Frequent, effective communication may minimize ‘financial toxicity’ of cancer treatments

Targeted therapies, immunotherapies and more advanced surgical procedures have dramatically improved cancer outcomes.

However, progress has come at a steep cost.

Cancer care expenditures in the United States are expected to reach $179 billion by 2020, a 39% increase from 2010. The average price of new drugs rose 10% per year from 1995 to 2013, and the cost of each additional year of life increased from $54,100 to $207,000 during that time, according to the National Bureau of Economic Research.

As oncology drug prices come under more intense scrutiny, troubling trends have emerged about the effects of escalating medical bills.

A staggering percentage of individuals who undergo cancer treatment report financial insolvency. Evidence suggests this can result in treatment nonadherence and poorer survival.

Photo by Shawn Rocco/Duke Health.

“I think of ‘financial toxicity’ as any financial harm experienced by patients as a result of cancer treatment,” Yousuf Zafar, MD, associate professor of medicine and public policy at Duke University School of Medicine and medical oncologist at Duke Cancer Institute, told HemOnc Today. “That can take many different forms. It can be a direct result of treatment costs, copays or coinsurance, or it can be more related to indirect costs, such as having to take time off work, find more child care or travel. Either way, there is a subset of patients who are at risk for experiencing this. When they do, they also are at risk for worsened outcomes.”

HemOnc Today spoke with clinicians and researchers about the increased burden of financial toxicity among patients with cancer; how costs impact their physical and emotional outcomes; and the extent to which oncologists should consider financial impact when formulating treatment plans.

Cost vs. affordability

The cost of cancer therapeutics and medicines used in supportive care — calculated at the ex-manufacturer level, before rebates and other price concessions — totaled $107 billion in 2015, an 11.5% increase from the year before.

Patients with commercial insurance plans who underwent active treatment for cancer paid an average of $58,000 in 2014, up 19% from 2013.

However, drug costs may not tell the entire story.

“We recognize too often patients struggle with affordable access to innovative treatments. [However], focusing solely on the list prices of medicines is misleading,” Holly Campbell, senior director of communications for the Pharmaceutical Research and Manufacturers of America, told HemOnc Today. “A new report from the IMS Institute found net prices for cancer medicines increased just 4.8% in 2015, as discounts and rebates negotiated by payers rose sharply.”

If discounts and rebates are rising, affordability — rather than price — becomes the greater concern.

At this year’s ASCO Annual Meeting, Goldstein and colleagues presented findings from a study that assessed both the price and affordability of cancer drugs in developed and undeveloped nations.

In the United States, median monthly prices were $8,694 for patented drugs and $645 for generic drugs. The median monthly price of generic drugs was 14% of gross domestic product per capita, whereas patented drugs were 192% of gross domestic product per capita.

The study did not account for one of the biggest factors in health costs — insurance.

“There is no doubt that the cost of the drugs that we use has gone up tremendously,” Lowell E. Schnipper, MD, chief of hematology/oncology at Beth Israel Medical Center, professor of medicine at Harvard Medical School and a HemOnc Today Editorial Board member, told HemOnc Today. “Because we are in a world of shared-cost insurance arrangements, the copay requirements are often exorbitant, particularly for middle-class patients.

“If you are exceedingly poor and have health care provided entirely, there probably is less of a burden, and if you are quite comfortable, the impact is not as enormous,” Schnipper added. “But for the people stuck in the middle of those two ends, the data are pretty secure that there is considerable financial duress, and that translates into emotional duress.”

Approximately 91% of the U.S. population is covered by some form of health insurance, according to CDC data. However, coverage adequacy remains a concern.

A survey conducted by The Kaiser Family Foundation, in collaboration with The New York Times, queried 1,371 adults aged 18 to 64 years about their ability to pay medical bills.

Twenty-six percent reported that they, or someone in their household, had difficulty paying medical bills within the prior 12 months. Twenty percent of those who reported these struggles were insured at the time. Of this subgroup, 75% said they could not afford copays, deductibles or coinsurance.

Difficulty paying medical bills appeared most prevalent for those with an annual household income below $50,000 (37%); however, it also was problematic for 26% of those with annual household incomes between $50,000 and $99,999, and 14% of those with incomes of $100,000 or more.

“Patients are struggling with affordable access because of a rapid rise in the number of health plans with high deductibles for medicines, which doubled in the last 3 years,” Campbell said.

The ability of insured patients to pay is particularly relevant to discussions about cancer drugs.

IV therapies are covered under the “medical benefit” component of insurance plans, whereas most oral anticancer medications that do not have an injectable equivalent are covered by prescription drug plans.

The discrepancy can lead to considerable costs for patients whose only option may be an oral medication.

Drug parity laws require group and individual private insurance plans to cover oral anticancer medications with the percent of cost-sharing that is “no less favorable than that provided by IV/injected chemotherapy.”

As of last year, 36 states and the District of Columbia had laws that address parity or cap out-of-pocket expenses for oral cancer medications. However, some states have loopholes that allow insurers to increase cost-sharing under medical plans so that cost-sharing for IV therapies matches that of oral drugs.

Cost-sharing contributes greatly to a person’s inability to pay medical bills. However, it may be difficult to enumerate a patient’s cost-sharing to screen them for their financial toxicity risk, Zafar said.

“Studies have suggested that risk for financial strain has very little to do with income, education or other sociodemographic variables,” he said. “It has a lot to do with the patient’s insurance and where they are in their deductible. That information can be found, but not easily and not in real time. We need to find better ways to integrate that type of information into the point of care.”

Financial sacrifices

Large copays and medical bills can have devastating consequences.

Whitney and colleagues surveyed 1,592 cancer survivors about the financial impact of their treatment. Results — presented at the Palliative Care Symposium in 2014 — showed 27% had at least one financial difficulty, such as debt, bankruptcy or worry about medical bills.

Thirty-seven percent of employed participants reported having to modify their work plans by changing to a flexible schedule, switching to a less demanding job, not taking a promotion, retiring early, delaying retirement, or taking extended or unpaid time off.

A study by Ramsey and colleagues — published in Health Affairs — showed patients with cancer were 2.65 times more likely to go bankrupt than people without cancer.

“The number of personal bankruptcies due to medical catastrophic illness is meaningful,” Schnipper said. “If you are unfortunate enough to get sick and are from middle-class or lower–middle-class economic situations, you may have very important decisions to make. We know people who stretch their prescription to every other day or every third day so they pay a $300 copay every 3 months rather than each month.”

Thomas Gregory Knight, MD, of University of North Carolina at Chapel Hill, and colleagues surveyed 1,992 patients with cancer. Results, presented at ASCO, showed 26% of respondents had more expensive medical care than they could afford.

This inability to pay affected their quality of care. Sizable percentages indicated they could not afford prescription medications (18%), mental health care (5.7%), dental visits (23%), doctors’ visits (11.5%), medical tests (6.3%) or over-the-counter medications (7.7%).

“You can prescribe the best drug in the world, but if patients can’t afford it and they can’t get it, then it won’t be effective,” Knight said in a press release.

In a study published in Journal of Clinical Oncology, Neugut and colleagues reported that copays ranging from $30 to $90 increased the odds of noncompliance among women who received adjuvant hormonal therapy for breast cancer.

Dusetzina and colleagues reported in Journal of Clinical Oncology that monthly copayments of $53 or more resulted in a 70% increased likelihood that patients with chronic myeloid leukemia would discontinue imatinib (Gleevec, Novartis) within the first 6 months.

Results like this suggest even relatively small budgetary changes can trigger nonadherence to potentially life-saving medication.

“I worry about patients not filling prescriptions due to cost — or worse, filling the prescription and paying thousands of dollars for it,” Zafar said.

Behavioral and psychosocial impact

The impact of financial distress from cancer treatment may extend beyond patients’ inability to pay. Research suggests these hardships impact quality of life — and outcomes — in profound ways.

“There are three ways in which financial toxicity impacts a patient’s life: material, behavioral and psychosocial,” Matthew P. Banegas, PhD, MPH, researcher at Kaiser Permanente Center for Health Research, told HemOnc Today. “By categorizing financial hardship into those three domains, we are hoping to show that financial hardship can mean different things.”

Material hardship includes aspects typically associated with financial difficulties, such as mounting debt or filing for bankruptcy, Banegas said.

Changes in spending habits due to material hardships — such as foregoing vacation or selling possessions to afford treatment — constitute behavioral hardships.

Data from the Kaiser Foundation/New York Times survey showed individuals who reported problems with medical bills were less likely to have a checking or savings account (78% vs. 90%); credit card (53% vs. 77%); 401(k) or retirement account (43% vs. 62%); or other types investments, such as stocks and bonds (17% vs. 38%).

Medical costs forced many with insurance to delay vacations or major household purchases (77%); spend less on food, clothing and basic household items (75%); use most or all their savings (63%); or take an extra job or work more hours (42%).

“Patients have large medical bills, and they are trying to figure out how they are going to make all of this work,” Banegas said. “This leads to incredible distress.”

Yabroff and colleagues surveyed 1,202 adult cancer survivors about financial hardships.

The results — published in Journal of Clinical Oncology — showed 20.4% reported borrowing money or going into debt, filing for bankruptcy, being unable to pay for care, or making financial sacrifices because of medical costs. Adjusted analyses showed younger survivors who were nonwhite, female or who experienced an employment change due to cancer were more likely to experience financial hardships.

“Some patients may have poor assets but a good support system, whereas other patients who are well-off but self-employed may run into trouble because they do not have employer-based health insurance,” Jonas de Souza, MD, MBA, assistant professor of medicine at University of Chicago Medicine, told HemOnc Today. “Every case will be different, and that is why it is so important to have a personalized approach.”

Financial strain also has been linked to psychosocial effects.

In an analysis published in Cancer, Kale and Carroll found financial distress negatively affected mental and physical quality-of-life measures. More than one-quarter (28.7%) of 19.6 million cancer survivors analyzed reported financial burden.

These survivors were more likely to experience depressed moods (OR = 1.95; 95% CI, 1.29-2.95) or psychological distress (OR = 1.75; 95% CI, 0.99-3.08). A greater proportion of survivors with financial burdens worried about cancer recurrence (69% vs. 35%) and how recurrence would affect their responsibilities at home or at work (70% vs. 38%).

“Financial burdens can be incredibly disruptive to patients’ lives and their well-being,” Zafar said. “We did a study where we found that high financial burden was associated with worse quality of life both in patients actively receiving treatment and survivors. This suggests that it’s a long-lasting effect, possibly due to some of the indirect costs, like taking time off work and lost savings.”

Thus, an assessment of patient-reported outcomes for financial strain should continue over the course of treatment.

“It is not a one-time assessment,” Zafar said. “Just like we would assess for nausea over the course of treatment, we need to asses financial strain throughout treatment, as that strain might change.”

Although collection of patient-reported outcomes related to financial distress has been inconsistent — particularly with regard to psychosocial consequences — harnessing these data can improve quality of care.

“Once we are able to collect and incorporate patient-reported data into cancer care, we may be able to provide more tailored cancer care for an individual,” Banegas said. “Let’s say we know someone is distressed — maybe we need to connect them with a social worker or patient navigator. We can start to alter their care to meet their needs.”

This is especially important as data emerge showing that financial toxicity may affect outcomes.

In a study published in Journal of Clinical Oncology, Ramsey and colleagues reported that filing for bankruptcy increased risk for mortality (HR = 1.79; 95% CI, 1.64-1.96). In disease-specific analysis, patients with prostate (HR = 2.07), colorectal (HR = 2.47), breast (HR = 1.48) or lung (HR = 1.55) cancers demonstrated notably greater mortality risks.

However, a clear association has not been established, Schnipper said.

“I would be cautious about quoting science that shows that people are dying more rapidly from financial toxicity,” Schnipper said. “I understand financial toxicity to be the inability to meet bills and deal with the illness without the added stress of going bankrupt or missing payments on other essential matters. I don’t use the term ‘financial toxicity’ as a conversion of an economic problem into a human health problem.”

Open discussions

Experts with whom HemOnc Today spoke cited the need for patients, providers, and government and industry officials to have open, honest discussions about costs.

There are two distinct categories of cost conversations, Zafar said.

“The first is to think about cost of cancer treatment to the health system, the national health expenditure and value of care from a societal perspective. That conversation often leads down a path of deciding whether treatment should be prescribed based on cost,” he said.

“The second cost conversation has to do with affordability,” he added. “In clinic, it is my primary concern to make sure my patient is receiving the best treatment and adhering to it. If we are not having an affordability discussion with our patients, they are at risk for financial side effects and, as a result, nonadherence. Not addressing affordability is counter to what we want, which is the best for our patients.”

Although macro-solutions to address patients’ financial burden — such as legislation and awareness advocacy — will take time to implement, this open communication between patients and their oncologists could pay immediate dividends.

Zafar and colleagues surveyed 300 patients receiving treatment for solid tumors. Results, published in American Journal of Managed Care, showed cost discussions helped minimize financial distress.

Fifty-two percent of respondents expressed a desire to discuss treatment-related cost with physicians. However, only 19% of patients reported having those conversations with their physician; of that subgroup, 57% reported lower out-of-pocket costs as a result.

“When patients talked to their oncologists, costs were reduced, but reductions were caused by a change in treatment in only a minority of cases,” Zafar said. “Seventy-five percent of costs were reduced when providers appealed to insurance companies or connected patients to financial assistance programs. The resources are out there. We just need to make those connections. It comes down to frequent and effective communication.”

However, a study by Hamel and colleagues showed cost discussions do not happen consistently.

Researchers analyzed video recordings of clinical interactions between 114 black individuals and 19 medical oncologists who met for the first time to discuss treatment.

Results, presented at this year’s Quality Care Symposium, showed 56% of these initial visits did not include cost discussions. When those discussions did take place, patients were more likely than oncologists to initiate them (61% vs. 38%). In 9% of cases, the oncologist acknowledged the patient’s initiation of cost discussions but did not address the subject.

Oncologists may not initiate the conversation because it is unlikely they know the cost of a given therapy, Zafar said.

“I don’t think the conversation is awkward for physicians,” he said. “I think oncologists feel uncomfortable speaking on matters about which they are uninformed.

“To know on that very day where the patient is in their deductible, how much coinsurance they have and how much will be covered by their insurance is, in many cases, nearly impossible,” he added. “Knowing the market price of any particular intervention is not very useful. The way to bring it up is to let them know that cancer treatment overall is expensive, and certain drugs might be particularly expensive.”

Before meeting with a patient, Zafar brings their insurance and prescription information to the Duke pharmacy so cost can be addressed immediately.

“I talk with the patient about potential treatment benefits and physical harm — which is what I would do anyway — and then the pharmacist comes into the room, says ‘This is how much it is going to cost’ and asks if it is feasible,” he said. “That way, we discuss the potential financial harm before the patient leaves clinic.”

Other strategies are being developed to help oncologists feel more comfortable broaching the subject.

de Souza and colleagues established PROM-COST, an 11-point metric that estimates a patient’s vulnerability to financial distress related to advanced cancer.

“We want to have a tool at the clinical level so oncologists can identify patients who might experience financial toxicity,” de Souza said. “We ought to talk about the impact of costs as a side effect, the same way we discuss hair loss or fatigue. As we learn more, we hope that someday we can tell patients that a certain percentage of patients have financial distress related to a particular therapy. It is something that we may need to discuss with a social worker or financial counselor to see if they are one of those patients and how we can help.”

Zafar and colleagues also are developing a web-based mobile app for patients that can screen patients for financial toxicity risk and alert providers about the results. The app also will connect patients with financial resources, coach patients about how to discuss costs and educate them on the variables of drug prices.

“These tools take the pressure off the oncologist to know everything,” Zafar said. “It’s important for the oncologist to be involved, but we should get our patients involved, as well. If we as oncologists think about this as an issue of affordability and adherence, and realize there are resources available, I think we would be much more willing to broach the subject.”

Addressing cost

The issue of cost goes beyond discussions between patients and physicians. Legislators, pharmaceutical manufacturers and insurance companies also play a role.

“With 500 biopharmaceutical companies vying to research and develop new medicines, the marketplace for cancer medicines is profoundly competitive,” Campbell said. “We need to concentrate on pragmatic proposals that increase competition, modernize the FDA, remove barriers that limit paying for value, and empower and engage consumers with information to make better informed health care decisions. There is a right way and a wrong way to find real solutions for America’s patients.”

ASCO recognized this complexity and created the Task Force on the Cost of Cancer Care in 2007 — renamed the Value in Cancer Care Task Force in 2013 — to evaluate the rising cost of care from the perspectives of all stakeholders and remove the taboo surrounding the cost discussion. The task force developed a framework to compare the relative clinical benefit, toxicity and cost of treatments in the medical oncology setting.

The society also launched Cancer.Net, a website designed to offer timely information that helps patients and their providers make informed care decisions.

“I think the culture is starting to change, with more doctors becoming familiar with this as an issue for their patients, and more patients feeling empowered to discuss this issue with their doctors,” Schnipper said. “These kinds of efforts — both patient and physician directed — are what we try to bring out in educational programs.”

The society is soliciting software engineers to develop a cost-assessment tool component of the value framework to provide individualized information directly to patients. This will incorporate clinical benefit, cost of care and insurance information.

“This way, patients will be able to compare treatment options and discuss them with their physicians,” Schnipper said. “If a newly approved immunotherapy doubles the survival, despite it being a very high personal cost, a patient might agree to the therapy. But, if it increases the probability of survival by only a few months, patients who have mortgage debt or college loans for their children — any usual expenses of living — at least deserve to know the impact this illness will have in the bigger picture.”

Greater transparency is another way to begin the transition from conversations to solutions.

“I strongly believe that — just as with any other side effect — once a drug is above a certain price point, and we can imagine that the cost-sharing to the patient is going to be high, there should be a label on the drug alerting patients that there may be financial toxicity related to cost,” de Souza said.

Only with greater transparency can patients make informed decisions, Banegas said.

“Unlike any other market, the price of our care is not transparent to us,” he said. “If we want to buy a TV, we can look at the different prices of TVs and their different features to make a decision about which is the best option. In health care, we can’t often do that. Patients need that information available to make a decision best in line with their personal preferences and social and financial capabilities.”

Broader solutions to improve cancer care affordability also are necessary.

“We could allow the government to negotiate prices with the pharmaceutical industry, like Canada, Europe and Australia do,” Zafar said. “Value-based insurance could decrease cost-sharing that patients experience. Also, pharmaceutical manufacturers clearly have a role, and they should work to price their products reasonably while, understandably, still turning a profit.”

de Souza and colleagues are building a database — to which patients can contribute at costofcancercare.org — to better understand the risk for financial toxicity across cancer subtypes, disease stage and treatment platforms.

Other large-scale solutions include improvement in cost-sharing insurance plans and legislative options. State drug parity laws aim to improve affordability of oral anticancer medication, but those laws only impact patients who are fully covered with private insurance.

ASCO and other oncology organizations have endorsed the Cancer Drug Coverage Parity Act of 2015 (SB1566; HR2739). The legislation would require no less favorable coverage for oral anticancer drugs compared with IV therapies at the national level.

“This is an issue we need to address as a society as a whole,” Banegas said. “If the goal is to improve our health and recover from this disease, it is going to take us as individual citizens to show that having to pay such a high price for these treatments is not sustainable. Hopefully that will resonate with our policymakers so they can put in place actions to address these issues.”

However, until such laws are passed, oncologists may have to make additional strides to ensure their patients can afford prescribed treatments.

“What can we do in clinic tomorrow to help our patients?” Zafar said. “We can ask simple questions — like, ‘Are you able to afford this treatment?’ — that can go a long way. We can understand that, as oncologists, we may not have a good idea of what a treatment can cost, but we can turn to people around us who do.” – by Nick Andrews

References:

de Souza JA, et al. Cancer. 2016;doi:10.1002/cncr.28814.

Dusetzina SB, et al. J Clin Oncol. 2014;doi:10.1200/JCO.2013.52.9123.

Hamel L, et al. The burden of medical debt: Results from the Kaiser Family/New York Times medical bills survey. Available at: kaiserfamilyfoundation.files.wordpress.com/2016/01/8806-the-burden-of-medical-debt-results-from-the-kaiser-family-foundation-new-york-times-medical-bills-survey.pdf. Accessed Aug. 25, 2016.

Hamel LM, et al. Abstract 178. Presented at: Quality Care Symposium; Feb. 26-27, 2016; Phoenix.

Howard DH, et al. Pricing in the market for anticancer drugs. National Bureau of Economic Research. Available at: www.nber.org/papers/w20867.pdf. Accessed Aug. 25, 2016.

IMS Health. Global Oncology Trend Report. A review of 2015 and outlook to 2020. Available at: www.imshealth.com/en/thought-leadership/ims-institute/reports/global-oncology-trend-report-a-review-of-2015-and-outlook-to-2020. Accessed Aug. 25, 2016.

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Neugut AI, et al. J Clin Oncol. 2011;doi:10.1200/JCO.2010.33.3179.

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Schnipper LE, et al. J Clin Oncol. 2016;doi:10.1200.JCO.2015.61.6706.

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The following were presented at: ASCO Annual Meeting; June 3-7, 2016; Chicago:

Goldstein DA, et al. Abstract 6500.

Knight TG, et al. Abstract 6624.

Paramanathan D, et al. Abstract 10065.

For more information:

Matthew P. Banegas, PhD, MPH, can be reached at matthew.p.banegas@kpchr.org.

Holly Campbell can be reached at hcampbell@phrma.org.

Jonas de Souza, MD, MBA, can be reached at jdesouza@bsd.uchicago.edu.

Lowell E. Schnipper, MD, can be reached at lschnipp@bidmc.harvard.edu.

John Sweetenham, MD, can be reached at john.sweetenham@hci.utah.edu.

Yousuf Zafar, MD, can be reached at yousuf.zafar@duke.edu.

Disclosure: Banegas, Campbell, de Souza, Schnipper, Sweetenham and Zafar report no relevant financial disclosures.

 

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