Researchers from the University of California and the University of California San Diego (UCSD) have begun working on a prototype “cyberinfrastructure” that would allow cancer researchers to collect and interpret data from multiple sources to compare the effectiveness of preventive measures, drugs, treatments, and interventions during the course of clinical trials.
The project, known as CYCORE (Cyberinfrastructure for Comparative Effectiveness Research), will aggregate data from clinical trials, patient medical records, self-reported and objectively monitored social and behavioral data, data on cancer outcomes from regional cancer registries, and cost-benefit analyses. The goal is to allow scientists to better collate ever-increasing amounts of data, and to use that both to impact the design of future trials and to positively affect patient outcomes in the present.
A key part of the project will involve home and mobile phone-based sensing devices that will allow real-time capture of pertinent patient data. Kevin Patrick, MD, a professor in UCSD’s Department of Family and Preventive Medicine and a principal investigator in the project, emphasized the novelty of the approach in a press release discussing the effort. “A primary focus will be on tackling the problem of obtaining, in patients’ homes, objective person-level data on behaviors such as adherence to cancer medications, diet, physical activity, sleep, environmental exposures, and quality of life,” he said. These factors are wide ranging, encompassing everything from physiological matters (eg, cardiac function, blood pressure, sleep-related EEG data, etc), to behavior-related issues (eg, do they take their medication as prescribed, do they exercise, do they seem lethargic, are they still smoking, do they eat appropriate foods, etc), to environmental factors (eg, is there secondhand smoke in the home, is their neighborhood experiencing significant amounts of air pollution, is the patient always alone, etc).
“These factors are enormously important in the course of medical treatment, but are almost always assessed through infrequent and after-the-fact self-reports,” Dr Patrick added. “To have these data in near-continuous form will greatly expand our understanding of who does well on what treatment, when, why, and for how long.”
Laura Wolszon, PhD, a program director on the project, elaborated, saying “one of the reasons that cancer treatments haven’t progressed further is because researchers don’t typically evaluate the impact of a patient’s behavior and personal environment when deciding whether one treatment works better than another. The more data we use, the more accurate and effective will be the treatment plan for that patient and, probably, others.”
The researchers are constructing the prototype using data from their partner, M. D. Anderson Cancer Center, but the final goal is to include data from all cancer clinical trials. The research team emphasizes that the program will be open source, allowing others to modify it for their own purposes, and will be adaptive to changes in policy along the way—say, if changes in privacy laws occur that suddenly restrict access to certain data.
Baltimore, MD—A long-held business truism is that “if you can’t measure it, you can’t manage it.” The application of this belief to the oncology setting was demonstrated at a session of the Association of Community Cancer Centers’ (ACCC) 36th Annual National Meeting. Kimberly Bergstrom, PharmD, chief clinical officer for McKesson Specialty Care Solutions, told attendees of the growing importance of developing and using standardized chemotherapy treatment regimens, and of the tools that can benchmark performance and foster compliance with treatment guidelines.
Public and private payers are moving to control exploding healthcare costs, Dr Bergstrom told attendees, and because increased cost control was inevitable, it is in providers’ interest to get a seat at the table.
“It is an important topic, because this is one of those things, if we don’t get a handle on it, it’s going to happen to us,” she said. “People and groups and organizations are going to start dictating how we provide cancer care, and we can’t let that happen.”
Cost Increases, Cost Management
According to Dr Bergstrom, the last decade has seen a shift by payers in their approach to managing spending for oncology drugs. Up until the early 2000, there was little in the way of medical policy guidance and pre-authorization. In the early to middle part of that decade, preauthorization and guidance was applied to select high-value and high-risk products. From the mid-2000s on, medical policy has increasingly been based on care guidelines and pathway, and this evolution has led to increasingly complex administrative requirements and data needs on the parts of both payers and providers.
Health plans are taking a number of long- and short-term approaches to managing costs, she said. The plans “have a huge interest in reducing your drug margin to save them money,” said Dr Bergstrom. “They want to move [physicians] away from their dependence on the drug margin and move to more service-based fees. They want to separate the oncology income from drug sales.”
But many payers, said Dr Bergstrom, are currently reducing costs on their own terms, and cutting into providers’ bottom lines.
“This really provides us with a great dilemma,” she said. “Decreased revenue, increased administrative burden, and costs. Payers are managing specialized care aggressively. And they’re using 2 key tools that they know best: they’re reducing your fee schedules and they’re requiring prior authorization.”
But reduced costs don’t have to mean reduced care. According to Dr Bergstrom, cost control and standardization of effective treatment regimens should go hand in hand.
“They are creating payment policies that actually reward clinical performance,” she said. “A lot of that has to do with the focus on standardized treatment guidelines and rewards for achieving certain clinical measures.”
Dr Bergstrom argued that increased payer scrutiny creates an opportunity for caregivers to examine practice efficiency, to present community-based oncology as a cost-efficient means of care delivery, and to explore a wider use of data-based performance. Standardized chemotherapy regimens increase practice efficiency, reduce errors, simplify billing, and make it easier to measure outcomes of care, Dr Bergstrom suggested. And from the payer’s perspective, improved care consistency and predictability of costs is appealing, as is the ability to prove quality and value to plan sponsors and patients.
There are a number of free clinical tools that can help with benchmarking and standardization (Table). In addition, limiting the number of chemotherapy regimens via an electronic medical record and standardizing prechemotherapy medications, supportive care drugs, and antineoplastic dosing are helpful means of standardizing care, Dr Bergstrom suggested.
Other analytical tools provide the ability to track and manage costs, reimbursement, and profitability. With today’s narrow financial margins, Dr Bergstrom noted, making physicians aware that a particular chemotherapy regimen is “underwater” (ie, more expensive than the reimbursement given for it) in real time is essential. She recommended that practices regularly check their standardized regimens against the quarterly changed Medicare fee schedule to ensure continued profitability. Some of these chemotherapy management tools include ION Protocol Analyzer (www.iononline.com), McKesson’s Onmark Regimen Profiler (www.onmarkservices.com), and P4 PBIS eobONE (www.p4healthcare.com).
Having a clinical and cost conversation is essential in today’s environment, Dr Bergstrom emphasized. “If you can get your physicians together and talk about how to focus your approach to care for certain diagnoses, and really narrow the choices of regimen, you will improve quality across the team,” she said. “Because all of a sudden instead of every physician doing a slightly different version of CHOP or FOLFOX...everyone’s going to be singing from the same songbook. The nurses aren’t confused. Everyone is standardized. Your billers know what to bill: it’s the same thing over and over again.”
“Payers need consistency of care,” concluded Dr Bergstrom. “If they can predict what the costs of cancer care are, they will be able to set their premiums better.”
