Can Patients Afford to Be Adherent to Expensive Oral Cancer Drugs?: Unintended Consequences of Pharmaceutical Development.

Abstract

The increased availability of oral cancer agents in oncology care is promoting a gradual shift from cancer therapy exclusively being administered in the health care setting to patients with cancer being able to self-administer therapy in their own home. Simultaneously, the costs associated with cancer therapy, particularly oral therapies, continue to increase.1 Average copays for insured cancer patients are approximately 20% of the cost of the prescribed therapy, costing them more than $25,000 per year to adhere to some oral cancer treatment regimens.1 With this type of financial burden, it is no surprise that people with cancer are nearly 3 times more likely to file for bankruptcy than people without cancer.2 Such costs prevent cancer patients from being adherent to their prescribed regimen3 or require them to seek alternative ways to pay for their cancer care. For example, a number of veterans are transferring their medical care from non–Veteran Affairs to Veteran Affairs providers after receiving a single prescription for expensive oral agents.4 As prices increase for oral cancer drugs, supply chain integrity, specifically the risk of counterfeit cancer drugs, and related patient safety may also be of concern. In the United States, documented use of counterfeit drugs by patients with cancer has been associated with adverse events and treatment failure.5 At the policy level, there is strong evidence showing that reducing out-of-pocket costs positively affects medication adherence,6 and this may be particularly relevant for cancer treatment. At the time of this writing, advocates are pushing for the passage of the Cancer Drug Coverage Parity Act of 2013, which will ensure that patients diagnosed with cancer will pay comparable costs for oral and intravenous cancer therapies.7 This Act may be particularly important for cancer survivors insured by Medicare—the nation's largest payer for cancer care—who report foregoing their prescription medications as a result of cost.8 However, what this piece of legislation is unable to do is reduce the price tags pharmaceutical companies attach to many of their oral cancer medications. Thus, in tandem with the implementation of the Patient Accountability and Affordable Care Act, these federal mandates may improve access to cancer care but not necessarily guarantee that cancer care will be more affordable.9 As we wait in hopeful expectation for passage of the federal Parity Act, what do patients with cancer do in the meantime if they cannot afford their medications? They either do not take their medications as prescribed, or they do not take them at all. Zullig et al10 found that nearly half of surveyed cancer patients were nonadherent to their prescribed medications as a result of cost. These patients were more likely to borrow money or use credit, and even forego basic needs, to get their medication. Most of these patients also had prescription drug coverage and health insurance—reminding us again about the compounding issues of access and affordability. Although oncologists are aware and overwhelmingly concerned about their patients being able to afford their cancer treatment, most clinicians are not sure what they can do about it.11 A key contribution that Zullig et al make to the oncology community is their suggestion to screen patients for (1) financial barriers to purchasing their prescribed medications and (2) medication adherence behaviors.10 Conducting a financial screening would enable clinicians to know if their patients are experiencing or anticipate difficultly in paying out-of-pocket costs for their prescribed medications. Screening for medication adherence behaviors would inform clinicians, in combination with their patient's financial profile, of other nonfinancial reasons why their patients may or may not be taking their medications as prescribed. To assess patient financial barriers, a systematic review of self-report instruments measuring barriers to medication adherence reported five different instruments to assess financial burden for medications, which range from one simple question to subscales including multiple items.12 To assess medication nonadherence behaviors, Marcum, Sevick, and Handler (2013) suggest that clinicians use previously validated screening instruments to diagnose six broad medication nonadherence patient profiles (eg, patient has conflicting normative beliefs about medication, patient perceives lack of therapeutic effectiveness) and address nonadherence with the appropriate educational or behavioral interventions.13 Given the variety of financial and medication adherence screening instruments, clinicians have the opportunity to choose the tools that best fit their clinical environments. In the event that “financial toxicity”10 is diagnosed during the financial and medication adherence screening processes, clinicians can consider assisting their patients with enrolling into patient assistance programs (Table 1). These charity programs, generally provided voluntarily through pharmaceutical and nonprofit organizations, provide support in the form of free or discounted medications and/or financial support for eligible patients. There are also supplemental cancer insurance policies that can help patients pay treatment-associated out-of-pocket costs and other related expenses.14 Our work has shown that patient assistance programs can improve health outcomes for patients with certain chronic conditions15 and provide commonly prescribed orally administered cancer and supportive care medications.16 Eligibility for patient assistance programs is often based on health insurance coverage and income criteria specific to each program, as well as the type and cost of the cancer drug. Clinicians should be aware that given the high cost of cancer therapies, patients who have prescription drug coverage, such as through Medicare Part D, and household incomes over $60,000 per year may still be eligible for certain medications through patient assistance programs. Table 1. Examples of Programs That Can Assist Patients With Paying for Oral Cancer Medications Even though patient assistance programs can be helpful, the process for applying to these programs has been characterized as challenging.17 For example, many patient assistance programs require patients to complete a unique application form for each individual program, often including patient proof of income (eg, tax returns, W-2), and health care provider signature. Furthermore, patients may be required to reapply each time they need assistance, ranging from every 30 days to once per year. As a result of these complexities, health care providers are generally needed to assist patients with applications. Given the time constraints placed on clinicians within the health care system, they may consider designating other health professionals, such as nurses, pharmacists, social workers, or even cancer survivor volunteers, to assist patients with patient assistance program enrollment. Patient navigators could also play an integral part in enrolling patients into patient assistance programs. There is growing evidence regarding the efficacy of patient navigation in improving cancer screening; however, there is room for further investigation of the role of navigators in improving diagnostic follow-up and adherence to cancer treatment.18 Accrediting bodies, such as the American College of Surgeons Commission on Cancer and National Accreditation Programs for Breast Centers, require accredited cancer programs and health care facilities to provide patient navigation services. Assisting patients with cancer with patient assistance program enrollment could be a strategic approach for cancer programs and health care systems to comply with these accreditation mandates. As both clinicians and policymakers work hard to help patients with cancer overcome financial barriers to prescribed therapies, the most successful outcome may lie in balancing the underlying tension between cancer drug pricing policies and social and economic policies that contribute to differences in the distribution of social determinants of health (eg, income, employment, education). To resolve this tension will require the political will of high-level players who often have fundamentally opposing priorities and interests. While this tension remains, cancer will, unfortunately, affect the lives of the “haves” and the “have nots.” For this reason, we must take action within our professional and community spheres of influence to advocate for policies and programs aimed at eliminating financial distress as a reason for treatment nonadherence. Patients with cancer cannot afford for us not to.