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Cost of Cancer Care: Evaluating Financial Toxicity

Courtney C. Cavalieri, PharmD BCOP
Clinical Hematology/Oncology Pharmacist
Huntsman Cancer Institute at the University of Utah Salt Lake City, UT


It’s no secret: the cost of cancer care is rising. Over the last few years, a plethora of reports have surfaced examining the seemingly outrageous cost of new cancer therapies in relation to their effectiveness. A 2010 analysis estimated the national cost of cancer care will increase from $125 billion in 2010 to $158 billion in 2020.1   Why are expenses increasing? Reported contributing factors include an aging population with an increasing prevalence of cancer, the advent of new drugs and new techniques in radiation therapy and surgery, the increasing use of more expensive diagnostic techniques, and the availability of health care to a larger population.2,3

An oft-cited cost from “bench to bedside” for anticancer medications is $1 billion, which is too often used as justification for the high price of drugs.4 Unfortunately, the principle of “just price or fair price” does not apply to cancer medications, which are priced by their own market rules and do not follow the idiom of being priced at “what the market will bear.”5 The hope is that the price reflects the benefits and value of the treatment, as well as the cost of research and development. However, this not always the case. National headlines were made in 2012 when Bach and colleagues submitted an editorial in The New York Times that drew attention to the price of zivaflibercept, which was twice that of bevacizumab despite producing similar efficacy results in patients with metastatic colorectal cancer.6 Imatinib, a tyrosine kinase inhibitor (TKI), cost $30,000 per year in 2001 when it was approved for chronic myeloid leukemia, and had inflated to $80,000–$92,000 in 2012. This was even though newer TKIs have since been approved in imatinib-resistant disease and have even shown improvements in early surrogate end points when compared head-to-head with imatinib.4 So what actually determines the cost of a drug? The lead contributor may be reimbursement. The majority of cancer medications are dispensed within the confines of a physician’s office or ambulatory infusion clinic and are therefore covered by the patient’s medical benefits (versus pharmacy benefits). Manufacturers may competitively increase the prices of drugs to provide the dispensing physician a larger margin of financial benefit while ignoring the harmful effect on the patient’s financial situation.7Throughout the continuum of cancer treatment, patients undergo various procedures and systemic therapies. Numerous risks and adverse events of these treatments are well documented, but all these interventions share one toxicity in common that has gained a new official name: “financial toxicity.” Doctors Yousuf Zafar and Amy Abernethy highlighted the life-altering effect of financial toxicity in a two-part series published in the journal Oncology describing one patient and her family.3,8 The 67-year-old breast cancer patient, nicknamed “Janet,” admitted to her physician that her family doesnt travel anymore, nor do they do anything” due to her “$100,000 illness.” “It sucks,” she admitted, “but what are you going to do?” 3 Patients who are uninsured may trigger concerns about cost at the forefront of their care. However, with increasing medical expenses across the board, even patients with adequate insurance are feeling the sting of medical debt. Third-party payers have shifted costs to patients, increasing their out-of-pocket costs. Not only have we seen more high-deductible plans, but insurance premiums have also had a huge impact on patients’ bank accounts. Between 1999 and 2011, premiums in- creased 170%, while worker earnings increased only 50%.3

Cancer patients have an especially daunting problem. Nationally, 9.7% of adults with chronic conditions report a high objective financial burden. This is compared to 13% of cancer patients in the same age range.3 Cancer care is one of the fastest growing components of U.S. healthcare costs, and patients are feeling the growing pains. Patients who experience high out- of-pocket costs report reduced spending on food and clothing, poor adherence to costly medications, and avoidance of recommended procedures and appointments.2 It has unfortunately been accepted as “the norm” by many patients, cancelling vacations, using life savings, and working overtime just to pay for their treatments.3 Out of a surveyed group of insured patients applying for financial assistance, 68% reported they cut back on leisure activities, 46% reduced spending on food and clothes, 46% used their savings, and 17% sold possessions or property just to pay for cancer-related costs. 9

So, what can be done about this? The first step has already been taken. Transitioning cancer cost from the elephant in the room to a public conversation has already had an effect. Within a week of Bach and colleagues’ New York Times editorial, the manufacturer of zivaflibercept reduced the price by half.4 Last year, 60 Minutes aired a special on the cost of cancer drugs in which the term “financial toxicity” was broadcast to the masses. In the special, Leonard Saltz, MD, blamed pharmaceutical companies for taking advantage of people’s fear and anxiety about their cancer diagnosis. Hagop Kantarjian, MD, very bluntly admitted, “The only drug that works is a drug that the patient can afford.” 10  Dr. Saltz has continued his quest to draw attention to the unsustainable costs of cancer care. This year, in the plenary session at the American Society of Clinical Oncology (ASCO) annual meeting, he highlighted concerns with the new immunotherapy drugs reporting annual costs potentially reaching $1 million per patient.11

There are a variety of factors that allow this extraordinary cost of medications. One of the biggest barriers is the prohibition of the Centers for Medicare and Medicaid Services (CMS) to negotiate the price of drugs coming to market, which Dr. Saltz addressed as a start to the high-cost solution. Another barrier that needs to be ameliorated is the allowance of pharmaceutical companies to pay fees to delay the introduction of competing generics.12 Dr. Saltz also reinforced that the U.S. Food and Drug Administration (FDA) should be allowed to consider price in the approval process as other nations do.11  The United Kingdom’s National Institute for Health and Care Excellence has a formalized process involving clinical and econometric analyses to determine the value of a new therapeutic option. Canada, Australia, France, and Germany all have similar processes that consider efficacy, toxicity, and cost in the context of disease prevalence, medical need, and prevailing alternatives. Despite the United States far exceeding these other countries in healthcare spending, improvements in health outcomes have failed to match that growth. Adults in the United States, more than any of these other countries, had access issues to health care because of treatment cost.13  Patients in the United States are paying two-three times more for the same drug than patients in Canada, Australia, and other European countries. 10 We are aware of the overarching issues that need to be addressed, but until they are, we have to focus on each individual patient. The question that needs to be answered first is: When is the appropriate time, if any, to talk about cost with patients? Cancer patients may be more sensitive to a discussion regarding cost in relation to value. Patients may be hesitant to broach the subject of cost on their own due to embarrassment about financial distress or inflated beliefs in benefit from therapy.8 If patients are not coming forward on their own, is there a way to identify patients who may be more susceptible to financial toxicity? Singling out patients by age, ethnicity, education level, income, or employment status will not necessarily identify all patients at risk. Insured patients may be falling under the radar of who we typically think will suffer from financial toxicity. Stump and colleagues reported almost half of insured cancer patients they surveyed report concerns about costs, and 22.3% report personal and family sacrifices just to pay for their cancer care.14   One recommendation is to monitor for financial toxicity the same way we would for any other toxicity from treatment: at each visit, patients would be screened for adverse events as they normally are, but with the inclusion of financial distress or concerns.8

The COST (comprehensive score for financial toxicity) measure was developed for exactly this purpose. The 11-item questionnaire assesses patients’ concerns about their current financial situation, future financial issues, and direct and indirect financial barriers. The final COST measure score can be used to assess the severity of an individual patient’s financial toxicity.15

ASCO formed the Task Force on the Cost of Cancer Care in 2007 to address how to help providers deliver the highest-quality care with- out compromising for cost. In 2013, the ASCO Board of Directors charged the Task Force to develop a system to compare relative clinical benefit, toxicity, and the cost of treatment in the medical oncology setting. This framework was published in June 2015. 2 This framework is guided by the core principles of the physician-patient relationship to ensure informed decision-making and to encourage the provider to be a good steward of healthcare resources. The task force defined value in cancer care by emphasizing clinical benefit (efficacy), toxicity (safety), and cost (efficiency). Value was then assessed using quality-adjusted life-years and incremental cost-effectiveness ratios. Two frameworks were then developed: one for advanced cancer and another for potentially curative cancer. In the advanced disease framework, clinical benefit is given a categorical score based on the fractional improvement in median overall survival (OS) when com- paring a new therapy with the standard-of-care therapy. If OS was not reported or assessed, progression-free survival (PFS) is used. If neither OS nor PFS is available, overall response rate (ORR) is used. In the curative framework, the hazard ratio (HR) between OS of the new and standard of care regimens is used. If the HR for OS is not available, then the HR for disease-free survival (DFS) is used. OS, PFS/ DFS, and ORR are all weighted differently, with OS being weighted the highest as it represents the most important component of the value assessment. In both frameworks, toxicity is given a categorical score (-20 to +20) based on the relative toxicity of the new therapy versus the standard of care. Bonus points can also be awarded for statistically significant improvement of cancer-related symptoms or improvement in treatment-free interval. Once the points are combined, it results in the net health benefit (NHB) score. Two types of cost estimates are included: drug acquisition cost and patient cost. The NHB is then compared to cost to facilitate the assessment of value. 2

There are weaknesses with these frameworks. First, their comparisons are extremely narrow in scope. They can only compare therapies within the context of the study and not to other regimens. Second, the information provided by these frameworks must be able to be presented in an understandable way to patients to ensure their participation in treatment-related decisions. 2 As the task force continues to strengthen these frameworks for general use, they are still useful conversation-starters about the value of care.

Pharmacists are primed to help patients handle financial toxicity—not only on an individual basis, but also as a whole organization. Kantarjian and colleagues recommended that professional societies representing cancer specialists should reduce the hype around new antineoplastics that have no major effects on patient outcomes. 5 Pharmacists can provide information through pharmacy technicians specifically trained to handle prior authorization requests and well-versed in the various patient assistance programs. Pharmacy technicians specially dedicated to these programs can greatly reduce the stress on patients who may not be familiar with the particular avenues available. When a patient is set to start a new, possibly cost-prohibitive treatment, the pharmacy technician would be immediately involved to search out and summarize the financial assistance programs for which the patient may be eligible.

Pharmacists can also be more involved with economic analyses re- search. This is especially impactful to show how cost affects patient adherence, and therefore outcomes. If the discussion of cost is brought to the forefront of prescribing, pharmacists and prescribers can have open conversations about what is in the patient’s best inter- est. This may not always be appropriate when considering chemotherapy. However, when discussing supportive care options, there may be a variety of medications to choose from that are similar in effectiveness yet vastly different in cost.

The evaluation of cost in relation to benefit is not a new concept. Aristotle was the first to examine cost in relation to worth in the Nicomachean Ethics. More than 2,000 years later, we are still striving for Aristotle’s justum pretium: the just price. Determining the just price for cancer care is a conflict the oncology community is not quite prepared to handle. However, the first steps towards curing financial toxicity are being taken with increased conversation and development of cost- conscious practice guidelines.

 

References

1.     Mariotto AB, Yabroff KR, Shao Y, et al. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst2011;103:117-128.

2.     Schnipper LE, Davidson NE, Wollins DS, et al. American Society of Clinical Oncology Statement: A conceptual framework to assess the value of cancer treatment options. J Clin Oncol.2015;33(23):2563-2577.

3.      Zafar SY, Abernathy AP. Financial Toxicity, part I: A new name for a growing problem. Oncology. (Williston Park). 2013;27(2):80-81.

4.     Kantarjian H, Fojo T, Mathisen M, et al. Cancer drugs in the United States: Justum Pretium—The just price. J Clin Oncol.

2013;31:3600-3604.

5.     Kantarjian H, Steensma D, Sanjuan JR, et al. High cancer drug prices in the United States: Reasons and proposed solutions.

J Oncol Pract. 2014;10:e208-211.

6.     Bach P, Saltz L, Wittes R. In cancer care, cost matters. New York Times, October 15, 2012:A25.

7.      Danzon PM, Taylor E. Drug pricing and value in oncology. The Oncologist. 2010;15 (Suppl) 1:24-31.

8.     Zafar SY, Abernethy AP. Financial Toxicity, part II: How can we help with the burden of treatment-related costs? Oncology.

2013;27(4):253-254.

9.      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. The Oncologist. 2013;18:381-390.

10.   The cost of cancer drugs. "60 Minutes." CBS television. October 5, 2014.

11.    Saltz L. Perspectives on value. Presented at: Annual Meeting of the American Society of Clinical Oncology; May 31, 2015; Chicago, IL..

12.   Pfister DG. Cost of cancer care: Oncologists need to be part of the solution. J Clin Oncol. 2013;31:3487-3489.

13.    Commonwealth Fund Commission on a high performance health system: Why not the best? Results from the National Scorecard on US Health System Performance. 2011. Available at: http:// www.commonwealthfund.org/~/media/files/publications/fund- report/2011/oct/1500_wntb_natl_scorecard_2011_web_v2.pdf. Accessed July 2015.

14.   Stump TK, Eghan N, Egleston BL, et al. Cost concerns of patients with cancer. J Oncol Pract. 2013;9:251-257.

15.   de Souza JA, Yap BJ, Hlubocky FJ, et al. The development of a financial toxicity patient-reported outcome in cancer. The COST measure. Cancer. 2014;120:3245-3253.


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