The FDA Could Help Address Financial Toxicity During the Approval Process

OncologyLive, Vol. 20/No. 18, Volume 29, Issue 18

Given the widespread financial impact the high cost of cancer drugs has on the healthcare system, it may be time for the FDA to take a broader approach when reviewing oncology drug applications. By also examining the cost of the drug, the FDA could shine a light on escalating drug costs and play a leadership role in creating new programs and initiatives that help patients pay for promising new therapies.

Cancer is among the costliest medical conditions to treat in the United States,1 causing many patients to experience “financial toxicity.” This term is often used to describe how out-of-pocket costs can cause financial distress to patients.

One of the major challenges with financial toxicity as it relates to any disease state, but especially to oncology, is the high cost of medication. Compared with other illnesses, cancer drug costs can be astronomical. For instance, a blood pressure medication may be available as a generic for as little as $35 to $60 a month, whereas individual oncology drugs and biologics often cost more than $10,000 a month.2

There are additional treatment expenses that patients must bear, such as labs, scans, management of adverse events, emergency department visits, and hospitalization. Logistic toxicity, which is the administrative burden of healthcare, is another. This includes travel time to the many appointments that could affect a patient’s ability to work.3 All of these factors contribute to the patient’s total cost of care, which is quite substantial with cancer and much greater than just the cost of the drugs alone.

Over the past 10 years, chemotherapy drugs and biologics have become increasingly expensive: Spending on cancer agents soared 43% from 2014 to 2018 (Figure 1).4 Meanwhile, the use of high-priced supportive agents and hematopoietic growth factors has become more prevalent.2 As commercial payers have been forced to help carry the burden of high drug costs, they have increased premiums, deductibles, and copayments, transferring more treatment costs to patients. Now, out-of-pocket expenses for a single cancer drug can be more than $20,000 to $30,000 per year, creating extreme financial and emotional distress that can impact outcomes. A recent analysis found that even for patients with Medicare Part D, which is intended to make prescription costs more affordable, out-ofpocket costs for individual specialty tier drugs can exceed $16,000.5,6

In another recent study, 32% of cancer survivors reported cancer-related financial problems, and 18.3% of those patients postponed recommended treatment due to costs.7 Additionally, patients with cancer are 2.65 times more likely to go bankrupt than people without cancer.2 Not surprisingly, severe financial distress that leads to bankruptcy after a cancer diagnosis appears to be a risk factor for mortality.

From a much broader perspective, the financial toxicity of cancer treatment—driven in large part by high drug costs—not only affects patients with cancer, but also the entire healthcare ecosystem. The steady upward march of overall costs has become unsustainable.

Given the widespread financial impact the high cost of cancer drugs has on the healthcare system, it may be time for the FDA to take a broader approach when reviewing oncology drug applications. By also examining the cost of the drug, the FDA could shine a light on escalating drug costs and play a leadership role in creating new programs and initiatives that help patients pay for promising new therapies.

There is also financial toxicity from the perspective of companies that offer insurance to employees. Partly because of the high cost of medications, employers have to pay more for their employee health plans, which in turn increases the amount employees must be charged for coverage.

Some Patients Get Help; Others Do Not

Funding programs are available through drug manufacturers to help patients with copays. Unfortunately, they are not available to patients who have government insurance, making it extremely challenging to secure resources for them. Consequently, if patients have Medicare, a Medicare Part D plan, Medicaid, or any other type of government-funded insurance, copay cards do not apply. However, there are other funds or grants that may be available to some patients through charitable foundations. Typically, any insurance beneficiary is eligible to apply, but grants are usually based on income. If a patient reaches a certain income level, they cannot receive assistance.

A Multilayered Approach for Drug Approvals is Needed

The investment in new oncology drugs has paid off handsomely, as 5-year cancer survival rates have improved by as much as 20% over the past 2 decades.5 Granted, cancer prevention programs and early detection have played a role in improving outcomes, but there is no denying that innovative new cancer drugs have transformed some terminal cancers into chronic diseases. As researchers learn more and better ways to employ these novel drugs, the knowledge base of how to defeat cancer grows substantially. The high cost of a promising drug should not inhibit its approval by the FDA, but it should trigger collaborative efforts by the FDA and other entities to help financially challenged patients secure funding to cover its cost.

Great progress could be made in reducing the financial toxicity patients with cancer face if the FDA added a second layer to the approval process that addressed cost. First, the drug would be approved based on the improved outcomes it provides; second, the cost of the drug would be examined. If the agent is very expensive and would add to the financial toxicity challenge that currently exists, the FDA should make this fact known. This would start a fruitful discussion about improving patient access.

The FDA Cannot Do It Alone

Because of its role in bringing drugs to market, the FDA can and should become a leader in helping to solve the financial toxicity crisis. By creating awareness about the high cost of a specific drug coming to market, the FDA can help ensure there is funding available so the new agent is affordable for patients. However, collaboration from many government agencies and private organizations will be required.

In its leadership role, the FDA should spearhead the conversation about the need for change. As it examines drug approvals from the “safe and effective” perspective, the FDA should broaden its discussion to include financial toxicity. The FDA could organize special committees from other government entities and outside organizations to examine how they can collaborate to help patients secure additional funding. Acting as the champion for affordable drug costs, the FDA may be able to influence patients’ ability to utilize copay cards for particular medications. To accomplish this, rules and regulations governing who can participate in financial assistance programs would have to change.

Addressing the Stigma Around Financial Need

Many patients are too embarrassed to let their physician know they cannot afford their care (Figure 2).7 We cannot help patients access financial resources if we do not know they are struggling. We need to acknowledge financial toxicity is real and that it can affect all patients who need expensive medications or treatments. As healthcare professionals, we need to remove the stigma around someone expressing a concern over treatment costs. By being more up front in our conversations with patients, right at the point of diagnosis, we can acknowledge that medications and treatments are going to be very expensive while also informing the patient there are resources available to help. It is important for patients with cancer to understand they do not have to manage the financial aspect of their treatment on their own.

The FDA Can Be An Agent of Change

The government is taking a serious look at the total cost of care, which is really where financial toxicity comes into play, rather than just drug costs. New valuebased programs are emerging designed to improve the quality of and access to care while reducing the total cost of care.

Given the new emphasis on costs and value-based delivery models, the time might be right for the FDA to broaden its approach to drug approvals. Although it is wonderful to have promising new drugs available, the ability to truly improve survivorship is lost if only a few patients can afford them. The FDA has an opportunity to exhibit leadership and change healthcare by looking at the affordability of new drugs as they are submitted for review. The agency is in the unique position to influence other arms of the government and industry to control costs, change policies that restrict assistance, and collaborate to provide financial resources for all patients in need. This would help ensure that all patients have equal access to the life-changing therapies coming to market.


  1. Soni A. Trends in the five most costly conditions among the U.S. civilian noninstitutionalized population, 2002 and 2012. Agency for Healthcare Research and Quality website. https:// Published April 2015. Accessed September 5, 2019.
  2. Financial toxicity and cancer treatment (PDQ)-health professional version. National Cancer Institute website. managing-care/track-care-costs/financial-toxicity-hp-pdq#_1. Updated August 2, 2019. Accessed September 3, 2019.
  3. Schattner E. Logistic toxicity, an unmeasured burden of healthcare. Forbes website. logistic-toxicity-an-unmeasured-burden-of-health-care-for-people- with-cancer-and-other-illness/#4baf7a62dfef. Published August 14, 2015. Accessed September 3, 2019.
  4. Global oncology trends 2019. IQVIA Institute for Human Data Science website. Published May 2019. Accessed July 16, 2019.
  5. Devoe CE. Strategies to address the unsustainable costs of cancer drugs in the US. Becker’s Hospital Review. beckershospitalreview. com/supply-chain/strategies-to-address-the-unsustainable- costs-of-cancer-drugs-in-the-us.html. Published June 23, 2017. Accessed September 3, 2019.
  6. Cubanski J, Koma W, Neuman T. The out-of-pocket cost burden for specialty drugs in Medicare Part D in 2019. KFF website. for-specialty-drugs-in-medicare-part-d-in-2019/. Published February 1, 2019. Accessed September 6, 2019.
  7. Kent EE, Forsythe LP, Yabroff KR, et al. Are survivors who report cancer-related financial problems more likely to forgo r delay medical care? Cancer. 2013;119(20):3710-7. doi: 10.1002/cncr.28262.