ASCO GU 2020: Financial Toxicity and Quality of Life: Understanding and Improving Patient Centered Outcomes in Genitourinary Malignancies

San Francisco, CA (UroToday.com) The Keynote Address is always a highly anticipated talk at GU ASCO, and this year Dr. David Penson from Vanderbilt University provided an overview of financial toxicity and quality of among oncology patients.

Dr. Penson started by highlighting the goals of any new treatment for cancer, as quoted from Dr. Ian Tannock: We want the patient to live longer and better, and in the end, what matters to patients is overall survival and quality of life. Defining quality of life is challenging as there are numerous definitions available in the literature but none that do a great job of capturing the concept. The National Cancer Institute’s definition of quality of life is “the overall enjoyment of life” – not exactly easy to measure. A relevant model to help define health-related quality of life is provided by Dr. Penson in the following figure:

ASCO GU 2020 health related quality of life model

The taxonomy of financial hardship in cancer is comprised of three arenas:

  1. Material conditions: for example, out-of-pocket expenses, missed work, reduced/lost income, and medical debt/bankruptcy
  2. Psychological response: for example, feeling of distress due to costs of cancer care, and concern about wages/income meeting expenses related to costs of cancer care
  3. Coping behaviors: for example, taking less of or skipping medication or delaying or missing a physician visit
Dr. Penson’s goals for his presentation are to (i) introduce the concept of financial toxicity in cancer therapy and make people aware of the negative impact this has on all patient-centered outcomes, and (ii) to review the financial toxicity of common GU malignancies. He hopes that we will be aware of the negative effects of financial toxicity of our therapies on quality of life and that this will generate a desire to start a discussion with our patients around the cost of treatment and a willingness to understand their non-clinical financial situation. Furthermore, he hopes we think twice before ordering costly interventions which may have little impact on the clinical course but large impact on the patient’s finances and quality of life.

The scope of the financial burden is that out-of-pocket costs are a side effect of medical care. In a study of data from the 2011 National Cancer for Health Statistics, Americans <65 years of age noted that 40-50% had financial burden from medical care, and was still 20-25% in those ≥65 years of age.1 Specific to financial toxicity of cancer survivors, data from the 2013-2016 National Health Interview Survey suggest that 16-27% of patients have problems paying their medical bills, 44-52% are worried about paying medical bills, and 9-14% delayed medical care secondary to financial worries. In Dr. Penson’s opinion, these data are only going to get worse.

When looking further at the median monthly out of pocket expenses, Dr. Penson highlighted a 2013 pilot study assessing the financial toxicity of cancer treatment.2 Among 254 participants, Zafar et al. conducted baseline and follow-up surveys regarding the impact of health care costs on well-being and treatment among cancer patients who contacted a national copayment assistance foundation along with a comparison sample of patients treated at an academic medical center. There were 75% of patients that applied for drug copayment assistance. Forty-two percent of participants reported a significant or catastrophic subjective financial burden, 68% cut back on leisure activities, 46% reduced spending on food and clothing, and 46% used savings to defray out-of-pocket expenses. Shockingly, to save money, 20% took less than the prescribed amount of medication, 19% partially filled prescriptions, and 24% avoided filling prescriptions altogether. Annual out-of-pocket costs do not fare much better. Among 1,409 Medicare beneficiaries (median age, 73 years [IQR 69-79 years]; 46.4% female and 53.6% male) diagnosed with cancer, the type of supplementary insurance was significantly associated with mean annual out-of-pocket costs incurred after cancer diagnosis:3 

  • $2116 among those insured by Medicaid
  • $2367 among those insured by the Veterans Health Administration
  • $5976 among those insured by a Medicare health maintenance organization
  • $5492 among those with employer-sponsored insurance
  • $5670 among those with Medigap insurance coverage
  • $8115 among those insured by traditional fee-for-service Medicare but without supplemental insurance coverage
For Medicare beneficiaries, the Affordable Care Act (ACA) will close the Part D coverage gap (doughnut hole), which will reduce cost-sharing from 100% in 2010 to 25% in 2020 for drug spending above $2,960 until the beneficiary reaches $4,700 in out-of-pocket spending. To assess this impact, Dusetzina and Keathing4 used the Medicare July 2014 Prescription Drug Plan Formulary, Pharmacy Network, and Pricing Information Files from the Centers for Medicare & Medicaid Services for 1,114 stand-alone and 2,230 Medicare Advantage prescription drug formularies. The average price per month for included medications was $10,060 (range, $5,123 to $16,093). In 2010, median beneficiary annual out-of-pocket costs for a typical treatment duration was $12,160 (IQR $12,102 to $12,262) for sunitinib. With the assumption that prices remain stable after the doughnut hole closes, beneficiaries will spend approximately $2,550 less. As such, out-of-pocket costs for Medicare beneficiaries taking orally administered anticancer medications are high and will remain so after the doughnut hole closes.

According to data from UNC Chapel Hill, financial toxicity is a possible cause of poor compliance. In a study of 134 bladder cancer patients, 33 (24%) endorsed financial toxicity (defined as “to pay more for medical care than you can afford”). Participants who were younger (p = 0.02), black (p = 0.01), reported less than a college degree (p = 0.01) and had noninvasive disease (p = 0.04) were more likely to report financial toxicity.5 Patients who endorsed financial toxicity were more likely to report delaying care (39% vs 23%, p = 0.07) due to the inability to take time off work or afford general expenses. Furthermore, those with financial toxicity reported worse physical and mental health (p = 0.03 and <0.01, respectively), and lower cancer-specific health-related quality of life (p = 0.01), physical well-being (p = 0.01) and functional well-being (p = 0.05). In a study looking at the impact of cancer on a patient’s net worth and debt, Gilligan et al.6 assessed 9.5 million estimated new diagnoses of cancer from 2000-2012. At two years after diagnosis, 42.4% depleted their entire life's assets, with higher adjusted odds associated with worsening cancer, requirement of continued treatment, demographic and socioeconomic factors (ie, female, Medicaid, uninsured, retired, increasing age, income, and household size), and clinical characteristics (ie, current smoker, worse self-reported health, hypertension, diabetes, lung disease). The average losses were $92,098. At four years past diagnosis, financial insolvency extended to 38.2%, with several consistent socioeconomic, cancer-related, and clinical characteristics remaining significant predictors of complete asset depletion.

Financial toxicity also affects general quality of life. Data from the 2011 Medical Expenditure Panel Survey suggested that among 19.6 million cancer survivors (1,329 patients completed the survey), 28.7% reported at least one financial problem.7 Furthermore, 7.6% borrowed money, 11.5% could not afford to cover the cost of medical care visits, and 20.9% worried about paying their medical bills. Financial toxicity is also associated with worse survival. Looking at data from the Western Washington SEER registry (1995-2009) linked to federal bankruptcy records, patients who filed for bankruptcy were more likely to be younger, female, and nonwhite, to have local- or regional- (vs distant-) stage disease at diagnosis, and have received treatment.8 After propensity score matching, 3,841 patients remained in each group (bankruptcy v no bankruptcy). The adjusted hazard ratio for mortality among patients with cancer who filed for bankruptcy versus those who did not was 1.79 (95% CI, 1.64-1.96). Hazard ratios varied by cancer type, including colorectal, prostate, and thyroid cancers with the highest hazard ratios. Importantly, excluding patients with distant-stage disease from the models did not have an effect on results.

According to Dr. Penson, we have an opportunity to communicate costs to our patients. Looking at the breast cancer literature, 2,293 members of the American Society of Breast Surgeons were surveyed, with a 25% response rate [9]. Shockingly, only 6% of providers included out-of-pocket costs among the top three most influential factors in clinical decision making. As follows is the reasons why providers were hesitant to discuss the impact of out-of-pocket cost:

ASCO GU 2020 impact of out of pocket cost table

Summarizing the financial toxicity among all cancer patients, Dr. Penson highlighted the following points:

  • The scope of the problem is greater than many providers appreciate
  • Patients cope by avoiding necessary care to save money, and/or going into debt
  • Financial toxicity has a negative impact on other clinical outcomes
  • Cost communication is not routinely part of the doctor-patient interaction
  • We need to start by acknowledging the problem, learning more about costs so we can inform our patients, begin a discussion of financial toxicity with patients, and include financial toxicity as a potential adverse event in future studies and in shared decision-making discussions.
Dr. Penson then discussed the highlighted each of prostate, bladder and kidney cancer and the impact of financial toxicity, starting with prostate cancer. A study from 2010 assessed out-of-pocket costs among 512 patients newly diagnosed with prostate cancer and undergoing either radical prostatectomy or radiation therapy.10 Participants completed self-reported generic and prostate-specific HRQoL and indirect-cost surveys at baseline and at 3, 6, 12, and 24 months follow-up. Total mean out-of-pocket costs varied between radical prostatectomy and EBRT groups at 3-month ($5576 vs. $2010), 6-month ($1776 vs. $2133), 12-month ($757 vs. $774), and at 24-month follow-up ($458 vs. $871). Linear mixed models indicated that radical prostatectomy was associated with lower medication costs (OR 0.61, CI 0.48-0.89) and total out-of-pocket costs (OR 0.71, CI 0.64-0.92). Prostate-specific HRQoL items of urinary function (OR 0.72; adjusted-CI = 0.58-0.84), bowel function (OR 0.96; adjusted-CI = 0.78-0.98), sexual function (OR 0.85; adjusted-CI = 0.72-0.92), urinary bother (OR 0.79; adjusted-CI = 0.67-0.83), and sexual bother (OR 0.88; adjusted-CI = 0.76-0.93) were inversely related to out-of-pocket costs. Surgical approach may be a way to temper cost, as robotic prostatectomy has been associated with a $138 decreased out of pocket cost to the patient compared to open radical prostatectomy. Importantly, this is not a problem among prostate cancer patients unique to the United States: both Australia and Canada have reported financial toxicity among prostate cancer patients.

Indeed, bladder cancer is an expensive disease to treat, with an annual cost of nearly $4 billion per year, however little is known about the financial toxicity among bladder cancer patients. As mentioned earlier in the talk, the UNC study5 showed that 24% of patients endorsed financial toxicity (defined as “to pay more for medical care than you can afford”). Participants who were younger (p = 0.02), black (p = 0.01), reported less than a college degree (p = 0.01) and had noninvasive disease (p = 0.04) were more likely to report financial toxicity. Beyond this one study, Dr. Penson notes that there are no other studies assessing financial toxicity in this expensive, complex, morbid disease.

According to Dr. Penson, kidney cancer financial toxicity is all about the drugs. Over the past two decades, there has been an explosion of new therapies for renal cell carcinoma. These drugs have inherently changed the way we approach the disease and have resulted in benefits in terms of prolonging survival. These agents, however, are quite costly with annual wholesale costs of these agents ranging from $75,000 to $200,000 per year. The risk of financial toxicity in this setting is considerable and often not considered in medical decision making. While other components in healthcare will contribute to financial toxicity, Dr. Penson believes that the drugs are the key drivers here. A study from 2015 assessed the associated costs for mRCC in the US using the LifeLink Health Plan Claims Database.11 A total of 1,527 mRCC patients were analyzed; in 2010, nine unique treatment regimens were used for first-line treatment, 8 for second-line treatment, and 8 for third-line treatment. For 767 patients receiving modern therapy who were < 65 years old, and stratifying by whether the first-line treatment was oral or intravenous, drug cost per patient with ancillary services was $59,664 versus $86,518, respectively (p = 0.001). Total costs and drug out-of-pocket costs per patient during the first year increased by the number of medication switches: $111,680 to $2355 for no switches, $149,994 to $2538 for 1 switch, and $196,706 to $3524 for 2 or more switches. Impressively, in 2004 the median drug cost was $11,458, while by 2010 it rose to $68,660.

Dr. Penson concluded this talk on financial toxicity with the following summary points:

  • Financial toxicity should be considered an adverse event of therapy, similar to other side effects of treatment
  • This patient-centered endpoint can have a profound effect on our patient’s quality of life and daily existence
  • While perhaps not completely avoidable, financial toxicity and its effect on our patients must be minimized
How can we help minimize financial toxicity?

  • Discuss it upfront with our patients, creating an environment where it is acceptable to talk about it. If you don’t know the specifics, identify someone in your institution that dose
  • Treat financial toxicity as another possible side effect when undertaking shared-decision making
  • Think about the financial impact on the patient before you – do not order discretionary testing or follow-ups that may not change management, and do not initiate therapies that may have little or no proven clinical benefit to the patient
  • Consider the cost to the patient when choosing medical therapy for GU cancers

Presented by: David Penson, MD, MPH, Vanderbilt University, Nashville, Tennessee 

Written By: Zachary Klaassen, MD, MSc – Assistant Professor of Urology, Georgia Cancer Center, Augusta University/Medical College of Georgia @zklaassen_md at the 2020 Genitourinary Cancers Symposium, ASCO GU #GU20, February 13-15, 2020, San Francisco, California

References:

1. Ubel PA, Abernethy AP, Zafar SY. Full disclosure—out-of-pocket costs as side effects. N Engl J Med 2013 Oct 17;369(16):1484-1486.
2. Zafar SY, Peppercorn JM, Schrag D, et al. The financial toxicity of cancer treatment: A pilot study assessing out-of-pocket expenses and the insured cancer patient’s experience. Oncologist 2013;18(4):381-390.
3. Narang AK, Nicholas LH. Out-of-pocket Spending and Financial Burden Among Medicare Beneficiaries with Cancer. JAMA Oncol 2017 Jun 1;3(6):757-765.
4. Dusetzina SB, Keating NL. Mind the Gap: Why Closing the Doughnut Hole is Insufficient for Increasing Medicare Beneficiary Access to Oral Chemotherapy. J Clin Oncol 2016 Feb 1;34(4):375-380.
5. Casilla-Lennon MM, Choi SK, Deal AM, et al. Financial toxicity among patients with bladder cancer: Reasons for Delay in Care and Effect on Quality of Life. J Urol 2018 May;199(5):1166-1173.
6. Gilligan AM, Alberts DS, Roe DJ, et al. Death or Debt? National Estimates of Financial Toxicity in Persons with Newly-Diagnosed Cancer. Am J Med 2018 Oct;131(10):1187-1199.
7. Kale HP, Carroll NV. Self-reported financial burden of cancer care and its effect on physical and mental health-related quality of life among US cancer survivors. Cancer 2016 Apr 15;122(8):283-289.
8. Ramsey SD, Bansal A, Fedorenko CR, et al. Financial Insolvency as a Risk Factor for Early Mortality Among Patients with Cancer. J Clin Oncol 2016 Mar 20;34(9): 980-986.
9. Greenup RA, Rushing CN, Fish LJ, et al. Perspectives on the costs of cancer care: A Survey of the American Society of Breast Surgeons. Ann Surg Oncol 2019 Oct;26(10):3141-3151.
10. Jayadevappa R, Schwartz JS, Chhatre S, et al. The burden of out-of-pocket and indirect costs of prostate cancer. Prostate 2010 Aug;70(11):1255-1264.
11. Geynisman DM, Hu JC, Liu L, et al. Treatment patterns and costs for metastatic renal cell carcinoma patients with private insurance. Clin Genitourin Cancer 2015 Apr;13(2):e93-100.

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Watch: Financial Toxicity and Quality of Life: Understanding and Improving Patient-Centered Outcomes in Genitourinary Malignancies - David Penson