According to the lead study investigator, work needs to be done to ensure financial toxicity is not a deterrent to clinical trial enrollment and that trial sponsors and payers should consider trial expense reimbursement.

Clinical trials have additional visits and costs compared to the standard of care, Dr. Ryan W. Huey, an assistant professor in the department of gastrointestinal medical oncology at The University of Texas MD Anderson Cancer Center in Houston, said during a pre-recorded presentation of the data. And while financial toxicity has been well described for patients with cancer, it is less well established for patients who enroll in clinical trials.

To evaluate financial toxicity, which is the direct and indirect impact of health care costs that lead to significant financial burden, and out of-of-pocket costs for patients with cancer enrolled in early phase clinical trials, Huey and colleagues surveyed patients who were on a trial for more than a month. The goal, Huey said during the presentation, was to talk to patients who accurately understood what their monthly expenses were while on their respective trial.

The researchers collected data regarding patient demographics, including, but not limited to, patient and disease characteristics, as well as insurance status.

Using the 12-question COmprehensive Score for Financial Toxicity (COST)Functional Assessment of Chronic Illness Therapy (FACIT) survey, the researchers assessed the financial toxicity that 213 patients (with a median age of 59 years) in early-phase clinical trials experienced. More than half of the trial participants surveyed were female (59%) and more than three-fourths (79%) were non-Hispanic white. Other characteristics patients were grouped by included yearly household income, type of insurance, employment status and length of time spent on current trial.

More than half of the participants (55%) had employer-provided insurance, 38% had Medicare, 11% had personally purchased insurance and the remaining participants had either Medicaid (2%), VA-provided insurance (4%), personally purchased supplemental insurance (9%) or other (1%).

Forty percent of the patients were employed either full- or part-time, while 37% were retired and 15% were unemployed.

Half of the participants traveled more than 300 miles to receive their cancer care. The other half either traveled less than 100 miles (23%) for their cancer care or traveled 101 to 300 miles (27%).

Thirty percent of the participants were either fully (6%) or partially (24%) reimbursed for their travel.

Out-of-pocket, patients spent a median of $1,075 a month on non-medical expenses. Expenses attributed to medical costs accounted for $475 out-of-pocket per month. The survey demonstrated that more than half (55%) of patients felt that their expenses attributed to medical costs were higher than expected. Sixty-four percent of patients also reported that they felt their non-medical expenses were higher than expected.

Factors associated with a worse financial burden included an annual household income of less than $60,000, participating on at least one previous phase 1 clinical trial and living more than 100 miles away from the clinical trial site.

Huey concluded his presentation noting that the economic burden patients participating on clinical trials experience is high, and that most of the costs are related to nonmedical expenses.

Financial toxicity disproportionately affects patients with lower income and those who travel far to receive their care, he said. And costs are often higher than expected. Work needs to be done to ensure this financial toxicity is not a deterrent to enrollment. And sponsors and payers should consider the role of trial expense reimbursement.

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