IS IT POSSIBLE to identify patients with cancer who are at risk for financial stress and intervene to reduce that risk? And could reducing financial stress—or financial toxicity, as it is often called in the context of cancer care—improve both health-related quality of life and physical health? Evidence suggests the answers to both questions are yes, according to speakers in a plenary session on this issue at the 2017 Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology (MASCC/ISOO) Annual Meeting in Washington, DC.
High costs are a special area of concern for MASCC and its members, who now add financial toxicity to other side effects of treatment that may have an impact on their patients’ outcomes. In observational studies, financial stress has been associated with nonadherence to therapy, including partially filled prescriptions and skipping or abandoning treatments, according to the National Cancer Institute’s PDQ document on Financial Toxicity and Cancer Treatment.1
“Getting control of and managing financial toxicity will improve the health outcomes of patients.”— Pricivel Carrera, LLM, PhD
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“Getting control of and managing financial toxicity will improve the health outcomes of patients,” said Pricivel Carrera, LLM, PhD, of the University of Twente, Enschede, Netherlands, speaking on “The Financial Hazard of Personalized Medicine and Supportive Care.” In countries with universal coverage of health care, the very high cost of specialty drugs is an urgent issue. This is being discussed not just across hospital boardrooms but at the health system level given the challenge of ensuring patient access to innovative drugs, on the one hand, and the budget impact of protecting patients from the financial burden of treatment on the other hand, she said.
Speakers at the MASCC/ISOO meeting addressed two current approaches to financial toxicity—the development of value-based decision-making tools for the clinic and research on the risks, prevalence, and impact of financial toxicity.
THE FIRST of the value-based decision-making tools were launched in 2015 with the goal of helping patients and doctors compare the benefits, side effects, and costs of different treatment options. Ronan J. Kelly, MBA, MD, of Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, described some of the new tools, which made their debut in 2015.
They include ASCO’s Value Framework, which uses data from randomized clinical trials to calculate a numeric net health benefit based on survival data and toxicities; and the National Comprehensive Cancer Network®’s NCCN Evidence Blocks®, which rate systemic therapies on efficacy, safety, quality, and quantity of evidence; consistency of evidence; and cost.
Other emerging tools include the European Society for Medical Oncology’s Magnitude of Clinical Benefit Scale, which is applied prospectively to new cancer drugs approved by the European Medicines Agency. In the United States, the Institute for Clinical and Economic Review has developed a tool that assigns a care value to new drugs approved by the U.S. Food and Drug Administration (FDA); the care value reflects clinical benefit plus cost-effectiveness as well as a health system value, showing how the drug may affect the overall health system.
“We cannot continue to accept novel therapies with very small benefits at exorbitant prices.”— Ronan J. Kelly, MBA, MD
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These and other value-based decision-making tools continue to be developed, Dr. Kelly said. At the same time, Medicare’s new Quality Payment Program will be going into effect, increasing the overall emphasis on value in the U.S. health-care system. “We cannot continue to accept novel therapies with very small benefits at exorbitant prices,” he said.
Researching Risk Factors …
THE SECOND, and related, approach to financial toxicity has come from researchers who want to learn more about its causes and consequences and how to mitigate its effects.
One aim has been to identify and quantify the risk factors and outcomes associated with financial toxicity. A tool, the Comprehensive Score for Financial Toxicity (COST), has been developed to measure a patient’s risk for financial stress. The COST questionnaire includes 11 brief statements about financial costs, resources, and concerns. For each question, patients are asked to circle one of five possible responses that helped determine their level of concern.
Jonas de Souza, MD, MBA
A validation study, published in Cancer,2 showed that the scores correlated directly with income, psychological distress, race, employment status, and number of inpatient admissions, said Jonas de Souza, MD, MBA, a head and neck cancer specialist and health services researcher at the University of Chicago Medicine, who led development of the Comprehensive Score for Financial Toxicity tool. Speaking at the MASCC/ISOO meeting, he noted that financial distress was also linked directly to health-related quality of life, an important finding because it established the Comprehensive Score for Financial Toxicity as a clinically relevant patient-reported outcome.
Another study, published recently in JAMA Oncology,3 has shed more light on which patients are at higher risk of financial toxicity. Amol K. Narang, MD, and Lauren Hersch Nicholas, PhD, at Johns Hopkins, used national data from 1,409 patients with cancer eligible for Medicare who were surveyed by the Health and Retirement Study between 2002 and 2012. The authors found that the patients’ mean annual out-of-pocket spending was $3,737, and their financial burden amounted to 11.4% of household income. Medicare beneficiaries with no supplemental insurance had a mean out-of-pocket expense that was 23.7% of household income, and for 10% of that group, the out-of-pocket figure was 63.1%.
Rena M. Conti, PhD
“These results suggest that physicians and policymakers should be particularly concerned about financial toxicity among Medicare beneficiaries without supplemental insurance or underinsured,” say Dr. de Souza and Rena M. Conti, PhD, in an accompanying commentary.
… And Interventions
THEIR COMMENTARY also outlined three priority areas for future research aimed at helping to formulate interventions to address financial toxicity.
One recommendation is to learn more about which components of care induce financial distress and for which patients. While the high costs of targeted drugs are often mentioned in association with financial toxicity, nonpharmaceutical components of care may also play a role. The COST verification study, for instance, found high financial distress among patients who had three or more hospital admissions in a given year.
“It is imperative that our health-care system ensures patients access to the promise of dramatically improved quality of life without bankrupting their ability to pay for life’s other necessities or exacerbating national disparities in health and wealth.”— Jonas De Souza, MD, MBA, and Rena M. Conti, PhD
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A second priority is to gain an understanding of the types and sources of charitable aid already being provided to cancer patients. And a third is to study financial distress in association with the organizational context in which cancer treatment is provided. For example, the use of outpatient hospital treatment vs community-based treatment may make a difference in cost.
A potential use of the Comprehensive Score for Financial Toxicity tool, Dr. de Souza said, is to measure the impact of interventions aimed at reducing financial toxicity. Another is in the FDA-required postmarketing assessment of new drugs.
“It is imperative,” he and Dr. Conti wrote in their commentary, “that our health-care system ensures patients access to the promise of dramatically improved quality of life without bankrupting their ability to pay for life’s other necessities or exacerbating national disparities in health and wealth.” ■
DISCLOSURE: Drs. Carrera, Kelly, de Souza, Nicholas, and Conti reported no conflicts of interest.
1. National Cancer Institute: Financial Toxicity and Cancer Treatment (PDQ®)– Health Professional Version. Available at www.cancer.gov/about-cancer/ managing-care/financial-toxicity-hp-pdq. Accessed July 18, 2017.
2. De Souza JA, Yap BJ, Wroblewski K, et al: Measuring financial toxicity as a clinically relevant patients-reported outcome: The validation of the Comprehensive Score for Financial Toxicity (COST). Cancer 123:476-484, 2017.
3. Narang AK, Nicholas LH: Out-of-pocket spending and financial burden among Medicare beneficiaries with cancer. JAMA Oncology 3:757- 765, 2017.