Newly approved oncology therapies in the United States continue to expand cancer treatment options for patients. In 2015, 18 cancer drugs were approved by the FDA, 9 of which were oral drugs.¹ The oncology pipeline currently has an estimated 836 drugs in clinical development, with 25% being oral agents.²

The emergence of targeted therapies for treating cancer has allowed for more precise treatment based on tumor mutations and patient genotypes. This past year, we also witnessed the emergence of immuno-oncology drugs being utilized for an increasing number of tumor types, such as melanoma, lung, and renal cell cancers. However, these breakthrough therapies come with escalating costs.

The “financial toxicity of cancer” is a term being used to describe the increased financial burden faced by patients with cancer due to multiple factors, including increased out-of-pocket (OOP) expenses for co-pays and deductibles for prescription drugs and medical care, lost income for patients while undergoing treatment, and indirect costs experienced by caregivers. Insurance companies, struggling to cover the rising expenses of cancer drugs, are shifting more of the cost burden to patients.

Over the past decade, oral cancer drugs have become more prevalent in the treatment armamentarium. Many patients now receive combination chemotherapy consisting of intravenous and oral drugs within the same regimen or as single therapies administered sequentially through multiple lines of therapy.

Cost and Coverage

Traditional infusion chemotherapy is covered under a patient’s medical coverage, and for Medicare patients, under Part B benefits; however, there are a few oral cancer drugs that are also covered under Medicare Part B. Oral cancer drugs are billed through a patient’s prescription benefits, and for Medicare patients, under Part D. Under the Affordable Care Act, the Medicare Part D benefit now includes coverage in the coverage gap (“donut hole”). Before 2011, there was no coverage between the initial coverage limit to the OOP threshold and commencement of catastrophic coverage (Table 1⁴). The “donut hole” will be completely phased out by 2020 using a combination of Part D benefits and discounts for generic and brand-name drugs. However, despite the emergence of Part D benefits and the shrinking donut hole, due to the extremely high cost of oral cancer drugs, patients continue to have challenges with medication access because of OOP expenses. The cost for new oral cancer drugs is in the range of $10,000 per month (Table 2⁵).

The federal anti-kickback statute precludes pharmaceutical companies from allowing Medicare beneficiaries to use co-pay coupons to help cover the cost of Part D drugs. The law specifies that coupons cannot be used for the purchase and/or payment of drugs paid for by any federal healthcare program, including Medicare Part D.⁶ It is acknowledged that allowing patients to use coupons would save OOP expenses for patients significantly; however, coupons could potentially induce patients to use more expensive brand-name drugs, subsequently increasing costs to the Medicare system and taxpayers.

Payers are managing oral cancer drugs by shifting management to their pharmacy benefit managers (PBMs), and PBMs then further control costs by limiting dispensing through specific specialty/mail order pharmacies. PBMs also place oral cancer drugs into cost-sharing tiers with variable co-pay expectations for patients. Overall, more of the cost burden of cancer care is being shifted to patients. Simply coping with the physical and emotional burden of a cancer diagnosis can be overwhelming for patients, even before the financial ramifications are taken into consideration. There are numerous reports of patients and families going into debt or declaring bankruptcy in order to cover the costs of their cancer medications, as well as examples of patients cutting back on drug doses and groceries, and utilizing less heat in their homes.⁷ All of the aforementioned are desperate measures patients may take to maintain medication access. The quality of cancer care suffers as a result, in addition to poor compliance and adherence to life-saving treatment plans.

As cancer therapeutics becomes more complex and costly, with more options for patients, healthcare providers are being challenged to take on a larger role in assisting patients to maintain access to treatments. Discussion about the cost of chemotherapy is now a standard part of pretreatment planning and has to be communicated from the physician when treatment alternatives are discussed with patients. Some community oncology practices employ staff specifically trained as financial counselors to meet with patients prior to the start of their treatment. Patients meet with financial counselors and are apprised of their insurance benefits and limitations, allowing for a better understanding of their insurance coverage for their treatment plans and out-of-pocket expenses before their therapy begins.

Oral cancer therapies present a unique set of clinical management challenges for healthcare providers. Patients take these medications at home unsupervised, and therefore, patient education becomes more critical to ensure patients are taking their medications appropriately; timely follow-up contact with patients also needs to occur on a regular basis to monitor compliance and to mitigate potential toxicities. Clinical staff need to regularly assess if affordability is negatively impacting access to appropriate care.

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