Financial Toxicity: The Elephant in the (Side Effect) Room

Barry D. Brooks, MD

September 2014, Vol 5, No 7 - The Patient Perspective


We have all had that patient—the patient who is prescribed a new targeted therapy and cannot comply with it because it is just too expensive. When asked directly about the reasoning for the noncompliance, the patient suggests that taking the treatment is just too expensive and, in fact, it is cheaper to die.

Financial Toxicity Is a Medical Side Effect
In 2013, Zafar, Ubel, and their Duke colleagues, introduced a new term for an important, frequently undisclosed side effect of modern cancer therapy: financial toxicity.1-3 They persuasively argued that financial toxicity should be treated like any medical side effect, because it is as likely as any physical toxicity to cause noncompliance with a prescribed regimen.

I enthusiastically embraced the term and began using it in my everyday lexicon with patients, payers, and my colleagues. Unfortunately, after the 3 publications from the Duke team in 2013, “financial toxicity” has not found its way into publications and essays that focus on the financial burden resulting from increasing copays, coinsurance, and high deductibles introduced in the Affordable Care Act era.

A poignant study by Dusetzina and colleagues published this year reported that commercial patients with chronic myelogenous leukemia (CML) and higher copays were 70% more likely to abandon therapy than similar patients with lower copays (17% vs 10%, respectively).4 CML is compatible with a normal life expectancy if a patient takes the close to a miracle drug imatinib (Gleevec), but CML is typically lethal within 5 to 6 years if one does not take it.

Despite this clear clinical benefit, at 6 months, the patients in the highest quartile copay discontinued therapy 70% more often, even though the mean copay differential was only $36 monthly.4 For a drug that offers patients a functional cure, this level of price sensitivity is truly surprising. Imatinib is generally well tolerated and was abandoned in these patients for its financial toxicity, not for its gastrointestinal or bone marrow toxicities.

What is the scale of this problem? In the study by Zafar and colleagues, 42% of the 254 patients reported substantial financial burden.1 To conserve money, “20% took less than the prescribed amount of medication, 19% partially filled prescriptions, and 24% avoided filling prescriptions altogether.”1 Although this study was enriched with patients seeking copay assistance, almost 66% of the patients were not taking their medication as prescribed because of a single, largely unaddressed, side effect: financial toxicity.

Similarly, a study by Fenn and colleagues concluded that “increased financial burden as a result of cancer care costs is the strongest independent predictor of poor quality of life among cancer survivors.”

Oncologists often avoid talking about the cost of the treatments that they prescribe, because they lack granular knowledge of an individual patient’s financial burden and the skills needed to negotiate this dimly lit part of oncology practice, preferring to say, “That’s not my job.” Addressing a side effect that caused more than 50% of patients to not take a medication as prescribed would certainly be considered part of an oncologist’s job, if that toxicity were other than financial. The point is that financial toxicity is a medical toxicity: if patients do not take their medication, they cannot benefit from it.

Insurance Coverage and Noncompliance
Noncompliance is more common with oral oncolytics than other types, because parenteral medications tend to be covered under the more generous medical part of a patient’s insurance, whereas oral medications are frequently covered under the prescription benefit. Less costly prescriptions at the first and second tiers of benefits usually require a modest copay of $0 to $10 for the first tier and perhaps $20 to $40 for the second tier.

Treatments for cancer are frequently in a third tier, in which benefits switch from a copay (a fixed dollar amount) to coinsurance (a percent of total cost). For example, a postmenopausal patient with breast cancer may have no copay for tamoxifen, a $30 copay for anastrozole, and coinsurance payment of $3000 (total cost $9000) for everolimus (Afinitor).

Oral oncolytics now make up approximately 25% of our therapies for cancer, but more than 50% of new oncology drug approvals are oral medications. Oral oncolytics are never inexpensive, with new ones typically priced at $7000 to $10,000 monthly.

Gone are the days when an oncologist can hand a patient a prescription and then breeze into the next examination room. Instead, oncologists need to wade deeper into the sometimes messy engagement known as the doctor–patient relationship and discuss the financial challenges associated with the treatment being prescribed. If a patient reports that he or she cannot afford a treatment, and if there is no copay assistance available, the oncologist should be willing to discuss less costly alternative therapies.

Prescribing less than the best therapy for a patient is extremely uncomfortable for the majority of oncologists, but we should not let the perfect be the enemy of the good. For example, for many years, I have substituted tamoxifen (Nolvadex) for an aromatase inhibitor in financially challenged patients with postmenopausal luminal A-type breast cancer. The benefit of these drugs is very similar, but before the availability of generic options for aromatase inhibitors, the difference in price was approximately 100-fold between the 2 drug classes. In this circumstance, most financially strapped patients have been willing to trade 1% or 2% of clinical benefit for affordability.

However, with a disease such as CML, no inexpensive alternative medication is currently available. All an oncologist can do in such a case is to help the patient obtain copay assistance. Payers, including Medicare, should create a new class of drug coverage for critical oral oncolytics that require only a modest copay.

Although payers acknowledge this decidedly patient-unfriendly aspect of their coverage, no comprehensive programs to address this increasing burden have been put forward. Drug makers are part of this problem as well. Although many companies have good patient-assistance programs, new drugs always cost more than the ones they replace.

When oncologists prescribe costly new regimens, they should begin discussing the potential for financial toxicity just as they discuss the potential for any other unavoidable medical side effect. Perhaps this simple act will begin to draw attention to the proverbial elephant in the room that is responsible for more patients’ poor compliance with prescribed cancer regimens than any other medical side effect. Patients with cancer can never be cured by a medication they cannot afford to take.

Financial toxicity is everyone’s problem. Having a name for our pain does not remedy the problem, but it is a start.




References
  1. 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;18:381-390.
  2. Ubel PA, Abernethy AP, Zafar SY. Full disclosure—out-of-pocket costs as side effects. N Engl J Med. 2013;369:1484-1486.
  3. Bath C. Disclosing medical costs can help avoid ‘financial toxicity.’ ASCO Post. 2013;4.
  4. Dusetzina SB, Winn AN, Abel GA, et al. Cost sharing and adherence to tyrosine kinase inhibitors for patients with chronic myeloid leukemia. J Clin Oncol. 2014;32:306-311.
  5. Fenn KM, Evans SB, McCorkle R, et al. Impact of financial burden of cancer on survivors’ quality of life. J Oncol Pract. 2014 May 27 [Epub ahead of print].