just 4% of the world’s population, it uses nearly 80% of CSFs sold by a leading manufacturer, according to invited discussant Thomas J. Smith, MD, a professor of oncology and palliative medicine at Johns Hopkins University in Baltimore.
“When we rewrote the ASCO [American Society of Clinical Oncology] guidelines on CSF use in 2015, there were some specific indications: dose-intense chemo for adjuvant breast cancer and uroepithelial cancer and ... when the risk of febrile neutropenia is about 20% and dose reduction is not an appropriate strategy. We were quick to point out that most regimens have a risk of febrile neutropenia much less than that,” he noted.
Dr. Agiro and his colleagues’ findings are valid, real, and reproducible, Dr. Smith maintained. However, it is unclear to what extent the observed levels of CSF use represented overuse.
“In lung cancer, there are very few regimens that have a febrile neutropenia rate close to 20%,” he elaborated. “What we don’t know is how much of this [use] was actually justified. I would suspect it is 10% or 15%, rather than 40%.”
CSF use, as guided by the new tool, “might not support increased dose density [of chemotherapy], but I would challenge anybody in the audience to show me data in normal solid tumor patients that [show that] dose density maintained by CSFs makes a difference in overall survival,” he said.
Questions yet to be addressed include the difficulty and cost of using the decision support tool and the possible negative impact on practices’ finances, according to Dr. Smith.
“When ESAs [erythropoiesis-stimulating agents] came off being used so much, some of my friends’ practices took a 15% to 20% drop in their revenue, and this is an important source of revenue for a lot of practices,” he explained. “So, I hope that when we take this revenue away, that we are cognizant of that and realize that it’s just another stress on practices, many of which are under significant stress already.”
Study details
An estimated 26% of uses of CSFs in patients with lung cancer are not in accordance with the ASCO practice guidelines, according to Dr. Agiro. “Such variations from recommendations are sometimes the reason why different stakeholders take actions” to improve care, such as ASCO’s Quality Oncology Practice Initiative (QOPI) and the American Board of Internal Medicine’s Choosing Wisely initiative (J Oncol Pract. 2015;11:338-43).
The decision support tool evaluated in the study uses preauthorization before delivery of care and, therefore, differs from point-of-care interventions, he noted.
“The tool allows access to a library of chemotherapy regimens and their associated, expected febrile neutropenia risk based on the myelotoxicity of the planned regimens as indicated in published trials. The tool is accessible online and provides real-time recommendations that are tailored based on disease- and patient-specific factors for either the use of CSF or not,” he elaborated.
According to the tool’s algorithm, use is recommended for patients who are given a regimen with a high risk of febrile neutropenia (greater than 20%) and is not recommended for those given a low-risk regimen (less than 10%). It is tailored according to the presence of additional risk factors for the intermediate-risk group.
Oncologists use the tool only for patients starting a new chemotherapy and only in the first cycle, when the risk of febrile neutropenia is highest, according to Dr. Agiro. “Once the approval is given in the first cycle, it remains in effect for the next 6 months, so they don’t have to use it again and again in additional cycles,” he explained.
The decision support tool was implemented in nine states starting in July 2014. In the study, which was funded by Anthem, the investigators analyzed administrative claims data from commercially insured adult patients starting chemotherapy for lung cancer, assessing changes in outcomes between a preimplementation period (April 2013 to Dec. 2013) and a postimplementation period (July 2014 to March 2015).
Analyses were based on 1,857 patients in the states that implemented the tool and 1,610 patients in the states that did not.
The percentage of patients receiving CSFs in the 6 months after starting chemotherapy fell in states that implemented the decision support tool (from 48.4% to 35.6%) but remained stable in states that did not (43.2% and 44.4%), Dr. Agiro reported. The adjusted difference in differences was –8.7% (P less than .001).
Meanwhile, the percentage of patients admitted for febrile neutropenia or experiencing this outcome while hospitalized increased in both states implementing the tool (from 2.8% to 4.3%) and those not implementing it (from 3.1% to 5.1%). Although the magnitude of increase was smaller in the former (+1.5% vs. +2.0%), the difference was not significant. Findings were essentially the same among the subset of patients aged 65 years and older.
“It’s important to study both intended and unintended consequences of such interventions,” Dr. Agiro noted. “Our study goes beyond financial considerations by looking at unintended outcomes: in this case, focusing on the incidence of febrile neutropenia, an outcome that is of prime interest to patients and oncologists and payers alike.”
The study may have missed some cases of febrile neutropenia, he acknowledged. “Also, there are other important outcomes of concern. For example, were there any delays in chemotherapy administration or immune recovery that could have been triggered by the implementation of the decision support program?”
The impact, both intended and unintended, on practices warrants evaluation as well, he further noted. “An important question could be, ‘Does it take less time to use this decision support tool compared to the time taken with normal care processes?’ ”
Dr. Agiro disclosed that he is employed by, has stock or other ownership interests in, and receives research funding from Anthem.