During the Health Services Research and Quality of Care session on the second day of the annual meeting of the American Society of Clinical Oncology, being held at the McCormick Convention Center, Chicago, oncologists discussed barriers to patient participation in cancer clinical trials, and discussed attributes of the high cost of care.
During the Health Services Research and Quality of Care session on the second day of the annual meeting of the American Society of Clinical Oncology, being held at the McCormick Convention Center, Chicago, May 29-June 2, 2015, Ryan David Nipp, MD, clinical fellow in medicine at the Dana-Farber Cancer Institute, presented results from their study evaluating the impact of an equity program intervention on the financial burden of cancer patients participating in clinical trials. Additionally, they evaluated patient barriers to clinical trial participation.
“Cancer care is a big financial burden on patients,” said Dr Nipp, adding “clinical trial participants are uniquely susceptible to this financial toxicity.”
For this study, the Cancer Care Equity Program (CCEP) at the Massachusetts General Hospital—implemented in 2014—partnered with the Lazarex Cancer Foundation to achieve the goals of community outreach, patient navigation, and financial assistance said Dr Nipp. The objective of the study presented was to fund non-clinical expenses related to clinical trial (CT) participation, such as lodging, travel, etc. “To determine the impact of the CCEP on CT enrollment, we compared CT enrollment in 2014 (after initiating the CCEP) to 2012 and 2013, and financial barriers were assessed through patient surveys,” he said.
Patients enrolled in or being screened for a CT were referred to CCEP by their cancer care team. These referrals, he showed, came from oncology provider, nurse, social worker, or physician who determine a patient’s eligibility for financial assistance. Non-clinical expenses, said Dr Nipp, include travel costs, parking, etc. He then showed a table of the demographic characteristics of the patients who had participated in the trial; there was a higher proportion of patients with commercial insurance in 2014 compared with 2012 and 2013 combined, likely a result of Medicare expansion in the state.
The results showed that trial enrollment in 2014 was significantly greater than in the previous years—17% more than in 2012 and 40% greater than in 2014. Importantly, a greater number of minority patients enrolled in the trial in 2014; additionally, enrollment of low-income populations as well as those who had to travel >50 miles from MGH, increased in 2014. Additionally, CCEP patients were primarily female, <65 years old, had metastatic disease, and had enrolled in phase 1 CTs.
Compared with non-CCEP patients, a higher number of CCEP patients were concerned with medical costs, travel, lodging, and insurance coverage, all associated with CT participation.
Dr Nipp concluded that cost of clinical trial participation is a major concern among cancer trial participants and that the CCEP had a significant impact on improving participation. Future studies, he said, would address financial burdens of the participants, develop tools to identify those needing financial aid, and encourage stakeholders to support efforts to remove financial barriers to trial participation.
Commenting on the study, Ann Partridge, MD, MPH, a medical oncologist at Dana-Farber Cancer Institute, who moderated the session, said that although demographics did not vary much across the years being compared, the researchers had managed to hit the target. “We need to understand, though, how much the reimbursement helped patients decide on trial participation. What’s the denominator—how many patients qualified for the trial but did not participate for financial reasons and were missed.” It’s essential, she pointed out, that all the stakeholders involved with providing cancer care need to come together. “As we try to improve cancer care and reduce disparities, a robust evaluation of our efforts is necessary,” Dr Patridge concluded.
Another talk in the session, “How should we estimate costs of care attributable to cancer?” was presented by Aileen B. Chen, MD, assistant professor of radiation oncology at the Dana-Farber Cancer Institute.
Indicating that the cost of cancer care touched $100 billion in 2010-2011, Dr Chen said it accounted for >5% of healthcare spending
“However, the question is how do you accurately estimate these costs?” she asked. Not all of this spending is directly associated with cancer and there are no standardized methods. She introduced several approaches that were used in their analysis:
The study, she said, used SEER-Medicare data, and they calculated mean Medicare spending from 1 month prior until 11 months following diagnosis among patients >66 years of age, diagnosed with lung, breast, prostate, and colorectal cancers from 2007-2009.
Cancer-attributable costs, she showed, were highest for all patients when using their own pre-diagnosis costs as comparison. Cancer-attributable costs were higher among breast and prostate, but were lower among lung and colorectal patients, when using non-cancer controls, and matching by comorbidity in addition to demographic characteristics.
She pointed to a few study limitations, including the fact that their data were limited to Medicare patients with 4 most common cancers. Additionally, she pointed to the need for using more sophisticated modeling techniques.
Dr Chen concluded that calculating cancer-attributable costs is important to understand what we are spending on cancer. She acknowledged that the choice of comparison groups substantially influences the proportion of total medical costs attributed to cancer, and in their study, the highest variation was observed for prostate cancer.
“Choice of reference group should be clearly delineated in the analyses of cost and value,” said Dr Chen.